Basal Stent Kosten-Effektivitats Trial‒Prospective Validation Examination - BASKET-PROVE

Description:

The goal of the trial was to compare percutaneous coronary intervention (PCI) with sirolimus-eluting stents versus everolimus-eluting stents versus bare-metal stents among patients with coronary artery disease.

Hypothesis:

Adverse cardiovascular outcomes will be similar between drug-eluting stents and bare-metal stents in large coronary arteries.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with acute or chronic coronary artery disease undergoing PCI with a 3-4 mm diameter stent

    Number of screened applicants: 2,323
    Number of enrollees: 2,314
    Duration of follow-up: Median 2 years
    Mean patient age: 66 years
    Percentage female: 26%

Exclusions:

  • Cardiogenic shock
  • Treatment of in-stent restenosis or thrombosis
  • Unprotected left main PCI
  • Bypass graft stenosis
  • Anticipated surgery within 12 months
  • Need for anticoagulation
  • Increased risk for bleeding
  • Noncompliance to long-term antiplatelet therapy

Primary Endpoints:

  • Death from cardiovascular cause or nonfatal MI at 2 years

Secondary Endpoints:

  • Target vessel revascularization
  • Stent thrombosis

Drug/Procedures Used:

Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) were randomized to sirolimus-eluting stents (n = 775), everolimus-eluting stents (n = 774), or bare-metal stents (n = 765).

Concomitant Medications:

Aspirin 75-100 mg daily indefinitely and clopidogrel 75 mg daily for 1 year

Principal Findings:

Overall, 2,314 patients were randomized. There was no difference in baseline characteristics between participants. In the sirolimus-eluting stent group, the mean age was 66 years, 26% were women, 18% had diabetes, ST-elevation myocardial infarction (MI) was present in 34%, and mean total stent length per patient was 30 mm. The proportion of patients on aspirin and clopidogrel at 1 year was 82% and at 2 years was 19%.

The primary outcome, death from cardiac causes or nonfatal MI, was 2.6% in the sirolimus-eluting stent group, 3.2% in the everolimus-eluting stent group, and 4.8% in the bare-metal stent group (p = 0.13 for sirolimus-eluting vs. bare-metal stents and p = 0.37 for everolimus-eluting vs. bare-metal stents).

Target vessel revascularization occurred in 4.3% of the sirolimus-eluting stent group, 3.7% of the everolimus-eluting stent group, and 10.3% of the bare-metal stent group (p = 0.005 for sirolimus-eluting vs. bare-metal stents and p = 0.002 for everolimus-eluting vs. bare-metal stents). Cardiac death occurred in 1.7%, 1.7%, and 2.9% (p = NS), nonfatal MI occurred in 0.9%, 1.7%, and 2.6% (p = NS), and definite stent thrombosis occurred in 0.4%, 0.3%, and 0.8% (p = NS), respectively, for sirolimus-eluting, everolimus-eluting, and bare-metal stents.

Interpretation:

Among patients undergoing PCI with a 3-4 mm diameter stent, there was no difference in the composite outcome of cardiovascular death or nonfatal MI between drug-eluting versus bare-metal stents. Sirolimus- and everolimus-eluting stents were associated with reduced need for long-term revascularization (~4% rate) compared with bare-metal stents (~10% rate). Stent thrombosis was similar between stent types. Compliance with long-term dual antiplatelet therapy was high, which may have contributed to lower than expected cardiovascular outcomes. This reduced the ability of the trial to detect a difference in cardiovascular outcomes between treatment groups. Another limitation of the trial is that one-third of events were adjudicated in a nonblinded fashion.

References:

Kaiser C, Galatius S, Erne P, et al. Drug-eluting versus bare-metal stents in large coronary arteries. N Engl J Med 2010;Nov 16:[Epub ahead of print].

Presented by Dr. Christoph Kaiser at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2010.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Metals, Drug-Eluting Stents, Thrombosis, Immunosuppressive Agents, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents


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