Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing - EXCELLENT (6 vs. 12 Months of Clopidogrel)

Description:

The goal of the trial was 1) to compare treatment with an everolimus-eluting stent (EES) versus sirolimus-eluting stent (SES), and 2) to compare treatment with 6 months of dual antiplatelet therapy versus 12 months of dual antiplatelet therapy after percutaneous coronary intervention (PCI).

Hypothesis:

The EES will be noninferior to the SES in preventing late-loss and 6 months of clopidogrel will be noninferior to 12 months in preventing target vessel failure.

Study Design

  • Placebo Controlled
  • Parallel
  • Factorial

Patient Populations:

  • Patients at least 18 years of age undergoing elective PCI of a 2.25-4.25 mm vessel

    Number of enrollees: 1,443
    Duration of follow-up: Angiographic to 9 months, clinical to 12 months, with projected follow-up anticipated to 5 years
    Mean patient age:
    Percentage female:

Exclusions:

  • MI within the last 72 hours
  • Prior PCI of the target vessel
  • Left ventricular ejection fraction <20%
  • Cardiogenic shock
  • Renal or liver dysfunction
  • Left main artery stenosis, in-stent restenosis, chronic total occlusion, or bifurcation lesion
  • Sensitivity to study medication
  • Systemic use of everolimus or sirolimus within the last 12 months
  • Pregnancy
  • Bleeding diathesis, coagulopathy, or thrombocytopenia (<100,000 cells/mm3)
  • Gastrointestinal or genitourinary bleeding within the last 3 months
  • Anemia (hemoglobin <10 mg/dl)
  • Major surgery within the last 2 months or planned surgery within the next 12 months
  • Limited life expectancy
  • Enrollment in another investigational study

Primary Endpoints:

  • Target vessel failure at 12 months, defined as the composite of cardiovascular death, MI, and target vessel revascularization
  • In-segment late-loss at 9 months

Secondary Endpoints:

  • All-cause mortality
  • Stent thrombosis
  • TIMI major bleeding

Concomitant Medications:

Korean patients undergoing PCI were randomized by factorial design to 1) an EES versus an SES, and 2) 6 months of clopidogrel (n = 722) versus 12 months of clopidogrel (n = 721).

Principal Findings:

Overall, 1,443 patients were randomized.

For the analysis of clopidogrel duration, the primary outcome of target vessel failure at 12 months occurred in 4.7% of the 6-month clopidogrel group versus 4.4% of the 12-month clopidogrel group (p for noninferiority = 0.0031). Among patients who received an EES, the primary outcome was 5.2% versus 5.1% (p for noninferiority = 0.0029), and among patients who received an SES, the primary outcome was 5.0% versus 2.2% (p for noninferiority = 0.27), respectively, for 6 months versus 12 months of clopidogrel.

Cardiovascular death was 0.3% versus 0.4% (p = 0.65), myocardial infarction (MI) was 1.8% versus 1.1% (p = 0.28), and target vessel revascularization was 3.1% versus 3.2% (p = 0.87), respectively.

Stent thrombosis was 0.8% versus 0.4% (p = 0.32), and TIMI major bleeding was 0.3% versus 0.6% (p = 0.41), respectively.

Angiographic results according to stent type were presented separately (see EXCELLENT [EES vs. SES] trial).

Interpretation:

Among Korean patients undergoing PCI, 6 months of clopidogrel was noninferior to 12 months in regard to target vessel failure. There appeared to be effect modification by stent type, such that 6 months of clopidogrel was noninferior to 12 months among recipients of an EES.

In contrast, noninferiority to duration of clopidogrel was not demonstrated in the SES group. This leaves open the possibility that 12 months of clopidogrel therapy after an SES might result in superior outcomes; however, 6 months of clopidogrel after an EES may be adequate.

References:

Presented by Dr. Hyeon-Cheol Gwon at the ACC.11/i2 Summit, New Orleans, LA, April 5, 2011.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Platelet Aggregation Inhibitors, Thrombosis, Ticlopidine, Sirolimus, Purinergic P2Y Receptor Antagonists, Stents, Percutaneous Coronary Intervention


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