Comparative Outcomes of Peripheral Vascular Interventions in Patients on Chronic Anticoagulation with Factor Xa Inhibitors and Vitamin K Antagonists.

OBJECTIVE: In patients undergoing revascularization for peripheral arterial disease (PAD), low-dose Factor Xa inhibitors (FXaI) taken with aspirin improved limb and cardiovascular outcomes compared to aspirin alone. Further, in atrial fibrillation and venous thromboembolism, FXaI are recommended over vitamin K antagonists (VKA) for chronic anticoagulation. While studies have evaluated different perioperative anticoagulation regimens in patients treated for PAD, the optimal regimen for chronic anticoagulation in patients with PAD undergoing PVI has not been determined. This analysis compares outcomes of patients after PVI that require chronic anticoagulation with FXaI and VKA.

METHODS: The Vascular Quality Initiative-PVI database was used. Patients consistently treated with FXaI or VKA before the procedure, at discharge and on long-term follow up were defined as those receiving chronic anticoagulation. Patient demographics, procedural details, and perioperative and long-term outcomes were compared between FXaI and VKA groups.

RESULTS: A total of 109,268 patients were analyzed, and 6,885 were chronically anticoagulated with FXaI (N = 2,427) or VKA (N = 4,458). Patients anticoagulated with VKA were more frequently males (65.3% vs 61.0%, P< 0.001) with ESRD (9.7% vs 4.6%, P< 0.001) and more likely to be treated for CLTI (58.1% vs 52.7%, P< 0.001). Rates of hematoma following PVI were significantly higher in patients taking VKA compared to FXaI (3.5% vs 1.9%, P< 0.001). Multivariable logistic regression analysis showed that VKA were associated with increased perioperative hematoma than FXaI (OR = 1.89 [1.30 - 2.82]). Compared to patients taking VKA, those receiving FXaI had lower rates of major amputation (6.7% vs 8.4%, P=0.020) and mortality (7.6% vs 15.2%, P=< 0.001). Using Kaplan-Meier analysis, patients consistently anticoagulated with FXaI had improved amputation-free survival (AFS) after PVI. Adjusting for significant patient and procedural characteristics, Cox proportional hazard regression demonstrated that there is an increased risk for major amputation or mortality in patients using VKA compared to FXaI (HR 1.61, [1.36-1.90]).

CONCLUSIONS: Chronic anticoagulation with FXaI as compared to VKA was associated with superior perioperative and long-term outcomes in patients with PAD undergoing PVI. FXaI should be the preferred agents over VKA for chronic anticoagulation in patients with PAD undergoing PVI.