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
The Lancet Oct 13, 2021
Kim CJ, Park MW, Kim MC, et al. - Findings demonstrate that a uniform unguided de-escalation strategy implemented in stabilised patients with acute myocardial infarction post- index percutaneous coronary intervention (PCI) provided significant decrease in the risk of net clinical events up to 12 months, chiefly by decreasing the bleeding events.
This is an open-label, assessor-masked, multicentre, non-inferiority, randomised trial (TALOS-AMI) of acute myocardial infarction patients taking aspirin and ticagrelor without major ischaemic or bleeding events during the first month post-index PCI.
Participants were randomized (1:1) to a de-escalation (n=1349) (clopidogrel plus aspirin) or active control (n=1348) (ticagrelor plus aspirin) group.
When switching from ticagrelor to clopidogrel, unguided de-escalation without a loading dose of clopidogrel was implemented.
Occurrence of primary endpoints [a composite of cardiovascular death, myocardial infarction, stroke, or bleeding type 2, 3, or 5 per Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months] at 12 months was evident in 59 (4·6%) in the de-escalation group and 104 (8·2%) patients in the active control group (hazard ratio HR 0·55).
Less frequent occurrence of composite of BARC 2, 3, or 5 bleeding was evident in the de-escalation group (3·0% vs 5·6%, HR 0·52).
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