Endovascular therapy versus bypass for chronic limb-threatening ischemia in a real-world practice

Objectives The recent BEST-CLI study showed that bypass was superior to endovascular therapy (ET) in patients with chronic limb threatening ischemia (CLTI) deemed suitable for either approach who had an available single segment great saphenous vein (GSV). However, the superiority of bypass among those lacking GSV was not established. We aimed to examine comparative treatment outcomes from a real-world CLTI population using the Vascular Quality Initiative (VQI)-Medicare-Linked database. Methods We queried the VQI-Medicare-Linked database for patients with CLTI who underwent first-time lower extremity revascularization (2010-2019). We performed two one-to-one propensity score matchings (PSM): ET vs. bypass with GSV (BWGSV) and ET vs. bypass with prosthetic graft (BWPG). The primary outcome was amputation-free survival (AFS). Secondary outcomes were freedom from amputation and overall survival (OS). Results Three cohorts were queried: BWGSV (N=5,279, 14.7%), BWPG (N=2,778, 7.7%), and ET (N=27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4,705 pairs of ET vs. BWGSV and 2,583 pairs of ET vs. BWPG. In the matched cohorts of ET vs. BWGSV, ET was associated with greater hazards of death (Hazard Ratio [HR]=1.34, 95% Confidence Interval [CI], 1.25-1.43; P<.001), amputation (HR=1.30, 95% CI, 1.17-1.44; P<.001) and amputation/death (HR=1.32, 95% CI, 1.24-1.40; P<.001) up to 4-years. In the matched cohorts of ET vs. BWPG, ET was associated with greater hazards of death up to 2-years (HR=1.11, 95% CI, 1.00-1.22; P=.042) but not amputation or amputation/death. Conclusions In this real-world multi-institutional Medicare-linked PSM analysis, we found that BWGSV is superior to ET in terms of OS, freedom from amputation and AFS up to 4-years. Moreover, BWPG was superior to ET in terms of OS up to 2-years. Our study confirms the superiority of BWGSV to ET as observed in the BEST-CLI trial.