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Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial
- Source :
- The Lancet. 398:1305-1316
- Publication Year :
- 2021
- Publisher :
- Elsevier BV, 2021.
-
Abstract
- Summary Background In patients with acute myocardial infarction receiving potent antiplatelet therapy, the bleeding risk remains high during the maintenance phase. We sought data on a uniform unguided de-escalation strategy of dual antiplatelet therapy (DAPT) from ticagrelor to clopidogrel after acute myocardial infarction. Methods In this open-label, assessor-masked, multicentre, non-inferiority, randomised trial (TALOS-AMI), patients at 32 institutes in South Korea with acute myocardial infarction receiving aspirin and ticagrelor without major ischaemic or bleeding events during the first month after index percutaneous coronary intervention (PCI) were randomly assigned in a 1:1 ratio to a de-escalation (clopidogrel plus aspirin) or active control (ticagrelor plus aspirin) group. Unguided de-escalation without a loading dose of clopidogrel was adopted when switching from ticagrelor to clopidogrel. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, or bleeding type 2, 3, or 5 according to Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months. A non-inferiority test was done to assess the safety and efficacy of de-escalation DAPT compared with standard treatment. The hazard ratio (HR) for de-escalation versus active control group in a stratified Cox proportional hazards model was assessed for non-inferiority by means of an HR margin of 1·34, which equates to an absolute difference of 3·0% in the intention-to-treat population and, if significant, a superiority test was done subsequently. To ensure statistical robustness, additional analyses were also done in the per-protocol population. This trial is registered at ClinicalTrials.gov, NCT02018055. Findings From Feb 26, 2014, to Dec 31, 2018, from 2901 patients screened, 2697 patients were randomly assigned: 1349 patients to de-escalation and 1348 to active control groups. At 12 months, the primary endpoints occurred in 59 (4·6%) in the de-escalation group and 104 (8·2%) patients in the active control group (pnon-inferiority Interpretation In stabilised patients with acute myocardial infarction after index PCI, a uniform unguided de-escalation strategy significantly reduced the risk of net clinical events up to 12 months, mainly by reducing the bleeding events. Funding ChongKunDang Pharm, Medtronic, Abbott, and Boston Scientific.
- Subjects :
- Male
Ticagrelor
medicine.medical_specialty
medicine.medical_treatment
Population
Myocardial Infarction
Hemorrhage
Percutaneous Coronary Intervention
Internal medicine
Republic of Korea
medicine
Clinical endpoint
Humans
cardiovascular diseases
Myocardial infarction
education
Aged
education.field_of_study
Aspirin
business.industry
Dual Anti-Platelet Therapy
Standard treatment
Percutaneous coronary intervention
General Medicine
Middle Aged
medicine.disease
Clopidogrel
Stroke
Treatment Outcome
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 01406736 and 02018055
- Volume :
- 398
- Database :
- OpenAIRE
- Journal :
- The Lancet
- Accession number :
- edsair.doi.dedup.....5b16dfbe777174a9396ce4034e9df841