Deepak Bhatt, MD, discusses the results of the COMPASS trial and how they have impacted clinical practice.
Few, if any trials, have altered the landscape of care the way the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial has changed the way cardiologists treated coronary and peripheral artery disease.
The trial, which found that 2.5 mg rivaroxaban (Xarelto) combined with aspirin was associated with fewer adverse cardiovascular events than aspirin or rivaroxaban alone, was discontinued before completion by an independent safety board for what Deepak Bhatt, MD, MPH, called “overwhelming efficacy”.
Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, was an investigator in the COMPASS trial and recently sat down with MD Magazine® to discuss everything from COMPASS trial to threats to cardiovascular health. We asked Bhatt to explain the results and the overarching clinical impact it has had on care for coronary artery and peripheral artery disease.
MD Mag: Can you describe the results and implications of the COMPASS trial?
Bhatt: The COMPASS trial was a large study, over 27,000 patients who were randomized to receive either aspirin alone, aspirin plus low dose rivaroxaban, or a low dose of rivaroxaban alone. So, 3 different arms and basically the goal was to see in patients with stable coronary artery disease and/or stable peripheral artery disease — who are high ischemic risk — would one of these strategies be better than the other.
That is, should we stick with just aspirin alone, which is typically what's being done with these patients. Would we be better off with a low dose of a novel oral anticoagulant alone or is the best thing a combo of the 2 — that is aspirin but a reduced dose of a NOAC and as it turns out the study found a significant benefit of aspirin plus low dose rivaroxaban. By that, I mean 2.5 mg twice a day which I'll just point out is a lower dose than say the atrial fibrillation dose. It's a lot lower dose — so we have to be careful in terms of picking the right dose but in the trial it was this lower dose that was used in combination with aspirin and compared with aspirin alone significantly reduced ischemic events including a significant reduction in cardiovascular mortality.
So overall, a very positive trial. In fact, it was so positive that the independent data safety monitoring board keeping an eye on the trial said stop the trial because of overwhelming efficacy, including a lower rate of mortality that they observed. So, a very positive trial and the benefits seemed to be consistent both in those with coronary artery disease and in those with peripheral artery disease though in an absolute sense of absolute risk reduction and that sort of thing the benefit was highest in those with the greatest degree of atherosclerosis.
So, for example, patients with so-called polyvascular disease, that is both coronary artery disease and peripheral artery disease, seem to derive the greatest degrees of benefit. Now, the downside of intensifying the antithrombotic regimen predictably is more bleeding, including significantly more major bleeding. So, in terms of using this therapy — certainly, physicians would want to not use it in patients who are at high bleeding risk or patients that have had problems with bleeding in the past, but in patients who are low bleeding risk but who are at high ischemic risk — such as a patients say with peripheral artery disease it's symptomatic and who also has coronary artery disease — in that sort of patient assuming they are at low bleeding risk this seems to be a very appealing form of therapy to use