Dr Deepak Bhatt on the Impact of the COMPASS Trial on Standard of Care

The COMPASS trial results could reshape the standard of care for patients with coronary artery disease (CAD) and peripheral artery disease (PAD), according to Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital and Harvard Medical School.

Transcript (slightly modified)

How do you think the COMPASS trial results will change the standard of care for patients with coronary artery disease or peripheral artery disease?

What impact the results of COMPASS will have on clinical care, remains to be seen. The data, I think, are really quite strong in terms of benefit and net clinical benefit, with a good safety profile and the caveat that in this trial patients at high bleeding risk were excluded, as is typically the case with randomized clinical trials. As well, there was a run-in period where patients were on aspirin for a month and both arms had to tolerate it. So, for the patient, obviously if it was having intolerance to aspirin, or bleeding on aspirin, then they wouldn’t have likely been enrolled into the randomized part of the trial. Patients who aren’t adherent with their aspirin during that run-in phase wouldn’t get into the trial either. So, you want to make sure it’s a patient that’s adherent to the therapy they’re on already—say aspirin, for example—and then make sure they don’t have a history that puts them at high risk of bleeding. But, assuming that that’s the case, and they otherwise fit the inclusion criteria for COMPASS with respect to stable CAD or PAD, you know, the data is quite strong.

Of course, before being able to use it in the US will depend on what the FDA says—the 2.5 mg twice a day dose of rivaroxaban isn’t approved for this indication, it’s not even available in terms of potential off-label use. So, it really is a matter of the drug going through the regulatory process and if it is approved it remains to be seen how guidelines will adopt it.

I suspect guidelines may view the data favorably because the trial is not in isolation. There was an ATLAS 2 trial performed using this same dose of rivaroxaban; actually both the doses were used in different arms. That was an acute coronary syndrome or post acute coronary syndrome trial. In that trial, rivaroxaban 2.5 twice a day, largely on a background of aspirin and clopidogrel also reduced ischemic events significantly. In that trial there was a very statistically significant reduction in all-cause mortality with even curves continuing to diverge in 2 years.

So, viewed in that light, not just as one trial, especially when trials stopped early, but rather in 2 trials now—ATLAS 2 and COMPASS, a very large study—I think it’s a compelling story for that 2.5 twice a day dose. But, it remains to be seen how the FDA feels—they did not approve the 2.5 milligram dose for ACS.