Polymer persistence in 1st and 2nd generation DES meant to allow drug release has been associated with a chronic inflammatory response that might be associated to restenosis, neo atherosclerosis and stent thrombosis.
This is the rationale behind the development of polymer free and bioresorbable polymer-based DES. They have both been compared against permanent polymer DES, but never against each other.
This single blind randomized study of all-comers had a non-inferiority design and compared the polymer free Biolimus A9 (BioFreedom) against the bioresorbable sirolimus DES with ultra-thin struts (Orsiro).
Dual antiaggregation was indicated for 6 months (AAS plus clopidogrel) in stable patients and for one year (AAS plus ticagrelor or prasugrel) for patients undergoing acute coronary syndrome.
It included 3151 patients (1572 for BioFreedom vs 1579 for Orsiro).
Primary end point was target vessel failure (classic composite) which resulted 5.3% for BioFreedom vs 4% for Orsiro, with the latter reaching non-inferiority.
Definite thrombosis resulted identical, with 0.7% for each device, and there was an advantage for Orsiro in terms of revascularization, with 1.3% vs 3.5% for BioFreedom.
Read also: TCT 2018 | LEADERS FREE II: Polymer-Free DES in Patients at High Risk for Bleeding with 1 Month of Antiplatelet Therapy.
The study reached non-inferiority in an unselected population (all comers) showing the safety of both devices, with an advantage for Orsiro only in terms of revascularization.
Original title: SORT OUT IX: A Randomized Trial Comparing a Polymer-Free Coronary Drug-Eluting Stent with an Ultra-Thin Strut Bioresorbable Polymer- Based Drug-Eluting Stent in an All-Comers Patient Population.
Presenter: Lisette Okkels Jensen.
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