ORLANDO, Fla.—When ATLAS-ACS2 was unveiled Nov. 13 at the American Heart Association (AHA) conference, showing a 38 percent reduction in mortality benefit for cardiovascular death with the use of a low dose of rivaroxaban (Xarelto) out to two years, the cardiovascular community sat up and took notice. Since questions remain about appropriate dosing and bleeding rates, ACC President David R. Holmes Jr., MD, explained some of those considerations to Cardiovascular Business (CVB).
CVB: Is the ALTAS-ACS trial a game changer?
Holmes: The trial points out that we need some additional treatment for patients with acute coronary syndromes [ACS] with a prior MI who are at high risk for subsequent events. The current standard of care is dual-antiplatelet therapy, or aspirin and a thienopyridine for one year after a heart attack.
For any new potential therapy, the risk-to-benefit ratio will be of tremendous importance. It is of interest that while fatality was not increased with the use of the drug, intracranial hemorrhage [ICH] was increased. ICH tends to be the most lethal of all strokes. Going forward, we will need to evaluate which specific patient populations, like the elderly, will be able to tolerate this drug, and at what dose they will be able to tolerate the additional drug.
It is certainly a potential game changer, as it brings along a totally different approach. It now depends upon how it should be rolled out in the broader patient population.
CVB: If this third therapy gets approved for ACS at such low doses of 2.5 BID or 5 BID, what is the cross-over atrial fibrillation population to do since rivaroxaban is approved at 10 BID for them?
Holmes: This is an issue that we do not know the answer to. Events, such as bleeding, stroke, atrial fibrillation and ACS, tend to cluster in older patients. It is my opinion now that this will be an additional agent to tailor therapy for broad groups of patients to try to bring together patient-specific therapy.
CVB: What is the potential cost burden to patients if they had a third drug to take? Could it affect adherence?
Holmes: The cost burden to patients will be huge. We are already concerned about costs, in this era when we are already constrained. Patients are looking to get off medications, not add more medications. Having said that, maybe part of the strategy going forward is to identify the highest risk group of patients, and then add the third drug to the highest risk group. Risk stratification is an increasingly important part of modern cardiovascular disease. We’re not going to give to everyone because not everyone will take it, and not everyone can afford to take it. We have to assess both the clinical and economic considerations with new therapies.