PMID- 37207790 OWN - NLM STAT- MEDLINE DCOM- 20230828 LR - 20240327 IS - 1097-6809 (Electronic) IS - 0741-5214 (Print) IS - 0741-5214 (Linking) VI - 78 IP - 3 DP - 2023 Sep TI - Comparison of lower extremity bypass and peripheral vascular intervention for chronic limb-threatening ischemia in the Medicare-linked Vascular Quality Initiative. PG - 745-753.e6 LID - S0741-5214(23)01186-2 [pii] LID - 10.1016/j.jvs.2023.05.015 [doi] AB - OBJECTIVE: There is a relative lack of comparative effectiveness research on revascularization for patients with chronic limb-threatening ischemia (CLTI). We examined the association between lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) for CLTI and 30-day and 5-year all-cause mortality and 30-day and 5-year amputation. METHODS: Patients undergoing LEB and PVI of the below-the-knee popliteal and infrapopliteal arteries between 2014 and 2019 were queried from the Vascular Quality Initiative, and outcomes data were obtained from the Medicare claims-linked Vascular Implant Surveillance and Interventional Outcomes Network database. Propensity scores were calculated on 15 variables using a logistic regression model to control for imbalances between treatment groups. A 1:1 matching method was used. Kaplan-Meier survival curves and hierarchical Cox proportional hazards regression with a random intercept for site and operator nested in site to account for clustered data compared 30-day and 5-year all-cause mortality between groups. Thirty-day and 5-year amputation were subsequently compared using competing risk analysis to account for the competing risk of death. RESULTS: There was a total of 2075 patients in each group. The overall mean age was 71 +/- 11 years, 69% were male, and 76% were white, 18% were black, and 6% were of Hispanic ethnicity. Baseline clinical and demographic characteristics in the matched cohort were balanced between groups. There was no association between all-cause mortality over 30 days and LEB vs PVI (cumulative incidence, 2.3% vs 2.3% by Kaplan Meier; log-rank P-value = .906; hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.62-1.44; P-value = .80). All-cause mortality over 5 years was lower for LEB vs PVI (cumulative incidence, 55.9% vs 60.1% by Kaplan Meier; log-rank P-value < .001; HR, 0.77; 95% CI, 0.70-0.86; P-value < .001). Accounting for competing risk of death, amputation over 30 days was also lower in LEB vs PVI (cumulative incidence function, 1.9% vs 3.0%; Fine and Gray P-value = .025; subHR, 0.63; 95% CI, 0.42-0.95; P-value = .025). There was no association between amputation over 5 years and LEB vs PVI (cumulative incidence function, 22.6% vs 23.4%; Fine and Gray P-value = .184; subHR, 0.91; 95% CI, 0.79-1.05; P-value = .184). CONCLUSIONS: In the Vascular Quality Initiative-linked Medicare registry, LEB vs PVI for CLTI was associated with a lower risk of 30-day amputation and 5-year all-cause mortality. These results will serve as a foundation to validate recently published randomized controlled trial data, and to broaden the comparative effectiveness evidence base for CLTI. CI - Copyright (c) 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Cleman, Jacob AU - Cleman J AD - Vascular Medicine Outcomes Program, Yale University, New Haven, CT. FAU - Romain, Gaelle AU - Romain G AD - Vascular Medicine Outcomes Program, Yale University, New Haven, CT. FAU - Grubman, Scott AU - Grubman S AD - Vascular Medicine Outcomes Program, Yale University, New Haven, CT. FAU - Guzman, Raul J AU - Guzman RJ AD - Division of Vascular Surgery, Yale School of Medicine, New Haven, CT. FAU - Smolderen, Kim G AU - Smolderen KG AD - Vascular Medicine Outcomes Program, Yale University, New Haven, CT; Department of Psychiatry, Yale School of Medicine, New Haven, CT. FAU - Mena-Hurtado, Carlos AU - Mena-Hurtado C AD - Vascular Medicine Outcomes Program, Yale University, New Haven, CT. Electronic address: carlos.menahurtado@yale.edu. LA - eng GR - T32 HL155000/HL/NHLBI NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230518 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 SB - IM MH - Aged MH - Aged, 80 and over MH - Female MH - Humans MH - Male MH - Middle Aged MH - Chronic Limb-Threatening Ischemia MH - *Endovascular Procedures/adverse effects MH - Ischemia/diagnosis/surgery MH - Limb Salvage MH - Lower Extremity/blood supply MH - Medicare MH - *Peripheral Arterial Disease MH - Retrospective Studies MH - Risk Factors MH - Treatment Outcome MH - United States/epidemiology MH - Comparative Effectiveness Research PMC - PMC10964324 MID - NIHMS1934502 OTO - NOTNLM OT - Angioplasty OT - Chronic limb-threatening ischemia OT - Comparative effectiveness research OT - Peripheral vascular disease COIS- The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. EDAT- 2023/05/20 09:42 MHDA- 2023/08/22 06:42 PMCR- 2024/03/26 CRDT- 2023/05/19 19:23 PHST- 2023/02/14 00:00 [received] PHST- 2023/05/10 00:00 [revised] PHST- 2023/05/11 00:00 [accepted] PHST- 2023/08/22 06:42 [medline] PHST- 2023/05/20 09:42 [pubmed] PHST- 2023/05/19 19:23 [entrez] PHST- 2024/03/26 00:00 [pmc-release] AID - S0741-5214(23)01186-2 [pii] AID - 10.1016/j.jvs.2023.05.015 [doi] PST - ppublish SO - J Vasc Surg. 2023 Sep;78(3):745-753.e6. doi: 10.1016/j.jvs.2023.05.015. Epub 2023 May 18.