Firstly, the trial was a randomised double blind trial, that was designed and analysed by the drug company responsible, an important fact to take into consideration. Over 18,000 patients were involved, and the primary outcome was based on non-inferiority, with the secondary outcome looking for superiority.
Ischaemic stroke, haemorrhagic stroke, transformation all happened less often in the apixaban (but relatively small numbers). All cause mortality was less also, with a HR of 0.89, and less major bleeding.
ROCKET-AF proved non-inferiority for rivaroxaban, and this study is showing the benefits of apixaban – looks like the reign of warfarin is coming to an end. Wonder when we’ll see the head to head between rivaroxaban and apixaban?
If you’re interested in this area, AVERROES, RE-LY and ROCKET-AF are some of the critical trials to read. In the meantime, check out ARISTOTLE at the NEJM, here.
IMAGE Tilemahos Efthimiadis
When a drug or drug class is looking to revolutionise a market, they often start with the various trials in their phases, with safety and then non-inferiority proved. Often you’ll see a few scattered articles here and there, and suddenly when non-inferiority is proved, a whole bunch of randomised trials come out. In the New England Journal this month, we have ARISTOTLE – the randomised controlled trial to prove how good apixaban really is, and perhaps the trial that will finally make us make the switch.