A Prospective, Randomized, “All-Comers” Trial of Biodegradable Polymer-Coated Biolimus-Eluting Stents vs. Biocompatible Polymer-Coated Zotarolimus-Eluting Stents - SORT-OUT VI
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.
The objective was to compare, by noninferiority design, the efficacy and safety of these two devices in an “all-comers” population.
- 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%
- 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
- Composite of cardiac death, MI, or target lesion revascularization
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).
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
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.
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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