Sirolimus and paclitaxel drug-coated balloons perform similarly in coronary arteries
A meta-analysis of 8 trials and 1,043 patients finds sirolimus- and paclitaxel-coated balloons deliver similar results in coronary artery disease, with a few caveats.
Summary
Coronary artery disease is the world's leading killer, and doctors increasingly use drug-coated balloons instead of stents to reopen narrowed arteries without leaving metal behind. This review pooled eight randomized trials with 1,043 patients comparing balloons coated with sirolimus against those coated with paclitaxel, the long-established standard. For most measures, including artery re-narrowing, repeat procedures, heart attacks, and death, the two performed about the same. Paclitaxel balloons looked slightly better on two measures: late lumen enlargement and, in a sensitivity analysis, re-narrowing in new (de novo) lesions. These signals were fragile and came from small trials. Both balloon types appear safe, but longer and larger studies are needed.
Detailed Summary
Coronary artery disease is the leading cause of death and disability worldwide. Low- and middle-income countries alone account for about 7 million deaths and 129 million disability-adjusted life years each year. Stents reopen narrowed arteries, but they leave permanent metal behind and require prolonged dual antiplatelet therapy. Drug-coated balloons (DCBs) deliver an antiproliferative drug to the vessel wall during a 30-60 second inflation and leave no implant. Paclitaxel dominates the evidence base, while sirolimus, an mTOR inhibitor, is a newer alternative. Head-to-head data have been limited.
The authors searched PubMed, Web of Science, Cochrane Library, Scopus, and Embase through July 2025. They screened 1,816 records, removed 612 duplicates, reviewed 63 full texts, and included eight randomized trials with 1,043 patients. Three trials studied de novo lesions, four studied in-stent restenosis, and one studied bifurcation lesions. Follow-up ranged from 6 to 12 months. Sirolimus platforms were SeQuent SCB 4 mg/mm² (five trials), MagicTouch 1.27 mg/mm² (two), and Acotec (one). Cochrane RoB 2 rated two trials low risk and six as some concerns, with none high risk.
For the primary outcome, late lumen loss, there was no significant difference (mean difference 0.06 mm, 95% CI -0.02 to 0.14, P = 0.16; I² = 61%). The results were similar for de novo lesions (0.10 mm) and in-stent restenosis (0.03 mm). Egger's test showed no small-study effects (P = 0.32). Secondary angiographic outcomes also showed no differences. These were acute lumen gain, diameter stenosis, and minimum lumen diameter. Binary restenosis (RR 1.22, 95% CI 0.78-1.91), target lesion revascularization (RR 1.04, 0.74-1.46), and MACE (RR 1.02, 0.68-1.53, 1,043 patients) were likewise similar.
Safety outcomes were statistically indistinguishable. All-cause mortality had RR 0.58 (0.20-1.65), cardiac death RR 0.43 (0.11-1.65), and target vessel myocardial infarction RR 1.37 (0.46-4.08). Event counts were small, so the confidence intervals are wide. Subgroup analyses by sirolimus platform and dose also found no significant differences in late lumen loss: SeQuent 0.06 mm, MagicTouch 0.15 mm, and Acotec -0.02 mm. The Acotec trial showed a possible trend toward less binary restenosis (RR 0.34, 0.12-1.03, P = 0.06).
Two outcomes favored paclitaxel. Late lumen enlargement was lower with paclitaxel balloons (RR 0.66, 95% CI 0.49-0.87, P = 0.004; three studies, 256 patients; I² = 0%). After a leave-one-out sensitivity analysis excluding the Zhou 2025 bifurcation trial, binary restenosis in de novo lesions also favored paclitaxel (reported effect 2.32, 95% CI 1.17-4.62, P = 0.02). Both findings are fragile. One came from a post hoc exclusion, and the other rests on three small trials. Late lumen enlargement is conventionally a favorable vessel response, so the direction and interpretation of that result deserve caution.
Overall, sirolimus and paclitaxel balloons appear similarly safe and effective in the short term. Interpretation is limited by small trials, follow-up of 6 to 12 months, mixed lesion types and devices, and populations that were 73-92% male. The pooled analysis is not powered for hard clinical events, and the authors call for larger, longer studies to match balloon type to specific lesions and patients.
Key Findings
- Eight RCTs with 1,043 patients showed no significant difference in late lumen loss between sirolimus and paclitaxel balloons (MD 0.06 mm, 95% CI -0.02 to 0.14, P = 0.16)
- MACE was similar across all 1,043 patients (RR 1.02, 95% CI 0.68-1.53, P = 0.93, I² = 0%)
- Target lesion revascularization did not differ (RR 1.04, 95% CI 0.74-1.46, P = 0.83) across seven studies with 993 patients
- Late lumen enlargement favored paclitaxel balloons (RR 0.66, 95% CI 0.49-0.87, P = 0.004) in three studies with 256 patients
- After excluding the Zhou 2025 trial, de novo binary restenosis favored paclitaxel (reported effect 2.32, 95% CI 1.17-4.62, P = 0.02); the overall result was non-significant (RR 1.22)
- Safety was statistically similar: all-cause mortality RR 0.58 (0.20-1.65), cardiac death RR 0.43 (0.11-1.65), target vessel MI RR 1.37 (0.46-4.08)
- Late lumen loss did not differ across sirolimus platforms (SeQuent 0.06 mm, MagicTouch 0.15 mm, Acotec -0.02 mm), suggesting formulation alone does not explain outcomes
Methodology
This PRISMA- and Cochrane-guided systematic review and meta-analysis searched five databases through July 2025 and included only RCTs (8 trials, 1,043 patients, 6-12 months of follow-up). Two authors screened studies, and risk of bias was assessed with Cochrane RoB 2. Analyses used RevMan 5.4 with fixed- or random-effects models, mean differences for continuous outcomes, and risk ratios for dichotomous outcomes. Heterogeneity (I², chi-square) was handled with leave-one-out sensitivity analysis, and publication bias was assessed with funnel plots and Egger's test. Subgroup analyses split results by lesion type (de novo vs in-stent restenosis) and by sirolimus platform and dose.
Study Limitations
Only eight relatively small trials were included, with 6-12 months of follow-up and moderate heterogeneity (I² up to 61%) in several outcomes. Six of the eight trials had some risk-of-bias concerns. The significant paclitaxel advantages came from a small three-study analysis and a post hoc leave-one-out exclusion, and the subgroups mixed different devices, doses, and lesion types. Populations were predominantly male, and the authors call for larger, longer trials. No conflict-of-interest details were given in the supplied text, and the discussion section was truncated.
Enjoyed this summary?
Get the latest longevity research delivered to your inbox every week.
Enter your email to subscribe: