Intravascular ultrasound (IVUS) has been shown to improve outcomes of drug-coated balloon (DCB) angioplasty for treatment of femoropopliteal artery (FPA) disease. However, the optimal IVUS criteria for achieving improved outcomes of DCB angioplasty for FPA disease remain uncertain. The study aimed to identify IVUS predictors for loss of patency at 12 months after DCB angioplasty for FPA disease. After excluding one patient due to insufficient IVUS imaging data, 98 patients in the IVUS-guidance group of the IVUS-DCB trial were included in the analysis. IVUS parameters predicting loss of patency at 12 months and their optimal cut-off values were investigated. Among the 98 patients who underwent IVUS-guided FPA intervention, 16 patients (16.3%) lost primary patency within 12 months. End-stage renal disease on hemodialysis and, bailout stenting, postprocedural dissection length >50% were independent procedural predictors for 12-month patency loss. Receiver operating characteristic (ROC) curve demonstrated that postprocedural minimal lumen area (MLA) ≥ 11.6 mm2 (area under the ROC curve: 0.685, 95% CI: 0.513 to 0.857) as the optimal cut-off value for sustained primary patency. In survival analysis, patients with MLA ≥ 11.6 mm2 had a hazard ratio of 0.27 (95% CI: 0.09 to 0.80, p-value = 0.019, risk difference: 19.8) for lower risk of patency loss. A postprocedural MLA ≥11.6 mm2 was an independent IVUS predictor for sustained primary patency after DCB angioplasty in patients with FPA disease. Our findings suggest that lesion optimization and achieving sufficient lumen area under IVUS guidance during DCB angioplasty are crucial for maintaining target vessel patency.

BackgroundEndovascular treatment (EVT) is recommended for superficial femoral artery (SFA) lesions, and good results have been reported after implantation of drug-eluting stents (DES) for SFA. However, the major concern after implantation is acute thrombosis during the follow-up period, resulting in major amputation and major adverse limb events. In this study, we examined the incidence and outcome of acute thrombosis after DES implantation in the SFA.Objectives and MethodsDES implantation for a femoropopliteal lesion was performed in 288 patients at multiple centers in Japan from 2019 to 2021. A total of 25 patients (8.6%) with DES acute occlusion were analyzed retrospectively. The primary endpoint was amputation-free survival (AFS) after acute occlusion.ResultsThe median patient age was 77 years, with 48% having diabetes, 40% undergoing maintenance dialysis, and 66% having chronic limb-threatening ischemia (CLTI). The mean time from initial DES implantation to acute occlusion was 153.5 ± 177.6 days, with a median of 104 days. EVT was performed in 18 patients (72%), surgical revascularization in 3 (12%), and conservative treatment in 4 (16%). Two deaths within 30 days were both due to sepsis. No major amputation or major adverse cardiovascular events occurred within 30 days. The 1-year rates of patency and freedom from target lesion revascularization after DES thrombosis were 22.9% and 48.8%, respectively. AFS at 1 year was 55.1%.ConclusionAcute DES occlusion is relatively frequent, and the outcome is poor. Therefore, the indication of DES implantation for a complex SFA lesion may require careful consideration. Further investigation may be needed in DES implantation for a complex SFA lesion.

Superficial femoral artery disease poses significant challenges in patients with peripheral artery disease due to its unique anatomic and physiological characteristics. While conservative measures remain the initial approach for chronic, stable symptoms, endovascular therapies have gained prominence due to their minimally invasive nature, expedited recovery times, and preservation of future treatment options when performed correctly. Options for endovascular interventions include balloon angioplasty (percutaneous transluminal angioplasty [standard], drug-coated balloon), stenting (bare metal, drug-eluting, covered stents), with or without adjunct therapy (atherectomy or intravascular lithotripsy). Randomized controlled trials have demonstrated superior outcomes with drug-coated balloons and drug-eluting stents over bare metal stents or percutaneous transluminal angioplasty alone, particularly in long, heavily calcified lesions. However, challenges such as in-stent restenosis, stent fracture, and in-stent thrombosis persist, driving ongoing innovation in device technology and drug formulations on devices. Emerging therapies such as bioresorbable scaffolds and percutaneous bypass devices offer promising alternatives. Further research is needed to refine treatment strategies, minimize risks, and optimize outcomes.

While the efficacy and safety of drug-coated balloons (DCBs) for treating short femoropopliteal lesions are well-established, evidence on long-term outcomes for long lesions remains limited. This study aims to compare the 2-year clinical outcomes of DCB angioplasty between long and short femoropopliteal lesions and identify risk factors for patency loss. This real-world and single-center cohort study included 234 patients with de novo stenosis or restenosis or occlusion of the femoropopliteal arteries (115 long lesions > 15 cm, 141 short lesions ≤ 15 cm) who underwent successful DCB treatment from January 2019 to December 2021 at Peking Union Medical College Hospital. The primary safety endpoint was defined as freedom from major adverse events (death, target limb amputation or thrombosis). The primary effectiveness endpoint was defined as 2-year primary patency, defined as freedom from both clinically driven target lesion revascularization (CD-TLR) and restenosis. Primary patency was significantly lower in long lesions (48.3% vs. 62.5%, p = 0.005), while freedom from CD-TLR rate showed no difference (83.6% vs. 87.4%, p = 0.25). Long lesions exhibited higher rates of occlusions (p < 0.001), in-stent restenosis (p = 0.025), and advanced ischemia (Rutherford Clinical Category (RCC) 4-6, p = 0.038). Multivariate analysis identified lesion length > 15 cm (p = 0.017) and RCC 4-6 (p = 0.026) as independent predictors of patency loss. Within the long lesion subgroup, only RCC 4-6 maintained prognostic significance (p = 0.027), and no significant predictors emerged in the short lesion group. Major adverse events occurred in 12.4% of patients, predominantly in long lesions with severe comorbidities. While DCB angioplasty achieved acceptable 2-year safety outcomes, long femoropopliteal lesions (> 15 cm) demonstrated significantly inferior primary patency compared to short lesions (48.3% vs. 62.5%, p = 0.005). Advanced ischemia (RCC 4-6) is a risk factor for patency loss.

Endovascular literature has been under scrutiny due to perceived poor-quality data. This has been attributed to multiple reasons, including but not limited to smaller sample size, absence of standardization of reporting methodology and investigational treatment protocols, and limited funding resources. The goal of the current study was to review the design of randomized controlled trials investigating contemporary stents for the femoropopliteal segment, with reported >70-80% primary efficacy rate and address issues with their respective reporting methodology.

This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (CRD42024508602). The Medline (PubMed), Scopus, and Cochrane databases were reviewed for randomized controlled trials reporting on the safety and efficacy of femoropopliteal Zilver PTX, Eluvia, Viabahn, and Supera stents through February 2024. Data were collected regarding baseline, lesion, and procedural characteristics and postprocedural outcomes.

17 articles were identified, presenting the results of 11 trials. 80% of the studied individuals were males having intermittent claudication (overall 81%; Rutherford class (RC) 2; 8 trials; 29%; RC 3; 8 trials; 46%). The mean preprocedural ankle-brachial index (ABI) was 0.64 (0.56-0.72). Details about run-off vessels, inflow or outflow disease treatment, and antithrombotic regimen compliance were missing in most papers. Only 3 trials had long-term data (≥36 months). Critical information about postprocedural and during follow-up ABI values, amputation rates, and stent fracture rates were not reported in 6, 5, and 13 articles, respectively. The definition of the primary efficacy endpoint was similar in all studies, although the peak systolic velocity (PSV) ratio cutoff that was used ranged from 2.0 to 2.5 (1 study: 2.5; 6 studies: 2.4; 5 studies: 2.0). Post-treatment clinical benefit was often defined as improvement in RC and/or ABI, although individual values were not always provided.

The studies exhibited considerable variation in assessment of outcomes and reporting methodology. Standardized reporting methods for lesion or procedural characteristics and post-treatment clinical benefit need to be established to facilitate translation of clinical trials results to actual practice.

The femoropopliteal segment is a common anatomic location for peripheral artery disease. The clinical presentation of occlusive disease of the femoropopliteal segment can range from symptomatic or severe claudication if in isolation, or acute or chornic limb threatening ischemia often in the setting of multilevel disease. Patients can be treated with various therapies to improve symptoms and restore perfusion, including medical, exercise, endovascular, and open surgical therapies. The current literature is rapidly evolving on the best management algorithms and strategies based on patient presentation, severity of occlusive disease, and desired therapy goals. This paper summarizes current literature on available medical, endovascular, and surgical therapies for treating peripheral artery occlusive disease of the femoropopliteal segment.

To report our experience of short-term results of drug-coated balloon (DCB) combined with chocolate balloon in the treatment of femoropopliteal artery lesions.

From June 2021 to December 2022, patients with femoropopliteal artery lesions (Rutherford classification 2-6) who underwent DCB combined with Chocolate PTA balloon catheter treatment were included. Clinical data of the patients were collected, and follow-up was conducted at 3, 6, and 12 months. The primary patency rate and the freedom from clinically-driven target lesion revascularization (f-TLR) rate were calculated by Kaplan-Meier survival curves.

This study included a total of 43 patients (mean age 72.84 ± 10.19 years, male proportion 67.4%) with 47 lesions. Among them, 17 lesions (36.2%) presented severe stenosis with an average lesion length of 110.41 ± 47.67 mm. Thirty lesions (63.8%) were identified as chronic total occlusions (CTO), with an average occlusion length of 104.13 ± 61.12 mm. The Kaplan-Meier survival curve estimated a primary patency rate of 87.2% at 6 months and 78.7% at 12 months. The f-TLR rate at 12 months was 85.1%, estimated by Kaplan-Meier survival curve. The mean ankle-brachial index (ABI) increased from 0.53 ± 0.12 before the surgery to 0.87 ± 0.12 at 12 months postoperatively, and this difference was statistically significant (p < 0.001). A total of 91.5% of patients (43/47) showed a decrease in Rutherford classification at 12 months postoperatively. The proportion of patients with Rutherford class 4-6 decreased from 70.2% (33/47) preoperatively to 4.3% (2/47) at 12 months postoperatively, and this difference was statistically significant (p < 0.001). Among the limbs, 34 (72.3%) experienced dissection during the surgery, with 29 cases classified as type B or lower dissection and 5 cases classified as type C or higher (severe dissection) (10.6%). Two limbs (4.3%) required the use of salvage stents. There were no procedure- or device-related deaths within the 12-month period. Twelve limbs (25.5%) underwent minor amputations (toe amputations).

The combination of DCB and chocolate balloon angioplasty has achieved satisfactory patency rates and f-TLR results in 1-year follow-up for the treatment of femoropopliteal artery lesions. However, further confirmation of these findings is needed through multicenter data and long-term follow-up results.

Peripheral artery disease (PAD) is a common vascular condition affecting over 200 million people worldwide. It is primarily characterized by stenosis or occlusion of peripheral arteries due to atherosclerosis. The infrainguinal segment is frequently involved in PAD, making revascularization decisions for infrainguinal arterial disease (IAD) complex. Multiple factors, including the patient's condition and anatomical characteristics, must be carefully considered when determining the optimal treatment approach. Once these factors are evaluated, the first revascularization strategy is selected from among open, endovascular, or hybrid modalities, based on high-level evidence. Endovascular therapy is widely accepted as the standard treatment for simple IAD, with balloon angioplasty and stenting being the commonly used techniques. However, advancements in endovascular techniques have enabled the treatment of increasingly complex lesions. Additionally, drug-based technologies have enhanced the durability of treatment outcomes, including improvements in primary patency rates and freedom from target lesion revascularization. Similar to surgical endarterectomy, percutaneous atherectomy has been developed to remove atherosclerotic plaques and mitigate intimal calcification. The purpose of this paper is to present an algorithm for revascularization of IAD through a comprehensive review of studies comparing the outcomes of various treatment modalities.

A global treatment algorithm was developed for the endovascular revascularization of femoropopliteal lesions and chronic total occlusions, aiming toward a more standardized approach to endovascular treatment in patients with peripheral artery disease. The following steps are proposed. 1) Evaluation of lesion morphology based on preprocedural imaging by Duplex sonography and intravenous ultrasound for selection of lesion preparation tools. Lesion characteristics are mainly defined by calcification, lesion length, and the presence of total occlusion and in-stent restenosis. 2) Selection of vessel preparation strategies, which encompass plain old balloon angioplasty, atherectomy, thrombectomy, intravascular lithotripsy and specialty balloons, or a combination of the preceding, based on lesion and patient-specific characteristics. In addition, a Delphi consensus was applied for the appropriateness of lesion preparation strategies, depending on lesion anatomy, length, plaque morphology, and subintimal versus intraluminal guidewire crossing. 3) Definitive lesion treatment strategies using drug-coated balloons, bare-metal stents, drug-eluting stents, and/or covered stents or a combination. By establishing this treatment algorithm in routine practice, improvements in vessel- and patient-specific outcomes are anticipated, which will be further enhanced by continuous collaboration among experts from different countries and disciplines and by randomized controlled trials.

The endovascular treatment of the femoropopliteal segment is the most frequent revascularization option in patients with peripheral arterial occlusive disease (PAOD); however, the plain old balloon angioplasty has limitations, especially in complex and calcified lesions, and can lead to dissections and recoil. In order to improve the technical success and the efficacy of the endovascular treatment in complex, sometimes severely calcified or thrombotic lesions or also in lesions in mobile segments, a lesion preparation strategy before the actual lesion treatment is frequently applied. Lesion preparation methods include atherectomy, thrombectomy or intravascular lithotripsy. Through lesion preparation plaques and/or organized thrombi can be minimally invasively removed or calcium deposits can be even fragmented with low threshold barotrauma, without damaging the vessel wall. Subsequently, the definitive treatment of the lesion can be carried out using drug-coated balloons (DCB), bare metal stents (BMS), drug-eluting stents (DES) or a combination of these. Due to the heterogeneity of patient and lesion characteristics, no 'one fits all' strategy is so far available; however, the choice of the appropriate instruments should be carried out based on the patient and lesion characteristics present, whereby for the lesion-specific parameters the extent of the morphology and underlying pathology plays an important role.

To understand the relative safety and efficacy of endovascular treatment modalities used for superficial femoral artery (SFA) disease, we performed a network meta-analysis to compare outcomes between percutaneous transluminal angioplasty (PTA), atherectomy (A), bare metal stent (BMS), brachytherapy/radiotherapy, covered stent graft (CSG), cutting balloon angioplasty (CBA), drug-coated balloon (DCB), drug-eluting stent (DES), and intravascular lithotripsy (L).

We performed a systematic literature search of PubMed from January 2000 to January 2023 to identify randomized trials comparing endovascular interventions for the treatment of SFA disease. The primary end points were technical success and 12-month primary patency.

In total, 57 studies (9089 patients) were included. The mean age of the included patients was 68.4 years, 41.4% had diabetes, 18.3% had critical limb ischemia, and 81.3% had de novo lesions. A mean of 1.2 lesions were treated per patient. Technical success was superior for CSG, BMS, and A+DCB compared with PTA, while A+DCB and CSG were superior to DCB. All interventions except brachytherapy alone had superior primary patency compared with PTA. There were no significant differences in 12-month mortality or major amputation. All interventions except L+DCB, PTA+A, and CBA were superior to PTA regarding target lesion revascularization, while only DCB, DES, and BMS were better than PTA at improving Rutherford classification.

In SFA disease, PTA alone is mostly inferior to other endovascular techniques. This comparison of other endovascular techniques will be valuable for endovascular device selection in the treatment of SFA disease.

Most clinical trials of drug-coated balloon (DCB) for the treatment of femoropopliteal artery stenosis chose 12-month primary patency rate (PPR) or 6-month late lumen loss (LLL) as the primary endpoint. It is still debatable whether 6-month LLL can be served as an appropriate surrogate endpoint for 12-month PPR. This study aimed to identify whether LLL can serve as an appropriate surrogate endpoint in peripheral DCB clinical trials, and shed light on the selection of primary outcome for subsequent confirmatory clinical trials of DCB in the treatment of femoropopliteal artery stenosis.

The linear regression model was used to evaluate the correlation between 12-month PPR and 6-month LLL. Pooled standardized mean differences (SMDs) and relative gain between the DCB and plain old balloon angioplasty (POBA) group were computed to assess the consistency and surrogacy, using fixed or random effect model as appropriate. The coefficient of variation (CV) was calculated for both endpoints to compare their degree of variation overall and at study level.

A total of 34 studies are eligible for this study. A significant negative linear correlation was found between 12-month PPR and 6-month LLL (R2=0.67, slope=-0.309, p=0.007). The SMD (DCB-POBA) of LLL and PPR was -0.76 (95% confidence interval [CI]: -0.98, -0.54), and 0.59 (95% CI: 0.46, 0.72) (p=0.18). The pooled relative gain of PPR (43%, 95% CI: 35%, 50%) was significantly lower than that of LLL (72%, 95% CI: 61%, 84%) (p<0.001). Coefficient of variation of LLL was larger than that of PPR overall in DCB and POBA groups.

Although a significant moderate correlation was observed between 12-month PPR and 6-month LLL, PPR shows more conservative and robust than LLL, which may exaggerate clinical benefits. Late lumen loss should be used discreetly depending on different situations and clinical benefits for patients.

This study addresses the critical issue of primary endpoint selection in clinical trials of drug-coated balloon for femoropopliteal artery stenosis. By elucidating the moderate correlation between 6-month late lumen loss (LLL) and 12-month primary patency rate (PPR), the findings underscore the limitations of LLL as a surrogate endpoint due to its variability and potential to overstate clinical benefits. The study advocates for the use of 12-month PPR as a more robust and conservative endpoint in pivotal trials, particularly for novel devices. These findings provide clinicians with a nuanced understanding of outcome measures, promoting evidence-based decision-making and regulatory alignment to ensure patient benefits in vascular interventions.

This study aimed to develop and internally validate nomograms for predicting restenosis after endovascular treatment of lower extremity arterial diseases.

A total of 181 hospitalized patients with lower extremity arterial disease diagnosed for the first time between 2018 and 2019 were retrospectively collected. Patients were randomly divided into a primary cohort (n=127) and a validation cohort (n=54) at a ratio of 7:3. The least absolute shrinkage and selection operator (LASSO) regression was used to optimize the feature selection of the prediction model. Combined with the best characteristics of LASSO regression, the prediction model was established by multivariate Cox regression analysis. The predictive models' identification, calibration, and clinical practicability were evaluated by the C index, calibration curve, and decision curve. The prognosis of patients with different grades was compared by survival analysis. Internal validation of the model used data from the validation cohort.

The predictive factors included in the nomogram were lesion site, use of antiplatelet drugs, application of drug coating technology, calibration, coronary heart disease, and international normalized ratio (INR). The prediction model demonstrated good calibration ability, and the C index was 0.762 (95% confidence interval: 0.691-0.823). The C index of the validation cohort was 0.864 (95% confidence interval: 0.801-0.927), which also showed good calibration ability. The decision curve shows that when the threshold probability of the prediction model is more significant than 2.5%, the patients benefit significantly from our prediction model, and the maximum net benefit rate is 30.9%. Patients were graded according to the nomogram. Survival analysis found that there was a significant difference in the postoperative primary patency rate between patients of different classifications (log-rank p<0.001) in both the primary cohort and the validation cohort.

We developed a nomogram to predict the risk of target vessel restenosis after endovascular treatment by considering information on lesion site, postoperative antiplatelet drugs, calcification, coronary heart disease, drug coating technology, and INR.

Clinicians can grade patients after endovascular procedure according to the scores of the nomograms and apply intervention measures of different intensities for people at different risk levels. During the follow-up process, an individualized follow-up plan can be further formulated according to the risk classification. Identifying and analyzing risk factors is essential for making appropriate clinical decisions to prevent restenosis.

Endovascular arterial recanalization has become the mainstay therapy for peripheral arterial occlusive disease. Although immediate technical success is achieved in greater than 90% of cases, longer-term results continue to vary based on the clinical presentation, and the treated target lesion. In the current era, sustained patency can be expected following intervention in the carotid, coronary, renal, and iliac arteries. However, maintaining patency in the femoropopliteal and tibial arteries continues to be present a significant challenge. Endovascular intervention in the peripheral arteries is met with heavy complex plaque burdens, multiple serial stenoses and occlusions, sluggish blood flow, low mean and oscillatory shear stress, and repetitive axial, radial and torsional deformation that hinder its outcomes. In order to maximize the longevity of endovascular intervention, its therapeutic armamentarium has developed to include vessel preparation, drug delivery, and arterial scaffolding. Nevertheless, in the aggregate of real-world clinical practice, recurrence of stenosis still complicates up to 50% of all infrainguinal endovascular procedures after only one year. Unfortunately, this timeline is often insufficient to reliably address lifestyle limiting symptoms, heal a wound, or save a threatened extremity. The purpose of this review is to discuss the pathophysiology, incidence, risk factors, morphology and treatment of restenosis following peripheral endovascular intervention.

Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.

This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4.

No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.

Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.

Endovascular therapy (EVT) has become the preferred treatment modality for femoropopliteal disease. However, there is limited evidence regarding its procedural and clinical outcomes according to the affected area.

The aim of this study is to investigate clinical outcomes and device effectiveness according to treatment extent in the superficial femoral artery (SFA), popliteal artery (PA), or both.

In this study, we analysed EVT for SFA (2,404 limbs), PA (155 limbs), SFA/PA (383 limbs) using the population in the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) registry. The primary endpoint was target lesion revascularisation (TLR) at 2 years.

The SFA/PA group exhibited a higher prevalence of anatomical complexity, characterised by long lesions, moderate to severe calcification, and total occlusion. The procedures were successful in 97.2% of SFA, 92.9% of PA, and 95.6% of SFA/PA EVTs. The 2-year TLR rates were 21.1%, 18.6%, and 32.7% in the SFA, PA, and SFA/PA groups, respectively. SFA/PA EVT was associated with a significantly increased risk for TLR compared to the SFA group (adjusted hazard ratio [HR] 1.48 [1.09-2.00]; p=0.008) and a trend towards an increased risk compared to the PA group (adjusted HR 1.80 [1.00-3.27]; p=0.052). After overlap weighting, the use of a drug-coated balloon (DCB) was shown to be beneficial, with the lowest TLR rate after SFA and SFA/PA EVT.

In this large real-world registry, SFA/PA EVT was associated with an increased risk for TLR at 2 years compared to the SFA or PA EVT groups, with favourable outcomes when using a DCB or drug-eluting stent in the SFA/PA EVT group.

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.

The aim of this project is to explore practice patterns of experienced vascular specialists involved in the treatment of patients with arterial femoro-popliteal in-stent occlusion (ISO) and to understand key concepts and shared thoughts, throughout an international cross-sectional survey.

The web-based survey was in English and included 31 questions. One-hundred experts were invited by email to fill in the survey anonymously on Google Forms using a dedicated link. Reminders were sent after the first 2 weeks. In addition to reporting of pooled responses, subanalyses of answers were also performed, according to country of origin (European vs non-European), years of experience (≤20 years vs >20 years), and type of institution (Academic/University vs Non-academic/Private).

A total of 77 physicians from 22 countries completed the survey. Most responders were males (70/77, 91%). Most of the participants were vascular surgeons (58/77, 75%). Endovascular therapy was the preferred option in patients presenting with either acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Atherectomy/thrombectomy+Drug-Coated Balloon (DCB) was the preferred endovascular modality (32/77, 42%). No differences between country of origin, years of experience, and type of institution of the participants were found.

The international SUrvey oN TReatment Of Occluded Femoro-Popliteal Stent (SUNROOF) survey has suggested that endovascular therapy is the preferred method for the treatment of femoro-popliteal ISO. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks good-level scientific evidence and appropriate guidelines.

The international SUNROOF survey included 31 questions. It was performed by 77 vascular physicians from 22 countries. More than a half of respondents considered an endovascular approach as the preferred treatment modality in acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Most responders agreed they would intensify the follow-up protocol and anti-thrombotic medications regimen after a first in-stent occlusion episode. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks of good level scientific evidence and appropriate guidelines.

Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by sex, race, and ethnicity. This study aimed to examine amputation and revascularization rates up to 4 years after femoropopliteal (FP) PVI for IC by sex, race, and ethnicity. Patients who underwent FP PVI for IC between 2016 and 2020 from the PINC AI Healthcare Database were analyzed. The primary outcome was any index limb amputation, assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HRs) were estimated using Cox proportional hazard regression models. This study included 19,324 patients with IC who underwent FP PVI, with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs 47.8%, p = 0.0003); Black patients were more likely than White patients to receive atherectomy (50.7% vs 44.9%, p <0.001), and Hispanic patients were less likely than non-Hispanic patients to receive atherectomy (41% vs 47%, p = 0.0004). Unadjusted rates of any amputation were similar in men and women (6.4% for each group, log-rank p = 0.842), higher in Black patients than in White patients (7.8% vs 6.1%, log-rank p = 0.007), and higher in Hispanic patients than in non-Hispanic patients (8.8% vs 6.3%, log-rank p = 0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR 1.13, 95% confidence interval 1.04 to 1.22) and any FP revascularization (adjusted HR 1.10, 95% confidence interval 1.01 to 1.20). No statistical difference in amputation rate was observed among comparison groups. Women and men with IC had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than did White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences among different populations.

Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease.

Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently.

After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014).

In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more).

The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII C = 67, 54.9%; TASCII D = 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (P < .001) and ankle-brachial index measurements (P < .001). Complex target lesions (P = .017) and 1 stenosis-free outflow vessel (P = .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (P = .044), diabetes (P = .007), and 1 stenosis-free outflow vessel (P = .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.

Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed.

This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death.

A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05).

This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group.

One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

Statins are widely used in coronary and peripheral arterial disease, but their impact on patency of stents placed for peripheral arterial disease is not well-studied. The purpose of this study was to evaluate femoropopliteal stent primary patency according to statin intensity at the time of stent placement and compare this effect to other covariates that may influence stent patency.

A retrospective review identified 278 discrete femoropopliteal stent constructs placed in 216 patients over a 10-year period; Rutherford categories were 2 (3.6%), 3 (12.9%), 4 (21.2%), 5 (49.6%), and 6 (12.6%). Stent locations were common femoral (1.8%), common femoral/superficial femoral (0.7%), superficial femoral (50.7%), superficial femoral/popliteal (32.7%) and popliteal (14.0%) arteries; 63.3% of stents were paclitaxel-eluting. Primary patency of each stent construct was determined with duplex ultrasound, angiography, or computed tomographic angiography. Greater than 50% restenosis or stent occlusion was considered loss of patency. Cox proportional hazard and Kaplan-Meier modeling were used to assess the effect of statin use and additional covariates on stent patency.

Patients on any statin at the time of stent placement were half as likely to undergo loss of primary unassisted patency as patients on no statin therapy (hazard ratio, 0.53; 95% confidence interval, 0.19-0.87; P = .004). Moderate/high intensity statin therapy conferred 17 additional months of median stent patency compared to the no statin group. Antiplatelet therapy, anticoagulant therapy, drug-eluting stents (versus bare metal or covered stents), and Rutherford class were not predictive of stent patency (P = 0.52, 0.85, 0.58, and 0.82, respectively).

Use of statin therapy at the time of femoropopliteal stent placement was the most predictive examined variable influencing primary unassisted patency.

To evaluate the best endovascular treatment for de novo femoropopliteal lesions at long-term follow-up through network meta-analysis of randomized controlled trials.

Medical databases were searched on September 17, 2023. 17 trials and 7 treatments were selected. Outcomes were primary patency, target lesion revascularization (TLR), major amputation and all-cause mortality at 3 and/or 5 years.

Regarding 3-year primary patency, drug-eluting stents (DES) was the best and better than balloon angioplasty (BA; odds ratio [OR], 4.96; 95% confidence interval [CI], 2.68-9.18), bare metal stents (BMS; OR, 2.81; 95% CI, 1.45-5.46), cryoplasty (OR, 6.75; 95% CI, 2.76-16.50), covered stents (CS; OR, 3.25; 95% CI, 1.19-8.87) and drug-coated balloons (DCB; OR, 2.04; 95% CI, 1.14-3.63). Regarding 5-year primary patency, DES was the best and better than BMS (OR, 2.34; 95% CI, 1.10-4.99). Regarding 3-year TLR, DES was the best and better than BA (OR, 0.24; 95% CI, 0.13-0.44). Regarding 5-year TLR, DES was the best and better than BA (OR, 0.20; 95% CI, 0.09-0.42) and balloon angioplasty with brachytherapy (OR, 0.21; 95% CI, 0.06-0.74). Regarding 3- and 5-year major amputation, DCB was the best. Regarding 3-year mortality, DES was the best and better than CS (OR, 0.09; 95% CI, 0.01-0.67).

DES was the best treatment regarding 3-year primary patency, TLR and mortality, and DCB was the best regarding major amputation. DES was the best treatment regarding 5-year TLR, and DCB was the best regarding primary patency and major amputation. DES and DCB should be given priority in treating femoropopliteal lesions.

Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions.

In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms.

Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms.

In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization.

Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Drug-coated balloons (DCBs) have been widely used in endovascular therapy for femoropopliteal arteries with atherosclerotic lesions. Vascular response after DCBs remains unclear. This mini-review proposes a possible mechanism of restenosis after the DCB strategy. Balloon dilatation including DCBs expands the vascular lumen by producing dissections, which is composed of the original vascular lumen and the cavity surrounded by dissected flaps. The cavity surrounded by dissected flaps is eventually replaced with the thrombus in the healing process after balloon dilatation. However, the thrombus may propagate to the expanded vascular lumen through the entry point of the dissection. Subsequently, the thrombus both in the cavity and the expanded lumen would be organized over time. The vascular lumen in the chronic-phase after DCBs may be influenced by the propagated thrombus from the cavity surrounded by dissected flaps.

The arterial circulatory system diseases are common in clinical practice, and their treatment options have been of great interest due to their high morbidity and mortality. Drug-eluting balloons, as a new type of endovascular interventional treatment option, can avoid the long-term implantation of metal stents and is a new type of angioplasty without stents, so drug-eluting balloons have better therapeutic effects in some arterial circulatory diseases and have been initially used in clinical practice. In this review, we first describe the development, process, and mechanism of drug-eluting balloons. Then we summarize the current studies on the application of drug-eluting balloons in coronary artery lesions, in-stent restenosis, and peripheral vascular disease. As well as the technical difficulties and complications in the application of drug-eluting balloons and possible management options, in order to provide ideas and help for future in-depth studies and provide new strategies for the treatment of more arterial system diseases.

Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD.

Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics.

A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%).

The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations.

The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD).

A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials.

After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored.

The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported. PROSPERO registration number: CRD42022288214.

To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application.

Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity score matching (PSM) was used to match the confounding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outcome assessments included the disappearance rate of pharyngeal pain (within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events.

Of 7,699 enrolled participants, 6,693 (86.9%) received acupoint application and 1,450 (21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group (AG) and non-application group (NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG (P<0.05). The disappearance time of pharyngeal pain in the AG were shorter than that in the NAG (logrank P<0.001, hazard ratio=1.51, 95% confidence interval: 1.41-1.63). The median age of effective cases was 4 years, mainly 3-6 years old (40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG (P<0.05). The commonly used acupoints for the effective cases were Tiantu (RN 22), Shenque (RN 8) and Dazhui (DU 14). The commonly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently (support 84.39%). A total of 1,324 (17.2%) patients experienced AEs, and mainly occurred in the AG, with significant difference in the incidence of AEs between goups (P<0.05). All AEs reported were the first grade, and the average regression days of AEs was 2.8 days.

Acupoint application in patients with pharyngeal pain resulted in improved effective rate and shortened duration, especially children aged 3-6 years old, and those with tonsil diseases. Acupoint of RN 22, RN 8 and DU 14, Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae were the most commonly used herbs in the treatment of pharyngeal pain.

Despite widespread use of anti-restenosis devices, drug-coated balloons (DCBs) and drug-eluting stents (DESs), their appropriate use for femoropopliteal (FP) lesions has not been well investigated and the risk factors for restenosis have not been compared. To investigate risk factors associated with restenosis after endovascular therapy using DCB and DES for contemporary FP lesions.

This single-center, retrospective, observational study evaluated 378 FP lesions in 273 patients treated with DCB (278 lesions in 193 patients) or DES (120 lesions in 106 patients). The DCB used was high-dose DCB (IN.PACT, Admiral. Medtronic, Inc.) and DES was fluoropolymer-based DES (ELUVIA, Boston Scientific). Vessel preparation failure was defined as a residual stenosis of ≥50% and a dissection grade of D or greater on pre-dilatation angiography. The outcome measure was restenosis, and factors associated with restenosis in the DCB and DES groups were assessed using a Cox proportional hazards model.

The 2-year restenosis rate was not significantly different between the DCB and DES groups (29%±4% vs. 24%±5%, p=0.42). Interaction analysis demonstrated that popliteal lesions and plaque burden of ≥50% were restenosis-related factors for DES but not for DCB, whereas vessel preparation failure was a factor for DCB but not for DES (p<0.05). Vessel diameter of <6 mm and nodular calcification were risk factors in both groups (p<0.05).

In contemporary FP lesions, smaller vessels and nodular calcification were shared restenosis-related factors for high-dose DCB and fluoropolymer-based DES. Popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB.

Shared and differential restenosis-related factors after endovascular therapy using high-dose drug-coated balloons (DCBs) and fluoropolymer-based drug-eluting stents (DESs) in contemporary femoropopliteal (FP) lesions are unclear. This single-center retrospective study included 378 FP lesions in 273 patients with lower-extremity arterial disease (high-dose DCB, 278 lesions in 193 patients; fluoropolymer-based DES, 120 lesions in 106 patients). Smaller vessels and calcified nodules were shared restenosis-related factors for both high-dose DCB and fluoropolymer-based DES, whereas popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB.

Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery.

Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years.

A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes.

This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.

Both stent grafts (SG) and drug-coated balloons (DCBs) have shown to be effective treatments for long and complex femoropopliteal (FP) lesions. However, there has not been a clinical trial comparing the 2 treatments directly. This study aims to compare the primary patency (PP) and clinical outcomes of SG and DCB for endovascular treatment of complex FP Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions in patients.

From July 2013 to May 2019, a retrospective study was conducted at 2 medical centers to compare the clinical outcomes of Viabahn SG and DCB angioplasty in patients with TASC C/D FP lesions. The study used overlap weighting to adjust for differences in baseline characteristics and to reduce the impact of confounding factors and selection bias between the 2 groups. The primary endpoint was PP through 24 months, and the secondary endpoints included freedom from clinical-driven target lesion revascularization (CD-TLR), all-cause of death rate, and major amputation rate.

A total of 161 limbs in 150 patients with TASC C/D FP lesions were treated either with Viabahn SGs (67 limbs, 65 patients) or DCBs (94 limbs, 85 patients). In the DCB group, 22 target vessels (23.4%) underwent directional atherectomy before DCB angioplasty and 37 target vessels (39.4%) underwent bail-out bare-metal stent implantation for early recoil or severe dissection. The SG group had significantly higher PP rates at both the 12 and 24 months than in the DCB group (75.8% vs 39.2%, p=0.02; 64.1% vs 31.9%, p=0.02), respectively. However, there were no significant differences between the 2 groups in terms of CD-TLR, death rate, and major amputation rate. According to the results of multivariate analysis, DCB angioplasty was the only independent predictor associated with restenosis (hazard ratio [HR]=0.264, 95% confidence interval [CI]=0.100-0.696, p=0.007).

This study showed that SG was associated with a significantly higher PP rate in complex long FP lesions compared with DCB angioplasty. However, there was no significant difference in the freedom from CD-TLR and major amputation rate. It is important to follow the criteria for using SG strictly to avoid early restenosis, which can lead to acute thrombosis and severe limb ischemia. Closer monitoring is recommended for patients who undergo SG implantation.

There has no head-to-head clinical trial that compares DCB and SG in complex long FP lesions. This study showed that SG following the criteria was associated with a significantly higher PP rate compared with DCB angioplasty. Closer monitoring is recommended for patients with SG to avoid acute thrombosis. Randomized controlled trials comparing SG and DCB are necessary.

Aim: Complex atherosclerotic femoro-popliteal lesions have traditionally been treated with bypass surgery. A prosthetic graft is used to save the vein graft for more distal revascularisations or when a vein graft is unavailable. The endovascular approach has gained popularity and is offered as a first-line strategy for complex lesions. This study aimed to evaluate whether endovascular procedures can be used as a first-line treatment strategy for complex native femoro-popliteal lesions over open surgery with prosthetic bypass in patients with peripheral arterial disease (PAD). Methods: This single-centre retrospective observational study was conducted between 2013 and 2021; it included patients with symptomatic PAD who required limb revascularisation at the femoro-popliteal segment and who had complex lesions. The primary endpoints analysed were technical success, primary patency, freedom from clinically driven target lesion revascularisation (cdTLR), freedom from major adverse limb and cardiovascular events (MALE and MACE, respectively), freedom from limb loss, and survival. The secondary endpoints were length of in-hospital stay, and duration and costs of the procedure. Results: We identified 185 limbs among 174 suitable candidates for comparison, wherein 105 were treated with an endovascular procedure and 80 with a femoro-popliteal prosthetic bypass. Most patients in both groups presented with chronic limb-threatening ischaemia, and >90% of them had an American Society of Anesthesiologists (ASA) physical status classification of >3. The endovascular group had more octogenarians (p = 0.02) and patients with coronary disease (p = 0.004). The median follow-up was 30 months. The technical failure rate for endovascular procedures was 4.7%, versus 0% in the open group (p = 0.047). Freedom from MACE was similar in both groups. The endovascular group showed superior primary patency (p < 0.0001), cdTLR (p < 0.0001), MALE (p < 0.0001), and freedom from limb loss (p = 0.0018) at 24 and 48 months. Further analysis performed for the open above-the-knee sub-group showed that the aforementioned endpoints were similar between the groups at 12 months and were better in the endovascular group at 24 and 48 months. Procedural time and in-hospital stay were longer in the open group than in the endovascular group (p < 0.0001 and p < 0.001, respectively). The procedural cost in the endovascular group was 10-fold lower than that in the prosthetic bypass group. Conclusions: Endovascular procedures are safe for treating complex femoro-popliteal lesions in patients at a high risk for surgery and show better outcomes at 24 months than prosthetic bypasses do. The latter may be considered as an alternative should endovascular treatment fail.

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.

To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs.

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.

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].

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.

In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates.

The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC.

From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression.

The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only.

IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation.