Basel Stent Kosten-Effektivitäts Trial–PROspective Validation Examination II - BASKET-PROVE II

Description:

It has been hypothesized that very late stent thrombosis is a result of the polymer coating of drug-eluting stents. A biodegradable polymer might retain stent efficacy while enhancing safety. The goal of the trial was to evaluate treatment with a biodegradable-polymer drug-eluting stent versus a durable-polymer drug-eluting stent versus a thin-strut bare-metal stent.

Hypothesis:

A biodegradable-polymer drug-eluting stent will be noninferior to a durable-polymer drug-eluting stent (or superior to a bare-metal stent) in regard to efficacy, but will be superior in regard to safety.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Participants undergoing percutaneous coronary intervention with stent size ≥3.0 mm

    Number of enrollees: 2,291
    Duration of follow-up: 2 years
    Mean patient age: 62 years
    Percentage female: 22%

Exclusions:

  • Cardiogenic shock
  • In-stent restenosis
  • Stent thrombosis
  • Unprotected left main or bypass graft disease
  • Planned surgery within 12 months
  • Need for oral anticoagulation
  • Increased bleeding risk
  • Intolerance or noncompliance to antiplatelet therapy
  • History of stroke or transient ischemic attack

Primary Endpoints:

  • Primary efficacy endpoint: cardiovascular death, MI, or target vessel revascularization
  • Primary safety endpoint: cardiovascular death, MI, or definite/probable stent thrombosis

Drug/Procedures Used:

Subjects with stable or unstable coronary artery disease undergoing stent implantation were randomized to a biodegradable-polymer drug-eluting stent (biolimus-A9-eluting; n = 765) versus a durable-polymer drug-eluting stent (everolimus-eluting; n = 765) versus a thin-strut bare-metal stent (silicon carbide coated; n = 761).

Concomitant Medications:

Subjects were treated with aspirin and prasugrel. Prasugrel was recommended for 12 months after an acute coronary syndrome or 4 weeks for stable coronary artery disease.

Principal Findings:

Overall, 2,291 patients were randomized. The mean age was 62 years, 22% were women, 35% were current smokers, 9% had a prior myocardial infarction (MI), and 21% had diabetes. Presentation was stable angina in 36%, non–ST-segment elevation MI (NSTEMI) in 34%, and STEMI in 30%.

At 2 years of follow-up, the primary efficacy outcome of cardiovascular death, MI, or target vessel revascularization occurred in 7.6% of the biodegradable-polymer drug-eluting stent group vs. 6.8% of the durable-polymer drug-eluting stent group vs. 12.7% of the bare-metal stent group (noninferiority established for biodegradable-polymer vs. durable-polymer, p = 0.042; superiority established for biodegradable-polymer vs. bare-metal stent, p = 0.0011).

At 2 years of follow-up, the primary safety outcome of cardiovascular death, MI, or definite/probable stent thrombosis occurred in 3.7% of the biodegradable-polymer drug-eluting stent group vs. 3.8% of the durable-polymer drug-eluting stent group vs. 5.0% of the bare-metal stent group (biodegradable-polymer vs. durable-polymer, p = 0.91; biodegradable-polymer vs. bare-metal stent, p = 0.20).

Definite/probable stent thrombosis was 0.4% vs. 0.7% vs. 0.8%, respectively, for biodegradable-polymer vs. durable polymer vs. bare-metal stent.

Interpretation:

Among patients with stable or unstable coronary artery disease (NSTEMI/STEMI), a biodegradable-polymer drug-eluting stent was noninferior to a durable-polymer drug-eluting stent with regard to efficacy. However, adverse events were numerically increased with the biodegradable-polymer drug-eluting stent. A biodegradable-polymer drug-eluting stent was superior to a bare-metal stent with regard to efficacy. The combined safety endpoint was similar between all stent designs. Definite/probable stent thrombosis at 2 years was low between all stent designs. Although this study seems to weaken the association between durable-polymers and very late stent thrombosis, current-generation drug-eluting stents utilize newer polymers and anti-proliferative agents compared with first-generation drug-eluting stents.

References:

Kaiser C, Galatius S, Jeger R, et al. Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents: Main Results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial. Circulation 2014;Nov 19:[Epub ahead of print].

Presented by Dr. Christoph A. Kaiser at the American Heart Association Scientific Sessions, Chicago, IL, November 19, 2014.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Chronic Angina

Keywords: Coronary Artery Disease, Myocardial Infarction, Angina, Stable, Thrombosis, Drug-Eluting Stents, Polymers, Sirolimus, Carbon Compounds, Inorganic, Silicon Compounds, Diabetes Mellitus, Percutaneous Coronary Intervention, AHA Annual Scientific Sessions


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