A Prospective, Randomized, “All-Comers” Trial of Biodegradable Polymer-Coated Biolimus-Eluting Stents vs. Biocompatible Polymer-Coated Zotarolimus-Eluting Stents - SORT-OUT VI

Description:

The goal of the trial was to evaluate treatment with a biodegradable polymer biolimus-eluting stent compared with a durable polymer zotarolimus-eluting stent among a broad spectrum of patients with coronary artery disease.

Hypothesis:

The objective was to compare, by noninferiority design, the efficacy and safety of these two devices in an “all-comers” population.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients ≥18 years of age with stable coronary artery disease or acute coronary syndrome
  • Coronary stenosis ≥50% in a vessel with a reference diameter of 2.25-4.0 mm

    Number of enrollees: 2,999
    Duration of follow-up: 12 months
    Mean patient age: 66 years
    Percentage female: 24%

Exclusions:

  • Limited life expectancy or inability to provide informed consent
  • Allergy to aspirin, clopidogrel, prasugrel, ticagrelor, zotarolimus, or biolimus
  • Elevated bleeding risk from 12 months of dual antiplatelet therapy

Primary Endpoints:

  • Composite of cardiac death, MI, or target lesion revascularization

Drug/Procedures Used:

Symptomatic patients across the spectrum of coronary artery disease were randomized to a biodegradable polymer biolimus-eluting stent (BioMatrix Flex; n = 1,497) versus a durable polymer zotarolimus-eluting stent (Resolute Integrity; n = 1,502).

Principal Findings:

Overall, 2,999 patients were randomized. The mean age was 66 years, 24% were women, 18% had diabetes, and mean body mass index was 27 kg/m2. The indication for percutaneous coronary intervention (PCI) was stable angina in 45%, unstable angina/non-ST-segment elevation myocardial infarction (NSTEMI) in 34%, and STEMI in 17%. The use of a glycoprotein IIb/IIIa inhibitor was 5%.

The primary outcome of cardiac death, MI, or target lesion revascularization at 12 months occurred in 5.1% of the biolimus group versus 5.3% of the zotarolimus group (p for noninferiority = 0.006).

- Cardiac death: 1.7% vs. 1.5% (p = 0.58), respectively, for biolimus vs. zotarolimus
- MI: 0.9% vs. 1.3% (p = 0.30), respectively
- Target lesion revascularization: 3.1% vs. 3.5% (p = 0.60), respectively
- Target vessel revascularization: 4.7% vs. 4.5% (p = 0.75), respectively
- Definite or probable stent thrombosis: 0.5% vs. 0.8% (p = 0.61), respectively

Interpretation:

Among a broad spectrum of patients undergoing PCI, the biolimus-eluting stent with biodegradable polymer was noninferior to the zotarolimus-eluting stent with durable polymer. Both stents were associated with low adverse cardiovascular events.

References:

Presented by Dr. Bent Raungaard at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 29, 2013.

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

Keywords: Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Follow-Up Studies, Angina, Stable, Sirolimus, Percutaneous Coronary Intervention, Stents, Body Mass Index, Coronary Stenosis, Thrombosis, Polymers, Diabetes Mellitus


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