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Journal Club 18 September 2013

September 18, 2013 Leave a comment

Paper

Dabigatran versus Warfarin in Patients with Mechanical Heart Valves

Presenter

LAM

Summary

Background

Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective
alternative to warfarin in patients with atrial fibrillation. We evaluated the use
of dabigatran in patients with mechanical heart valves.

Methods

In this phase 2 dose-validation study, we studied two populations of patients: those
who had undergone aortic- or mitral-valve replacement within the past 7 days and
those who had undergone such replacement at least 3 months earlier. Patients were
randomly assigned in a 2:1 ratio to receive either dabigatran or warfarin. The selection
of the initial dabigatran dose (150, 220, or 300 mg twice daily) was based on
kidney function. Doses were adjusted to obtain a trough plasma level of at least
50 ng per milliliter. The warfarin dose was adjusted to obtain an international normalized
ratio of 2 to 3 or 2.5 to 3.5 on the basis of thromboembolic risk. The primary end
point was the trough plasma level of dabigatran.

Results

The trial was terminated prematurely after the enrollment of 252 patients because
of an excess of thromboembolic and bleeding events among patients in the dabigatran
group. In the as-treated analysis, dose adjustment or discontinuation of
dabigatran was required in 52 of 162 patients (32%). Ischemic or unspecified stroke
occurred in 9 patients (5%) in the dabigatran group and in no patients in the warfarin
group; major bleeding occurred in 7 patients (4%) and 2 patients (2%), respectively.
All patients with major bleeding had pericardial bleeding.

Conclusions

The use of dabigatran in patients with mechanical heart valves was associated with
increased rates of thromboembolic and bleeding complications, as compared with
warfarin, thus showing no benefit and an excess risk.

Further Material

The editorial is here. The supplementary appendix is here

Randomized Trial of Preventive Angioplasty in Myocardial Infarction

September 17, 2013 Leave a comment

The PRAMI trial presented at ESC 2013 is available here.

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