Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice - OPTIMIZE

Oct 31, 2013
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Christopher P. Cannon, MD, FACC
Trial Sponsor:
Medtronic Comercial Ltda, and Cardiovascular Research Center, both in São Paulo, Brazil
Date Presented:
01/01/2013
Date Published:
01/01/2013
Date Updated:
10/31/2013
Original Posted Date:
10/31/2013
References

Description:

The goal of the trial was to evaluate 3 months of dual antiplatelet therapy compared with 12 months after implantation of an Endeavor zotarolimus-eluting stent.

Hypothesis:

Three months of dual antiplatelet therapy will be noninferior to 12 months in preventing net adverse events.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • Patients with stable/unstable angina or recent MI undergoing implantation of an Endeavor zotarolimus-eluting stent in a reference vessel diameter of 2.5-4.0 mm

    Number of enrollees: 3,119 patients
    Duration of follow-up: 12 months
    Mean patient age: 61 years
    Percentage female: 37 years

Exclusions:

  • Primary or rescue PCI
  • Saphenous vein graft lesion
  • Previous PCI with a drug-eluting stent
  • PCI with a bare-metal stent within the last 6 months
  • Scheduled elective surgery within the next 12 months

Primary Endpoints:

  • Composite of death, MI, stroke, or major bleeding at 12 months

Secondary Endpoints:

  • Stent thrombosis
  • Target vessel revascularization
  • Target lesion revascularization
  • Death, MI, emergent coronary artery bypass grafting (CABG), or target lesion revascularization
  • Dual antiplatelet therapy compliance
  • Major bleeding

Drug/Procedures Used:

A broad spectrum of patients in Brazil that received an Endeavor zotarolimus-eluting stent were randomized to 3 months of dual antiplatelet therapy (n = 1,563) versus 12 months (n = 1,556).

Principal Findings:

Overall, 3,119 patients were randomized. The mean age was 61 years, 37% were women, 35% had diabetes, 7% had renal insufficiency, 21% had prior percutaneous coronary intervention (PCI), and 32% had a recent acute coronary syndrome. Total stent length was 33 mm.

The primary outcome of death, myocardial infarction (MI), stroke, or major bleeding at 12 months occurred in 6.0% of the 3-month group versus 5.8% of the 12-month group (p for noninferiority = 0.002). The outcomes were similar among all tested subgroups. The primary outcome, after landmark analysis at 3 months, occurred in 2.6% of the 3-month group versus 2.6% of the 12-month group (p = 0.91).

Other individual outcomes, after landmark analysis at 3 months:

- All-cause death: 1.9% vs. 1.7% (p = 0.79), respectively, for 3 vs. 12 months

- MI: 0.8% vs. 0.6% (p = 0.51), respectively

- Stroke: 0.3% vs. 0.1% (p = 0.42), respectively

- Major bleeding: 0.2% vs. 0.4% (p = 0.31), respectively

- Any bleeding: 0.4% vs. 1.0% (p = 0.07), respectively

- Definite/probable stent thrombosis: 0.1% vs. 0.3% (p = 0.18), respectively

Interpretation:

Among stable angina and low-risk acute coronary syndrome patients who received an Endeavor zotarolimus-eluting stent, 3 months of dual antiplatelet therapy was noninferior to 12 months of therapy. Noninferiority was established on the primary composite outcome of death, MI, stroke, or major bleeding. There was no signal of increased stent thrombosis after the 3-month landmark with the shorter duration of dual antiplatelet therapy. Shorter durations of dual antiplatelet therapy will need to be tested for other drug-eluting stents.

References:

Feres F, Costa RA, Abizaid A, et al., on behalf of the OPTIMIZE Trial Investigators. Three vs Twelve Months of Dual Antiplatelet Therapy After Zotarolimus-Eluting Stents: The OPTIMIZE Randomized Trial. JAMA 2013;Oct 31:[Epub ahead of print].

Presented by Dr. Fausto Feres at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 31, 2013.

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Stroke, Renal Insufficiency, Follow-Up Studies, Angina, Stable, Thrombosis, Drug-Eluting Stents, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus


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