ADVERTISEMENT
TCT: Eliminating Long-Term Aspirin for Acute Coronary Syndrome Patients is Safe, Effective, and Reduces Bleeding Complications
Results from new Mount Sinai led study further support possible need to change current standard of care for these high-risk patients
Results from new Mount Sinai led study further support possible need to change current standard of care for these high-risk patients
Principal Investigator: Roxana Mehran, MD, Director of Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine at Mount Sinai
Conference: Transcatheter Cardiovascular Therapeutics (TCT 2023) – Featured Science Presentation
Journal: Circulation (simultaneous publication)
Bottom Line: This is the largest study of its kind evaluating ticagrelor monotherapy, and ticagrelor plus aspirin (the standard treatment) in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI) and stent implantation. It combines data from two international clinical trials: “TWILIGHT” and “TICO.” Results from this new joint analysis show ticagrelor alone after PCI significantly reduced total bleeding events in high-risk patients compared with ticagrelor plus aspirin (the standard treatment), without increasing total adverse cardiac events such as heart attack and stroke. Takeaways are that withdrawing aspirin can minimize the bleeding risk, while providing adequate ischemic protection, which could lead to a new standard of care for a high-risk patient population.
This work substantiates primary results of the Mount Sinai led TWILIGHT trial that demonstrated that among high-risk patients undergoing PCI, early aspirin withdrawal followed by ticagrelor monotherapy reduced the occurrence of bleeding events without ischemic harm when compared with a prolonged regimen of ticagrelor plus aspirin.
Why study is important: Patients with acute coronary syndrome undergoing PCI require intensive antithrombotic therapy for up to 12 months after angioplasty. This is necessary to prevent stent-related thrombotic events and typically consists of a combination of aspirin and a potent P2Y12 inhibitor (ticagrelor or prasugrel). This combination therapy can cause more frequent bleeding episodes in this sick patient population that’s at increased risk of bleeding. A novel approach has been proposed to drop aspirin after a short period of combination therapy.
Why study is unique: The Mount Sinai led TWILIGHT study was conducted in both stable and unstable patients while the TICO trial (out of South Korea) focused on acute patients. In this analysis, researchers pooled data from patients in both trials with acute coronary syndrome to provide the strongest evidence about the safety and efficacy of ticagrelor monotherapy in this high-risk population. It was important to corroborate the use of ticagrelor monotherapy, which is a therapy that has already been endorsed by the American and European Cardiology Guidelines.
How research was conducted: TICO and TWILIGHT studies tested ticagrelor monotherapy after a three month course of dual antiplatelet therapy with standard therapy. Researchers conducted an individual patient data (IPD) meta-analysis of these two trials. They included all patients with acute coronary syndrome randomized in TWILIGHT and applied similar criteria in TICO, excluding participants who experienced an ischemic or major bleeding event within the first three months post-angioplasty. They followed patients from three months after angioplasty (e.g., the time when aspirin was withdrawn in patients assigned to the ticagrelor monotherapy arm) up to to 12 months after the procedure.
Results: Of the 7,529 enrolled patients, 3,726 received ticagrelor monotherapy, and 3,803 received a combination of ticagrelor and aspirin. At 12 months after angioplasty (9 months of study follow-up), only 29 patients (0.8 percent) in the group receiving ticagrelor monotherapy experienced a major bleeding event, compared to 80 patients (2.1 percent) in the group taking ticagrelor plus aspirin. This translated into a significant 63% risk reduction in favor of ticagrelor monotherapy. There were no differences in mortality, myocardial infarction, stroke, or stent thrombosis between the two regimens.
What this means for physicians: It is often challenging for physicians to provide the most effective antithrombotic protection without raising the risk of bleeding for patients with acute coronary syndrome. This becomes even more significant for patients who have multiple comorbidities, are fragile, and have undergone complex revascularization procedures. These study findings underscore the value of dropping aspirin after a short period of combination therapy with ticagrelor, and proceeding with a ticagrelor monotherapy strategy, offering a safe and effective option for physicians seeking to reduce bleeding risk in their patients without increasing the likelihood of ischemic or thrombotic complications.
Quotes:
“We are very honored to have collaborated with our colleagues in Korea, to pool individual patient data on two similar trials, and now have some definitive answers in how to treat patients with acute coronary syndromes. This strategy of short (3-months) dual antiplatelet therapy (ticagrelor plus aspirin) followed by ticagrelor monotherapy is associated with less bleeding without any compromise in ischemic events,” says principal investigator Roxana Mehran, MD, Director of Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine at Mount Sinai
“These novel and compelling data challenge the conventional paradigm of using dual antiplatelet therapy in all patients after an acute coronary syndrome. The net clinical benefit provided by ticagrelor monotherapy offers clinicians a reassuring alternative to long-term dual antiplatelet therapy in these high-risk patients,” adds co-investigator Usman Baber, MD, Associate Professor of Medicine at the University of Oklahoma Health Sciences Center
Mount Sinai Heart is one of the nation’s top 4 hospitals in Cardiology/Heart Surgery
Mount Sinai Heart ranks No. 1 in New York and No. 4 globally according to Newsweek’s “The World’s Best Specialized Hospitals.” The Mount Sinai Hospital is also No. 1 in New York for cardiology, cardiac surgery, and vascular surgery and No. 4 nationally, according to U.S. News & World Report®.
It is part of Mount Sinai Health System, which is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. Hospitals within the System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report's® “Best Hospitals” Honor Roll for 2023-2024.
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.
Find More:
The Latest Clinical & Industry News
Grand Rounds With Morton Kern, MD
