PMID- 37888915 OWN - NLM STAT- MEDLINE DCOM- 20240108 LR - 20240410 IS - 1533-4406 (Electronic) IS - 0028-4793 (Linking) VI - 390 IP - 1 DP - 2024 Jan 4 TI - Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. PG - 9-19 LID - 10.1056/NEJMoa2305637 [doi] AB - 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.). CI - Copyright (c) 2023 Massachusetts Medical Society. FAU - Varcoe, Ramon L AU - Varcoe RL AD - From 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.). FAU - DeRubertis, Brian G AU - DeRubertis BG AD - From 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.). FAU - Kolluri, Raghu AU - Kolluri R AD - From 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.). FAU - Krishnan, Prakash AU - Krishnan P AD - From 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.). FAU - Metzger, David C AU - Metzger DC AD - From 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.). FAU - Bonaca, Marc P AU - Bonaca MP AUID- ORCID: 0000-0002-9860-3584 AD - From 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.). FAU - Shishehbor, Mehdi H AU - Shishehbor MH AD - From 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.). FAU - Holden, Andrew H AU - Holden AH AD - From 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.). FAU - Bajakian, Danielle R AU - Bajakian DR AD - From 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.). FAU - Garcia, Lawrence A AU - Garcia LA AD - From 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.). FAU - Kum, Steven W C AU - Kum SWC AD - From 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.). FAU - Rundback, John AU - Rundback J AD - From 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.). FAU - Armstrong, Ehrin AU - Armstrong E AD - From 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.). FAU - Lee, Jen-Kuang AU - Lee JK AD - From 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.). FAU - Khatib, Yazan AU - Khatib Y AD - From 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.). FAU - Weinberg, Ido AU - Weinberg I AUID- ORCID: 0000-0003-4633-5132 AD - From 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.). FAU - Garcia-Garcia, Hector M AU - Garcia-Garcia HM AD - From 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.). FAU - Ruster, Karine AU - Ruster K AD - From 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.). FAU - Teraphongphom, Nutte T AU - Teraphongphom NT AD - From 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.). FAU - Zheng, Yan AU - Zheng Y AD - From 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.). FAU - Wang, Jin AU - Wang J AUID- ORCID: 0000-0002-5627-6642 AD - From 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.). FAU - Jones-McMeans, Jennifer M AU - Jones-McMeans JM AD - From 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.). FAU - Parikh, Sahil A AU - Parikh SA AUID- ORCID: 0000-0002-0551-5885 AD - From 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.). CN - LIFE-BTK Investigators LA - eng SI - ClinicalTrials.gov/NCT04227899 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20231025 PL - United States TA - N Engl J Med JT - The New England journal of medicine JID - 0255562 RN - 9HW64Q8G6G (Everolimus) RN - 0 (Immunosuppressive Agents) SB - IM CIN - Nat Rev Cardiol. 2024 Jan;21(1):8. PMID: 37932422 CIN - N Engl J Med. 2024 Apr 4;390(13):1243. PMID: 38598584 CIN - N Engl J Med. 2024 Apr 4;390(13):1243-1244. PMID: 38598585 CIN - N Engl J Med. 2024 Apr 4;390(13):1244-1245. PMID: 38598586 MH - Humans MH - Absorbable Implants MH - *Angioplasty/adverse effects/methods MH - Angioplasty, Balloon/adverse effects/methods MH - *Blood Vessel Prosthesis Implantation/methods MH - Chronic Disease MH - *Chronic Limb-Threatening Ischemia/etiology/surgery MH - *Drug-Eluting Stents MH - Everolimus/administration & dosage/adverse effects/therapeutic use MH - Immunosuppressive Agents/administration & dosage/adverse effects/therapeutic use MH - Ischemia/drug therapy/etiology/surgery MH - *Peripheral Arterial Disease/complications/drug therapy/surgery MH - *Popliteal Artery/surgery MH - Tissue Scaffolds MH - Treatment Outcome FIR - Varcoe, Ramon L IR - Varcoe RL FIR - Parikh, Sahil A IR - Parikh SA FIR - DeRubertis, Brian G IR - DeRubertis BG FIR - Bajakian, Danielle R IR - Bajakian DR FIR - Holden, Andrew IR - Holden A FIR - Armstrong, Ehrin J IR - Armstrong EJ FIR - Bonaca, Marc IR - Bonaca M FIR - Krishnan, Prakash IR - Krishnan P FIR - Kum, Steven IR - Kum S FIR - Metzger, D Christopher IR - Metzger DC FIR - Garcia, Lawrence IR - Garcia L FIR - Rundback, John IR - Rundback J FIR - Shishehbor, Mehdi IR - Shishehbor M FIR - Yu, Shawn IR - Yu S FIR - Liu, Guangda IR - Liu G FIR - Nie, Hong IR - Nie H FIR - Li, Xiaolin IR - Li X FIR - Ying, Celes IR - Ying C FIR - Toth, Cynthia IR - Toth C FIR - Halsrud, Kristin IR - Halsrud K FIR - Otterbach, Kim IR - Otterbach K FIR - Rodriguez, Orlando IR - Rodriguez O EDAT- 2023/10/27 12:43 MHDA- 2024/01/04 11:44 CRDT- 2023/10/27 08:33 PHST- 2024/01/04 11:44 [medline] PHST- 2023/10/27 12:43 [pubmed] PHST- 2023/10/27 08:33 [entrez] AID - 10.1056/NEJMoa2305637 [doi] PST - ppublish SO - N Engl J Med. 2024 Jan 4;390(1):9-19. doi: 10.1056/NEJMoa2305637. Epub 2023 Oct 25.