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Published on: November 8, 2024
Rationale and design of the on-treatment PLAtelet Reactivity-Guided Therapy Modification FOR ST-Segment Elevation
Igor Mrdovic1, Lidija Savic, Gordana Krljanac
1University of Belgrade School of Medicine, Belgrade, Serbia.
Insights
This trial investigates if adjusting antiplatelet therapy based on platelet reactivity improves outcomes for ST-elevation myocardial infarction (STEMI) patients after primary percutaneous coronary intervention (PPCI). It aims to reduce major adverse cardiovascular events in high-risk individuals.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- High platelet reactivity is linked to increased ischemic events post-percutaneous coronary intervention (PCI).
- Previous large trials have not demonstrated clinical benefit from modifying antiplatelet therapy guided by platelet reactivity in acute coronary syndrome patients undergoing PCI.
Purpose of the Study:
- To evaluate if modifying antiplatelet regimen based on on-treatment platelet reactivity assessment improves clinical outcomes.
- To assess the benefit in moderate to high-risk patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI).
Main Methods:
- The PLATFORM trial is a prospective, randomized, controlled clinical trial involving approximately 632 STEMI patients with RISK-PCI score >3 undergoing PPCI.
- Patients are randomized to either treatment modification or standard therapy.
- Low aspirin responders receive 200 mg aspirin; low clopidogrel responders receive 180 mg ticagrelor for 1 year. Primary endpoint is MACE (death, MI, stroke, TVR); safety endpoint is TIMI major bleeding.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The PLATFORM trial will determine if ticagrelor combined with aspirin, guided by platelet reactivity, improves outcomes compared to standard antiplatelet therapy.
- This is specifically for moderate to high-risk STEMI patients undergoing PPCI.
Objectives:
The present trial aims at examining whether antiplatelet regimen modification, guided by assessment of the on-treatment platelet reactivity, might result with clinical benefit in moderate to high-risk patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Background:
High platelet reactivity has been associated with an increased rate of ischemic events after PCI. Recent large trials did not show a clinical benefit of platelet reactivity-guided therapy modification in acute coronary syndrome patients treated by PCI.
Methods:
PLATFORM is an investigator-initiated, prospective, randomized, parallel-group, controlled clinical trial. Approximately 632 STEMI patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing PPCI will be randomly allocated to treatment modification or standard therapy. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year. The primary end-point is the time to the first composite major adverse cardiovascular events (MACE) including death, nonfatal infarction, stroke, or immediate target vessel revascularization. Key safety end-point is the rate of TIMI major bleeding unrelated to coronary artery bypass graft surgery. Our secondary end-points are individual components of MACE, definite stent thrombosis, total bleeding, and the need for blood transfusions. Patients will be followed-up at 30 days and at 1 year after PPCI.
Conclusion:
PLATFORM will determine whether the platelet reactivity-guided use of ticagrelor in combination with 200 mg aspirin, compared with standard antiplatelet regimen, improves clinical outcome in moderate to high-risk STEMI patients undergoing PPCI.
Clinical Trial Registration:
U.S. National Institutes of Health (NIH) at www.clinicaltrials.gov. ClinicalTrials.gov Identifier: NCT01739556, and Current Controlled Trials at www.controlledtrials.com. International Standard Randomized Controlled Trial Number ISRCTN83081599.
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