Dr Deepak Bhatt Highlights COMPASS Trial Results

The results of the COMPASS trial testing rivaroxaban plus aspirin in patients with coronary artery disease or peripheral artery disease showed such significant benefits for reducing ischemic events that it was stopped early, explained Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital and Harvard Medical School.

The results of the COMPASS trial testing rivaroxaban plus aspirin in patients with coronary artery disease or peripheral artery disease showed such significant benefits for reducing ischemic events that it was stopped early, explained Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital and Harvard Medical School.

Transcript

What where the findings of the COMPASS trial and what do they mean for patients with coronary artery disease and peripheral artery disease?

The COMPASS trial took patients with stable coronary artery disease (CAD) or stable peripheral artery disease (PAD) and randomized them into 1 of 3 arms: aspirin alone, the control arm; or rivaroxaban 5 mg twice a day alone, the experimental arm of anticoagulant alone versus antiplatelet alone; and then a combo arm of aspirin plus 2.5 mg twice a day of rivaroxaban–so a very low dose of rivaroxaban. In fact, both those doses I mentioned are much lower than the atrial fibrillation dose, for example.

And these 3 arms of patients were followed for about an average of 2 years or so, and what was found for the primary efficacy endpoint, of cardiovascular death, myocardial infarction, or stroke, was a significant reduction in that important triple ischemic composite. In fact, it was so significant that the data safety monitoring board stopped the trial early because they felt that the data showed overwhelming efficacy. In fact, that's what the company-issued press release said when the trial was stopped. In addition to seeing a benefit in that triple ischemic endpoint, they also saw a lower rate of mortality, of all-cause mortality. So that combination of findings made them say, "stop the trial," which is what the COMPASS investigators then did.

The efficacy results, I think, are quite robust. In terms of bleeding, there's always a downside with potent antithrombotic therapy. There was a significant excess in major bleeding. Fortunately, there was no, at least, statistically significant excess in fatal bleeding or intercrancial bleeding. So overall, a very good net clinical benefit–about a 20% or so reduction in that endpoint.

Overall, I would then say that it was a very positive trial. How exactly to integrate it into the practice of stable CAD, stable PAD versus other therapies, that is going to be a topic of discussion, I'm sure.