Sex Differences in Outcomes by Revascularization Strategy in Patients With Femoropopliteal Peripheral Arterial Disease: A Substudy of the REVIVE Pooled Analysis.

BACKGROUND

Women have been underrepresented in peripheral artery disease revascularization trials. We aimed to analyze sex-specific outcomes after endovascular therapy (EVT) with stent implantation versus bypass surgery (BSx) in patients with symptomatic femoropopliteal peripheral artery disease, leveraging data from the REVIVE (Revascularization Strategies in Patients With Peripheral Arterial Disease Involving the Femoropopliteal Arteries) study.

METHODS

The REVIVE study pooled individual patient data from 5 randomized controlled trials comparing EVT with stent implantation versus BSx. The primary end point was major adverse limb events, a composite of all-cause death, major amputation, or reintervention. Secondary end points included amputation-free survival, the individual components of major adverse limb events, and primary patency at 2 years. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days.

RESULTS

Of 639 patients, 185 (29.0%) were women. At 2 years, there were no significant differences in major adverse limb events between EVT and BSx in women (40.6% versus 42.1%; adjusted hazard ratio [aHR], 0.93 [95% CI, 0.57-1.52]) and men (39.7% versus 34.4%; aHR, 0.98 [95% CI, 0.69-1.39]; P-interaction=0.963). Similarly, there were no differences in secondary end points between EVT and BSx, regardless of sex. EVT, compared with BSx, was associated with lower rates of early complications (8.7% versus 25.9%, P=0.002 in women and 5.9% versus 21.5%, P<0.001 in men; P-interaction =0.77) and shorter hospital stay (3.7±5.7 versus 7.2±4.3 days, P<0.001 in women and 2.8±3.2 versus 7.4±5.1, P<0.001 in men).

CONCLUSIONS

Our analysis supports the efficacy and safety of EVT with stent implantation as an alternative to BSx in patients with symptomatic peripheral artery disease involving the femoropopliteal segment, regardless of sex.