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Sirolimus and paclitaxel-coated balloons show similar outcomes for coronary in-stent restenosisSirolimus and paclitaxel balloons show similar results for heart disease

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Key Takeaway
Consider that sirolimus and paclitaxel-coated balloons have similar outcomes for coronary in-stent restenosis, with minor angiographic differences.

This is a GRADE-assessed systematic review and meta-analysis comparing sirolimus-coated balloon (SCB) angioplasty to paclitaxel-coated balloon (PCB) angioplasty for coronary in-stent restenosis. The analysis included 3,633 participants. For the primary outcomes, target lesion failure showed no notable variations (RR, 1.08; 95% CI, 0.90-1.29, P = 0.36), and target lesion revascularization also showed no notable variations (RR, 1.16; 95% CI, 0.98-1.37, P = 0.08). Secondary outcomes, including stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, and survival, were similar between groups. Angiographic endpoints like late lumen loss and acute gain showed no discernible variations, but minimal lumen diameter was significantly smaller in the SCB group (MD, -0.08 mm; 95% CI, -0.14 to -0.01, P = 0.02). The authors acknowledge low interstudy heterogeneity for most clinical outcomes and moderate heterogeneity for some angiographic measures. They conclude that SCB and PCBs have similar overall safety and effectiveness, suggesting that customized selection may improve outcomes, but caution against inferring causation or overstating angiographic findings without clinical context.

A new analysis of 12 studies involving 3,633 people with coronary artery disease compared two types of drug-coated balloons used to reopen blocked heart arteries. One balloon is coated with sirolimus, the other with paclitaxel. Both are used to treat in-stent restenosis, a condition where a previously placed stent becomes narrowed again.

The review found that the two balloons performed similarly on key outcomes such as the need for repeat procedures, heart attacks, stent clots, and death. There were no notable differences in target lesion failure or target lesion revascularization. However, one angiographic measure, the minimal lumen diameter after the procedure, was slightly smaller with the sirolimus balloon. The clinical importance of this difference is unclear.

The analysis was a systematic review with GRADE assessment, which is a high-quality method for summarizing evidence. The researchers noted low heterogeneity for most outcomes, meaning the studies were consistent. No major safety concerns were reported.

Readers should know that this is a pooled analysis of existing studies, not a new trial. The findings suggest that both balloon types are reasonable options, and the choice may depend on individual patient factors. As always, treatment decisions should be made with a doctor.

What this means for you:
Sirolimus and paclitaxel balloons work similarly for coronary artery disease.

Study Details

Study typeMeta analysis
Sample sizen = 3,633
EvidenceLevel 1
PublishedJun 2026
View Original Abstract ↓
Despite advances in percutaneous coronary procedures, in-stent restenosis remains a significant challenge. Although sirolimus- and paclitaxel-coated balloons are promising alternatives, their comparative safety and efficacy remain uncertain. PubMed, Embase, and Cochrane databases were searched using relevant keywords from inception until August 2025. A total of 11 studies (7 randomized controlled trials and 4 observational cohort studies) were included, comprising 3633 participants overall. The primary outcomes assessed were target lesion revascularization and target lesion failure. Meanwhile, the Secondary outcomes included stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, survival, binary restenosis, and angiographic endpoints (acute gain, diameter stenosis, in-segment late lumen loss, in-lesion late lumen loss, and in-segment minimal lumen diameter). Interstudy heterogeneity was assessed using I ² and X ² statistics ( I ²>50% = significant heterogeneity). Interstudy heterogeneity was low for most outcomes, including all primary clinical endpoints, with moderate heterogeneity observed only for select angiographic measures (notably in-segment late lumen loss and diameter stenosis). Statistical analysis was conducted using R software and RStudio (version 4.4.2), with a P value of < 0.05 indicating statistical significance. This meta-analysis examined studies that compared paclitaxel-coated balloon (PCB) versus standard balloon [sirolimus-coated balloon (SCB)] angioplasty. Regarding primary outcomes, there were no notable variations in target lesion failure [risk ratio (RR), 1.08, 95% CI, 0.90-1.29, P = 0.36] or target lesion revascularization (RR, 1.16, 95% CI, 0.98-1.37, P = 0.08). With all aggregated estimates being nonsignificant, secondary outcomes such as stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, and survival were similar between groups. Angiographic endpoints revealed no discernible variations in late lumen loss (in-lesion and in-segment), acute gain, or diameter stenosis. Nonetheless, the SCB group's minimal lumen diameter was significantly smaller than that of the PCB group (MD, -0.08 mm, 95% CI, -0.14 to -0.01, P = 0.02). In treating coronary in-stent restenosis, SCB and PCBs show similar overall safety and effectiveness; lesion-specific angiographic variations indicate that customized selection may improve patient outcomes.
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