DAPT de-escalation strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. The EASTYLE trial will evaluate a hybrid DAPT de-escalation strategy (reduced-dose ticagrelor, followed by aspirin early discontinuation) in AMI patients, compared with a conventional DAPT strategy.
In ACS patients undergoing percutaneous coronary intervention, conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention comprises aspirin with a potent P2Y12 inhibitor (prasugrel or ticagrelor) for 12 months. Although this approach reduces ischaemic risk, patients are exposed to a substantial risk of bleeding during the stabilized period. Strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Abbreviation of DAPT duration after 1-6 months, followed by monotherapy with aspirin or a P2Y12 inhibitor, reduces bleeding without an increase in ischaemic events in patients at high bleeding risk, particularly those without high ischaemic risk. Either strategy requires assessment of the ischaemic and bleeding risks of each individual. Previous clinical and laboratory evidence demonstrates that a conventional-dose of ticagrelor has a potent antiplatelet effect, which appears to have a potential to increase the risk of bleeding during the stabilized period. Adjunctive use of aspirin to P2Y12 inhibitor would be important to protect the risk of thrombotic events in AMI patients, which use has a limited benefit with increased bleeding rate during the the stabilized period. The EASTYLE trial will evaluate clinical benefit of step-down de-escalation DAPT strategy including downgrading of P2Y12 inhibition (from 90 mg to 60 mg ticagrelor at 1 month post-PCI) and abbreviation of DAPT duration (aspirin discontinuation at 3 months post-PCI), compared with a conventional DAPT strategy in AMI patients. This trial will support that the optimal platelet inhibition would be attenuated over time even in AMI patients. The result will make a big step toward precision medicine in the field of antiplatelet treatment in AMI patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,312
De-escalation strategy indicates conventional DAPT (ticagrelor 90 mg twice daily + aspirin 100 mg once daily) for 1 month, followed by de-escalation DAPT (ticagrelor 60 mg twice daily + aspirin 100 mg once daily) between 1 and 3 months. Between 3 and 12 months, patients will be treated with ticagrelor monotherapy (ticagrelor 60 mg twice daily).
Conventional stratetgy indicates conventional DAPT including ticagrelor 90 mg twice daily and aspirin 100 mg once daily during 12 months.
DongA University Hospital
Busan, South Korea
RECRUITINGPrimary endpoint (NACE)
MACCE (all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke) + major bleeding (BARC type 2, 3, or 5 bleeding)
Time frame: 12 months
Major adverse cardiac and cerebrovascular events (MACCE)
all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke
Time frame: 12 months
Bleeding events
BARC type 2, 3 or 5 bleeding; BARC 3 or 5 bleeding; TIMI major or minor bleeding; GUSTO severe or moderate bleeding; ISTH major bleeding
Time frame: 12 months
All-cause death
any mortality
Time frame: 12 months
CV death
Death related CV system
Time frame: 12 months
MI
Myocardial infarction
Time frame: 12 months
Stent thrombosis
definite or probable stent thrombosis by Academic Research Consortium (ARC) definition
Time frame: 12 months
Ischemic stroke
Stroke
Time frame: 12 months
Cardiac death, or MI
Coronary thrombotic events
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Time frame: 12 months
Cardiac death, MI or stent thrombosis
Coronary thrombotic events
Time frame: 12 months
Cardiovascular death, MI or stroke
MACE
Time frame: 12 months
TLR
target lesion revascularization
Time frame: 12 months
TVR
target vessel revascularization
Time frame: 12 months
Any revascularization
Re-PCI during follow-up
Time frame: 12 months