Biotronik has completed patient enrolment for the BIOFLOW-IV study. The study is intended to support Japanese government approval of the Orsiro hybrid drug-eluting stent, which received CE mark in 2011.
BIOFLOW-IV is an international, multicentre, randomised, controlled study for patients with coronary artery disease in which more than 40 clinical sites are participating. The study compares Orsiro with Xience Prime (Abbott Vascular) and has a primary endpoint of target vessel failure at one year post enrolment.
“With a thinner strut than conventional drug-eluting stents, Orsiro may have the advantage of being more rapidly covered by neointima. In addition, the unique proBIO passive coating on the surface of the stent has the potential to enhance its long-term safety,” commented Shigeru Saito, Shonan Kamakura Hospital, Kanagawa, Japan, one of the BIOFLOW-IV coordinating investigators.
Orsiro has already achieved positive results in a number of European trials including BIOSCIENCE, results of which were presented in a Hot Line session at the European Society of Cardiology Congress in 2014 and published in The Lancet. BIOSCIENCE compared Orsiro with Xience Prime using a primary endpoint of target lesion failure at 12 months.
The large-scale, randomised, controlled, non-inferiority BIOFLOW-IV study involved more than 2,000 patients from a real-world population. After 12 months, Orsiro met its study objective of non-inferiority versus Xience Prime, hence performing as best in class and demonstrating its benefit in treating a large group of patients suffering from coronary artery disease.