J Vasc Surg. 2024 Jan 24:S0741-5214(24)00256-8. doi: 10.1016/j.jvs.2024.01.196. Online ahead of print.
ABSTRACT
OBJECTIVE: The role of direct oral anticoagulants (DOACs) in chronic limb-threatening ischemia following revascularization is unknown. Current evidence-based guidelines do not provide clear guidance on the role of anticoagulation or the selection of anticoagulant. Current practice is highly varied and based on provider and patient preference. The purpose of this study was to measure the impact of different anticoagulants on the incidence of major adverse limb events (MALE) following revascularization for chronic limb-threatening ischemia, major adverse cardiovascular events (MACE), all-cause mortality, and hospitalization for major bleeding events.
METHODS: This was a single-center, observational, retrospective cohort study. Subjects were eligible if they were 18 years or older, underwent endovascular or open revascularization for chronic limb-threatening ischemia, rest pain, or tissue loss, and were subsequently prescribed apixaban, rivaroxaban, or warfarin. The primary endpoint was the incidence of MALE, including above ankle amputation or major index-limb reintervention, within one year of index event. Secondary endpoints included rate of all-cause mortality, MACE, and incidence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding.
RESULTS: From January 1, 2017 to September 20, 2022, 141 patients met the inclusion and exclusion criteria and were reviewed. The median age was 67 years, with 92 patients prescribed apixaban or rivaroxaban and 49 patients prescribed warfarin. Of these, 42 were prescribed triple antithrombotic therapy, 88 dual antithrombotic therapy, and 13 anticoagulant monotherapy. The primary outcome of one-year MALE occurred in 36.7% of the warfarin group and 33.7% of the DOAC group (relative risk (RR), 1.09; 95% CI, 0.53-2.25; P = 0.72). Secondary outcomes of one-year MACE (10.2% vs 4.3%; RR, 2.35; 95% CI, 0.60-9.18; P = 0.18) and one-year all-cause mortality (26.5% vs 16.3%; RR, 1.63; 95% CI, 0.70-3.78; P = 0.15) did not differ between groups. The secondary safety outcome of one-year ISTH major bleeding occurred in 16.3% of the warfarin group and 4.3% of the DOAC group (RR, 3.76; 95% CI, 1.07-13.19; P = 0.015).
CONCLUSIONS: In patients with chronic limb-threatening ischemia who were revascularized and prescribed anticoagulation with apixaban, rivaroxaban, or warfarin on discharge, no difference in MALE, MACE, or all-cause mortality was found. However, one-year admissions for ISTH major bleeding was significantly higher among patients prescribed warfarin. A randomized trial may confirm these findings.
PMID:38278371 | DOI:10.1016/j.jvs.2024.01.196