Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease
Ramon L Varcoe1, Brian G DeRubertis1, Raghu Kolluri1
1From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.).
Background:
Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown.
Methods:
In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death.
Results:
The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group.
Conclusions:
Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).
