PMID- 37318428 OWN - NLM STAT- MEDLINE DCOM- 20230925 LR - 20230927 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 78 IP - 4 DP - 2023 Oct TI - Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in the BEST-CLI Trial. PG - 1012-1020.e2 LID - S0741-5214(23)01275-2 [pii] LID - 10.1016/j.jvs.2023.05.040 [doi] AB - OBJECTIVE: Anticipated perioperative morbidity is an important factor for choosing a revascularization method for chronic limb-threatening ischemia (CLTI). Our goal was to assess systemic perioperative complications of patients treated with surgical and endovascular revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. METHODS: BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies for patients with CLTI. Two parallel cohorts were studied: Cohort 1 included patients with adequate single-segment great saphenous vein (SSGSV), whereas Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE-composite myocardial infarction, stroke, death), non-serious (non-SAEs) and serious adverse events (SAEs) (criteria-death/life-threatening/requiring hospitalization or prolongation of hospitalization/significant disability/incapacitation/affecting subject safety in trial) 30 days after the procedure. Per protocol analysis was used (intervention received without crossover), and risk-adjusted analysis was performed. RESULTS: There were 1367 patients (662 OPEN, 705 ENDO) in Cohort 1 and 379 patients (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality in Cohort 1 was 1.5% (OPEN 1.8%; ENDO 1.3%) and in Cohort 2 was 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 was 4.7% for OPEN vs 3.13% for ENDO (P = .14), and in Cohort 2, was 4.28% for OPEN and 1.05% for ENDO (P = .15). On risk-adjusted analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (hazard ratio [HR] 1.5; 95% confidence interval [CI], 0.85-2.64; P = .16) or Cohort 2 (HR, 2.17; 95% CI, 0.48-9.88; P = .31). The incidence of acute renal failure was similar across interventions; in Cohort 1 it was 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, 0.85-3.12; P = .14), and in Cohort 2, it was 4.2% OPEN vs 1.6% ENDO (HR, 2.86; 95% CI, 0.75-10.8; P = .12). The occurrence of venous thromboembolism was low overall and was similar between groups in Cohort 1 (OPEN 0.9%; ENDO 0.4%) and Cohort 2 (OPEN 0.5%; ENDO 0%). Rates of any non-SAEs in Cohort 1 were 23.4% in OPEN and 17.9% in ENDO (P = .013); in Cohort 2, they were 21.8% for OPEN and 19.9% for ENDO (P = .7). Rates for any SAEs in Cohort 1 were 35.3% for OPEN and 31.6% for ENDO (P = .15); in Cohort 2, they were 25.5% for OPEN and 23.6% for ENDO (P = .72). The most common types of non-SAEs and SAEs were infection, procedural complications, and cardiovascular events. CONCLUSIONS: In BEST-CLI, patients with CLTI who were deemed suitable candidates for open lower extremity bypass surgery had similar peri-procedural complications following either OPEN or ENDO revascularization: In such patients, concern about risk of peri-procedure complications should not be a deterrent in deciding revascularization strategy. Rather, other factors, including effectiveness in restoring perfusion and patient preference, are more relevant. CI - Copyright (c) 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Siracuse, Jeffrey J AU - Siracuse JJ AD - Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University, Chobanian and Avedisian School of Medicine, Boston, MA. Electronic address: jeffrey.siracuse@bmc.org. FAU - Farber, Alik AU - Farber A AD - Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University, Chobanian and Avedisian School of Medicine, Boston, MA. FAU - Menard, Matthew T AU - Menard MT AD - Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. FAU - Conte, Michael S AU - Conte MS AD - Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA. FAU - Kaufman, John A AU - Kaufman JA AD - Department of Interventional Radiology, Oregon Health & Science University, Portland, OR. FAU - Jaff, Michael AU - Jaff M AD - Harvard Medical School, Boston, MA. FAU - Kiang, Sharon C AU - Kiang SC AD - Division of Vascular Surgery, Loma Linda University Medical Center and Veterans Affairs, Loma Linda, CA. FAU - Ochoa Chaar, Cassius I AU - Ochoa Chaar CI AD - Division of Vascular and Endovascular Surgery, Yale University, School of Medicine, New Haven, CT. FAU - Osborne, Nicholas AU - Osborne N AD - Division of Vascular and Endovascular Surgery, University of Michigan, Ann Arbor, MI. FAU - Singh, Niten AU - Singh N AD - Division of Vascular and Endovascular Surgery, University of Washington, Seattle, WA. FAU - Tan, Tze-Woei AU - Tan TW AD - Division of Vascular Surgery and Endovascular Therapy, University of Southern California, Los Angeles, CA. FAU - Guzman, Raul J AU - Guzman RJ AD - Division of Vascular and Endovascular Surgery, Yale University, School of Medicine, New Haven, CT. FAU - Strong, Michael B AU - Strong MB AD - Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. FAU - Hamza, Taye H AU - Hamza TH AD - HealthCore, Watertown, MA. FAU - Doros, Gheorghe AU - Doros G AD - Department of Biostatics, Boston University, School of Public Health, Boston, MA. FAU - Rosenfield, Kenneth AU - Rosenfield K AD - Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard Medical School, Boston, MA. LA - eng SI - ClinicalTrials.gov/NCT02060630 GR - U01 HL107407/HL/NHLBI NIH HHS/United States GR - U01 HL107352/HL/NHLBI NIH HHS/United States GR - U01 HL115662/HL/NHLBI NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20230614 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 SB - IM MH - Humans MH - Chronic Limb-Threatening Ischemia MH - Prospective Studies MH - Risk Factors MH - *Endovascular Procedures MH - *Peripheral Arterial Disease/diagnostic imaging/surgery MH - Limb Salvage MH - Ischemia/diagnostic imaging/etiology/surgery MH - Lower Extremity/blood supply MH - Treatment Outcome MH - Retrospective Studies OTO - NOTNLM OT - Bypass OT - Complications OT - Endovascular OT - Limb ischemia EDAT- 2023/06/15 13:07 MHDA- 2023/09/25 06:43 CRDT- 2023/06/15 10:31 PHST- 2023/05/01 00:00 [received] PHST- 2023/05/22 00:00 [revised] PHST- 2023/05/22 00:00 [accepted] PHST- 2023/09/25 06:43 [medline] PHST- 2023/06/15 13:07 [pubmed] PHST- 2023/06/15 10:31 [entrez] AID - S0741-5214(23)01275-2 [pii] AID - 10.1016/j.jvs.2023.05.040 [doi] PST - ppublish SO - J Vasc Surg. 2023 Oct;78(4):1012-1020.e2. doi: 10.1016/j.jvs.2023.05.040. Epub 2023 Jun 14.