PMID- 35074410 OWN - NLM STAT- MEDLINE DCOM- 20220426 LR - 20220508 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 75 IP - 5 DP - 2022 May TI - Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia. PG - 1696-1706.e4 LID - S0741-5214(22)00103-3 [pii] LID - 10.1016/j.jvs.2022.01.011 [doi] AB - OBJECTIVE: Although the current guidelines have recommended single antiplatelet therapy (SAPT) for patients undergoing revascularization for chronic limb-threatening ischemia (CLTI), antithrombotic management has varied by patient and provider. Our aim was to examine the effects of different postoperative antithrombotic regimens on 3-year clinical outcomes after infrapopliteal bypass for CLTI. METHODS: We identified patients who had undergone infrapopliteal bypass for CLTI in the Vascular Quality Initiative (VQI) registry from 2003 to 2017 with linkage to Medicare claims for long-term outcomes. We divided the patients into three cohorts according to the discharge antithrombotic regimen: SAPT (aspirin or clopidogrel), dual antiplatelet therapy (DAPT; aspirin and clopidogrel), or anticoagulation (AC) plus any antiplatelet (AP) agent. To reduce selection bias, we restricted the analysis cohorts to patients treated by providers who discharged >50% of patients with each antithrombotic regimen. Our primary outcome was 3-year major adverse limb events (MALE; major amputation or reintervention). The secondary outcomes included 3-year major amputation, reintervention, and mortality. We used Kaplan-Meier and Cox regression analyses to assess these outcomes stratified by antithrombotic regimen and adjusted for demographic, comorbid, clinical, and operative differences between the treatment groups with clustering at the center level. RESULTS: Among 1812 patients (median follow-up, >2 years), 693 (38%) were discharged with SAPT, 544 (30%) with DAPT, and 575 (32%) with AC+AP. At 3 years, the MALE rates were 75% with DAPT, 74% with AC+AP, and 68% with SAPT. In adjusted analyses with SAPT as the reference group, no differences were found in 3-year MALE with DAPT (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.85-1.3; P = .71) or AC+AP (aHR, 1.1; 95% CI, 0.96-1.3; P = .14). Across the treatment groups, we also found no differences in the individual end points of 3-year major amputation (DAPT: aHR, 0.98; 95% CI, 0.72-1.3; AC+AP: aHR, 1.3; 95% CI, 0.96-1.7), reintervention (DAPT: aHR, 1.0; 95% CI, 0.84-1.3; AC+AP: aHR, 1.1; 95% CI, 0.96-1.3), or mortality (DAPT: aHR, 1.1; 95% CI, 0.88-1.4; AC+AP: aHR, 0.95; 95% CI, 0.74-1.2). In a sensitivity analysis evaluating patients treated by providers who discharged >60%, >70%, or >80% of patients with these regimens, the association between antithrombotic regimen and MALE was unchanged. CONCLUSIONS: Compared with SAPT, DAPT and anticoagulation therapy were not associated with improved outcomes among Medicare beneficiaries who had undergone infrapopliteal bypass for CLTI at VQI participating centers. These findings support current guidelines recommending SAPT after lower extremity bypass and suggest that the routine use of DAPT or anticoagulation therapy might not provide clinical benefit in this high-risk, elderly population. However, further evaluation of the risks and benefits of various antithrombotic regimens in relevant subgroups is warranted. CI - Copyright (c) 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Marcaccio, Christina L AU - Marcaccio CL AD - Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. FAU - Patel, Priya B AU - Patel PB AD - Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. FAU - Wang, Sophie AU - Wang S AD - Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. FAU - Rastogi, Vinamr AU - Rastogi V AD - Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass; Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. FAU - Moreira, Carla C AU - Moreira CC AD - Division of Vascular Surgery, Rhode Island Hospital, Warren Alpert School of Medicine, Brown University, Providence, RI. FAU - Siracuse, Jeffrey J AU - Siracuse JJ AD - Division of Vascular and Endovascular Surgery, Boston University School of Medicine and Boston Medical Center, Boston, Mass. FAU - Schermerhorn, Marc L AU - Schermerhorn ML AD - Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. FAU - Stangenberg, Lars AU - Stangenberg L AD - Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address: lstangen@bidmc.harvard.edu. LA - eng GR - UL1 TR002541/TR/NCATS NIH HHS/United States GR - F32 HS027285/HS/AHRQ HHS/United States GR - T32 HL007734/HL/NHLBI NIH HHS/United States GR - U01 FD006936/FD/FDA HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PT - Research Support, U.S. Gov't, P.H.S. DEP - 20220121 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 RN - 0 (Anticoagulants) RN - 0 (Fibrinolytic Agents) RN - 0 (Platelet Aggregation Inhibitors) RN - A74586SNO7 (Clopidogrel) RN - R16CO5Y76E (Aspirin) SB - IM MH - Aged MH - Anticoagulants/adverse effects MH - Aspirin/adverse effects MH - Chronic Limb-Threatening Ischemia MH - Clopidogrel/adverse effects MH - Fibrinolytic Agents MH - Humans MH - Ischemia/diagnosis/drug therapy/surgery MH - Lower Extremity/blood supply MH - Medicare MH - *Peripheral Arterial Disease/diagnosis/surgery MH - *Platelet Aggregation Inhibitors/adverse effects MH - Risk Factors MH - Treatment Outcome MH - United States OTO - NOTNLM OT - Anticoagulation OT - Antiplatelet therapy OT - Antithrombotic therapy OT - Chronic limb-threatening ischemia OT - Infrapopliteal bypass EDAT- 2022/01/26 06:00 MHDA- 2022/04/27 06:00 CRDT- 2022/01/25 05:40 PHST- 2021/11/02 00:00 [received] PHST- 2022/01/03 00:00 [accepted] PHST- 2022/01/26 06:00 [pubmed] PHST- 2022/04/27 06:00 [medline] PHST- 2022/01/25 05:40 [entrez] AID - S0741-5214(22)00103-3 [pii] AID - 10.1016/j.jvs.2022.01.011 [doi] PST - ppublish SO - J Vasc Surg. 2022 May;75(5):1696-1706.e4. doi: 10.1016/j.jvs.2022.01.011. Epub 2022 Jan 21.