Perioperative Systemic Complications and Adverse Events in the BEST-CLI Trial

Abstract

Perioperative morbidity is a major deciding factor for choosing the revascularization method for chronic limb-threatening ischemia. Our goal was to assess systemic perioperative complications in the BEST-CLI trial. The BEST-CLI trial was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies. There were two Cohorts: Cohort 1 included patients with adequate single segment great saphenous vein, Cohort 2 included those without single segment great saphenous vein. Data were queried for major adverse cardiovascular events (MACE; a composite of myocardial infarction, stroke, death), nonserious (non-SAE) and SAE 30 days after randomization. Per protocol analysis was used (intervention received without crossover). There were 1367 (662 OPEN, 705 ENDO) patients in Cohort 1 and 379 (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality was low in Cohort 1 being 1.5% (OPEN 1.8%; ENDO 1.3%) and Cohort 2 being 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 were 4.98% for OPEN vs 3.3% for ENDO (P = .12) and Cohort 2 were 4.3% for OPEN and 1.6% for ENDO (P = .16). On multivariable analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (HR, 1.49; 95% CI, .85-2.62; P = .17) or Cohort 2 (HR, 2.25; 95% CI, .49-10.4; P = .3). Acute renal failure was similar by intervention with Cohort 1 being 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, .85-3.12; P = .14) and Cohort 2 being 4.2% vs 1.6% (HR, 2.86; 95% CI, .75-10.8; P = .12). Venous thromboembolism rates were also low with Cohort 1 at 0.7% (OPEN 0.9%; ENDO 0.4%) and Cohort 2 at 0.3% (OPEN 0.5%; ENDO 0%). Patients with non-SAE in Cohort 1 were 23.4% for OPEN and 17.9% for ENDO (P = .06) and in Cohort 2 were 21.8% for OPEN and 19.9% for ENDO (P = .71). Patients with SAE were Cohort 1 were 35.3% for OPEN and 31.6% for ENDO; P = .57 and Cohort 2 were for 25.5% OPEN and 23.6% for ENDO (P = .72) (Table). Most common etiologies for non-SAE and SAE were infectious, procedural complications, and related to underlying peripheral vascular disease. Patients with chronic limb-threatening ischemia who were deemed suitable for open lower extremity bypass surgery have similar periprocedural complications following either OPEN or ENDO revascularization. The choice of revascularization strategy should be based primarily on effectiveness in restoring adequate and durable limb perfusion.TableCardiovascular complications and adverse events by interventionOutcomeCohort 1 OPENCohort 1 ENDOP valueCohort 2 OPENCohort 2 ENDOP valuen = 662n = 705n = 188n = 191MACE4.98%3.3%.124.3%1.6%.16Non-SAE23.4%17.9%.0621.8%19.9%.71SAE35.3%31.6%.5725.5%23.6%.72ENDO, Endovascular; MACE, Major adverse cardiovascular event; OPEN, open repair; SAE, serious adverse event. Open table in a new tab