OPTIDUAL: 12 vs. 48 Months of DAPT After DES Placement
Extending dual antiplatelet therapy (DAPT) beyond the recommended 12 months after coronary stenting "should be considered" in patients at low risk for bleeding, according to results from the OPTIDUAL Trial presented Aug. 31 at ESC Congress 2015 in London.
The trial included 1,385 patients from 58 French sites who had undergone percutaneous coronary intervention with placement of at least one drug-eluting stent for either stable coronary artery disease or acute coronary syndrome. All patients had been on DAPT for one year and were randomly assigned to continue or to remain on aspirin alone for an additional 36 months.
Overall results found no statistical difference between the groups for the primary endpoint of a composite of all-cause death, myocardial infarction, stroke and major bleeding (5.8 percent in the extended-DAPT group and 7.5 percent in the aspirin only group). Rates of death were 2.3 percent in the extended-DAPT group compared to 3.5 percent in the aspirin group.
According to investigators, there was a borderline but non-statistically significant reduction in ischemic outcomes with extended DAPT (4.2 percent) compared to aspirin (6.4 percent) without increased bleeding or all-cause mortality.
"Given the lack of harm and the signal for benefit of prolonged DAPT in the OPTIDUAL trial, and the results from prior randomized trials testing long durations of DAPT, prolongation of DAPT beyond 12 months should be considered in patients without high-risk bleeding, who have received a drug-eluting coronary stent and are event-free at 12 months," said lead investigator Gérard Helft, MD, PhD, from the Institut de Cardiologie, Hôpital Pitié-Salpétrière, in Paris, France.
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