Strategies for antiplatelet management following acute coronary syndrome
Abstract
Acute coronary syndrome (ACS) is a major cardiovascular condition associated with high morbimortality and healthcare costs. STREAMLINE is a pragmatic, multicenter (66 centers in 6 countries), investigator-initiated clinical trial designed to address critical gaps in evidence on antiplatelet therapy after ACS. Current guidelines recommend 12 months of dual antiplatelet therapy (DAPT) combining aspirin and a potent P2Y12 inhibitor(i) (prasugrel or ticagrelor) as the standard strategy to reduce recurrent ischemic events. However, this strategy increases the risk of bleeding, particularly in vulnerable populations such as the elderly.
This trial tests 2 hypotheses:
- An abbreviated DAPT strategy (3 months of aspirin+P2Y12 inhibitor followed by single antiplatelet therapy [SAPT] with a potent P2Y12i) is non-inferior to the standard 12 mo DAPT strategy in preventing recurrent ischemic events while significantly reducing bleeding.
- A prasugrel-based abbreviated DAPT strategy is superior to a ticagrelor-based abbreviated DAPT strategy in reducing ischemic events without increasing bleeding.
The trial will enroll 8,100 ACS patients from 6 European countries, ensuring representation across diverse populations and high-risk groups. Patients will undergo sequential randomization into 2 arms: 2:1 for abbreviated vs. standard DAPT, followed by 1:1 for prasugrel vs. ticagrelor in the abbreviated group. Primary endpoints include the composite of death, non-fatal myocardial infarction, or stroke at 1 year, analyzed for non-inferiority (first hypothesis) and superiority (second hypothesis). Major bleeding (BARC 3-5) is the main secondary outcome.
This trial is expected to generate robust, high-impact evidence to guide clinical practice, optimize antiplatelet strategies, and improve outcomes for ACS patients, particularly those more vulnerable. Results will inform guideline committees, policymakers, and clinicians, contributing to safer and more effective treatment protocols for ACS.
Partners
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- Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD), coordinator
- Royal College of Surgeons Dublin, University (RSCI)
- Oslo University Hospital, Ullevål
- Mario Negri Institute for Pharmacological Research
- Saint John Paul II Hospital in Cracow
- Paula Stradiņa klīniskā universitates slimnīca (PSKUS)
- Biomedical Researhc Institute of Malaga and Nanomedicine Platform (IBIMA Plataforma BIONAND)
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Related Links
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- Link to the project –ERA4HEALTH website
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Aknowledgment