Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable...

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• The BioFreedom stent, a polymer-free biolimus A9-coated stent, has shown superiority in patients with high bleeding risk compared to bare-metal stents.
• This study aimed to compare the BioFreedom stent with the Orsiro stent, a modern ultrathin strut biodegradable polymer sirolimus-eluting stent.

Purpose of the Study:

• To evaluate the noninferiority of the BioFreedom stent compared to the Orsiro stent in an all-comers population undergoing percutaneous coronary intervention.

Main Methods:

• The Scandinavian Organization for Randomized Trials With Clinical Outcome IX (SORT OUT IX) trial was a large-scale, registry-based, randomized, multicenter, single-blind, noninferiority trial.
• The primary endpoint was major adverse cardiovascular events (cardiac death, myocardial infarction, or target lesion revascularization) within 1 year, analyzed by intention-to-treat.
• The trial was powered to assess noninferiority with a margin of 0.021 for major adverse cardiovascular events.

Main Results:

• 3151 patients were randomized to either the BioFreedom stent (1572) or the Orsiro stent (1579).
• At 1 year, major adverse cardiovascular events occurred in 5.0% of the BioFreedom group versus 3.7% of the Orsiro group (absolute risk difference 1.29%, Pnoninferiority=0.14), failing to meet noninferiority criteria.
• Target lesion revascularization was significantly higher in the BioFreedom group (3.5%) compared to the Orsiro group (1.3%).

Conclusions:

• The BioFreedom polymer-free stent did not meet noninferiority criteria for major adverse cardiovascular events compared to the Orsiro stent at 12 months.
• The Orsiro stent showed a statistically significant lower rate of target lesion revascularization.