Abstract Number: LB 01.1
Meeting: ISTH 2021 Congress
Background: Atherosclerosis is associated with heightened risk of venous thromboembolism (VTE) and patients with VTE are at increased risk of atherothrombosis. Shared pathobiologies likely underlying these associations include endothelial dysfunction, inflammation, and thrombin and platelet activation. Strategies targeting more than one of these pathways may have broad benefits for reducing thrombotic events across the spectrum of vascular territories in atherosclerosis.
Aims: To examine first and total arterial and venous vascular events in patients with symptomatic peripheral artery disease (PAD) after lower extremity revascularization (LER) as well as the effect of low-dose anticoagulation added to low-dose antiplatelet therapy on these outcomes.
Methods: VOYAGER PAD randomized 6,564 patients to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. Clopidogrel was allowed at the investigator’s discretion. Patients requiring therapeutic anticoagulation were excluded. Adjudicated events included MI, ischemic stroke, acute limb ischemia, major vascular amputation, and VTE (deep vein thrombosis, pulmonary embolism). First and total events were analyzed by proportional hazards models with excluded deaths treated as competing terminal events.
Results: Over 28 months (median), first and total event rates were 7.1 and 10.3 events/100 patient-years, respectively, in the placebo group. Rivaroxaban reduced first vascular event by 24% (HR 0.76, 95%CI 0.67-0.87, p<0.0001) and total vascular events by 23% (HR 0.77, 95%CI 0.67-0.89, p=0.0005) (Figure 1).
Among 925 patients with a nonfatal first event, 31% percent had a second event, with arterial the predominant type in both treatment arms (268 arterial, 16 venous) (Figure 2).
Conclusions: PAD patients are at high risk for arterial and venous vascular events after LER. VOYAGER PAD provides evidence for the benefit of dual pathway inhibition, combining low-dose anticoagulation with low-dose antiplatelet therapy, over antiplatelet therapy alone to protect against the adverse arterial and venous thrombotic risk profile of patients symptomatic for PAD who require revascularization.
To cite this abstract in AMA style:Berkowitz SD, Bauersachs RM, Szarek M, Nehler MR, Debus ES, Patel MR, Anand SS, Hess CN, Muehlhofer E, Haskell LP, Bonaca MP. Prevention Of Arterial And Venous Vascular Events In Symptomatic Peripheral Arterial Disease Patients After Lower Extremity Revascularization in the VOYAGER PAD trial: Dual Anticoagulant/Antiplatelet Regimen Vs Antiplatelet Therapy Alone [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/prevention-of-arterial-and-venous-vascular-events-in-symptomatic-peripheral-arterial-disease-patients-after-lower-extremity-revascularization-in-the-voyager-pad-trial-dual-anticoagulant-antiplatelet/. Accessed October 20, 2021.
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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/prevention-of-arterial-and-venous-vascular-events-in-symptomatic-peripheral-arterial-disease-patients-after-lower-extremity-revascularization-in-the-voyager-pad-trial-dual-anticoagulant-antiplatelet/