USA: In patients with peripheral artery disease (PAD), treatment with covered, bare-metal, or drug-eluting stents showed similar safety and efficacy outcomes at two years, according to results from REVIVE pooled analysis. The findings appeared in the January 2023 issue of the Journal of the American College of Cardiology.
"These results further support the safety and efficacy of endovascular therapy (EVT) as an alternative to bypass surgery (BSx) in patients with symptomatic femoropopliteal PAD," the researchers wrote in their study.
Considering the absence of powered studies to compare significant clinical outcomes after endovascular therapy with stent implantation versus bypass surgery for PAD patients, Serdar Farhan from Icahn School of Medicine at Mount Sinai in New York, New York, USA, and colleagues sought to conduct a pooled analysis of individual patient data from all randomized controlled trials (RCTs) comparing EVT vs bypass surgery.
Principal investigators of 5 of 6 available RCTs agreed to pool individual patient data. Major adverse limb events, a composite of major amputation, target limb intervention, or all-cause death (primary endpoint) were determined. Secondary endpoints included major adverse limb event components, amputation-free survival, and primary patency. Early complications were infection, bleeding, or all-cause death within 30 days.
The study revealed the following findings:
The analysis was done on 639 patients with a mean age of 68.1 years, and 29.0% were women. Baseline characteristics were similar between groups.
At two years, there were no significant differences between patients who received endovascular therapy and those who received bypass surgery regarding major adverse limb events (40.1% vs 36.4%; adjusted HR [aHR]: 1.04), amputation-free survival (88.1% vs 90.0%; aHR for death or amputation: 1.04) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT versus those who received bypass surgery (51.2% vs 61.3%; aHR for loss of primary patency: 1.31).
EVT was associated with remarkably lower rates of early complications (6.8% vs 22.6%) and shorter hospital stays (3.1 ± 4.2 days vs 7.4 ± 4.9 days).
"REVIVE helps fill in evidence gaps and sheds light on the high major adverse limb events rates in these patients irrespective of revascularization type," Marc Bonaca and Shea E. Hogan from CPC Clinical Research, Aurora, CO, wrote in an accompanying editorial.
"Our findings further support the safety and efficacy of EVT as an alternative to bypass surgery in patients with symptomatic femoropopliteal PAD," the authors concluded.
Reference:
The study, "Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease," was published in the American College of Cardiology Journal. DOI: https://www.jacc.org/doi/10.1016/j.jacc.2022.10.036