Rivaroxaban after TAVR linked with increased risk of adverse events compared to antiplatelet therapy

1. After successful transcatheter aortic valve replacement, compared to an anti-platelet based strategy, patients that received an anti-coagulation strategy including rivaroxaban at a dose of 10 mg daily had a higher risk of death, thromboembolic complications, and bleeding.

Evidence Rating: 1 (Excellent)

Transcatheter aortic-valve replacement (TAVR) is a treatment option for patients with severe symptomatic aortic stenosis. Currently, guidelines recommend dual antiplatelet therapy following successful TAVR to prevent thromboembolic events (TE) and complications such as stroke, MI, and DVT. Although rivaroxaban, a factor Xa inhibitor, has been shown to reduce TE events in other clinical settings, its suitability for post-TAVR anticoagulation has not been well studied. In this randomized controlled trial, 1644 patients without an absolute contraindication to anticoagulation or absolute indication for antiplatelet therapy were assigned to receive either anticoagulation (rivaroxaban 10 mg daily plus aspirin 75-100 mg daily for 3 months, followed by rivaroxaban monotherapy 10 mg) or dual antiplatelet therapy (aspirin 75-100 mg daily plus clopidogrel 75 mg daily for 3 months followed by aspirin monotherapy 75-100 mg). The primary efficacy outcome of interest was death or TE events, and the primary safety outcome was major bleeding events. After a median follow-up of 17 months, researchers found that there were significantly greater deaths or major TE events in the rivaroxaban group (HR 1.35, 95% confidence ratio 1.01 to 1.81, p=0.04) compared to the antiplatelet group. Deaths from any cause were also higher in the anticoagulant group (HR 1.69, 95% CI 1.13 to 2.53) when compared to the antiplatelet group. Based on an intention to treat analysis there were also a greater number of major, disabling, or life-threatening bleeding events in the anticoagulant group (HR, 1.50, 95% CI 0.95 to 2.37, p=0.08), though these results did not reach statistical significance. Overall, the results of this study do not support anticoagulant therapy with rivaroxaban 10 mg daily as a noninferior alternative to the currently recommended dual antiplatelet therapy post TAVR, given its increased risk of both TE events and bleeding related complications.

Click to read the study in NEJM

Image: PD

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