While 18th century French essayist Joseph Joubert wasn’t specifically referring to the debate process that surrounds introducing new therapies to cardiovascular care, he does touch upon the crux of why debate is essential to every meaningful question. On May 23, at FDA headquarters in Silver Springs, Md., the Cardiovascular and Renal Drugs Advisory Committee engaged in a lively debate about the potential of introducing an antithrombin agent into the care cycle for patients with acute coronary syndrome (ACS), which would be a completely novel approach for these patients.
Unexpectedly, the majority of the day’s discussions revolved around what data weren’t there, as opposed to what data were there, due to the large number (approximately 8.5 percent) of patients in the ATLAS ACS 2 trial lost to follow up. Ultimately, the panelists voted not to recommend the drug for this patient population.
However, due to the intense preoccupation on the trial design and execution throughout the day, a more thought-provoking point initially introduced by cardiology luminary Eugene Braunwald, MD, of the TIMI Study Group at Harvard Medical School in Boston, was barely discussed. In the morning session, Braunwald tracked the history of cardiovascular care over the past 50 years, stating that the great progress in care needs to be attributed to improved developments in cardiovascular medicine.
Yet, “there is still room for improvement,” he added, advocating that this type of triple therapy approach for ACS patients might further drive down cardiovascular mortality, as seen in the ATLAS trial with the lower dose (2.5 mg BID) of the drug.
The ACS population is not an insignificant one, with 1.2 million patients in the U.S. alone.
Based on the study design, rivaroxaban would be introduced to patients after an ACS event (STEMI, non-STEMI or unstable angina) wi th the hopes of reducing the risk of thrombotic cardiovascular events. The drug, as in the trial, would be used in combination wi th aspirin alone or wi th aspirin plus clopidogrel or ticlopidine. The ATLAS trial did not assess the newer, more potent antiplatelet drugs, prasugrel or ticagrelor. The FDA’s final approval decision is still pending for this particular antithrombin agent.
While there was plenty of healthy debate about appropriate trial design and execution, particularly focused on the flaws of the ATLAS trial, what seemed lacking is any discussion about whether physicians who treat patients with ACS would be ready for such a paradigm shift.
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Justine Cadet, Cardiovascular Business