Stopping aspirin and using ticagrelor alone significantly reduced bleeding risks in high-risk heart patients following heart stent placement.
Summary: The ULTIMATE-DAPT study presented at the American College of Cardiology sessions suggests a single medication approach post-percutaneous coronary intervention is safer for high-risk patients. Withdrawing aspirin and continuing ticagrelor alone reduced bleeding by over 50% compared to the standard dual antiplatelet therapy. This regimen did not increase adverse events, challenging current guidelines. The trial, involving 3,400 patients, could change global standard care practices for acute coronary syndrome patients, according to the researchers.
Key Takeaways:
- The ULTIMATE-DAPT study found that withdrawing aspirin one month after percutaneous coronary intervention (PCI) and continuing with ticagrelor alone reduced major bleeding by more than half compared to dual antiplatelet therapy.
- The study involved 3,400 high-risk heart patients with recent or threatened heart attacks (acute coronary artery syndromes, or ACS) from 58 centers across four countries.
- The findings, which showed no increase in adverse ischemic events, suggest that current guidelines for post-PCI care could be revised to favor a single potent platelet inhibitor over dual therapy.
Withdrawing aspirin one month after percutaneous coronary intervention (PCI) in high-risk heart patients and keeping them on ticagrelor alone safely improves outcomes and reduces major bleeding by more than half when compared to patients taking aspirin and ticagrelor combined (also known as dual antiplatelet therapy or DAPT), which is the current standard of care.
These are the results from the ULTIMATE-DAPT study announced during a late-breaking trial presentation at the American College of Cardiology Scientific Sessions and published in The Lancet.
Researchers say this is the first and only trial 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, according to the researchers.
“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%. Moreover, there was no increase in adverse ischemic events, meaning continuing aspirin was causing harm without providing any benefit,” says Gregg W. Stone, MD, the study co-chair of ULTIMATE-DAPT, who presented the trial results, in a release.
“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,” says 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.
Study Details
The study analyzed 3,400 patients with ACS at 58 centers in four countries between August 2019 and October 2022. All of the patients had undergone PCI, a non-surgical procedure in which 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 on ticagrelor and aspirin. Researchers randomized the patients 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 patients were evaluated between one and 12 months after the procedure.
During the study period, 35 patients in the ticagrelor-placebo group had a major or minor bleeding event, compared to 78 patients in the ticagrelor-aspirin group, meaning that the incidence of overall bleeding incidents was reduced by 55% by withdrawing aspirin.
The study also analyzed major adverse cardiac and cerebrovascular events including death, heart attack, stroke, bypass graft surgery, or repeat PCI. These events occurred in 61 patients in the ticagrelor-placebo group compared to 63 patients in the ticagrelor-aspirin group, and were not statistically significant – further demonstrating that removing aspirin did no harm and improved outcomes.
“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,” Stone adds in a release. “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.”
This trial was funded by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project.
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