Withdrawing aspirin post-PCI decreases significant bleeding by over half, keeping security and effectiveness in high-risk heart clients on ticagrelor.
High- threat heart clients reveal enhanced results and minimized bleeding by over 50% when aspirin is withdrawn one month after PCI, with ticagrelor treatment alone, according to the ULTIMATE-DAPT research study.
Withdrawing aspirin one month after percutaneous coronary intervention (PCI) in high-risk heart clients and keeping them on ticagrelor alone securely enhances results and decreases significant bleeding by over half when compared to clients taking aspirin and ticagrelor integrated (likewise called double antiplatelet treatment or DAPT), which is the existing requirement of care.
These are the arise from the ULTIMATE-DAPT research study revealed throughout a late-breaking trial discussion at the American College of Cardiology Scientific Sessions on April 7, and released in < period class ="glossaryLink" aria-describedby ="tt" data-cmtooltip ="<div class=glossaryItemTitle>The Lancet</div><div class=glossaryItemBody>Founded in 1823 by Thomas Wakley, The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's oldest, most prestigious, and best known general medical journals. The journal publishes original research articles, review articles ("seminars" and "reviews"), editorials, book reviews, correspondence, as well as news features and case reports. The Lancet has editorial offices in London, New York, and Beijing. </div>" data-gt-translate-attributes="[{"attribute":"data-cmtooltip", "format":"html"}]" tabindex ="0" function ="link" >TheLancet
StudyFindings andImplications
This is the very first and just trial to evaluate high-risk clients with current or threatened cardiac arrest( intense coronary artery syndromes, or air conditioning) taking ticagrelor with a placebo beginning one month after PCI, and compare them with air conditioning clients taking ticagrelor with aspirin over the exact same duration.The substantial findings might alter the existing standards for requirement of care worldwide.
“Our study has demonstrated that withdrawing aspirin in patients with recent ACS one month after PCI is beneficial by reducing major and minor bleeding through one year by more than 50 percent. Moreover, there was no increase in adverse ischemic events, meaning continuing aspirin was causing harm without providing any benefit,” statesGregg W.Stone, MD, the research study co-chair of ULTIMATE-DAPT, who provided the trial results.
“It is my belief that it’s time to change the guidelines and standard clinical practice such that we no longer treat most ACS patients with dual antiplatelet therapy beyond one month after a successful PCI procedure. Treating these high-risk patients with a single potent platelet inhibitor such as ticagrelor will improve prognosis,” includesDrStone, who isDirector ofAcademicAffairs for theMountSinaiHealthSystem andProfessor ofMedicine(Cardiology), andPopulationHealthScience andPolicy, at theIcahnSchool ofMedicine atMountSinai
The main effectiveness endpoint of clinically-relevant bleeding, specified as BARC types 2, 3 or 5 bleeding, was examined in the intention-to-treat population in 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 risk of medically appropriate bleeding compared to continuing ticagrelor plus aspirin over the occurring 11 months. Credit: Mount Sinai Health System
Study Details and Results
The research study evaluated 3,400 clients with air conditioning at 58 centers in 4 nations in between August 2019 and October2022 All of the clients had actually gone through PCI, a non-surgical treatment in which interventional cardiologists utilize a catheter to put stents in the obstructed coronary arteries to bring back blood circulation. The clients were steady one month after PCI and were on ticagrelor and aspirin. Researchers 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. All clients were assessed in between 1 and 12 months after the treatment.
During the research study duration, 35 clients in the ticagrelor-placebo group had a significant or small bleeding occasion, compared to 78 clients in the ticagrelor-aspirin group, indicating that the occurrence of general bleeding events was minimized by 55 percent by withdrawing aspirin. The research study likewise evaluated significant negative heart and cerebrovascular occasions consisting of death, cardiac arrest, stroke, bypass graft surgical treatment, or repeat PCI. These occasions happened in 61 clients in the ticagrelor-placebo group compared to 63 clients in the ticagrelor-aspirin group, and were not statistically substantial– additional showing that eliminating aspirin did no damage and enhanced results.
The main security endpoint of MACCE, the composite heart death, myocardial infarction, ischaemic stroke, certain stent apoplexy, or clinically-driven target vessel revascularization, was examined in the intention-to-treat population in between one-month and 12- months post-PCI in clients 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 negative ischaemic occasions as clients who were preserved on ticagrelor plus aspirin.
PCI represents percutaneous coronary intervention; BARC represents Bleeding Academic Research Consortium; MACCE, significant negative cardiovascular or cerebrovascular occasions; HR, risk ratio; CI, self-confidence period.
Credit: Mount Sinai Health System
“It was previously believed 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, but the present study shows that is not the case, with contemporary drug-eluting stents now used in all PCI procedures. Discontinuing aspirin in patients with a recent or threatened heart attack who are stable one month after PCI is safe and, by decreasing serious bleeding, improves outcomes,”Dr Stone includes. “This study extends the results of prior work that showed similar results but without the quality of using a placebo, which eliminates bias from the study.”
Reference: “Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute 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 -2
This trial was moneyed by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & & Nanjing Municipal Clinical Trial Project.
