ASA - Bypass Versus Endovascular Therapy for Elective Infrapopliteal Interventions in Chronic Limb-Threatening Ischemia: Propensity Score-Matched Analyses of Vascular Quality Initiative Registry

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Bypass Versus Endovascular Therapy for Elective Infrapopliteal Interventions in Chronic Limb-Threatening Ischemia: Propensity Score-Matched Analyses of Vascular Quality Initiative Registry
*Sina Zarrintan¹, *Mohammed Hamouda¹, Joseph Mills², Michael S. Conte³, Alik Farber⁴, Mahmoud Malas¹
¹Department of Surgery, University of California San Diego, San Diego, CA; ²Michael E. Debakey Department of Surgery, Baylor College of Medicine, Houston, TX; ³Department of Surgery, University of California San Francisco, San Francisco, CA; ⁴Department of Surgery, Boston University Chobanian & Avedisian School of Medicine, Boston, MA

Background: The choice between bypass and endovascular therapy (ET) in patients with chronic limb-threatening ischemia (CLTI) is controversial, particularly when the distal target is within the infrapopliteal region. We used multi-institutional data from the Vascular Quality Initiative (VQI) to compare outcomes following revascularization in infrapopliteal CLTI.

Methods: We used VQI data (2018-2023) to compare bypass with single-segment great saphenous vein (SSGSV) vs. ET and bypass with an alternative conduit (AC) vs. ET in patients presenting with CLTI who underwent infrapopliteal only or femorotibial elective revascularizations. We performed two one-to-one propensity score matchings (PSM) in patients who had at least one follow-up. Two pairs of matched cohorts were created: SSGSV vs. ET and AC vs. ET. PSMs were conducted based on demographics, insurance, smoking status, comorbidities, prior procedures, type of CLTI (rest pain or tissue loss), and preoperative and discharge medications. The primary outcome was major adverse limb event (MALE) and/or death. MALE was defined as any major reintervention and/or major amputation (MA) following index revascularization. Secondary outcomes included death, MA, reintervention, MALE, and MA/death. All outcomes were analyzed up to one-year. Kaplan-Meier survival estimates, and Cox regression were used for analyses.

Results: There were 25,080 limbs and 20,730 patients. The interventions included: ET, N=21,449 (85.5%); SSGSV, N=2,299 (9.2%); and AC, N=1,332 (5.3%). After PSM, the SSGSV vs. ET (1,885 pairs) and AC vs. ET cohorts (1,042 pairs) were well balanced. In the matched cohorts, the SSGSV cohort was associated with decreased hazards of death (HR=0.80 [95% CI, 0.66-0.96]; P=0.020), and MA/death (HR=0.86 [95% CI, 0.74-0.99]; P=0.047) compared to the ET cohort (Table 1 and Figure 1A). Moreover, the AC cohort was associated with increased hazards of MA (HR=2.31 [95% CI, 1.69-3.16]; P<.001), MA/death (HR=1.28 [95% CI, 1.06-1.54]; P=0.010), and MALE (HR=1.22 [95% CI, 1.00-1.48]; P=0.046) and decreased hazards of reintervention (HR=0.65 [95% CI, 0.51-0.83]; P=0.001) compared to the ET cohort (Table 1 and Figure 1B). MALE/Death was not associated with the type of revascularization in matched cohorts.

Conclusions: Our multi-institutional analyses revealed superior one-year outcomes with bypass using SSGSV compared to ET in terms of survival and amputation-free survival (AFS). However, ET was superior to bypass with AC in terms of freedom from MA, AFS, and freedom from MALE, although it was associated with increased reintervention. We conclude that bypass with SSGSV should be considered first-line therapy for CLTI when the distal target is the infrapopliteal vessels. However, when a good quality SSGSV is not available, ET can offer lower amputation and MALE risk and higher AFS compared to AC. These decisions should be individualized based on each patient�s physiologic and anatomic factors.
Table 1: One-year outcomes following elective first-time infrapopliteal interventions for CLTI (after PSM)

Outcome	Bypass with SSGSV vs. ET		Bypass with AC vs. ET
Outcome	HR (95% CI)	P-Value	HR (95% CI)	P-Value
Death	0.80 (0.66-0.96)	0.020	0.85 (0.67-1.08)	0.193
Major Amputation	0.99 (0.78-1.25)	0.928	2.31 (1.69-3.16)	<.001
Death/Major Amputation	0.86 (0.74-0.99)	0.047	1.28 (1.06-1.54)	0.010
Reintervention	0.95 (0.79-1.14)	0.585	0.65 (0.51-0.83)	0.001
MALE	1.12 (0.96-1.30)	0.138	1.22 (1.00-1.48)	0.046
MALE/Death	0.99 (0.88-1.12)	0.953	1.11 (0.95-1.29)	0.194

AC, alternative conduit; CI, confidence interval; CLTI, chronic limb-threatening ischemia; ET, endovascular therapy; HR, hazard ratio; MALE, major adverse limb event; PSM, propensity score matching; SSGSV, single-segment great saphenous vein

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