A Prospective Randomized Investigation of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent - EVOLVE II

Description:

The goal of the trial was to evaluate treatment with a bioabsorbable-polymer drug-eluting stent compared with a durable-polymer drug-eluting stent among participants with obstructive coronary artery disease.

Hypothesis:

A bioabsorbable-polymer drug-eluting stent will be noninferior to a durable-polymer drug-eluting stent.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Participants with ≤3 coronary native coronary lesions in ≤2 epicardial vessels
  • Lesion length ≤34 mm
  • Reference vessel diameter ≥2.25 mm and ≤4 mm
  • Percent diameter stenosis >50% and <100%

    Number of enrollees: 1,684
    Duration of follow-up: 12 months
    Mean patient age: 64 years
    Percentage female: 27%

Exclusions:

  • Left main disease
  • Saphenous vein graft disease
  • Chronic total occlusion
  • Recent ST-segment elevation MI

Primary Endpoints:

  • Target lesion failure defined as cardiovascular death, target vessel MI, or target lesion revascularization at 12 months

Drug/Procedures Used:

Participants with obstructive coronary artery disease were randomized to a bioabsorbable-polymer everolimus-eluting stent (n = 846) vs. durable-polymer everolimus-eluting stent (n = 838).

Concomitant Medications:

P2Y12 inhibitor for 6 months

Principal Findings:

Overall, 1,684 patients were randomized. The mean age was 64 years, 27% were women, 22% were current smokers, 29% had a prior myocardial infarction (MI), and 31% had diabetes. Dual antiplatelet therapy at 12 months was 89.7% of the bioabsorbable-polymer group compared with 87.3% of the durable-polymer group.

At 12 months, the primary outcome of target lesion failure occurred in 6.7% of the bioabsorbable-polymer group vs. 6.5% of the durable-polymer group (p for noninferiority = 0.0005).

- Cardiac death: 0.5% vs. 0.9% (p = 0.34), respectively
- Target vessel MI: 4.3% vs. 4.7% (p = 0.71), respectively
- Clinically indicated target lesion revascularization: 2.6% vs. 1.7% (p = 0.221), respectively
- Definite/probable stent thrombosis (<30 days): 0.4% vs. 0.6% (p = 0.50), respectively
- Definite/probable stent thrombosis (≥30 days): 0% vs. 0%, respectively

Interpretation:

Among patients with obstructive coronary artery disease the bioabsorbable-polymer drug-eluting stent was noninferior to the durable-polymer drug-eluting stent. Noninferiority was achieved on the composite outcome of target lesion failure at 12 months. Stent thrombosis was low with both stent designs, with no events beyond 30 days. This study is designed to evaluate the long-term (5-year) safety of this novel stent platform.

References:

Presented by Dr. Dean J. Kereiakes at the American Heart Association Scientific Sessions, Chicago, IL, November 19, 2014.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, Thrombosis, Drug-Eluting Stents, Polymers, Constriction, Pathologic, Sirolimus, Diabetes Mellitus, AHA Annual Scientific Sessions


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