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.).
Insights
Everolimus-eluting resorbable scaffolds significantly improved limb outcomes for patients with chronic limb-threatening ischemia (CLTI) compared to angioplasty. This innovative treatment reduced reintervention and adverse events, offering a superior option for infrapopliteal artery disease.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomaterials Science
Background:
- Chronic limb-threatening ischemia (CLTI) with infrapopliteal artery disease often leads to restenosis and poor limb outcomes with angioplasty.
- The efficacy of drug-eluting resorbable scaffolds in managing these complex vascular conditions remains under investigation.
Purpose of the Study:
- To evaluate the effectiveness and safety of everolimus-eluting resorbable scaffolds compared to angioplasty in patients with CLTI.
- To assess the primary efficacy endpoint of freedom from major adverse limb events at one year.
Main Methods:
- A multicenter, randomized controlled trial involving 261 patients with CLTI and infrapopliteal artery disease.
- Patients were randomized (2:1) to receive either an everolimus-eluting resorbable scaffold or angioplasty.
- Primary efficacy endpoint: freedom from amputation, vessel occlusion, revascularization, or binary restenosis at 1 year. Primary safety endpoint: freedom from major adverse limb events and perioperative death at 6 months.
Main Results:
- The primary efficacy endpoint was met in 74% of scaffold patients versus 44% of angioplasty patients (P<0.001), demonstrating superiority.
- The primary safety endpoint was met in 165/170 scaffold patients and 90/90 angioplasty patients (P<0.001 for noninferiority).
- Serious adverse events related to the index procedure were low (2% scaffold vs. 3% angioplasty).
Conclusions:
- Everolimus-eluting resorbable scaffolds offer a superior treatment option compared to angioplasty for CLTI patients with infrapopliteal artery disease.
- The study met its primary efficacy endpoint, showing significant improvement in limb salvage and reduction in reintervention.
- The scaffold demonstrated favorable safety and efficacy, addressing a critical unmet need in vascular intervention.
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.).
