Dabigatran Disappoints in Patients with Mechanical Heart Valves

At plasma levels derived from successful AF treatment, dabigatran was associated with higher rates of both thrombotic and bleeding events, compared with warfarin.

Dabigatran is one of several new oral anticoagulants that are FDA-approved for treatment of nonvalvular atrial fibrillation (AF). To explore whether the beneficial effects of dabigatran extend to patients with prosthetic cardiac valves, researchers conducted a manufacturer-sponsored, phase 2 dose-validation trial in comparison with warfarin. Dabigatran dosage was adjusted to achieve trough plasma levels of ≥50 ng/mL, based largely on results of the RE-LY trial in AF patients (NEJM JW Cardiology Sep 1 2009); warfarin dosage was adjusted to obtain international normalized ratios of 2 to 3.5, depending on thromboembolic risk.

The trial was halted early because of excess thromboembolic and bleeding events in the dabigatran group; the final study…

Reviewing Author

Joel M. Gore, MD

Disclosures

Grant/Research SupportNIH–National Heart, Lung, and Blood Institute

Joel M. Gore, MD

Disclosures

Grant/Research SupportNIH–National Heart, Lung, and Blood Institute

Dabigatran Disappoints in Patients with Mechanical Heart Valves

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Reviewing Author