The ULTIMATE-DAPT study, presented at the American College of Cardiology Scientific Sessions and published in The Lancet, revealed that withdrawing aspirin one month after PCI in high-risk heart patients and keeping them on ticagrelor alone significantly improved outcomes and reduced major bleeding by more than 50% when compared to patients on dual antiplatelet therapy (DAPT) with aspirin and ticagrelor. This is the first trial to test high-risk patients with recent or threatened heart attacks taking ticagrelor with a placebo instead of aspirin after PCI. The findings suggest a potential change in the current guidelines for standard of care worldwide.
The study included 3,400 patients with ACS who had undergone PCI, with half of them continuing with ticagrelor and aspirin while the other half had aspirin withdrawn and were put on ticagrelor and a placebo. The results showed that patients in the ticagrelor-placebo group had significantly fewer major or minor bleeding events compared to the ticagrelor-aspirin group, with a 55% reduction in overall bleeding incidents. Additionally, there was no increase in adverse ischemic events, indicating that continuing aspirin beyond one month was causing harm without providing any benefits.
Dr. Gregg W. Stone, the study co-chair, emphasized that it may be time to change the guidelines and standard clinical practice so that most ACS patients are not treated with DAPT beyond one month after a successful PCI procedure. He believes that treating these high-risk patients with a single potent platelet inhibitor like ticagrelor can improve prognosis. The study results challenge previous beliefs that discontinuing dual antiplatelet therapy within one year after PCI in patients with ACS would increase the risk of heart attack and other ischemic complications.
The study, which involved patients from 58 centers in four countries, was conducted between 2019 and 2022 and funded by several organizations. It demonstrated that discontinuing aspirin in stable ACS patients one month after PCI is safe and can potentially improve outcomes by reducing serious bleeding incidents. By using a placebo in the trial, bias was eliminated, providing more robust evidence to support the benefits of withdrawing aspirin in these patients. Overall, the ULTIMATE-DAPT study could have a significant impact on the current standard of care for high-risk heart patients after PCI.