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" ... is consistent with the findings in Re-Align, although I wish it were presented and published in a peer reviewed journal. I do understand the urgency on behalf of the FDA to ensure that the use does not stray beyond its labeling for A-fib given both the prospective, randomized data from Re-Align and case reports of strokes on Pradaxa with mechanical valves. I don't think this is the final word on Pradaxa (or other new generation anticoagulants), but if we are to use them, the doses will undoubtedly be different, and presumably higher, than the doses used for A-fib. The question is whether one can find a dose that prevents thromboembolic strokes with the new generation anticoagulants at an acceptable level of bleeding. It's also worth noting that they did not recommend Pradaxa in patients with bioprosthetic valves, but didn't absolutely contraindicate it. Yet. ... "