Influence of specialty on endovascular practice patterns and outcomes in the BEST-CLI Trial

Abstract

Objective: The Best Endovascular vs best Surgical Therapy in Patients with Chronic Limb-threatening Ischemia (CLTI) (BEST-CLI) trial was a multi-specialty trial that compared endovascular therapy with open surgery in patients with CLTI. We evaluated differences in endovascular practice patterns and outcomes among participating specialties.

Methods: All patients who underwent endovascular therapy performed by interventional cardiologists (ICs), interventional radiologists (IRs), and vascular surgeons (VSs) who met credentialing criteria in the trial were included in the analysis. Between-specialty group differences in demographics and practice patterns were evaluated using analysis of variance. The primary endpoint was major adverse limb events (MALE) and death (MALE-death); subcomponents of major revascularization, above-ankle amputation, and death were also examined.

Results: VSs treated the majority of the patients in the endovascular arm of BEST-CLI and more frequently treated patients of African-American descent and those with grade 3 limb ischemia (P = .016). ICs more frequently treated patients of Hispanic ethnicity, and utilized P2Y12 inhibitors (P = .005), clopidogrel (P = .021), and dual antiplatelet therapy (P = .002) compared with IRs and VSs. ICs also more often treated tibial arteries (P = .007), and utilized atherectomy (P < .001), drug-coated balloon angioplasty (P < .001), and drug-eluting stents (P < .001). There was no difference in endovascular technical failure between the groups. Over the course of follow-up, IRs had a lower incidence of MALE-death compared with ICs (IC vs IR: rate ratio [RR], 2.34; 95% confidence interval [CI], 1.45-3.77; P = .0005) and VS (IR vs VS: RR, 0.54; 95% CI, 0.37-0.77; P = .0007). This was largely driven by a lower incidence of death (IC vs IR: RR, 3.16; 95% CI, 1.80-45.55; P < .0001; IR vs VS: RR, 0.44; 95% CI, 0.28-0.70; P = .0005) and major revascularization (IC vs IR: RR, 1.56; 95% CI, 0.67-3.63; P = .30; IR vs VS: RR, 0.55; 95% CI, 0.32-0.96; P = .034). There was no difference in above-ankle amputation between the groups (IC vs IR: RR, 1.55; 95% CI, 0.74-3.22; P = .24; IC vs VS: RR, 1.12; 95% CI, 0.60-2.07; P = .72, IR vs VS: RR, 0.72; 95% CI, 0.42-1.24; P = .24).

Conclusions: Significant differences in practice patterns were seen between ICs, IRs, and VSs in BEST-CLI. The majority of patients were enrolled by VSs. There was significant differences in severity of patient CLTI at presentation. Although IRs had a lower incidence of MALE-death, death, and major revascularization compared with ICs and VSs, there was no difference in major amputation between the specialties.

Keywords: Amputation; Critical limb ischemia; Enodvascular; Peripheral arterial disease.