BIOTRONIK Japan announces first patients enrolled in BIOFLOW-IV clinical study

BIOTRONIK Japan has announced enrollment of the first patient in the BIOFLOW-IV study, which aims to verify the efficacy and safety of the Orsiro Hybrid Drug-Eluting Stent (DES) from BIOTRONIK. 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, randomized, controlled, global study to compare the target vessel failure (TVF) rate of Orsiro DES and Abbott’s Xience Prime/Xpedition DES in a non-inferiority setting. 12 sites in Japan and 29 sites in the EU are participating in the multi-center study with the primary endpoint of TVF at 12 months.

Coordinating investigator of the BIOFLOW-IV study, Dr. Shigeru Saito (You will be visiting a website outside of PCRonline, we are not responsible for its contents), MD, Director of the Cardiology and Catheterization Laboratories and Vice President of Shonan Kamakura Hospital, Kanagawa, Japan, implanted the first stent in the study. He commented, “Orsiro has excellent deliverability and obviously thinner struts by IVUS observation than the current available DESs in Japan, which would be associated with earlier neointimal coverage after Orsiro implantation.”

Efficacy and safety of Orsiro as demonstrated by the BIOFLOW-I, -II, and -III studies:
In the BIOFLOW-I first in-man study, late lumen loss, which was the primary endpoint, was 0.05±0.22mm at 9 months.
Presented at EuroPCR 2013, BIOFLOW-II was a prospective, non-inferiority randomized controlled study comparing Orsiro with Xience Prime. The primary endpoint in-stent late lumen loss at 9 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 (TLF) at 9 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. As a prospective, all-comers, multi-center registry, its primary endpoint demonstrated 4.7% of TLF at 12 months.