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Chen K, Xu L, Liu X. Different drugs in drug-eluting stents for peripheral artery disease: a systematic evaluation and Bayesian meta-analysis. J Thromb Thrombolysis 2024; 57:520-530. [PMID: 38281227 DOI: 10.1007/s11239-023-02932-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 11/27/2023] [Indexed: 01/30/2024]
Abstract
Drug-eluting stents (DESs) have become the first-line treatment for symptomatic peripheral arterial disease (PAD). Currently, there are many types of DESs on the market. The same type of DESs has different concentrations, and various drugs in them show uneven efficacy. The selection of DESs remains controversial. This study was aimed at comparing the long-term real-world outcomes of different DESs in the treatment of peripheral arterial occlusive disease (PAOD). The databases including Cochrane Library, Embase, and PubMed were searched with a time frame until March 25, 2023. The primary patency (PP) and target lesion revascularization (TLR) at 6 months were used as the primary endpoints. A total of 32 studies (5467 patients) were eligible. At the six-month follow-up, DES-Evero 1 ug/mm2 ranked first in terms of PP, with a significant difference from BMSs (RR [95% CI] = 1.6). DES-Siro 0.9 ug/mm2, DES-Siro 1.4 ug/mm2, DES-Siro 1.95 ug/mm2, DES-PTX 0.167 ug/mm2, DES-PTX 1 ug/mm2 and covered stents (CSs) showed significantly better PPs than BMSs. In terms of TLR, DES-Siro 0.9 ug/mm2 (0.31) ranked first, and DES-Evero 1 ug/mm2 ranked last. Among the treatment modalities for PAD, different DESs showed overall encouraging results in improving PP and TLR compared with BMSs. DES-Evero 1 ug/mm2 showed the best PP, but it had the highest reintervention rate at 6 months. Sirolimus-eluting stents were not always more effective with higher concentrations of sirolimus. Among various DESs, sirolimus-eluting stents and everolimus-eluting stents were superior to paclitaxel-eluting stents.
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Affiliation(s)
- Keqin Chen
- Department of Vascular Surgery, The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University (The First Hospital of Changsha), 311 Yingpan Road, Changsha City, 410005, Hunan Province, China.
| | - Lei Xu
- Public Health Clinical Center, Xiangtan Central Hospital, Xiangtan, China
| | - Xiehong Liu
- Hunan Provincial Key Laboratory of Emergency and Critical Care Metabonomics, Institute of Emergency Medicine, The First Affiliated Hospital of Hunan Normal University (Hunan Provincial People's Hospital), Changsha, China
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5273-5287. [PMID: 37621588 PMCID: PMC10445070 DOI: 10.12998/wjcc.v11.i22.5273] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/04/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio. AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs. METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model. RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively]. CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5267-5281. [DOI: 10.12998/wjcc.v11.i22.5267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/03/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.
AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs.
METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model.
RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively].
CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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4
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Fong KY, Xin L, Ng J, Loh SEK, Ng JJ, Choong AMTL. A systematic review and meta-analysis of sirolimus-eluting stents for treatment of below-the-knee arterial disease. J Vasc Surg 2023; 77:1264-1273.e3. [PMID: 36183989 DOI: 10.1016/j.jvs.2022.09.022] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2022] [Revised: 08/29/2022] [Accepted: 09/19/2022] [Indexed: 10/14/2022]
Abstract
OBJECTIVE We performed a systematic review and meta-analysis to analyze the efficacy and safety of sirolimus-eluting stents (SESs) in the treatment of below-the-knee (BTK) arterial disease. METHODS An electronic literature search was conducted from inception to July 24, 2021. Retrospective, prospective, and randomized studies that had used SESs to treat BTK arterial disease and had reported the primary patency, technical success, target lesion revascularization, and/or mortality were included. Meta-analyses of the proportions were conducted to derive pooled summary statistics of the outcomes. Where Kaplan-Meier curves were provided for primary patency, a meta-analysis of the individual patient data was conducted via a graphic reconstruction tool to estimate primary patency at various follow-up points. For studies comparing SESs and bare metal stents (BMSs), a two-stage meta-analysis was performed to compare the 6-month primary patency of SESs vs BMSs. RESULTS Ten studies across 13 publications, including 995 patients, were retrieved for analysis. In the meta-analysis of proportions, across six studies (n = 339 patients), the pooled 6-month primary patency was 87.3% (95% confidence interval [CI], 81.6%-92.1%). Across seven studies (n = 283 patients), the pooled 6-month mortality was 5.4% (95% CI, 1.4%-11.2%). An individual patient data analysis of three studies (n = 282 patients) yielded a primary patency rate of 95.2% (95% CI, 92.7%-97.8%), 82.8% (95% CI, 78.3%-87.6%), 79.8% (95% CI, 75.0%-85.0%), and 79.8% (95% CI, 75.0%-85.0%) at 6, 12, 18, and 24 months, respectively. The 12-month target lesion revascularization rate across four studies (n = 324 patients) was 9.6% (95% CI, 6.4%-13.4%). In the two-stage meta-analysis of 6-month primary patency across three studies (n = 168 patients), the use of SESs was significantly favored over BMSs (risk ratio, 1.28; 95% CI, 1.12-1.46; P < .001). CONCLUSIONS The overall evidence suggests that the use of SESs appears to be safe and offers favorable outcomes for BTK arterial disease compared with BMSs.
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Affiliation(s)
- Khi Yung Fong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Liu Xin
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Magdalen College, University of Oxford, Oxford, UK
| | - Josiah Ng
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Stanley E K Loh
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Diagnostic Imaging, National University Health System, Singapore
| | - Jun Jie Ng
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore
| | - Andrew M T L Choong
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore; Cardiovascular Research Institute, National University of Singapore, Singapore.
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Violari E, Payomo A, Schiro BJ, Powell A, Gandhi RT, Pena CS. Endovascular Treatment of Infra-Inguinal Peripheral Arterial Disease (PAD): Update on Stent Technology. Tech Vasc Interv Radiol 2022; 25:100840. [PMID: 35842258 DOI: 10.1016/j.tvir.2022.100840] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
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Lysenko ER, Burov AI, Griaznov OG, Bushueva EV. [Use of endovascular drug-coated devices in lesions of femoropopliteoltibial arteries]. ANGIOLOGII︠A︡ I SOSUDISTAI︠A︡ KHIRURGII︠A︡ = ANGIOLOGY AND VASCULAR SURGERY 2021; 27:165-172. [PMID: 34528602 DOI: 10.33529/angiq2021305] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
Endovascular intervention is one of the main methods of treatment in atherosclerotic lesions of the infrainguinal segment in patients with chronic lower limb ischaemia. Recent years have witnessed active use of drug-eluting techniques, significantly improving the long-term outcomes of peripheral reconstructions. This article is a review of publications on the results of using modern drug-eluting balloon catheters and stents in the femoropopliteoltibial position. The accumulated data will help solve the main problems of the classic balloon angioplasty, reducing the incidence of restenosis, improving primary patency, and decreasing the need for repeat interventions in the remote period of follow-up.
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Affiliation(s)
- E R Lysenko
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
| | - A Iu Burov
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
| | - O G Griaznov
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
| | - E V Bushueva
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
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Recent advances and directions in the development of bioresorbable metallic cardiovascular stents: Insights from recent human and in vivo studies. Acta Biomater 2021; 127:1-23. [PMID: 33823325 DOI: 10.1016/j.actbio.2021.03.058] [Citation(s) in RCA: 42] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2020] [Revised: 03/24/2021] [Accepted: 03/25/2021] [Indexed: 12/12/2022]
Abstract
Over the past two decades, significant advancements have been made regarding the material formulation, iterative design, and clinical translation of metallic bioresorbable stents. Currently, magnesium-based (Mg) stent devices have remained at the forefront of bioresorbable stent material development and use. Despite substantial advances, the process of developing novel absorbable stents and their clinical translation is time-consuming, expensive, and challenging. These challenges, coupled with the continuous refinement of alternative bioresorbable metallic bulk materials such as iron (Fe) and zinc (Zn), have intensified the search for an ideal absorbable metallic stent material. Here, we discuss the most recent pre-clinical and clinical evidence for the efficacy of bioresorbable metallic stents and material candidates. From this perspective, strategies to improve the clinical performance of bioresorbable metallic stents are considered and critically discussed, spanning material alloy development, surface manipulations, material processing techniques, and preclinical/biological testing considerations. STATEMENT OF SIGNIFICANCE: Recent efforts in using Mg, Fe, and Zn based materials for bioresorbable stents include elemental profile changes as well as surface modifications to improve each of the three classes of materials. Although a variety of alloys for absorbable metallic stents have been developed, the ideal absorbable stent material has not yet been discovered. This review focuses on the state of the art for bioresorbable metallic stent development. It covers the three bulk materials used for degradable stents (Mg, Fe, and Zn), and discusses their advances from a translational perspective. Strategies to improve the clinical performance of bioresorbable metallic stents are considered and critically discussed, spanning material alloy development, surface manipulations, material processing techniques, and preclinical/biological testing considerations.
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Hwang K, Park SW. [Current Strategy in Endovascular Management for Below-the-Knee Arterial Lesions]. TAEHAN YONGSANG UIHAKHOE CHI 2021; 82:541-550. [PMID: 36238794 PMCID: PMC9432451 DOI: 10.3348/jksr.2021.0042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/09/2021] [Revised: 04/26/2021] [Accepted: 05/06/2021] [Indexed: 06/16/2023]
Abstract
The below-the-knee arterial tree is the thinnest of all the leg vessels and is an important path for blood flow to the foot. Hence, lesions including stenosis, especially obstruction, may lead to critical limb ischemia which represents the most severe clinical manifestation of peripheral arterial disease. It is characterized by the presence of ischemic rest pain, ischemic lesions, or gangrene attributable to the objectively proven arterial occlusive disease. Typically, the atherosclerotic disease process involving the below-the-knee arterial tree is diffuse in the majority of patients. The cornerstone of therapy is vascular reconstruction and limb salvage. Revascularization should be attempted whenever technically possible, without delay, in patients presenting critical limb ischemia and when the clinical status is not hopelessly non-ambulatory. Therefore, endovascular treatment can become the gold standard for the full range of patients including below-the-knee, limiting the clinical role of the classically trained surgeons.
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Taeymans K, Bosiers M, Deloose K, Callaert J, Keirse K, Verbist J, van den Eynde W, Torsello G, Wauters J. One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients. THE JOURNAL OF CARDIOVASCULAR SURGERY 2020; 61:445-450. [DOI: 10.23736/s0021-9509.19.10830-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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10
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Ferrone M, Cheng Y, Granada JF. Current concepts regarding drug dosing for peripheral stents. THE JOURNAL OF CARDIOVASCULAR SURGERY 2019; 60:439-449. [PMID: 31062571 DOI: 10.23736/s0021-9509.19.10995-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Drug-eluting stent (DES) are the mainstay therapy for the treatment of coronary artery disease. Stent design and drug-elution strategies have evolved over the years leading to the last generation DES which shows optimal safety and efficacy outcome. Peripheral arteries have different mechanical and biological features and the lessons learned from the coronary field have been difficult to introduce into the development of peripheral vascular technologies. First, due to its complex biomechanical behavior the use of metallic stents is limited in some vascular segments (i.e., distal superficial fermoral artery [SFA]). Also, peripheral vascular atherosclerosis is different containing higher levels of plaque burden and calcium. Finally, peripheral arterial disease tends to be more aggressive including longer lesions and higher incidence of total chronic occlusion. In general terms, restenosis in the peripheral vascular territory is more aggressive and occurs at a later time (~12 months) requiring a different pharmacokinetic profile compared to coronary technologies. Several strategies have been evaluated in the peripheral arteries raging from the bare metal stent to the drug coated balloon and drug eluting stent with outcome varying depending on the different field of application (i.e. SFA and below-the-knee). Results coming from the clinical trial are encouraging but further studies and direct comparison among the different technologies are demanded to determine the best therapy for peripheral vascular disease.
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Affiliation(s)
- Marco Ferrone
- Cardiovascular Research Foundation, Skirball Center for Innovation, Orangeburg, NY, USA.,Federico II University of Naples, Naples, Italy
| | - Yanping Cheng
- Cardiovascular Research Foundation, Skirball Center for Innovation, Orangeburg, NY, USA
| | - Juan F Granada
- Cardiovascular Research Foundation, Skirball Center for Innovation, Orangeburg, NY, USA -
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Spiliopoulos S, Vasiniotis Kamarinos N, Brountzos E. Current evidence of drug-elution therapy for infrapopliteal arterial disease. World J Cardiol 2019; 11:13-23. [PMID: 30705739 PMCID: PMC6354073 DOI: 10.4330/wjc.v11.i1.13] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2018] [Revised: 10/23/2018] [Accepted: 01/01/2019] [Indexed: 02/06/2023] Open
Abstract
New and sophisticated endovascular devices, such as drug-eluting stents (DES) and drug-coated balloons (DCB), provide targeted drug delivery to affected vessels. The invention of these devices has made it possible to address the reparative cascade of arterial wall injury following balloon angioplasty that results in restenosis. DESs were first used for the treatment of infrapopliteal lesions almost 20 years ago. More recently, however, DCB technology is being investigated to improve outcomes of endovascular below-the-knee arterial procedures, avoiding the need for a metallic scaffold. Today, level IA evidence supports the use of infrapopliteal DES for short to medium length lesions, although robust evidence that justifies the use of DCBs in this anatomical area is missing. This review summarizes and discusses all available data on infrapopliteal drug-elution devices and highlights the most promising future perspectives.
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Affiliation(s)
- Stavros Spiliopoulos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
| | - Nikiforos Vasiniotis Kamarinos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
| | - Elias Brountzos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
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Hammad TA, Prasad A. The Contemporary Role of Stents and Angioplasty for the Treatment of Infrapopliteal Disease in Critical Limb Ischemia. Curr Cardiol Rep 2017; 19:58. [PMID: 28508349 DOI: 10.1007/s11886-017-0871-9] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
PURPOSE OF REVIEW Critical limb ischemia (CLI) is associated with significant morbidity, mortality, and increased health care expenses. Revascularization has a central role in the treatment of CLI. Following publication of BASIL (bypass versus angioplasty in severe ischemia of the leg) trial a decade ago, an "endovascular first" approach had gained momentum and the technologies available for endovascular therapy have exponentially increased. Both the development of technology and technique, highlighted in this review, have allowed operators to treat complex infrapopliteal lesions which are central to CLI pathology. RECENT FINDINGS The role of atherectomy remains controversial but for calcified lesions it has become an accepted adjunctive tool for plaque modification. The place of drug delivery technologies requires further trials. The use of a drug-coated balloon (DCB) makes intuitive sense; however, choice of excipient, lower limit of vessel size, and impact on remodeling and thrombosis remain uncertain. The optimal treatment of infrapopliteal disease remains an area of active investigation. The endpoints in CLI trials continue to be challenging and calibration of patency in relation to wound healing remains a moving target. In addition, unaccounted variables continue to confound interpretation of CLI trials-including quality and nature of wound care, status of pedal-plantar loop patency, and management of underlying diabetes and other comorbidities. In summary, these challenges will also need to be addressed as the CLI field continues to mature in the twenty-first century.
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Affiliation(s)
- Tarek A Hammad
- Department of Medicine, Division of Cardiology, The University of Texas Health Science Center at San Antonio, San Antonio, TX, USA
| | - Anand Prasad
- Department of Medicine, Division of Cardiology, The University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
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13
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Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv 2014; 7:1048-1056. [PMID: 25234679 DOI: 10.1016/j.jcin.2014.04.015] [Citation(s) in RCA: 103] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/09/2014] [Accepted: 04/24/2014] [Indexed: 02/05/2023]
Abstract
OBJECTIVES This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus drug-eluting stents (DES) in long infrapopliteal lesions. BACKGROUND DES have an established role in the treatment of short infrapopliteal lesions, whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions. METHODS Inclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm. The primary endpoint was target lesion restenosis >50% assessed by digital angiography at 6 months. Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization. RESULTS Fifty patients were randomized to undergo infrapopliteal PCB angioplasty (25 arteries in 25 limbs; PCB group) or primary DES placement (30 arteries in 27 limbs; DES group). Immediate residual post-procedure stenosis was significantly lower in DES (9.6 ± 2.2% vs. 24.8 ± 3.5% in PCB; p < 0.0001). At 6 months, 5 patients died (2 in PCB vs. 3 in DES; p = 1.00) and 3 suffered a major amputation (1 in PCB vs. 2 in DES; p = 1.00). In total, 44 angiograms were evaluable with quantitative vessel analysis. Binary (>50%) angiographic restenosis rate was significantly lower in DES (7 of 25 [28%] vs. 11 of 19 [57.9%] in PCB; p = 0.0457). There were no significant differences with regard to target lesion revascularization (2 of 26 [7.7%] in DES vs. 3 of 22 [13.6%] in PCB; p = 0.65). Positive vessel wall remodeling was observed in 3 cases in the PCB arm (3 of 19 [(15.8%)] vs. 0 of 19 [0%] in DES; p = 0.07). CONCLUSIONS Compared with PCB in long infrapopliteal lesions, DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months. PCB may produce positive vessel remodeling. (Infrapopliteal Drug-Eluting Angioplasty Versus Stenting [IDEAS-I]; NCT01517997).
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Affiliation(s)
- Dimitris Siablis
- Interventional Radiology Department, Patras University Hospital, Patras, Greece
| | - Panagiotis M Kitrou
- Interventional Radiology Department, Patras University Hospital, Patras, Greece
| | | | - Konstantinos Katsanos
- Interventional Radiology Department, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, London, United Kingdom
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Katsanos K, Tepe G, Tsetis D, Fanelli F. Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting. Cardiovasc Intervent Radiol 2014; 37:592-603. [DOI: 10.1007/s00270-014-0876-3] [Citation(s) in RCA: 63] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/26/2013] [Accepted: 09/04/2013] [Indexed: 11/30/2022]
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Pastromas G, Katsanos K, Krokidis M, Karnabatidis D, Spiliopoulos S. Emerging stent and balloon technologies in the femoropopliteal arteries. ScientificWorldJournal 2014; 2014:695402. [PMID: 24672355 PMCID: PMC3932206 DOI: 10.1155/2014/695402] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2013] [Accepted: 10/31/2013] [Indexed: 02/05/2023] Open
Abstract
Endovascular procedures for the management of the superficial femoral (SFA) and popliteal artery disease are increasingly common. Over the past decade, several stent technologies have been established which may offer new options for improved clinical outcomes. This paper reviews the current evidence for SFA and popliteal artery angioplasty and stenting, with a focus on randomized trials and registries of nitinol self-expanding stents, drug-eluting stents, dug-coated balloons, and covered stent-grafts. We also highlight the limitations of the currently available data and the future routes in peripheral arterial disease (PAD) stent and balloon technology.
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Affiliation(s)
- Georgios Pastromas
- Department of Interventional Radiology, Patras University Hospital, 26504 Patras, Greece
| | - Konstantinos Katsanos
- Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, London SE1 7EH, UK
- Department of Imaging Sciences Biomedical Engineering, School of Medicine, King's College, London WC2R 2LS, UK
| | - Miltiadis Krokidis
- Department of Radiology, Addenbrooke's Hospital, NHS Foundation Trust, Cambridge CB2 0QQ, UK
| | - Dimitrios Karnabatidis
- Department of Interventional Radiology, Patras University Hospital, 26504 Patras, Greece
| | - Stavros Spiliopoulos
- Department of Interventional Radiology, Patras University Hospital, 26504 Patras, Greece
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Schmehl J, Tepe G. Current status of bare and drug-eluting stents in infrainguinal peripheral vascular disease. Expert Rev Cardiovasc Ther 2014; 6:531-8. [DOI: 10.1586/14779072.6.4.531] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Bunte MC, Shishehbor MH. Treatment of infrapopliteal critical limb ischemia in 2013: the wound perfusion approach. Curr Cardiol Rep 2013; 15:363. [PMID: 23605465 DOI: 10.1007/s11886-013-0363-5] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023]
Abstract
The primary goals of treatment for critical limb ischemia (CLI) are alleviation of ischemic rest pain, healing of arterial insufficiency ulcers, and improving quality of life. These goals are directed toward preventing limb loss and CLI-related mortality. Arterial revascularization serves as the foundation of a contemporary approach to promote amputation-free survival. Mounting evidence supports a wound-directed angiosome revascularization approach, increasingly achieved with endovascular techniques. Innovations in technology and wound-perfusion strategy have advanced patient care and are accelerating the pace of CLI treatment. The evolving angiosome revascularization approach has been augmented with a multidisciplinary wound care strategy that deserves particular emphasis. These state-of-the-art advances in CLI management are reported herein with considerations for the future treatment of CLI.
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Affiliation(s)
- Matthew C Bunte
- Robert & Suzanne Tomsich Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Mail code J3-5, 9500 Euclid Avenue, Cleveland, OH 44195, USA
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Abstract
In patients with critical limb ischemia, the first-line approach for limb salvage has shifted over the past decade from bypass surgery to endovascular intervention. Stenting for the treatment of lower-extremity arterial occlusive disease is an important tool and continues to evolve, with new stent designs and technologies that have been developed to provide superior patency rates and limb salvage. In this article, we discuss the role of peripheral stenting in the treatment of patients with critical limb ischemia, including a review of the relevant current literature and the future directions of such interventions.
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Affiliation(s)
- Hosam F El-Sayed
- Methodist DeBakey Heart & Vascular Center, The Methodist Hospital, Houston, Texas, USA
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Katsanos K, Spiliopoulos S, Diamantopoulos A, Karnabatidis D, Sabharwal T, Siablis D. Systematic review of infrapopliteal drug-eluting stents: a meta-analysis of randomized controlled trials. Cardiovasc Intervent Radiol 2013; 36:645-658. [PMID: 23435741 DOI: 10.1007/s00270-013-0578-2] [Citation(s) in RCA: 47] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2012] [Accepted: 01/13/2013] [Indexed: 02/08/2023]
Abstract
INTRODUCTION Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES. MATERIALS AND METHODS PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported. RESULTS Three RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10-1.44, p = 0.0006; NNT = 6.7). CONCLUSION DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.
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Affiliation(s)
- Konstantinos Katsanos
- Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, SE1 7EH, UK.
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Abstract
Technological advances in the past decade have shifted revascularization strategies from traditional open surgical approaches toward lower-morbidity percutaneous endovascular treatments for patients with lower extremity peripheral arterial disease (PAD). The continuing advances in stent design, more than any other advances, have fueled the growth of catheter-based procedures by improving the safety, durability, and predictability of percutaneous revascularization. Although the 2007 TransAtlantic Inter-Society Consensus (TASC) guidelines recommend endovascular therapy for type A and B aortoiliac and femoropopliteal lesions, recent developments in stent technology and increased experience of interventionists have suggested that a strategy of endovascular therapy first is appropriate in experienced hands for TASC type D lesions. The role of endovascular interventions is also expanding in the treatment of limb-threatening ischemia.
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21
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Bifurcated coronary stents for infrapopliteal angioplasty in critical limb ischemia. J Vasc Surg 2013; 57:1006-13. [DOI: 10.1016/j.jvs.2012.09.080] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2012] [Revised: 09/25/2012] [Accepted: 09/30/2012] [Indexed: 11/21/2022]
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Katsanos K, Karnabatidis D, Diamantopoulos A, Spiliopoulos S, Siablis D. Cost-effectiveness analysis of infrapopliteal drug-eluting stents. Cardiovasc Intervent Radiol 2013; 36:90-97. [PMID: 22414987 DOI: 10.1007/s00270-012-0370-8] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2011] [Accepted: 02/13/2012] [Indexed: 02/05/2023]
Abstract
INTRODUCTION There are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment. METHODS The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies. RESULTS Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518 (range 1,685-10,112). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581 (range, 4,945-21,428) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000 were associated with the least economically favorable scenario in both strategies. CONCLUSIONS Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.
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Affiliation(s)
- Konstantinos Katsanos
- Department of Interventional Radiology, School of Medicine, Patras University Hospital, 26504, Rion, Greece.
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23
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Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 2013. [PMID: 23194941 DOI: 10.1016/j.jacc.2012.08.989] [Citation(s) in RCA: 202] [Impact Index Per Article: 16.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
OBJECTIVES The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease. BACKGROUND Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES. METHODS Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography. RESULTS Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA. CONCLUSIONS SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.
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Affiliation(s)
- Dierk Scheinert
- Department for Angiology, Park-Krankenhaus Leipzig-Südost GmbH, Leipzig, Germany.
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Tillman B, Hardin-Young J, Shannon W, Russell AJ, Parenteau NL. Meeting the need for regenerative therapies: translation-focused analysis of U.S. regenerative medicine opportunities in cardiovascular and peripheral vascular medicine using detailed incidence data. TISSUE ENGINEERING PART B-REVIEWS 2012; 19:99-115. [PMID: 23031078 DOI: 10.1089/ten.teb.2011.0678] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/18/2023]
Abstract
Cardiac and vascular diseases represent one of the most substantial medical areas for the applications of regenerative medicine. Despite advances in endovascular repair, surgical intervention, and disease management, atherosclerosis and heart failure continue to be prominent health problems. This report analyzes the regenerative medicine treatment opportunities in both cardiovascular and peripheral vascular repair, examining the treatment opportunities for tissue-engineered vascular grafts as well as cell-based therapies. U.S. hospital discharge data were used to generate a detailed estimate of the relative target populations for cardiac and vascular disease. Gap analyses were performed for vascular access, small caliber vascular grafts, and cell-based therapies for revascularization and heart failure. The analysis compared current alternatives, gaps in medical need, and what a tissue-engineered or regenerative alternative should achieve for optimum medical and commercial feasibility. Although the number of coronary bypass grafts vastly outnumbered peripheral grafts, a detailed consideration of re-grafts and the success of first grafts combined with gap analysis (GAP) leads us to conclude that peripheral vascular disease is the more commercially feasible and attractive target opportunity for engineered small caliber grafts for the foreseeable future. Cardiac bypass would need substantial long-term clinical experience, which could be a significant hurdle. Vascular access, often regarded as a first-in-man indication, is an excellent opportunity for an engineered graft as an alternative to arteriovenous fistula that could overcome complications associated with a prosthetic graft. The GAP also suggests that for heart failure, cellular therapies should link near-term changes in repair, such as improvement in cardiac output and reduced scarring with limiting progression of the disease, reducing the need for complex pharmacologic management, and reducing rates of hospitalization. Naturally, researchers must determine where their technology and know-how can be applied most effectively, but it is clear from our analysis that an astute strategy in the use of science and technology will be important to successful translation in this space.
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Affiliation(s)
- Bryan Tillman
- The McGowan Institute of Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA, USA
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25
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Ryu HM, Kim JS, Ko YG, Hong MK, Jang Y, Choi D. Clinical outcomes of infrapopliteal angioplasty in patients with critical limb ischemia. Korean Circ J 2012; 42:259-65. [PMID: 22563339 PMCID: PMC3341423 DOI: 10.4070/kcj.2012.42.4.259] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2011] [Revised: 10/05/2011] [Accepted: 10/20/2011] [Indexed: 11/29/2022] Open
Abstract
Background and Objectives With recent advances in equipment and techniques, infrapopliteal angioplasty has shown results that are comparable to those of surgical bypass in patients with critical limb ischemia (CLI). In this study, we evaluated the efficacy and the feasibility of infrapopliteal angioplasty in patients with CLI. Subjects and Methods Between March 2002 and May 2008, infrapopliteal angioplasty was performed on 118 limbs of 101 patients (79 males; mean age 66 years) with CLI (Rutherford category 4, 5 or 6). Freedom from reintervention, limb salvage, and overall survival were analyzed. Results The median follow-up duration was 30 months. Initial technical and clinical success rates were 69.5% and 83.1%, respectively. No major complication requiring surgical intervention developed after angioplasty. Among 82 limbs with initial technical success, the rate of freedom from any reintervention at 2 years was 70.7% and that from limb salvage was 97.6%. Young age and Rutherford category 6 at initial presentation were independent predictors associated with poor 2 year primary patency in these patients with CLI. Overall survival at 1 year was 86.4% and that at 2 years 76.3%. A history of cerebrovascular accident was an independent predictor associated with poor 2 year survival in these patients. Conclusion Infrapopliteal angioplasty as a primary choice of treatment in CLI patients showed favorable clinical outcomes and feasibility.
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Affiliation(s)
- Hyeon Min Ryu
- Gumi CHA Medical Center, CHA University, Gumi, Korea
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26
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Werner M, Schmidt A, Freyer M, Bausback Y, Bräunlich S, Friedenberger J, Schuster J, Botsios S, Scheinert D, Ulrich M. Sirolimus-Eluting Stents for the Treatment of Infrapopliteal Arteries in Chronic Limb Ischemia: Long-term Clinical and Angiographic Follow-up. J Endovasc Ther 2012; 19:12-9. [DOI: 10.1583/11-3665.1] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]
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Katsanos K, Diamantopoulos A, Siablis D. Commentary: Prime Time for Infrapopliteal Drug-Eluting Stents? J Endovasc Ther 2012; 19:20-2. [DOI: 10.1583/11-3665c.1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]
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Karnabatidis D, Spiliopoulos S, Katsanos K, Siablis D. Below-the-knee drug-eluting stents and drug-coated balloons. Expert Rev Med Devices 2012; 9:85-94. [PMID: 22145843 DOI: 10.1586/erd.11.67] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
Endovascular procedures have evolved to the mainstream treatment of choice for revascularization of infrapopliteal obstructive disease, especially in patients suffering from critical limb ischemia and multiple comorbidities. However, standard balloon angioplasty is limited by the potential of a suboptimal acute outcome due to elastic recoil and/or flow-limiting dissection, followed by neointimal hyperplasia and progressive vascular restenosis even in the case of bare-metal stent use. Drug-eluting stents and drug-coated balloons are emerging endovascular technologies with the promise of significant inhibition of vessel restenosis and improved clinical outcomes. The current review outlines the drug-eluting properties of those instruments and summarizes the currently available clinical data. The authors critically appraise the current status and also provide a glimpse of the near future of endovascular below-the-knee treatments.
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Affiliation(s)
- Dimitris Karnabatidis
- Department of Radiology, Angiography Suite, Patras University Hospital, Rion, Greece.
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Abstract
Critical limb ischemia (CLI) is primarily a disease of advanced atherosclerosis but may occur in the setting of other causes. It is essential for the treating physician to understand the complexity of patients with CLI and the appropriate and emerging treatment approaches in this patient population. The authors provide a comprehensive review of the percutaneous endovascular management of CLI in this article.
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Abstract
The treatment of peripheral artery disease (PAD) focuses on risk factor modification, cardiovascular event reduction, limb viability, and symptom improvement. Hypertension, hyperlipidemia, and diabetes mellitus should all be controlled to recommended target levels, and smoking cessation is vital. Antiplatelet therapies, such as aspirin or clopidogrel, should be administered in all patients unless contraindicated. Whenever possible, patients who present with claudication should be offered a regimen comprised of both medical and exercise therapy, which often results in substantial improvement in symptoms. For patients presenting with more-advanced disease, such as acute limb ischemia, critical limb ischemia, and severely-limiting symptoms of PAD, revascularization is often necessary. As a result of the rapid evolution in endovascular revascularization technology and expertise, many patients with PAD can be treated percutaneously. Therefore, in this Review, we will focus on medical therapy and endovascular revascularization of patients with PAD, with reference to surgical bypass in specific clinical scenarios.
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Abstract
Restenosis by myointimal hyperplasia after peripheral arterial angioplasty or stenting is a major problem limiting its long-term efficiency and patency, and may lead to recurrent symptoms. Drug-eluting devices which inhibit the proliferation of neo-intimal growth of vascular smooth muscle cells may prevent restenosis. The aim of this article is to examine the evidence in published literature on the use of drug-eluting devices in the treatment of peripheral arterial diseases. A systematic literature review was undertaken of all published literature on this subject using Medline and cross-referenced. All published relevant articles on the use of drug-eluting stents and balloons in peripheral arterial disease were used. Cochrane Central Register of Controlled Trials and electronic databases were also searched for on-going studies. Published results from randomised studies such as the SIROCCO I and II Trials and the THUNDER study, together with single cohort studies, are now available. There are on-going studies comparing drug-eluting and non-drug-eluting devices. Evidence from the published literature suggests that drug-eluting stents and balloons are safe and effective in preventing restenosis after peripheral angioplasty. However, drug-eluting devices are more expensive and many are limited to single-use only. It is anticipated that results from all the on-going studies may allow a meta-analysis to show whether these preliminary data can translate into a clinically applicable cost-effective strategy in combating restenosis after peripheral angioplasty or stenting.
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Affiliation(s)
- Y C Chan
- Division of Vascular & Endovascular Surgery, Department of Surgery, University of Hong Kong Medical Centre, Queen Mary Hospital, Hong Kong. ycchan88@ hkucc.hku.hk
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Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Böhme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J 2011; 32:2274-81. [PMID: 21622669 DOI: 10.1093/eurheartj/ehr144] [Citation(s) in RCA: 133] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022] Open
Abstract
AIMS Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery. METHODS AND RESULTS 161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford-Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford-Becker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P= 0.004). CONCLUSION Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.
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Affiliation(s)
- Aljoscha Rastan
- Abteilung Angiologie, Herz-Zentrum Bad Krozingen, Südring 15, Bad Krozingen, Germany.
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Tepe G, Schmitmeier S, Zeller T. Drug-coated balloons in peripheral arterial disease. EUROINTERVENTION 2011; 7 Suppl K:K70-6. [DOI: 10.4244/eijv7ska13] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
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Salmerón Febres L, Al-Raies Bolaños B, Blanes Mompó J, Collado Bueno G, Cuenca Manteca J, Fernandez Gonzalez S, Linares Palomino J, López Espada C, Martínez Gámez J, Serrano Hernando J. Guía de actuación en técnicas y procedimientos endovasculares del sector infrainguinal. ANGIOLOGIA 2011. [DOI: 10.1016/j.angio.2011.05.007] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
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Karnabatidis D, Spiliopoulos S, Diamantopoulos A, Katsanos K, Kagadis GC, Kakkos S, Siablis D. Primary everolimus-eluting stenting versus balloon angioplasty with bailout bare metal stenting of long infrapopliteal lesions for treatment of critical limb ischemia. J Endovasc Ther 2011; 18:1-12. [PMID: 21314342 DOI: 10.1583/10-3242.1] [Citation(s) in RCA: 50] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner. METHODS The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion >4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (>50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity. RESULTS Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p < 0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p < 0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group. CONCLUSION Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.
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Affiliation(s)
- Dimitris Karnabatidis
- Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
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Spiliopoulos S, Katsanos K, Karnabatidis D, Diamantopoulos A, Kagadis GC, Christeas N, Siablis D. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial. Cardiovasc Intervent Radiol 2010; 33:929-938. [PMID: 20574796 DOI: 10.1007/s00270-010-9915-x] [Citation(s) in RCA: 40] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2010] [Accepted: 05/28/2010] [Indexed: 02/05/2023]
Abstract
The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as <30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis (>50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan-Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6-2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1-4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2-5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.
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Affiliation(s)
- Stavros Spiliopoulos
- Department of Diagnostic and Interventional Radiology, Angiography Suite, School of Medicine, Patras University Hospital, Patras, Rion, 26504, Greece.
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Rastan A, Schwarzwälder U, Noory E, Taieb FH, Beschorner U, Sixt S, Bürgelin K, Amantea P, Neumann FJ, Zeller T. Primary Use of Sirolimus-Eluting Stents in the Infrapopliteal Arteries. J Endovasc Ther 2010; 17:480-7. [DOI: 10.1583/10-3073.1] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
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Donas KP, Torsello G, Schwindt A, Schönefeld E, Boldt O, Pitoulias GA. Below knee bare nitinol stent placement in high-risk patients with critical limb ischemia is still durable after 24 months of follow-up. J Vasc Surg 2010; 52:356-61. [DOI: 10.1016/j.jvs.2010.02.281] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2009] [Revised: 02/18/2010] [Accepted: 02/24/2010] [Indexed: 11/26/2022]
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Balzer JO, Khan V, Thalhammer A, Vogl TJ, Lehnert T. Below the knee PTA in critical limb ischemia results after 12 months: Single center experience. Eur J Radiol 2010; 75:37-42. [DOI: 10.1016/j.ejrad.2010.04.014] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2010] [Accepted: 03/31/2010] [Indexed: 11/25/2022]
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Preventing Leg Amputations in Critical Limb Ischemia With Below-the-Knee Drug-Eluting Stents. J Am Coll Cardiol 2010; 55:1580-9. [DOI: 10.1016/j.jacc.2009.11.072] [Citation(s) in RCA: 127] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/10/2009] [Revised: 10/30/2009] [Accepted: 11/09/2009] [Indexed: 11/17/2022]
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Abstract
Infrainguinal peripheral occlusive disease is increasingly being treated by endovascular techniques. Bare metal stainless steel, self-expanding nitinol stents, drug-eluting and covered stents (stent grafts) are becoming increasingly more important adjuncts to percutaneous translumninal angioplasty in the treatment of peripheral artery disease. In this article the available evidence supporting the use of stents in the femoropopliteal and tibial arteries will be described as well as their limitations. Future stent developments will also be discussed.
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Allaqaband S, Kirvaitis R, Jan F, Bajwa T. Endovascular treatment of peripheral vascular disease. Curr Probl Cardiol 2009; 34:359-476. [PMID: 19664498 DOI: 10.1016/j.cpcardiol.2009.05.001] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Peripheral arterial disease (PAD) affects about 27 million people in North America and Europe, accounting for up to 413,000 hospitalizations per year with 88,000 hospitalizations involving the lower extremities and 28,000 involving embolectomy or thrombectomy of lower limb arteries. Many patients are asymptomatic and, among symptomatic patients, atypical symptoms are more common than classic claudication. Peripheral arterial disease also correlates strongly with risk of major cardiovascular events, and patients with PAD have a high prevalence of coexistent coronary and cerebrovascular disease. Because the prevalence of PAD increases progressively with age, PAD is a growing clinical problem due to the increasingly aged population in the United States and other developed countries. Until recently, vascular surgical procedures were the only alternative to medical therapy in such patients. Today, endovascular practice, percutaneous transluminal angioplasty with or without stenting, is used far more frequently for all types of lower extremity occlusive lesions, reflecting the continuing advances in imaging techniques, angioplasty equipment, and endovascular expertise. The role of endovascular intervention in the treatment of limb-threatening ischemia is also expanding, and its promise of limb salvage and symptom relief with reduced morbidity and mortality makes percutaneous transluminal angioplasty/stenting an attractive alternative to surgery and, as most endovascular interventions are performed on an outpatient basis, hospital costs are cut considerably. In this monograph we discuss current endovascular intervention for treatment of occlusive PAD, aneurysmal arterial disease, and venous occlusive disease.
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Conrad MF, Kang J, Cambria RP, Brewster DC, Watkins MT, Kwolek CJ, LaMuraglia GM. Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease. J Vasc Surg 2009; 50:799-805.e4. [DOI: 10.1016/j.jvs.2009.05.026] [Citation(s) in RCA: 87] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2009] [Revised: 05/13/2009] [Accepted: 05/14/2009] [Indexed: 11/25/2022]
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Shammas NW. Restenosis after lower extremity interventions: current status and future directions. J Endovasc Ther 2009; 16 Suppl 1:I170-82. [PMID: 19317571 DOI: 10.1583/08-2564.1] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
The incidence of restenosis after percutaneous peripheral interventions (PPI) varies considerably depending upon the vascular bed but appears to be highest in the femoropopliteal and tibioperoneal arteries. The restenosis process in the periphery does not appear to stop at the 6-month mark, as seen with bare metal stents in the coronary arteries, but continues for a longer time, possibly years, after the intervention. This review evaluates the incidence of restenosis following lower extremity arterial interventions and potential drugs or devices that could alter this process, including nonpharmacological (stents, cryoplasty, Cutting Balloon angioplasty, atherectomy, brachytherapy, and photodynamic therapy) and pharmacological (systemic and direct drug delivery) approaches. A global strategy to achieve optimal outcome with PPI is offered: (1) obtain excellent acute angiographic results with less dissection and recoil, (2) protect the distal tibial vascular bed, and (3) reduce smooth muscle cell proliferation with pharmacological intervention.
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Affiliation(s)
- Nicolas W Shammas
- Midwest Cardiovascular Research Foundation, Cardiovascular Medicine, Davenport, Iowa 52803, USA.
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Allie DE, Hebert CJ, Ingraldi A, Patlola RR, Walker CM. 24-carat gold, 14-carat gold, or platinum standards in the treatment of critical limb ischemia: bypass surgery or endovascular intervention? J Endovasc Ther 2009; 16 Suppl 1:I134-46. [PMID: 19317578 DOI: 10.1583/08-2599.1] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
Critical limb ischemia (CLI) remains a poorly understood, rarely reported, and inconsistently treated major global healthcare epidemic. The incidence in the US is estimated at 1% of the population aged 50 years and older and at approximately double that rate in the over-70 age group. These frequencies are expected to increase significantly with the aging population and the expected increase in diabetes. Within 1 year of being diagnosed with CLI, 40% to 50% of the now 20 million US diabetics will experience an amputation, and 20% to 25% will die. The estimate for treating CLI in the US alone is $10 to $20 billion per year, but just a 25% reduction in amputations could save $2.9 to $3.0 billion annually. Infrainguinal bypass surgery (IBS) utilizing autogenous saphenous vein has been considered the "24-carat gold standard" treatment for CLI, but over the last decade, endovascular therapy has emerged to seriously challenge IBS, which has created considerable controversy. Despite an overall lack of "hard" level I data, many interventionists are questioning the role of IBS as a first-line CLI therapy or are at least now considering IBS a "tainted" gold standard ("14-carat"). This review will examine the available evidence, but there should be no doubt regarding the huge global clinical and economic impact of CLI and amputations.
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Affiliation(s)
- David E Allie
- Louisiana Cardiovascular and Limb Salvage Center, APMC, Lafayette, Louisiana 70506, USA.
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Update on PADI trial: Percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Vasc Surg 2009; 50:687-9. [DOI: 10.1016/j.jvs.2009.04.073] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2009] [Revised: 04/17/2009] [Accepted: 04/24/2009] [Indexed: 11/21/2022]
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Werneck CC, Lindsay TF. Tibial Angioplasty for Limb Salvage in High-Risk Patients and Cost Analysis. Ann Vasc Surg 2009; 23:554-9. [DOI: 10.1016/j.avsg.2009.05.007] [Citation(s) in RCA: 40] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2008] [Revised: 03/31/2009] [Accepted: 05/21/2009] [Indexed: 11/28/2022]
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Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol 2009; 20:1141-1150. [PMID: 19620014 DOI: 10.1016/j.jvir.2009.05.031] [Citation(s) in RCA: 95] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2008] [Revised: 05/12/2009] [Accepted: 05/28/2009] [Indexed: 02/08/2023] Open
Abstract
PURPOSE To present the 3-year angiographic and clinical results of a prospective registry investigating the performance of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) for critical limb ischemia (CLI) treatment. MATERIALS AND METHODS A single-center double-arm prospective registry included patients with CLI who underwent infrapopliteal revascularization with angioplasty and "bailout" use of an SES or BMS. Clinical and angiographic follow-up was scheduled at regular time intervals. Primary clinical and angiographic endpoints included mortality, limb salvage, primary patency, binary angiographic restenosis (ie, >50%), and clinically driven repeat intervention-free survival. Results were stratified according to stent type, and cumulative proportion outcomes were determined by Kaplan-Meier plots. Multivariable Cox proportional-hazards regression analysis was applied to adjust for confounding factors of heterogeneity. RESULTS In total, 103 patients were included in the analysis; 41 (75.6% with diabetes) were treated with a BMS (47 limbs; 77 lesions) and 62 (87.1% with diabetes) with an SES (75 limbs; 153 lesions). At 3 years, SES-treated lesions were associated with significantly better primary patency (hazard ratio [HR], 4.81; 95% CI, 2.91-7.94; P < .001), reduced binary restenosis (HR, 0.38; 95% CI, 0.25-0.58; P < .001), and better repeat intervention-free survival (HR, 2.56; 95% CI, 1.30-5.00; P = .006) versus BMS-treated ones. No significant differences were identified between SESs and BMSs with regard to overall 3-year patient mortality (29.3% vs 32.0%; P = .205) and limb salvage (80.3% vs 82.0%; P = .507). CONCLUSIONS Infrapopliteal application of SESs for CLI significantly improves angiographic long-term patency and reduces infrapopliteal vascular restenosis versus BMSs, thereby lessening the rate of clinically driven repeat interventions.
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Affiliation(s)
- Dimitris Siablis
- Department of Radiology, University Hospital of Patras, GR 265 00, Rion, Greece.
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Lumsden AB, Davies MG, Peden EK. Medical and endovascular management of critical limb ischemia. J Endovasc Ther 2009; 16:II31-62. [PMID: 19624074 DOI: 10.1583/08-2657.1] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
Critical limb ischemia (CLI) is the term used to designate the condition in which peripheral artery disease has resulted in resting leg or foot pain or in a breakdown of the skin of the leg or foot, causing ulcers or tissue loss. If not revascularized, CLI patients are at risk for limb loss and for potentially fatal complications from the progression of gangrene and the development of sepsis. The management of CLI requires a multidisciplinary team of experts in different areas of vascular disease, from atherosclerotic risk factor management to imaging, from intervention to wound care and physical therapy. In the past decade, the most significant change in the treatment of CLI has been the increasing tendency to shift from bypass surgery to less invasive endovascular procedures as first-choice revascularization techniques, with bypass surgery then reserved as backup if appropriate. The goals of intervention for CLI include the restoration of pulsatile, inline flow to the foot to assist wound healing, the relief of rest pain, the avoidance of major amputation, preservation of mobility, and improvement of patient function and quality of life. The evaluating physician should be fully aware of all revascularization options in order to select the most appropriate intervention or combination of interventions, while taking into consideration the goals of therapy, risk-benefit ratios, patient comorbidities, and life expectancy. We discuss the incidence, risk factors, and prognosis of CLI and the clinical presentation, diagnosis, available imaging modalities, and medical management (including pain and ulcer care, pharmaceutical options, and molecular therapies targeting angiogenesis). The endovascular approaches that we review include percutaneous transluminal angioplasty (with or without adjunctive stenting); subintimal angioplasty; primary femoropopliteal and infrapopliteal deployment of bare nitinol, covered, drug-eluting, or bioabsorbable stents; cryoplasty; excimer laser-assisted angioplasty; excisional atherectomy; and cutting balloon angioplasty.
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Affiliation(s)
- Alan B Lumsden
- Department of Cardiovascular Surgery, Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, 6550 Fannin Street, Suite 1401, Houston, TX 77030, USA.
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Biondi-Zoccai GGL, Sangiorgi G, Lotrionte M, Feiring A, Commeau P, Fusaro M, Agostoni P, Bosiers M, Peregrin J, Rosales O, Cotroneo AR, Rand T, Sheiban I. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther 2009; 16:251-260. [PMID: 19642789 DOI: 10.1583/09-2691.1] [Citation(s) in RCA: 81] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE To report a systematic review of the literature published on the outcomes of stenting for below-the-knee disease in patients with critical limb ischemia (CLI). METHODS Potentially relevant studies of stent implantation in the infragenicular arteries in >or=5 patients with >or=1-month follow-up were systematically sought in BioMedCentral, ClinicalTrials.gov, The Cochrane Collaboration Register of Controlled Trials (CENTRAL), Google Scholar, and PubMed. Data were abstracted and pooled with a random-effect model to generate risk estimates with 95% confidence intervals (CI). Interaction tests were performed to compare different stent types. A risk of bias assessment was conducted separately, as were appraisals for small study bias, statistical heterogeneity, and inconsistency. RESULTS Eighteen nonrandomized studies were retrieved comprising 640 patients. After a median follow-up of 12 months, binary in-stent restenosis occurred in 25.7% (95% CI 11.6% to 40.0%), primary patency in 78.9% (95% CI 71.8% to 86.0%), improvement in Rutherford class in 91.3% (95% CI 85.5% to 97.1%), target vessel revascularization in 10.1% (95% CI 6.2% to 13.9%), and limb salvage in 96.4% (95% CI 94.7% to 98.1%). Head-to-head comparisons showed that sirolimus-eluting stents were superior to balloon-expandable bare metal stents in preventing restenosis and increasing primary patency (both p<0.001); sirolimus-eluting stents were also better than paclitaxel-eluting stents in terms of primary patency (p<0.001) and repeat revascularizations (p = 0.014). CONCLUSION Percutaneous infragenicular stent implantation after failed or unsuccessful balloon angioplasty is associated with favorable clinical results in patients with CLI. Notwithstanding limitations of primary studies, sirolimus-eluting stents appear superior to bare metal and paclitaxel-eluting stents in terms of angiographic and/or clinical outcomes.
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