The warfarin control arms of these trials can be problematic.There is always the issue of what percentage of time were the patients in the target INR range.Further ,heaven forbid, there may be even opportunities for stacking the deck.
There is still more drama to the story -the FDA panel that reviewed the data did not recommend its approval but the full deciding body at the FDA voted in favor. Some has also expressed concern about the current leading candidate for the head of the FDA since he was a prominent investigator in the trial.
We may never know or if we do it may take a while to sort that out, Meanwhile what about all the folks taking Xarelto? Can they be confident that this new or novel anticoagulant affords them greater safety than warfarin?Should they consider switching to apixaban? Should they even worry , after all there have been other trials that demonstrated efficacy and safety in the setting of venous thromboembolism and for prophylaxis in hip replacement.
More details can be found at Larry Huston;s excellent site "Cardiobrief". He also raises the issue of possible COI with the candidate for the Head Of the FRA, Robert M Califf who was a principal investigator in the Rocket-Af trial. As usual Dr Roy Poses offers important insights into the issue of COI and the ever spinning revolving door in health care in regard to the Dr. Califf and the unprecedented endorsement of him for the FDA post by the editorial folks at the NEJM.See here.
12/13/15Addendum; The folks who did the Rocket-af say they have now checked into the matter and that there is no need to worry. Sort of a move along nothing to see here type statement. Unfortunately they have not yet made public the data they collected and used to reach that reassuring conclusion. Stay tune.See here for details from the blog Cardiobrief by Larry Hustin which as usual has a wealth of useful information from the world of cardiology.