Base revascularization strategy on effectiveness in restoring adequate and durable limb perfusion, BEST-CLI subanalysis advises

The results of a subanalysis of the BEST-CLI trial found that patients with chronic limb-threatening ischemia (CLTI) who were deemed suitable for open lower-extremity bypass surgery “have similar periprocedural complications following either open or endovascular revascularization.”

The finding led researchers to assert that choice of revascularization strategy should be based primarily on effectiveness in restoring adequate and durable limb perfusion.

Submitting and presenting author Jeffrey J. Siracuse, MD, of the Boston University School of Medicine in Boston, is due to pres­ent the results of this study during the first SVS-VESS (Vascular and Endo­vascular Surgery Society) Scientific Session at VAM 2023, which is due to take place 1:30–3 p.m. on Wednesday June 14 in Potomac C.

In the study abstract for their subanalysis, Siracuse et al note that perioperative morbidity is a “major deciding factor” for choosing a revasculariza­tion method for CLTI. It was the objective in this study, they communicate, to assess systemic perioperative complications in the BEST-CLI trial.

By way of context, the authors write that the BEST-CLI trial was a prospective ran­domized trial comparing open and endovas­cular revascularization strategies. They detail that there were two cohorts, with cohort 1 including patients with adequate single-seg­ment great saphenous vein (SSGSV) and co­hort 2, those without SSGSV.

Data from the trial were analyzed for ma­jor adverse cardiovascular events (MACE)— defined as a composite of myocardial infarction, stroke and death— non-serious (non-SAE) and serious adverse events (SAE) 30 days after revasculariza­tion. The investigators share that they used a per-protocol analysis, which in this case was intervention received without crossover.

Siracuse and colleagues relay that there were 1,367 (662 open, 705 endovascular) patients in cohort 1 and 379 (188 open, 191 endovascular) in cohort 2 who met their in­clusion criteria. Sharing the results in their study abstract, the authors report that 30-day mortality was low—1.5% in cohort 1 (open 1.8%; endo­vascular 1.3%) and 1.3% in cohort 2 (2.7% open; 0% en­dovascular).

They add that the rate of MACE in cohort 1 was 4.98% for open vs. 3.3% for endovas­cular (p=0.12) and in cohort 2 was 4.3% for open and 1.6% for endovascular (p=0.16). The authors specify that on multivariate analysis, there was no difference in 30-day mortality MACE for open vs. endovascular for either cohort 1 (hazard ratio [HR] 1.49, 95% confidence interval [CI] 0.85–2.62, p=0.17) or cohort 2 (HR 2.25, 95% CI 0.49– 10.4, p=0.3).

Acute renal failure was found to be similar by inter­vention, Siracuse et al state, detailing that the rates in cohort 1 were 3.6% for open vs. 2.1% endovascular (HR 1.6, 95% CI 0.85–3.12, p=0.14) and cohort 2, 4.2% vs. 1.6% (HR 2.86, 95% CI 0.75–10.8, p=0.12). In addi­tion, they note that venous thromboembolism (VTE) rates were low, with cohort 1 at 0.7% (open 0.9%; endo­vascular 0.4%) and cohort 2 at 0.3% (open 0.5%; endo­vascular 0%).

Other results from the subanalysis include the fact that patients with non-SAE in cohort 1 were 23.4% for open and 17.9% for endo­vascular (p=0.06), and in co­hort 2 were 21.8% for open and 19.9% for endovascular (p=0.71). Furthermore, the investigators share that pa­tients with SAE in cohort 1 were 35.3% for open and 31.6% for endovascular (p=0.57), and cohort 2 were for 25.5% open and 23.6% endovascu­lar (p=0.72). Siracuse and colleagues detail that the most common etiologies for non- SAE and SAE were infectious, procedural complications, and related to underlying peripheral vascular disease.