Surgery or Endovascular Therapy for Patients with Chronic Limb-threatening Ischemia Requiring Infrapopliteal Interventions

The recent publications of randomized trials comparing open bypass surgery to endovascular therapy in chronic limb-threatening ischemia (CLTI) patients, BEST-CLI and BASIL-2, have resulted in potentially contradictory findings. The trials differed significantly regarding anatomic disease criteria as well as their primary endpoints. We performed an analysis of BEST-CLI patients with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a more precise comparative study for BASIL-2. BEST-CLI patients in cohort 1 (adequate saphenous vein conduit) who had significant infrapopliteal disease and underwent tibial level intervention were included. Patients were randomized to bypass or endovascular therapy with a stratification that included the presence or absence of infrapopliteal disease. The primary outcome was major adverse limb events (MALEs) or all-cause death. MALEs included any major limb amputation or major reintervention. A total of 665 patients were randomized to open tibial bypass (n =326) or tibial endovascular interventions (n = 339). The primary outcome of MALE or all-cause death at 3 years was significantly lower after open bypass at 48.5% compared with 56.7% (P = .0006) (Table and Figure). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .24), whereas MALEs were lower after bypass (23.3% vs 35.0%; P < .0001) including major reinterventions (10.9% vs 20.2%; P = .0002). Freedom from amputation or all-cause death was similar (43.6% vs 45.3%; P = .12); however, there was a trend toward lower amputation after bypass (13.5% vs 19.3%; P = .053). Perioperative (30-day) death was similar (2.5% vs 2.4%; P = .93), as was 30-day MACEs (5.3% vs 2.7%; P = .12). Similar results were obtained in the as-treated analyses of the primary and secondary outcomes. Among patients with suitable single segment great saphenous vein undergoing infrapopliteal intervention for critical limb ischemia, open bypass surgery had a lower incidence of major adverse limb events or death compared with endovascular intervention and similar amputation free survival. This supports the original conclusion of BEST-CLI favoring bypass surgery and continues to indicate contradictory findings in comparison to BASIL-2.TableThree-year outcomes after infrapopliteal open surgical bypass vs endovascular tibial interventions for patients with critical limb ischemiaAll patients (n = 665)Open (n = 326)Endovascular (n = 339)Hazard ratio (95% confidence interval) (open vs endovascular)P valueNo. (%)3-Year Kaplan-Meier %No. (%)3-Year Kaplan-Meier %No. (%)3-Year Kaplan-Meier %MALE or all-cause death312 (46.9)52.7%136 (41.7)48.5%176 (51.9)56.7%0.69 (0.56-0.85).0005All-cause death204 (30.7)35.6%99 (30.4)35.5%105 (31.0)35.8%0.86 (0.68-1.10).2390MALE171 (25.7)29.3%62 (19.0)22.9%109 (32.2)35.2%0.54 (0.40-0.73).0003Major limb amputation93 (14.0)16.5%37 (11.3)13.5%56 (16.5)19.3%0.67 (0.45-1.01).0513Major reintervention93 (14.0)15.7%30 (9.2)10.9%63 (18.6)20.2%0.44 (0.28-0.68).0001Minor reintervention186 (28.0)33.5%91 (27.9)32.9%95 (28.0)34.1%0.99 (0.75-1.32).9553Major amputation or all-cause death256 (38.5)44.4%120 (36.8)43.6%136 (40.1)45.3%0.84 (0.67-1.05).1216MACE242 (36.4)43.3%119 (36.5)43.2%123 (36.3)43.4%0.94 (0.75-1.18).5700Myocardial infarction70 (10.5)13.7%39 (12.0)15.1%31 (9.1)12.4%1.24 (0.80-1.93).3282Stroke36 (5.4)7.7%17 (5.2)7.2%19 (5.6)8.3%0.75 (0.42-1.37).3547MALE, Major adverse limb events.Boldface entries indicate statistical significance. Open table in a new tab