Vinereanu D, et al. - Using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial, researchers scrutinized stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban vs warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD). Findings shed light on the connection between aortic stenosis (AS) with a higher risk of stroke/systemic embolism, bleeding and death in anticoagulated patients with AF. When compared with warfarin, the efficacy and safety benefits of apixaban were discovered to be consistent, irrespective of the presence of mitral regurgitation (MR), aortic regurgitation (AR) or AS.

Methods

• The enrollment comprised of 14,793 patients with known VHD status.
• Candidates were categorised as having moderate or severe mitral regurgitation (MR) (n=3,382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324).
• The exclusion criteria constituted patients with moderate or severe mitral stenosis.
• A comparative evaluation was conducted of the baseline characteristics, efficacy and safety outcomes between each type and no significant VHD.
• Using an adjusted model, experts investigated the treatment effect.

Results

• Similar rates of stroke/systemic embolism and bleeding were demonstrated among patients with MR or AR and patients without MR or AR, respectively.
• Substantially higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) were reported among patients with AS than patients without AS.
• Data exhibited a similar superiority of apixaban over warfarin on stroke/systemic embolism in patients with vs without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with vs without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with vs without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19).
• No evidence was yielded with regard to a different effect of apixaban over warfarin in patients with any VHD subcategory, for each of the primary and secondary efficacy and safety outcomes.