Highlights
In the final SAFE-PAD report, paclitaxel-coated drug-coated devices used for femoropopliteal revascularization were not associated with excess long-term all-cause mortality compared with non-drug-coated devices.
The adjusted hazard ratio for death was 0.98 (95% confidence interval 0.97 to 0.99), satisfying the pre-specified 5% non-inferiority margin and remaining consistent across multiple sensitivity analyses and clinical subgroups.
