LONDON—Extending dual antiplatelet therapy (DAPT) beyond the recommended 12 months after coronary stenting “should be considered” in patients with a drug-eluting stent (DES) who are at low risk for bleeding, according to investigators from the OPTIDUAL trial.
The study showed that receiving DAPT—aspirin and clopidogrel—for an additional 36 months did not decrease the rate of major adverse cardiovascular and cerebrovascular events (MACCE).
However, there was a suggestion that it might reduce ischemic outcomes without excess bleeding.
“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 study investigator Gérard Helft, MD, PhD, of Hôpital Universitaire Pitié-Salpétrière in Paris, France.
He presented results of the trial at the ESC Congress 2015 (abstract 3159).
The study included 1385 patients from 58 French sites who had undergone percutaneous coronary intervention with placement of at least 1 DES for either stable coronary artery disease or acute coronary syndrome.
All patients had been on DAPT for 1 year and were randomly assigned to continue or to remain on aspirin alone for an additional 36 months.
There was no significant difference between the groups with regard to MACCE, a composite of all-cause death, myocardial infarction, stroke, and major bleeding. These events occurred in 5.8% of patients in the extended-DAPT group and 7.5% in the aspirin-only group (hazard ratio (HR=0.75, P=0.17).
Likewise, there was no significant difference between the treatment groups for any of the components of MACCE—stroke (HR=0.69, P=0.53), myocardial infarction (HR=0.67, P=0.31), major bleeding (HR=0.98, P=0.95), or death (HR=0.65, P=0.18).
There was a non-significant (but borderline) reduction in ischemic outcomes—a post-hoc outcome composite rate of death, myocardial infarction, or stroke—with extended DAPT. These events occurred in 4.2% of patients in the extended-DAPT group and 6.4% in the aspirin-only group (HR=0.64, P=0.06).
“The results are consistent with the recent findings on ischemic outcomes from the DAPT trial regarding the value of prolonging DAPT after DES placement,” Dr Helft said.
“There was no apparent harm, and the post-hoc efficacy signal on MACCE is consistent with the benefit seen in the DAPT trial. Thus, OPTIDUAL adds to the evidence suggesting benefit to extended DAPT after DES in patients who are event-free at 12 months.”
This study was funded by Assistance Publique - Hôpitaux de Paris and the Fédération Française de Cardiologie, with unrestricted grants from Cordis, Boston, Medtronic, Terumo, and Biotronik.
