Abstract
BACKGROUND: BEST-CLI (Best Endovascular vs Best Surgical Therapy in Patients with Chronic Limb-Threatening Ischemia [CLTI]) demonstrated the superiority of single-segment great saphenous vein bypass over endovascular treatment for patients with CLTI who were candidates for both treatment strategies. However, with the rise of endovascular techniques and the subsequent decrease in the number of vein bypass procedures being performed, concerns have emerged regarding the continued ability to perform surgical bypass safely and effectively. This study aimed to evaluate whether outcomes after lower extremity infrainguinal vein bypass for CLTI have changed over the past two decades by comparing data from two major randomized controlled trials: BEST-CLI and PREVENT III (Project or Ex-Vivo vein graft Engineering via Transfection III). METHODS: This post hoc comparative analysis included patients with CLTI who underwent lower extremity infrainguinal vein bypass in the multicenter, prospective BEST-CLI (2014-2019) and PREVENT III (2001-2003) trials. The primary outcome was a composite of major adverse limb event (MALE) or death at 1 year. Secondary outcomes included perioperative (30-day) rates of major adverse cardiovascular event (MACE) and MALE. Multivariable Cox and logistic regression models were used for 1-year and 30-day outcomes, respectively, to compare outcomes between the two cohorts; confirmatory analyses were conducted using propensity score methods. RESULTS: In total, 2114 patients underwent infrainguinal vein bypass for CLTI (710 BEST-CLI and 1404 PREVENT III). The mean patient age was 67.9 ± 11.0 years; 32.8% were female. Patients in BEST-CLI had higher use rates of aspirin, statins, and single segment great saphenous vein conduit. The primary end point of 1-year MALE or death was lower in BEST-CLI (21.0%) compared with PREVENT III (37.8%) (adjusted hazard ratio [HR], 0.50; 95% confidence interval [CI], 0.40-0.62; P < .0001)-this observation was consistent across predefined subgroups and in confirmatory analyses using propensity score methods. Major reinterventions (new bypass, surgical revision, thrombectomy, or endovascular intervention for graft occlusion) at 1 year were also lower in BEST-CLI (7.2% vs 18.4%; adjusted HR, 0.40; 95% CI, 0.28-0.57; P < .0001), although rates of any reinterventions were similar (25.8% vs 29.3%; adjusted HR, 0.90; 95% CI, 0.72-1.14; P = .39). Perioperative major cardiovascular and limb events were significantly lower in BEST-CLI: MACE (4.1% vs 7.8%; adjusted OR 0.47; 95% CI, 0.28-0.79; P = .005) and MALE (2.7% vs 6.3%; adjusted OR 0.44; 95% CI, 0.24-0.82; P = .009). CONCLUSIONS: Over the past two decades, outcomes after lower extremity infrainguinal vein bypass for CLTI have improved significantly. These advances likely reflect a combination of broad improvements in cardiovascular risk management, surgical techniques, and postoperative care for CLTI patients.