Sirolimus vs paclitaxel-coated balloons in in-stent coronary restenosis: A meta-analysis

doi:10.5662/wjm.v16.i1.111566

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Mar 20, 2026 (publication date) through Feb 10, 2026

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World Journal of Methodology

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Meta-Analysis

World J Methodol. Mar 20, 2026; 16(1): 111566
Published online Mar 20, 2026. doi: 10.5662/wjm.v16.i1.111566

Sirolimus vs paclitaxel-coated balloons in in-stent coronary restenosis: A meta-analysis

Debvarsha Mandal, Thomas Viji Pulickal, Dhritika Ahlawat, Wasiullah Haqbeen, Izma Kashif, Haroon Alamy, Pramoda Prattipati, Padmavathi Jaladi, Paula Kabiaru, Anjali Avula, Sandeep Kshetri, Irum Raza, Samir Shamieh, Rejina Chhetri

Debvarsha Mandal, Department of Internal Medicine, Avalon University School of Medicine, Willemstad 4797, Netherlands

Thomas Viji Pulickal, Department of Internal Medicine, All India Institute of Medical Sciences, Bhubaneswar 750017, India

Dhritika Ahlawat, Department of Internal Medicine, Government Medical College and Hospital, Chandigarh 0172, Chandīgarh, India

Wasiullah Haqbeen, Haroon Alamy, Department of Cardiology, Kabul University of Medical Sciences, Kabul 20, Afghanistan

Izma Kashif, Department of Cardiology, University College of Medicine and Dentistry, Lahore 05450, Punjab, Pakistan

Pramoda Prattipati, Department of Internal Medicine, Jawaharlal Nehru Medical College, Belagavi 0831, India

Padmavathi Jaladi, Department of Internal Medicine, S Nijalingappa Medical College, HSK Hospital and Research Centre, Bagalkot 587101, India

Paula Kabiaru, Department of Cardiology, University of Nairobi School of Medicine, Nairobi 00100, Kenya

Anjali Avula, Department of Cardiology, Guntur Medical College, Guntur 522001, India

Sandeep Kshetri, Department of Internal Medicine, Manipal College of Medical Sciences, Pokhara 33700, Nepal

Irum Raza, Department of Internal Medicine, Shalamar Medical College, Lahore 05450, Punjab, Pakistan

Samir Shamieh, Department of Internal Medicine, University of Jordan, Amman 11110-17198, Jordan

Rejina Chhetri, Department of Cardiology, Nepalgunj Medical College, Kohalpur, Banke, Kohal 21900, Nepal

Co-first authors: Debvarsha Mandal and Thomas Viji Pulickal.

Author contributions: Mandal D, Pulickal VT, and Chhetri R designed research; Ahlawat D, Haqbeen W, and Kashif I performed research; Alamy H and Prattipati P contributed new reagents or analytic tools; Jaladi P and Kabiaru P validated data; Avula A and Kshetri S analyzed data; Mandal D, Pulickal VT, and Raza I curated data; Ahlawat D, Kashif I, and Shamieh S wrote the paper; Prattipati P, Avula A, and Chhetri R reviewed and edited the paper; Jaladi P and Kshetri S created visualizations; Chhetri R supervised research; Kabiaru P, Shamieh S, and Chhetri R managed project administration; All authors read and reviewed the manuscript.

Conflict-of-interest statement: All authors declare no conflict of interest related to this study.

PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Rejina Chhetri, MD, Department of Cardiology, Nepalgunj Medical College, Kohalpur, Banke, Nepalgunj Medical College Chisapani Banke Baijanath 1 Chisapani, Kohal 21900, Nepal. rejinachhetri01@gmail.com

Received: July 3, 2025
Revised: August 6, 2025
Accepted: August 28, 2025
Published online: March 20, 2026
Processing time: 222 Days and 16.2 Hours

Abstract

BACKGROUND

In-stent restenosis (ISR) is a persistent challenge after percutaneous coronary intervention, with drug-coated balloons such as sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) being key treatment options. However, data comparing their efficacy and safety are limited.

AIM

To evaluate the comparative efficacy and safety of SCBs vs PCBs in patients with coronary ISR.

METHODS

A systematic search of PubMed, EMBASE, and ScienceDirect was conducted from inception to May 2025, following Systematic Reviews and Meta-Analyses guidelines. Eligible studies were randomized controlled trials and observational studies comparing SCBs and PCBs in adults with coronary ISR, reporting outcomes like target lesion revascularization (TLR), major adverse cardiovascular events (MACE), stent thrombosis, all-cause mortality, cardiac mortality, and myocardial infarction. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random-effects model. Heterogeneity was assessed with the I² statistic, and study quality was evaluated using the Cochrane Risk of Bias 2.0 tool and Newcastle-Ottawa Scale. A P value < 0.05 was considered significant.

RESULTS

Four studies (three randomized controlled trials and one observational study) were analyzed. No significant differences were found between SCBs and PCBs for TLR (RR 1.22, 95%CI: 0.72-2.06, P = 0.75, I² = 0%), MACE (RR 1.15, 95%CI: 0.70-1.90, P = 0.80, I² = 0%), stent thrombosis (RR 1.01, 95%CI: 0.57-1.78, P = 0.61, I² = 0%), all-cause mortality (RR 0.67, 95%CI: 0.11-4.06, P = 0.69, I² = 0%), cardiac mortality (RR 1.28, 95%CI: 0.16-10.28, P = 0.77, I² = 0%), or myocardial infarction (RR 0.99, 95%CI: 0.10-9.44, P = 0.35, I² = 0%). Studies had low to moderate risk of bias, with consistent treatment effects.

CONCLUSION

SCBs and PCBs show similar efficacy and safety for coronary ISR, allowing flexible use based on availability and patient needs. Future studies should explore long-term outcomes and high-risk groups to optimize ISR management.

Keywords: Sirolimus coated balloon; Paclitaxel coated balloon; In-stent restenosis; Coronary interventions; Cardiovascular outcomes

Core Tip: This meta-analysis systematically compares sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) for treating coronary in-stent restenosis (ISR). Synthesizing data from randomized controlled trials and observational studies, the findings demonstrate no significant differences between SCBs and PCBs in efficacy or safety outcomes, including target lesion revascularization and major adverse cardiovascular events. These results support flexible clinical use of either DCB type for ISR, while highlighting the need for further research into long-term outcomes and high-risk patient subgroups.