OPTImal DUAL Antiplatelet Therapy - OPTIDUAL
The goal of the trial was to evaluate dual antiplatelet therapy (DAPT) for an additional 36 months among subjects who received a drug-eluting stent and were event-free at 12 months.
Contribution to the Literature: The OPTIDUAL trial failed to reach primary outcome; however, extended duration of DAPT nonsignificantly reduced ischemic events without increasing bleeding.
Subjects who received a drug-eluting stent and were event-free at 12 months were randomized to an additional 36 months of DAPT with clopidogrel versus 36 months of aspirin monotherapy.
- Implantation of a drug-eluting stent for stable coronary artery disease or acute coronary syndrome
- Total number of enrollees: 1,385
The primary outcome of all-cause death, myocardial infarction, stroke, or major bleeding ooccurred in 5.8% of the 48-month DAPT group versus 7.5% of the 12-month DAPT group (p = 0.17).
- Death: 2.3% in the 48-month DAPT group vs. 3.5% in the 12-month DAPT group (p = 0.18)
- Death, myocardial infarction, or stroke: 4.2% in the 48-month DAPT group vs. 6.4% in the 12-month DAPT group (p = 0.06)
- Bleeding: 2.0% in both groups (p = 0.95)
Among patients who received a drug-eluting stent and were event-free at 12 months, ischemic outcomes, including all-cause mortality, were nonsignificantly reduced with extended duration of DAPT (clopidogrel) for an additional 36 months. This was without an apparent increase in bleeding. Despite low thrombogenicity of current-generation drug-eluting stents, several lines of evidence now suggest benefit to extending DAPT beyond 12 months.
Helft G, Steg PG, Le Feuvre C, et al., on behalf of the OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J 2015;Sep 12:[Epub ahead of print].
Presented by Dr. Gerard Helft at the European Society of Cardiology Congress, London, August 31, 2015.
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