OPTIDUAL: Extended DAPT not superior to 12-month therapy

LONDON — Extending dual antiplatelet therapy with clopidogrel and aspirin for 48 months was not superior to 12 months of therapy for the reduction of net adverse clinical events in patients with drug-eluting stents, according to results of the OPTIDUAL trial.

However, the data indicated a “borderline but non-statistically significant reduction in post-hoc analysis of ischemic outcomes with extended dual antiplatelet therapy [DAPT],” Gérard Helft, MD, PhD, from the Institut de Cardiologie, Hôpital Pitié-Salpétrière, in Paris, France, said at the European Society of Cardiology Congress.

Gérard Helft

The randomized, open-label trial included 1,385 patients with at least one DES for stable CAD or ACS who were recruited from 58 sites in France. All patients had received 1 year of clopidogrel and aspirin after DES implantation, after which they were randomized to continue therapy or remain on aspirin alone for up to 48 months. Follow-up was performed every 6 months between 12 and 48 months.

The primary outcome was net adverse clinical events, a composite of death, MI, stroke or major bleeding. At follow-up, NACE occurred in 5.8% of the extended-DAPT group vs. 7.5% of the aspirin-only group (HR = 0.75; 95% CI, 0.5-1.28; P = .17). Analysis of individual components of the primary endpoint yielded similar outcomes: death (HR = 0.65; 95% CI, 0.34-1.22; P = .18); MI (HR = 0.67; 95% CI, 0.31-1.44; P = .31); stroke (HR = 0.69; 95% CI, 0.22-2.18; P = .53); major bleeding (HR = 0.98; 95% CI, 0.47-2.05; P = .95).

In post-hoc analysis, ischemic outcomes including death, MI or stroke occurred in 4.2% of the extended-DAPT group vs. 6.4% of the aspirin-only group (HR = 0.64; 95% CI, 0.4-1.02; P = .06), without increasing bleeding (2% vs. 2%; P = .95) or all-cause mortality, Helft said during a press conference.

OPTIDUAL was designed as a superiority trial. While the data fail to show superiority for extended DAPT, “the results are consistent with the recent findings on ischemic outcomes from the DAPT trial regarding the value of prolonging DAPT after DES placement,” Helft said. – by Katie Kalvaitis

Reference:

Helft G. Hot Line III: Diabetes Mellitus/Pharmacology. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.

Disclosure: Helft reports receiving grants from the French Ministry of Health, the Fédération Française de Cardiologie, Biotronik, Boston Scientific, Cordis, Medtronic and Terumo, and personal fees from Abbott, Astra Zeneca, Bayer, Boehringer Ingelheim and Pfizer.