Biotronik Japan has announced enrolment of the first patient in the BIOFLOW-IV study, which aims to verify the efficacy and safety of the Orsiro Hybrid drug-eluting stent. The high quality and efficacy of Orsiro has already been confirmed by three important trials, BIOFLOW-I, -II, and –III, which demonstrated the safety and efficacy of Orsiro.
The BIOFLOW-IV study is the first prospective, randomised, controlled, global study to compare the target vessel failure rate of Orsiro drug-eluting stent and Abbott’s Xience Prime/Xpedition drug-eluting stent in a non-inferiority setting. Twelve sites in Japan and 29 sites in the European Union are participating in the multicentre study with the primary endpoint of target vessel failure at 12 months.
Coordinating investigator of the BIOFLOW-IV study, Shigeru Saito, director of the Cardiology and Catheterization Laboratories and vice president of Shonan Kamakura Hospital, Kanagawa, Japan, implanted the first stent in the study. He comments, “Orsiro has excellent deliverability and obviously thinner struts by IVUS observation than the current available drug-eluting stents in Japan, which would be associated with earlier neointimal coverage after Orsiro implantation.”
In the BIOFLOW-I first in-man study late lumen loss, which was the primary endpoint, was 0.05±0.22mm at nine months.
Presented at EuroPCR 2013 (21 May–24 May, Paris, France), BIOFLOW-II was a prospective, non-inferiority randomised controlled study comparing Orsiro with Xience Prime. The primary endpoint in-stent late lumen loss at nine months verified non-inferiority, which was confirmed with 0.10±0.32mm vs. 0.11±0.29mm, respectively. There was also no significant difference in target lesion failure at nine months, which was 4.8% in the Orsiro arm vs. 5.3% in the Xience arm.
The BIOFLOW-III study has also demonstrated excellent results, it states in a company release. As a prospective, all-comers, multicentre registry, its primary endpoint demonstrated 4.7% of target lesion failure at 12 months.