Withdrawing aspirin post-PCI reduces major bleeding by more than half, keeping safety and efficacy in high-risk heart clients on ticagrelor.High-risk heart patients reveal enhanced results and reduced bleeding by over 50% when aspirin is withdrawn one month after PCI, with ticagrelor treatment alone, according to the ULTIMATE-DAPT study.Withdrawing aspirin one month after percutaneous coronary intervention (PCI) in high-risk heart patients and keeping them on ticagrelor alone safely improves results and minimizes major bleeding by more than half when compared to patients taking aspirin and ticagrelor combined (likewise understood as dual antiplatelet therapy or DAPT), which is the existing requirement of care.These are the results from the ULTIMATE-DAPT research study announced throughout a late-breaking trial discussion at the American College of Cardiology Scientific Sessions on April 7, and released in The Lancet.Study Findings and ImplicationsThis is the first and just trial to check high-risk clients with current or threatened heart attack (acute coronary artery syndromes, or ACS) taking ticagrelor with a placebo beginning one month after PCI, and compare them with ACS clients taking ticagrelor with aspirin over the very same duration. Scientist randomized the clients after one month, withdrawing aspirin in 1,700 clients and putting them on ticagrelor and a placebo, while leaving the other 1,700 clients on ticagrelor and aspirin. These events took place in 61 clients in the ticagrelor-placebo group compared to 63 clients in the ticagrelor-aspirin group, and were not statistically considerable– further demonstrating that eliminating aspirin did no harm and enhanced outcomes.The main safety endpoint of MACCE, the composite cardiac death, myocardial infarction, ischaemic stroke, certain stent thrombosis, or clinically-driven target vessel revascularization, was examined in the intention-to-treat population in between 12-months and one-month post-PCI in clients who were event-free after one month of ticagrelor and aspirin.
Withdrawing aspirin post-PCI reduces major bleeding by more than half, maintaining security and efficacy in high-risk heart clients on ticagrelor.High-risk heart patients reveal improved outcomes and lowered bleeding by over 50% when aspirin is withdrawn one month after PCI, with ticagrelor treatment alone, according to the ULTIMATE-DAPT study.Withdrawing aspirin one month after percutaneous coronary intervention (PCI) in high-risk heart patients and keeping them on ticagrelor alone securely enhances outcomes and lowers significant bleeding by majority when compared to clients taking aspirin and ticagrelor integrated (also known as double antiplatelet therapy or DAPT), which is the present requirement of care.These are the arise from the ULTIMATE-DAPT study revealed throughout a late-breaking trial presentation at the American College of Cardiology Scientific Sessions on April 7, and published in The Lancet.Study Findings and ImplicationsThis is the very first and only trial to test high-risk patients with threatened or recent heart attack (acute coronary artery syndromes, or ACS) taking ticagrelor with a placebo starting one month after PCI, and compare them with ACS clients taking ticagrelor with aspirin over the same period. The considerable findings could change the current standards for standard of care worldwide.”Our research study has actually shown that withdrawing aspirin in patients with recent ACS one month after PCI is helpful by minimizing small and major bleeding through one year by more than 50 percent. There was no increase in adverse ischemic events, implying continuing aspirin was causing damage without supplying any advantage,” states Gregg W. Stone, MD, the study co-chair of ULTIMATE-DAPT, who presented the trial results.”It is my belief that its time to change the guidelines and basic clinical practice such that we no longer deal with most ACS patients with double antiplatelet therapy beyond one month after a successful PCI treatment. Dealing with these high-risk clients with a single potent platelet inhibitor such as ticagrelor will enhance diagnosis,” includes Dr. Stone, who is Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai.The main efficacy endpoint of clinically-relevant bleeding, specified as BARC types 2, 3 or 5 bleeding, was evaluated in the intention-to-treat population between one-month and twelve-months post-PCI in clients who were event-free after one month of ticagrelor and aspirin. Switching to ticagrelor monotherapy at one month led to a 55-percent decrease in the danger of medically appropriate bleeding compared with continuing ticagrelor plus aspirin over the ensuing 11 months. Credit: Mount Sinai Health SystemStudy Details and ResultsThe research study analyzed 3,400 clients with ACS at 58 centers in four nations between August 2019 and October 2022. All of the patients had gone through PCI, a non-surgical procedure in which interventional cardiologists use a catheter to put stents in the obstructed coronary arteries to bring back blood circulation. The clients were stable one month after PCI and were on ticagrelor and aspirin. Scientist randomized the clients after one month, withdrawing aspirin in 1,700 patients and putting them on ticagrelor and a placebo, while leaving the other 1,700 patients on ticagrelor and aspirin. All clients were evaluated in between 1 and 12 months after the procedure.During the study duration, 35 patients in the ticagrelor-placebo group had a major or small bleeding occasion, compared to 78 clients in the ticagrelor-aspirin group, suggesting that the occurrence of general bleeding occurrences was lowered by 55 percent by withdrawing aspirin. The research study likewise evaluated significant negative cardiac and cerebrovascular events consisting of death, heart attack, stroke, bypass graft surgery, or repeat PCI. These events happened in 61 clients in the ticagrelor-placebo group compared to 63 clients in the ticagrelor-aspirin group, and were not statistically considerable– additional demonstrating that eliminating aspirin did no damage and improved outcomes.The primary security endpoint of MACCE, the composite heart death, myocardial infarction, ischaemic stroke, guaranteed stent apoplexy, or clinically-driven target vessel revascularization, was evaluated in the intention-to-treat population between one-month and 12-months post-PCI in patients who were event-free after one month of ticagrelor and aspirin. During the next eleven months clients treated with ticagrelor monotherapy had comparable rates of adverse ischaemic events as patients who were kept on ticagrelor plus aspirin.PCI denotes percutaneous coronary intervention; BARC denotes Bleeding Academic Research Consortium; MACCE, significant negative cardiovascular or cerebrovascular events; HR, risk ratio; CI, confidence interval.Credit: Mount Sinai Health System”It was formerly believed that stopping dual antiplatelet therapy within one year after PCI in patients with ACS would increase the threat of heart attack and other ischemic problems, but the present research study shows that is not the case, with contemporary drug-eluting stents now utilized in all PCI procedures. Stopping aspirin in patients with a current or threatened heart attack who are steady one month after PCI is safe and, by reducing severe bleeding, improves outcomes,” Dr. Stone includes. “This study extends the results of prior work that showed similar outcomes but without the quality of using a placebo, which removes bias from the study.”Reference: “Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with severe coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial” by Zhen Ge, Jing Kan, Xiaofei Gao, Afsar Raza, Jun-Jie Zhang, Bilal S Mohydin, Fentang Gao, Yibing Shao, Yan Wang, Hesong Zeng, Feng Li, Hamid Sharif Khan, Naeem Mengal, Hongliang Cong, Mingliang Wang, Lianglong Chen, Yongyue Wei, Feng Chen, Gregg W Stone, Shao-Liang Chen, Xiaobo Li, Zhen Ge, Jing Kan, Muhammed Anjum, Fei Ye, Xiaofei Gao, Anjum Jalal, Ping Xie, Ling Tao, Xiang Chen, Hamid S Khan, Asim Javed, Yibin Shao, Xiaomei Guo, Feng Li, Tahir Saghir, Naeem Mengal, Shaoping Nie, Hong Qu, Xuesong Qian, Song Yang, Jing Chen, Dasheng Gao, Lijun Liu, Mingliang Wang, Lianglong Chen, Fan Liu, Tan Xu, Yinwu Liu, Badar Ul Ahad Gill, Qing Yang, Nin Guo, Shangyu Wen, Hongliang Cong, Lang Hong, Imad Sheiban, Afsar Raza, Yongyue Wei, Feng Chen, Gary S Mintz, Jun-Jie Zhang, Gregg W Stone and Shao-Liang Chen, 7 April 2024, The Lancet.DOI: 10.1016/ S0140-6736( 24 )00473-2This trial was funded by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & & Nanjing Municipal Clinical Trial Project.