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

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Health Services Research

Background:

• The BEST-CLI trial indicated bypass superiority over endovascular therapy (ET) for chronic limb-threatening ischemia (CLTI) when a great saphenous vein (GSV) is available.
• The comparative effectiveness of bypass versus ET in CLTI patients lacking GSV was not established.
• Real-world data is crucial for understanding treatment outcomes in diverse CLTI populations.

Purpose of the Study:

• To compare the effectiveness of endovascular therapy (ET) versus bypass surgery (using great saphenous vein or prosthetic graft) in a real-world CLTI population.
• To evaluate amputation-free survival, freedom from amputation, and overall survival.
• To provide evidence for treatment decisions in CLTI patients, particularly those without a suitable GSV.

Main Methods:

• Utilized the Vascular Quality Initiative-Medicare-linked database for patients with CLTI undergoing lower extremity revascularization (2010-2019).
• Performed propensity score matching (PSM) for two comparisons: ET vs. bypass with GSV (BWGSV) and ET vs. bypass with prosthetic graft (BWPG).
• Assessed amputation-free survival as the primary outcome, with freedom from amputation and overall survival as secondary outcomes.

Main Results:

• In matched cohorts, BWGSV demonstrated superior outcomes to ET, including lower rates of death, amputation, and amputation/death up to 4 years.
• ET vs. BWGSV: Hazard ratios for death, amputation, and amputation/death were significantly higher with ET.
• ET vs. BWPG: ET was associated with a higher hazard of death up to 2 years, but not amputation or amputation/death.

Conclusions:

• Bypass surgery with a great saphenous vein (BWGSV) is superior to endovascular therapy (ET) for CLTI patients regarding overall survival, freedom from amputation, and amputation-free survival up to 4 years.
• Bypass surgery with a prosthetic graft (BWPG) demonstrated superior overall survival compared to ET up to 2 years.
• These findings support the superiority of bypass, particularly BWGSV, over ET for CLTI, aligning with BEST-CLI trial results and extending them to a real-world setting.