Photo Credit: Rasi Bhadramani
Drug-coated scaffolds outperform angioplasty in treating chronic limb-threatening ischemia, leading to higher limb salvage rates and reduced need for repeat procedures, according to a retrospective study.
The following is a summary of “Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease,” published in the January 2024 issue of Cardiology by Varcoe et al.
Researchers conducted a retrospective study to compare angioplasty and drug-eluting resorbable scaffolds for infrapopliteal revascularization in chronic limb-threatening ischemia (CLTI), aiming to clarify their impact on reintervention and limb salvage.
They involved 261 patients with CLTI and infrapopliteal artery disease and were randomly assigned( 2:1 ratio) to receive either everolimus-eluting resorbable scaffold or angioplasty. At the 1-year mark, the primary endpoint was freedom from events such as amputation, vessel occlusion, clinically driven revascularization, and binary target lesion restenosis. The main safety endpoint, assessed at 6 months, focused on freedom from major adverse limb events.
The results showed the primary efficacy endpoint (i.e., no events) in 13 (173 patients) in the scaffold group and 48 (88 patients) in angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% CI, 15 to 46; one-sided P<0.001 for superiority). The primary safety endpoint was seen in 165 (170 patients) in the scaffold group and 90 (90 patients) in the angioplasty group with an absolute difference, −3 percentage points; 95% CI, −6 to 0; one-sided P<0.001 for noninferiority. Serious AEs after the procedure happened in 2% of scaffold group patients and 3% in the angioplasty group.
Investigators concluded that drug-coated stents trumped angioplasty for CLTI patients, saving limbs and reducing repeat procedures.
Source: nejm.org/doi/full/10.1056/NEJMoa2305637?query=featured_home