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

Kristina A. Giles, Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME. Electronic address: Kristina.Giles@MaineHealth.org.
Alik Farber, Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA.
Matthew T. Menard, Division of Vascular and Endovascular Surgery, Brigham and Woman's Hospital, Boston, MA.
Michael S. Conte, Division of Vascular and Endovascular Surgery, University of California San Francisco, CA.
Brian W. Nolan, Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME.
Jeffrey J. Siracuse, Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA.
Michael Strong, Brigham and Woman's Hospital, Boston, MA.
Gheorghe Doros, Department of Biostatistics, Boston University, School of Public Health, Boston, MA.
Maarit Venermo, Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki Finland.
Ezana Azene, Department of Interventional Radiology, Gundersen Health System, La Crosse, WI.
Kenneth Rosenfield, Vascular Medicine and Intervention, Massachusetts General Hospital, Boston, MA.
Richard J. Powell, Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH.

Abstract

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in chronic limb threatening ischemia (CLTI) patients, BEST-CLI and BASIL-2, has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomic disease patterns and 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 relevant comparator to the outcomes reported from BASIL-2. METHODS: The study population consisted of BEST-CLI patients with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (Cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major re-intervention. Outcomes were evaluated using Cox proportional regression models. RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all cause death at 3 years was significantly lower in the surgical group at 48.5% compared to 56.7% in the endovascular group (p=0.0018). Mortality was similar between groups (35.5% open vs. 35.8% endovascular; p=0.94 whereas MALE events were lower in the surgical group (23.3% vs. 35.0%; p<0.0001). This included a lower rate of major reinterventions in the surgical group (10.9%) compared to the endovascular group (20.2%; p=0.0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared to 45.3% the endovascular group (p=0.30) however there were fewer above ankle amputations in the surgical group (13.5%) compared to the endovascular group (19.3%; p=0.0205). Perioperative (30-day) death was similar between treatment groups (2.5% open vs 2.4% endovascular; p=0.93) as was 30-day MACE (5.3% open vs 2.7% endovascular; p=0.12). CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for CLTI, open bypass surgery was associated with a lower incidence of MALE or death and less major amputation compared to endovascular intervention. Amputation free survival was similar between the groups. Further investigations into differences in comorbidities, anatomic extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.