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Published on: January 18, 2018
Endovascular therapy versus bypass for chronic limb-threatening ischemia in a real-world practice
Sina Zarrintan1, Shima Rahgozar1, Elsie G Ross1
1Department of Surgery, Division of Vascular & Endovascular Surgery, University of California San Diego (UCSD), San Diego, CA.
Insights
Bypass surgery using great saphenous vein (GSV) is superior to endovascular therapy (ET) for chronic limb-threatening ischemia (CLTI) up to 4 years. Bypass with prosthetic graft also showed improved overall survival compared to ET up to 2 years.
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.
Objective:
The recent Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (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-Medicare-linked database.
Methods:
We queried the Vascular Quality Initiative-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 (PSMs): ET vs bypass with GSV (BWGSV) and ET vs bypass with a prosthetic graft (BWPG). The primary outcome was amputation-free survival. Secondary outcomes were freedom from amputation and overall survival (OS).
Results:
Three cohorts were queried: BWGSV (N = 5279, 14.7%), BWPG (N = 2778, 7.7%), and ET (N = 27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4705 pairs of ET vs BWGSV and 2583 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 amputation-free survival 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.
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