Key result
Prolonging DAPT to 24 months versus 6 months in elderly patients undergoing PCI did not significantly reduce ischemic events (HR 0.80; 95% CI 0.55-1.16; p=0.24) but increased bleeding risk.
Why the study?
Does 24-month prolonged dual antiplatelet therapy reduce ischemic events compared to 6-month therapy in elderly and non-elderly patients undergoing percutaneous coronary intervention?
RCT (n=1,970)
Does 24-month prolonged dual antiplatelet therapy reduce ischemic events compared to 6-month therapy in elderly and non-elderly patients undergoing percutaneous coronary intervention?
Hazard Ratio: 0.8 (95% CI 0.55–1.16)
p-value: p=0.24
Prolonging clopidogrel-based DAPT beyond 6 months after PCI increases bleeding risk without significantly preventing ischemic events, with a less favorable safety profile in elderly patients.
May favor shorter DAPT in elderly to curb bleeding; extends age-specific DAPT evidence from RCT.
AIMS: The aim of this study was to evaluate the efficacy and safety of 24-month vs. six-month dual antiplatelet therapy (DAPT) among elderly (≥75 years) and non-elderly patients (<75 years) undergoing percutaneous coronary intervention. METHODS AND RESULTS: The primary efficacy endpoint of the PRODIGY trial was the composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up. The key safety endpoint was type 2, 3 or 5 bleeding according to the BARC criteria. Of 1,970 participants, 587 (29.8%) were elderly and had a higher risk of adverse events compared with younger patients. The risk of the primary endpoint was not significantly reduced with 24-month compared to six-month DAPT among both elderly (HR 0.80, 95% CI: 0.55-1.16, p=0.24) and non-elderly patients (HR 1.48, 95% CI: 0.95-2.30, p=0.08), although interaction testing was significant (p=0.036). A 24-month versus six-month DAPT significantly increased the risk of BARC type 2, 3 or 5 bleeding in both older (HR 1.90, 95% CI: 1.06-3.38, p=0.03) and younger patients (HR 2.54, 95% CI: 1.43-4.53, p=0.002, p-interaction=0.48). However, measures of absolute risk difference indicated a less favourable safety profile of prolonged DAPT for older rather than younger patients. CONCLUSIONS: In the PRODIGY trial, prolonging clopidogrel-based DAPT beyond six months in elderly patients increased the risk of bleeding, without affording a significant prevention of ischaemic events.
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Piccolo et al. (2017) conducted an RCT in percutaneous coronary intervention (n=1,970). 24-month dual antiplatelet therapy vs. 6-month dual antiplatelet therapy was evaluated on Composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up (HR 0.80, 95% CI 0.55-1.16, p=0.24). Prolonging DAPT to 24 months versus 6 months in elderly patients undergoing PCI did not significantly reduce ischemic events (HR 0.80; 95% CI 0.55-1.16; p=0.24) but increased bleeding risk.
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