- Design
- Systematic review and meta-analysis of randomised trials
- Population
- 8 trials, 1043 patients with coronary artery disease
- Primary outcome
- Late lumen loss
- Effect
- MD 0.06 mm (95% CI -0.02 to 0.14)
A meta-analysis in BMC Cardiovascular Disorders pooled eight randomised trials (1043 patients) comparing sirolimus-coated with paclitaxel-coated balloons for coronary disease.
Late lumen loss did not differ (mean difference 0.06 mm, 95% CI -0.02 to 0.14). Paclitaxel balloons more often produced late lumen enlargement (RR for enlargement with sirolimus 0.66), and after sensitivity analysis showed less binary restenosis in de novo lesions.
The trials were small, used angiographic surrogates rather than clinical events, and mixed in-stent restenosis with de novo disease and several sirolimus formulations.
For now, balloon choice remains an operator decision guided by lesion type and the device-specific trial data available.
- Treat both balloon types as reasonable options; most outcomes did not differ
- Paclitaxel balloons may hold a small edge in de novo lesions, based on angiographic endpoints only
- Look for device-specific trial data, since sirolimus formulations differ
- Clinical event trials are still needed before one type is preferred
Why it matters
The switch to sirolimus balloons has been driven by concern about paclitaxel, not by better results.
Don't overread it
Late lumen loss and restenosis are imaging surrogates; no difference in clinical events was shown.
The statistics, in plain English
The confidence interval for late lumen loss crosses zero, so no difference was detected. The paclitaxel advantages came from secondary outcomes and a sensitivity analysis, which are more likely to be chance findings.
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