Findings from the SORT OUT IX trial presented Sept. 22 at TCT 2018 suggest that the polymer-free biolimus A9-coated BioFreedom stent was non-inferior to the thin strut, cobalt-chromium biodegradable polymer sirolimus-eluting Orsiro stent in an all-comer population.

The SORT OUT IX trial randomized 3,151 patients treated with percutaneous coronary intervention from four hospitals in Denmark to either the BioFreedom stent (N=1,572) or the Orsiro stent (N=1,579). Patients with stable angina pectoris received 6-month dual antiplatelet therapy (DAPT) (aspirin plus clopidogrel), while those with acute coronary syndromes received 12-month DAPT (aspirin plus ticagrelor/prasugrel). Clinical follow-up was conducted at one year for all but five patients.

In addition to non-inferiority of the BioFreedom stent compared with the Orsiro, both stents had similar safety and risk of definite stent thrombosis rates. Researchers did observe efficacy to be lower in the BioFreedom group compared with the Orsiro group.

Researchers noted that persistence of polymer material on first- and second-generation drug-eluting stents after completion of drug release may be a trigger of a chronic inflammatory response. As such, the polymer-free BiolimusA9-coated BioFreedom has shown superiority compared to bare metal stents in patients at greater risk of bleeding during DAPT. Results from SORT OUT IX add to the growing research assessing safety and efficacy in this patient group.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Drug-Eluting Stents, Polymers, Absorbable Implants

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