Key result
Femoropopliteal paclitaxel-coated devices increase 2-year all-cause mortality ~68% vs uncoated controls.
Why the study?
In-stent restenosis remains a persistent challenge after PCI, but data comparing the efficacy and safety of sirolimus-coated balloons versus paclitaxel-coated balloons are limited.
Meta-Analysis (n=4,663)
Relative Risk: 1.68 (95% CI 1.15–2.47)
Absolute Event Rate: 7.2% vs 3.8%
Meta-analysis finds equivalent safety and efficacy between sirolimus- and paclitaxel-coated balloons in coronary in-stent restenosis, suggesting both devices are effective treatment options.
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 I 2 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, I 2 = 0%), MACE (RR 1.15, 95%CI: 0.70-1.90, P = 0.80, I 2 = 0%), stent thrombosis (RR 1.01, 95%CI: 0.57-1.78, P = 0.61, I 2 = 0%), all-cause mortality (RR 0.67, 95%CI: 0.11-4.06, P = 0.69, I 2 = 0%), cardiac mortality (RR 1.28, 95%CI: 0.16-10.28, P = 0.77, I 2 = 0%), or myocardial infarction (RR 0.99, 95%CI: 0.10-9.44, P = 0.35, I 2 = 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.
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Mandal et al. (2026) conducted a meta-analysis in Peripheral arterial disease of the femoropopliteal artery (n=4,663). Paclitaxel-coated balloons and stents vs. Control arms (uncoated balloons or bare metal stents) was evaluated on All-cause patient death at 2 years (RR 1.68, 95% CI 1.15-2.47). Paclitaxel-coated balloons and stents applied in the femoropopliteal artery significantly increased the risk of all-cause death at 2 years (RR 1.68) and up to 5 years compared to control treatments.
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