International Circulation: You talked about the key clinical trials from ACC 2009. What do you think are the 2 most influential trials this year? What changes in clinical practice do you foresee will happen due to these trial results?
Alfred Bove: One of the most important trials from ACC was the SYNTAX trial. It was a trial compareing surgery to intervention in patients that needed some kind of revascularization. The outcome of the trial showed no difference between surgery and PCI. Among the two different communities, the intervention community thought it was wrong and, of course, the surgical community thought it was correct. Dr. Turco earlier today made a good review of the subsets of SYNTAX. There are places where either therapy would work the same but there are clearly some patients where surgery is better and some patients where PCI is better. Like every other trial when you have a large population of patients, the average may tell you one thing but we don’t see patients as the average. We see each patient as an individual. When you sort out the different kinds of patients, it is clear that there are choices that favor PCI in some cases and others that favor surgery. That is one of the important trials that I think is going to make a lot of changes in the way we approach patients and in our thinking regarding how we manage patients with coronary artery disease in need of revascularization. That is why I think the SYNTAX trial is important. The other trial that I mentioned was called RELY which is also a very important trial. We have been treating atrial fibrillation for many years with Warfarin. It is the only drug we have to reduce the risk of stroke. We have aspirin but aspirin is not quite as good. Warfarin is the drug everyone uses and have been part of clinical trials for years. It is believed to be the drug needed to reduce the risk of stroke in patients through a spectrum of ages from around 60 up to the 70s and 80s. People are looking at different alternatives to produce anticoagulation rather than Factor VII inhibition. Medications that seem to have promise are the thrombin inhibitor drugs. The first one was ximelagatran, which showed very nicely that it could match Warfarin in terms of the reduction of the risk of stroke. However, it turned out to have a very serious liver side effect and was never approved for use. Therefore, everyone began to work on changing the molecule so that it would be safer to the liver but still provide the benefit of anticoagulation. Now we have dabigatran, which was presented in the RELY trial. It shows an extremely good promise to be an alternative to Warfarin in atrial fibrillation. Dabigatran, when it was examined at two doses, showed a slightly better outcome than Warfarin both in terms of preventing stroke and reducing the number of bleeding events. The major complication with blood thinners is bleeding. It looks like Dabigatran is one of the drugs that could provide the anticoagulation benefit without a great risk of bleeding. Those two trials among others are having an appreciable impact in clinical practice and influencing how physicians make decisions.
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