Biotronik announces first patients treated in BIOFLOW-II clinical study


Biotronik announced on 13 July 2011 the start of an international study comparing the company’s Orsiro sirolimus-eluting coronary stent with Abbott Laboratory’s Xience Prime everolimus-eluting coronary stent. The first implantations in the BIOFLOW-II study took place in Europe last week.

BIOFLOW-II is a prospective international trial that will randomise approximately 440 patients with Orsiro or Xience Prime in a two-to-one manner at 19 European sites. The primary endpoint is in-stent late lumen loss at 9 months. Secondary endpoints include clinically driven target lesion revascularisation, target vessel revascularisation and target lesion failure. Clinical follow-up will take place at 1, 6 and 12 months—and annually out to 5 years.

Michael Haude, Neuss Luke Hospital, Germany, enrolled the first patient. The study is being conducted under the leadership of co-principal investigators Stephan Windecker, University Hospital Bern, Switzerland, and Thierry Lefevre, Hospital Jacques Cartier, France.

The Orsiro hybrid drug-eluting stent received CE mark approval earlier this year and features the latest development in Biotronik stent technology—a unique hybrid solution that combines passive and active components. Probio passive coating encapsulates the stent and minimises interaction between the metal stent and the surrounding tissue. Biolute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating is layered on the high performance Pro-Kinetic Energy stent platform, renowned for its advanced thin-strut stent design and outstanding deliverability.

The initial clinical trial of the Orsiro hybrid drug eluting stent, called BIOFLOW-I, met its primary endpoint with in-stent late lumen loss at 9 months of 0.05 mm ±0.22 mm. At 9 months, there was no binary restenosis, death, myocardial infarction or stent thrombosis—and only two patients required a repeat procedure.

Enrolment in BIOFLOW-III, a global, open-label registry that will include more than 1,000 patients, will begin later this year.