New research may lead to changes in the standard-of-care guidelines for heart attack patients who have undergone coronary stenting procedures. According to the ULTIMATE-DAPT study, high-risk heart patients who stop taking aspirin one month after percutaneous coronary intervention (PCI) and only take ticagrelor instead experience improved outcomes and a reduction in major bleeding by more than half, compared to those who continue taking aspirin and ticagrelor together (known as dual antiplatelet therapy or DAPT), which is the current standard of care.The trial presentation at the American College of Cardiology Scientific Sessions on Sunday, April 7, and published in The Lancet.
This trial is the first and only one to test high-risk patients with recent or threatened heart attack (acute coronary artery syndromes, or ACS) taking ticagrelor with a placebo starting one month after PCI, and compare them with ACS patients taking ticagrelor with aspirin over the same period. The significant findings could change the current guidelines for standard of care worldwide.
“Our study has demonstrated that withdrawing aspirin in patients with recent ACS one month after PCI is beneficial.”Gregg W. Stone, MD, the co-chair of ULTIMATE-DAPT, presented the trial results, stating that the study showed a reduction in both major and minor bleeding by over 50 percent in one year. Additionally, there was no increase in adverse ischemic events, indicating that continuing aspirin was causing harm without any benefit. Stone also expressed his belief that it is time to change the guidelines and standard clinical practice so that most ACS patients are no longer treated with dual antiplatelet therapy beyond one month after a successful PCI procedure. Instead, he suggested treating these high-risk patients with a single potent platelet inhibitor like ticagrelor to improve prognosis.,” adds Dr. Stone, who is the Director of Academic Affairs for the Mount Sinai Health System. He is also a Professor of Medicine (Cardiology), and Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai.
The study looked at 3,400 patients with ACS at 58 centers in four countries from August 2019 to October 2022. All of the patients had received PCI, a non-surgical procedure where interventional cardiologists use a catheter to place stents in the blocked coronary arteries to restore blood flow. The patients were stable one month after PCI and were taking ticagrelor and aspirin. After that, researchers randomly assigned the patients to different treatment groups.In a study lasting one month, 1,700 patients were taken off aspirin and given ticagrelor and a placebo, while another 1,700 patients continued taking ticagrelor and aspirin. All patients were assessed between 1 and 12 months after the procedure.
During the study, 35 patients in the group taking ticagrelor and placebo experienced a major or minor bleeding event, whereas 78 patients in the group taking ticagrelor and aspirin had similar incidents. This indicates that withdrawing aspirin reduced the overall incidence of bleeding events by 55 percent. The study also examined major adverse cardiac and cerebrovascular events such as death, heart attack, stroke, bypass graft surThe study found that discontinuing aspirin in patients who have undergone PCI for acute coronary syndrome did not increase the risk of heart attack or other ischemic complications. The events occurred in 61 patients who took ticagrelor and a placebo, compared to 63 patients who took ticagrelor and aspirin. The difference was not statistically significant, indicating that removing aspirin did not cause harm and actually improved outcomes. With contemporary drug-eluting stents now used in all PCI procedures, it is no longer necessary to continue dual antiplatelet therapy within one year after PCI. This new finding challenges the previous belief and provides valuable insights for patient care.heart attack patients who have undergone PCI and are stable one month after the procedure can benefit from a reduced risk of serious bleeding and improved outcomes, according to Dr. Stone. This study builds on previous research that showed similar results, but with the added strength of using a placebo to eliminate bias from the study.
Funding for this trial was provided by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project.