Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Dabigatran vs Warfarin in Patients with Valvular Heart Disease

Circulation; ePub 2016 Aug 5; Ezekowitz, et al

Publish date:: August 23, 2016

The comparison of dabigatran with warfarin was not influenced by the presence of any valvular heart disease (VHD) in a post-hoc analysis of the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial. The trial compared dabigatran (150 mg; D110) and dabigatran (110 mg; D110) BID with warfarin in 18,113 atrial fibrillation (AF) patients. The analysis found:

• 3,950 patients with any VHD: 3,101 had mitral regurgitation, 1,179 tricuspid regurgitation, 817 aortic regurgitations, 471 aortic stenosis, and 193 mild mitral stenosis.

• Patients with any VHD had higher rates of major bleeds (HR 1.32) but similar stroke or systemic embolism (SEE) rates (HR 1.09).

• Major bleed rates were lower for D110 patients when compared to warfarin (HR 0.73 with and HR 0.84 without VHD) and for D150 similar to warfarin in patients with (HR 0.82) or without VHD (HR 0.98).

• Stroke/SEE rates were lower in D150 patients vs warfarin with (HR 0.59) and without VHD (HR 0.67) and similar to warfarin for D110 irrespective of presence of VHD.

• Rates for D150 and D110 were lower vs warfarin for intracranial bleeds and death rates.

Citation: Ezekowitz MD, Nagarakanti R, Noack H, et al. Comparison of dabigatran versus warfarin in patients with atrial fibrillation and valvular heart disease: the RE-LY Trial. [Published online ahead of print August 5, 2016]. Circulation. doi:10.1161/CIRCULATIONAHA.115.020950.

Commentary: This analysis of the RE-LY trial shows that dabigatran works equally well to decrease the risk of stroke and with no change in safety profile in patients with atrial fibrillation with or without valvular heart disease. This is important since dagibatran was shown to be inferior to warfarin in patients with mechanical heart valves, associated with increased rates of thromboembolic and bleeding complications.¹ The current American Heart Association guidelines recommend equally the use of warfarin or the novel oral anticoagulants, including dabigatran, for patients with atrial fibrillation who do not have mechanical heart valves.² —Neil Skolnik, MD

1. Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369(13):1206-14.

2. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-267. doi:10.1161/CIR.0000000000000041.

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