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Scandinavian Organization for Randomized Trials With Clinical Outcome IX - SORT OUT IX
Contribution To Literature:
The SORT OUT IX trial showed that BioFreedom DCS did not meet criteria for noninferiority for MACE at 1 year compared with the Orsiro DES in an all-comers population with CAD.
Description:
The goal of this trial was to compare the safety and efficacy of BioFreedom drug-coated stent (DCS) compared with biodegradable polymer sirolimus-eluting stent (SES) in reducing clinical outcomes in a real-world population of patients presenting with coronary artery disease (CAD).
Study Design
Eligible patients were randomized in a 1:1 fashion to either BioFreedom (biolimus A9-coated DCS) or biodegradable polymer SES (Orsiro).
- Total number of enrollees: 3,151
- Duration of follow-up: 1 year
- Mean patient age: 66.3 years
- Percentage female: 23%
Inclusion criteria:
- ≥18 years old
- Evidence of CAD with >50% diameter stenosis
- Requires treatment with a drug-eluting stent (DES)
Exclusion criteria:
- Allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
- Participation in another randomized stent trial
- Inability to provide written informed consent
- Life expectancy of <1 year
Other salient features/characteristics:
- Secondary prevention cohort: 70.7%
- Previous percutaneous coronary intervention (PCI): 21%
- Indication for PCI: ST-segment elevation myocardial infarction (STEMI) (24%), NSTEMI (29%)
- Number of lesions per patient: 1.3
Principal Findings:
The primary outcome, major adverse cardiac events (MACE; cardiac death, MI, target lesion revascularization [TLR]) at 1 year for BioFreedom DCS vs. Orsiro DES, was 5.0% vs. 3.7% (hazard ratio 1.34, 95% confidence interval 0.96-1.89; p for noninferiority = 0.14, p for superiority = 0.09).
- Cardiac mortality: 1% vs. 1.8% (p = 0.06)
- MI not related to other lesion: 1.7% vs. 1.6% (p = 0.99)
- TLR: 3.5% vs. 1.3% (p < 0.0001)
Secondary outcomes for BioFreedom DCS vs. Orsiro DES:
- TLR at 30 days: 0.4% vs. 0.6% (p = 0.32)
- Definite or probable stent thrombosis at 12 months: 1.0% vs. 1.1% (p = 0.73)
Interpretation:
The results of this trial indicate that BioFreedom DCS did not meet criteria for noninferiority for MACE at 1 year compared with the Orsiro DES in an all-comers population with CAD. This was primarily driven by a higher risk of TLR, likely due the difference in stent thickness (120 micrometers for Biofreedom vs. 60-80 micrometers for Orsiro), and faster release of drug (1 vs. 3 months).
In the LEADERS FREE and LEADERS FREE II trials, the BioFreedom DCS was superior to bare-metal stent (BMS), suggesting that its efficacy was likely in between BMS and contemporary DES. In theory, the BioFreedom DCS could be used with a shorter duration of dual antiplatelet therapy, but this was not tested in this trial. It is currently not approved by the United States Food and Drug Administration (FDA).
References:
Jensen LO, Maeng M, Raungaard B, et al. Randomised Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation 2020;May 21:[Epub ahead of print].
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and ACS, Interventions and Coronary Artery Disease
Keywords: Acute Coronary Syndrome, Constriction, Pathologic, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Sirolimus, Stents, Thrombosis
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