Bypass versus Endovascular Therapy in Chronic Limb Threatening Ischemia Requiring Infra-Popliteal Interventions
Randall A Bloch1, Alex Lin1, Elisa Caron1
1Division of Vascular and Endovascular Surgery, St. Elizabeth's Medical Center, Boston University School of Medicine, Boston, MA.
Insights
For chronic limb threatening ischemia, autologous vein bypass surgery offers superior amputation-free survival and overall survival compared to endovascular therapy. However, endovascular therapy may be preferred when autologous vein is unavailable.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Regenerative Medicine
Background:
- Chronic limb threatening ischemia (CLTI) involving crural arteries presents significant clinical challenges.
- Existing studies like BASIL-2 and BEST-CLI offer conflicting evidence on endovascular therapy (EVT) versus surgical bypass (BP).
- A real-world registry comparison is needed to clarify treatment efficacy for infra-popliteal CLTI.
Purpose of the Study:
- To compare the real-world outcomes of EVT versus surgical bypass (BP) in patients with CLTI requiring infra-popliteal interventions.
- To evaluate amputation-free survival (AFS), overall survival (OS), and freedom from major amputation.
- To assess outcomes for BP using autologous vein (BPAV) and prosthetic conduit (BPPC) against EVT.
Main Methods:
- Analysis of the Vascular Quality Initiative (VQI) peripheral vascular intervention and infra-inguinal bypass registries (2017-2022).
- Inclusion of patients undergoing infra-popliteal procedures for CLTI.
- Construction of propensity score-matched cohorts to compare EVT vs. BP, EVT vs. BPAV, and EVT vs. BPPC.
Main Results:
- BP and EVT showed equivalent 2-year AFS (50.3% vs. 49.0%), but BP had superior OS (79.7% vs. 75.6%) and inferior limb salvage (71.4% vs. 81.4%).
- BPAV (primarily great saphenous vein) demonstrated superior 2-year AFS (53.9% vs. 52.5%) and OS (81.1% vs. 77.4%) with equivalent limb salvage compared to EVT.
- BPPC had significantly lower 2-year AFS (44.1% vs. 46.9%) and limb salvage (63.3% vs. 77.5%) than EVT, despite higher OS.
Conclusions:
- Autologous vein bypass (particularly with great saphenous vein) should be favored over EVT for CLTI when feasible, due to better AFS and OS.
- Endovascular therapy may be a preferred option when autologous vein is unavailable, offering better AFS and limb salvage than prosthetic bypass.
- These findings provide crucial real-world data for treatment decisions in complex infra-popliteal CLTI.
Objectives:
Chronic Limb Threatening Ischemia (CLTI) involving the crural arteries is clinically and anatomically challenging. The BASIL-2 trial and a subanalysis of the BEST-CLI trial examined the efficacy of endovascular therapy (EVT) versus surgical bypass (BP) among this cohort, but arrived at differing conclusions. This study aimed to compare the outcomes of EVT and surgical bypass among patients with CLTI requiring infra-popliteal interventions in a real-world registry.
Methods:
All infra-popliteal procedures performed for CLTI were identified in the peripheral vascular intervention and infra-inguinal bypass registries of the Vascular Quality Initiative (VQI) from 2017 to 2022. Patients were identified with significantly different risk profiles (19,505 EVT and 9,185 BP). Propensity score-matched cohorts were constructed to compare EVT versus BP, BP with autologous vein (BPAV), and BP with prosthetic conduit (BPPC). Amputation-free survival (AFS), overall survival (OS), and freedom from major amputation were examined.
Results:
5,236 well-matched pairs of EVT versus BP, 3,892 well-matched pairs of EVT versus BPAV, and 1,971 well-matched pairs of EVT versus BPPC were included. BP and EVT demonstrated equivalent AFS (2-year AFS: 50.3% vs. 49.0%, HR amputation/death: 0.947 [0.876-1.024], P = 0.229), which was due to superior OS in the BP group (2-year OS: 79.7% vs. 75.6%, HR all-cause mortality: 0.841 [0.761-0.928] P = 0.002) matched by inferior limb salvage in the BP group (2-year freedom from major amputation: 71.4% vs. 81.4%, HR major amputation: 1.432 [1.266-1.620], P < 0.001). BPAV, composed primarily (91%) of great saphenous vein bypass (GSV BP), was associated with significantly greater AFS than EVT (2-year AFS: 53.9% vs. 52.5%, HR amputation/death: 0.854 [0.778-0.938], P < 0.001), which was driven by greater OS (2-year OS: 81.1% vs. 77.4%, HR all-cause mortality: 0.872 [0.776-0.980], P = 0.015) with equivalent limb salvage (2-year freedom from major amputation: 76.0% vs. 81.4%, HR major amputation: 1.102 [0.951-1.278], P = 0.353). However, BPPC was associated with significantly lower AFS than EVT (2-year AFS: 44.1% vs. 46.9%, HR amputation/death: 1.279 [1.126-1.452], P = 0.001), which was driven inferior limb salvage in the BPPC group (2-year freedom from major amputation: 63.3% vs. 77.5%, HR major amputation: 2.165 [1.780-2.633], P < 0.001) despite higher OS in the BPPC group (2-year OS: 78.8% vs. 75.8%, HR all-cause mortality: 0.837 [0.706-0.992], P = 0.012).
Conclusion:
When feasible, BPAV (particularly with GSV) should be considered over EVT due to superior AFS and OS with equivalent limb salvage. However, when autologous vein is unavailable, an aggressive approach to EVT may be warranted due to superior AFS and limb salvage despite slightly higher OS in the BPPC group.
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