Real Safety and Efficacy of a 3-Month Dual Antiplatelet Therapy Following Zotarolimus-Eluting Stent Implantation - RESET Trial

Description:

The goal of the trial was to evaluate treatment with a zotarolimus-eluting stent (Endeavor) and 3 months of dual antiplatelet therapy compared with other drug-eluting stent types and 12 months of dual antiplatelet therapy.

Hypothesis:

Three months of dual antiplatelet therapy with the zotarolimus (Endeavor) stent will be noninferior to 12 months of therapy with other stent types.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • Patients with stable angina, unstable angina, or non-ST-elevation myocardial infarction
  • Diameter stenosis ≥50% and reference vessel diameter 2.5-4.0 mm

    Number of enrollees: 2,148
    Duration of follow-up: 1 year
    Mean patient age: 62 years
    Percentage female: 36%
    Ejection fraction: 62%

Exclusions:

  • History of cerebrovascular accident, peripheral arterial disease, thromboembolic disease, or stent thrombosis
  • Left ventricular ejection fraction <40%
  • In-stent restenosis, chronic total occlusion, or left main stenosis
  • Cardiogenic shock
  • ST-elevation myocardial infarction within 48 hours of symptom onset
  • Severe hepatic or renal dysfunction

Primary Endpoints:

  • Composite of cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, or bleeding at 1 year

Secondary Endpoints:

  • Definite or probable stent thrombosis
  • TIMI (Thrombolysis in Myocardial Infarction) major or minor bleeding

Drug/Procedures Used:

Patients undergoing percutaneous coronary intervention were randomized to a zotarolimus-eluting stent and 3 months of dual antiplatelet therapy (n = 1,059) versus other drug-eluting stent types and 12 months of dual antiplatelet therapy (n = 1,058).

Concomitant Medications:

  • Use of intraprocedural glycoprotein IIb/IIIa inhibitors was 2%.
  • At discharge, the use of statins was 87%, beta-blocker 67%, angiotensin-converting enzyme inhibitor 31%, and angiotensin-receptor blocker 31%.

Principal Findings:

Overall, 2,148 patients were randomized. The mean age was 62 years, 36% were women, mean body mass index was 25 kg/m2, 30% had diabetes, and mean ejection fraction was 62%. The treated lesion was the left anterior descending in 53%. In the standard therapy group, types of stents used were: sirolimus 29%, everolimus 30%, zotarolimus (Resolute) 42%. Mean stent diameter was 3.2 mm, and mean stent length per lesion was 23 mm.

The composite primary outcome of cardiovascular death, myocardial infarction, stent thrombosis, revascularization, or bleeding at 1 year occurred in 4.7% of the 3 months of dual antiplatelet therapy group versus 4.7% of the 12 months of dual antiplatelet therapy group (p for noninferiority < 0.01).

All-cause mortality, myocardial infarction, or stent thrombosis: 1.3% versus 0.8% (p = 0.48), myocardial infarction: 0.2% versus 0.4% (p = 0.41), target vessel revascularization: 3.9% versus 3.7% (p = 0.70), stent thrombosis: 0.2% versus 0.3% (p = 0.65), major or minor bleeding: 0.5% versus 1.0% (p = 0.20), respectively.

Interpretation:

Among patients who received a zotarolimus-eluting stent (Endeavor) and 3 months of dual antiplatelet therapy, composite outcomes were similar compared with other stent types and 12 months of dual antiplatelet therapy. Individual outcomes, including stent thrombosis and bleeding, were also similar between the study groups. The generalizability of this trial is limited by the use of three drug-eluting stent types in the control group.

References:

Presented by Dr. Myeong-Ki Hong at ACC.12 & ACC-i2 with TCT, Chicago, IL, March 24, 2012.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Body Mass Index, Thrombosis, Drug-Eluting Stents, Sirolimus, Diabetes Mellitus, Stents, Percutaneous Coronary Intervention


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