BIOFLOW-II Results Published for Biotronik's Orsiro SES With Biodegradable Polymer

March 9, 2015—Results of the randomized BIOFLOW-II trial were published online by Stephan Windecker, MD, et al in Circulation: Cardiovascular Interventions. The study assessed the noninferiority of Biotronik’s Orsiro, a novel biodegradable polymer sirolimus-eluting stent with ultrathin strut design, compared with a durable polymer everolimus-eluting stent (Xience Prime, Abbott Vascular) in terms of the primary endpoint of in-stent late lumen loss at 9 months.

In the multicenter noninferiority BIOFLOW-II study, a total of 452 patients were randomly assigned 2:1 to treatment with the Orsiro  (298 patients, 332 lesions) or Xience (154 patients, 173 lesions). The investigators reported that the Orsiro device was noninferior to the Xience Prime for the primary endpoint. Clinical outcomes showed similar rates of target lesion failure at 1 year without cases of stent thrombosis. Additionally, clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up, concluded the investigators in Circulation: Cardiovascular Interventions.