Abstract / Summary
The clinical effects of dual antiplatelet therapy de-escalation after acute myocardial infarction may differ by age. We evaluated whether the efficacy and safety of de-escalation from ticagrelor to clopidogrel differed by age in stabilized patients after percutaneous coronary intervention (PCI).
This was a prespecified secondary analysis of the TALOS-AMI randomized trial. Patients event-free 1 month after PCI receiving aspirin-ticagrelor were randomly allocated to de-escalation (aspirin-clopidogrel) or continuation (aspirin-ticagrelor). The primary net clinical endpoint was a composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke) and Bleeding Academic Research Consortium types 2, 3, or 5 bleeding at 1 year.
We included 2697 participants (mean age 60.0 ± 11.4 years; 16.8% women). Among patients aged <75 years (n = 2376), de-escalation reduced the primary net clinical endpoint (4.1% vs. 7.2%; adjusted hazard ratio (aHR), 0.54 [95% CI, 0.38-0.77]) and bleeding (2.8% vs. 4.9%; aHR, 0.54 [0.35-0.82]). Among patients aged ≥75 years, no significant differences were observed for the primary endpoint (6.4% vs. 11.6%; aHR0.54 [0.25-1.17]) or bleeding (3.2% vs. 7.9%; aHR, 0.41 [0.15-1.15]). Interaction testing showed no treatment effect modification by age for the primary endpoint (p for interaction = 0.978), MACE (p = 0.585), or BARC bleeding (p = 0.597). Among patients aged ≥75 years, 14/18 bleeding events occurred within 180 days.
Among stabilized, event-free patients 1 month after PCI, no significant age-treatment interaction was observed; therefore, the efficacy and safety of de-escalation in older adults (≥75 years) remain uncertain.
Trial registration: ClinicalTrials.gov (NCT02018055).
In this prespecified secondary analysis of the TALOS-AMI trial, clopidogrel-based de-escalation was associated with lower risks of the primary net clinical endpoint and BARC type 2, 3, or 5 bleeding among patients aged <75 years, while MACE did not differ significantly between treatment strategies. Among patients aged ≥75 years, no statistically significant between-group differences were observed for the primary net clinical endpoint, MACE, or BARC type 2, 3, or 5 bleeding. No statistically significant treatment-by-age interaction was detected using the prespecified 75 years cutoff, alternative 65 and 70 years cutoffs, or age as a continuous variable; the efficacy and safety of de-escalation specifically in older adults remain uncertain.