Everolimus-eluting resorbable scaffold superior to angioplasty for CLTI due to infrapopliteal artery disease

Among patients with CLTI and infrapopliteal artery disease, angioplasty is tied to frequent reintervention and adverse limb outcomes from restenosis. There needs to be more data available regarding the effect of the use of drug-eluting resorbable scaffolds on these outcomes. This was further investigated in the present study.

This multi-centre, randomized, controlled trial had 261 patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease (2:1 ratio). The patients received either an everolimus-eluting resorbable scaffold or an angioplasty.

Freedom from amputation above the ankle, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion at 1 year was the primary efficacy endpoint.

The primary safety endpoint was freedom from major adverse limb events at six months and perioperative death.

Key results from the study are:

• No events occurred (primary efficacy end point) in 135/173 patients in the scaffold group and 48/88 patients in the angioplasty group.
  
• Kaplan–Meier estimate was 74% vs 44%, and the absolute difference was 30 percentage points.
• The primary safety endpoint was observed in 165 /170 patients (97%) and 90/90 patients (100%) in the scaffold and angioplasty groups, respectively. The absolute difference was −3 percentage points.
• Serious adverse events (index procedure-related) occurred in 2% of the patients in the scaffold group and 3% in the angioplasty group.

In conclusion, considering the primary efficacy endpoint, using an everolimus-eluting resorbable scaffold is superior to angioplasty in patients with CLTI due to infrapopliteal artery disease. It could be a novel strategy for reducing lower extremity limb outcomes.

Abbott funded the study.

Reference:

Ramon L. Varcoe. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.October 25, 2023. DOI: 10.1056/NEJMoa2305637