Aortic & peripheral vascular diseaseMeta-analysis
Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis
- Patient-level meta-analysis of randomised controlled trials
- pooled analysis
Authors' conclusion
This meta-analysis found no association between paclitaxel-coated device exposure and risk of death, providing reassurance to patients, physicians, and regulators on the safety of paclitaxel-coated devices.
Study context
- Population
- Patients with femoropopliteal occlusive disease undergoing interventional procedures
- Participants
- 2,666 patients · 10 RCTs
- Comparison
- Paclitaxel-coated vs control devices
- Outcome
- Death (all-cause mortality), ITT analysis
- Follow-up
- Median 4.9 years
Pooled result
Death
Hazard ratio
1.14
95% CI 0.93–1.40
Paclitaxel-coated vs Control
HR 1.14 (95% CI 0.93–1.40)
As reported in the abstract
Further pooled results
| Outcome | HR | |
|---|---|---|
| Death, as-treated and crossover analyses — Paclitaxel-coated vs Control · as-treated | 1.13 (95% CI 0.92–1.39) | |
| Death, as-treated and crossover analyses — Paclitaxel-coated vs Control · late crossovers censored | 1.07 (CI 0.87–1.31) | |
| Death, as-treated and crossover analyses — Paclitaxel-coated vs Control · crossovers analysed from date of paclitaxel exposure | 1.04 (CI 0.84–1.28) | |
| 0.512Hazard ratio (log scale) |
Paclitaxel dose and mortality
- No significant effect of paclitaxel dose on mortality risk
Original publication
Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis. Lancet. Published 24 October 2023. doi:10.1016/s0140-6736(23)02189-x
Summarised from the published abstract; every number is checked against it