Does dabigatran increase risk of MI? HT @sandnsurf

dabigatranFollowing on from our recent CME on "NOACs", in this opinion piece published "online first" via Chest (you don't read it routinely? Apparently Mike Cadogan does - he tweeted out this article), the author asserts that the cumulative data for direct thrombin inhibitors, including dabigatran and bivalirudin, suggests an increased incidence of cardiac thrombosis:

(Where) randomized clinical trials have compared them to other active anticoagulants in settings where enough patients were exposed long enough, there is an unmistakable signal for increased myocardial infarction, coronary ischemia, and/or coronary stent and/or cardiac valve thrombosis.

Data from a database of over 18000 patients comparing dabigatran with warfarin to prevent embolic complications in atrial fibrillation demonstrated that dabigatran 150 mg bd was associated with 1.38 times the risk of myocardial infarction compared to warfarin (p=0.05, NNH= 476). A "correction" published soon after declared that they had missed a number of heart attacks in their counting, nudging the numbers out of statistical significance (sounds dodgy to me).

The data demonstrate that:

“the rate of myocardial infarction with well-controlled warfarin (for stroke prevention in patients with atrial fibrillation and acute VTE treatment or secondary VTE prevention) is lower than with dabigatran 150 mg twice daily”

"these differences did not emerge in trials with fewer patients or when  dabigatran was compared to placebo in a similar population"

Does that mean that warfarin is more effective at reducing risk of cardiac thrombosis? And are the effects significant (those are some large NNHs)?

What's your opinion?



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