OPTImal DUAL Antiplatelet Therapy - OPTIDUAL

Dec 16, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Assistance Publique, Hôpitaux de Paris; Fédération Française de Cardiologie; Unrestricted grants from Cordis, Boston, Medtronic, Terumo, and Biotronik
Date Presented:
08/31/2015
Date Published:
09/12/2015
Original Posted Date:
12/16/2015
References

Description:

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.

Study Design

  • Randomized
  • Parallel

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.

Inclusion criteria:

  • Implantation of a drug-eluting stent for stable coronary artery disease or acute coronary syndrome
  • Total number of enrollees: 1,385

Principal Findings:

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).

Secondary outcomes:

  • 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)

Interpretation:

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.

References:

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.

Keywords: Acute Coronary Syndrome, Aspirin, Coronary Artery Disease, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Platelet Aggregation Inhibitors, Secondary Prevention, Stents, Stroke, Ticlopidine, ESC Congress


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