Small vessel BIOFLOW-II subgroup analyses demonstrate top performance of Orsiro


Biotronik announced new results from the subgroup analyses of the BIOFLOW-II clinical trial at the EuroPCR 2014 congress in Paris, France. The results were presented by investigator Manel Sabaté, Hospital Clínico y Provincial de Barcelona, Barcelona, Spain.

BIOFLOW-II is a prospective, international, multicentre, randomised trial evaluating the safety and efficacy of Orsiro against Xience Prime (Abbott) with the primary endpoint of in-stent late lumen loss at nine months and a total of 452 patients enrolled. The one-year subgroup study results focused on the small vessel cohort, accounting for 57.3% (Orsiro n=168/298, Xience n=91/154) of all patients, and the diabetic subgroup, accounting for 28.3% (Orsiro n=84/298, Xience n=44/154) of all patients.


Clinical follow-up visits are performed at one, six and 12 months, and annually for five years post-procedure. The target lesion failure (TLF) rate in the small vessel cohort at 12 months was numerically lower in the Orsiro group at 7.4% compared to 12.3% with Xience (p=0.2065). No statistical significance was observed in TLF rate in the diabetic cohort at 12 months, with 6.0% in the Orsiro group and 4.5% in the Xience group (p=0.7201).

“The results of the BIOFLOW-II trial demonstrate the comparable performance of Orsiro and Xience Prime in the treatment of these classic challenging populations,” commented Sabaté during his presentation. “The lower TLF rate in the small vessel cohort at 12 months may be a first indicator that Orsiro should be the primary option for percutaneous coronary intervention in small vessels.”