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Enrollment begins for study of hybrid DES
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Biotronik announced that it has enrolled the first patient in the prospective, international BIOFLOW-V study evaluating the safety and efficacy of a hybrid drug-eluting stent.
The trial will include a planned 1,334 patients across as many as 150 sites throughout the United States, Canada, Europe, Israel and the Asia Pacific region, according to a company press release. Patients with CAD will be randomized at a 2:1 ratio to receive treatment with either the hybrid stent (Orsiro, Biotronik) or another drug-eluting stent currently on the market.
The stent is already available for use in Europe but is limited to investigational use in the U.S. According to the release, BIOFLOW-V follows 1-year results from the SORT OUT VII trial, presented at EuroPCR 2015, which indicated that Orsiro was noninferior to the Nobori stent (Terumo) in a large, all-comers population, with a threefold reduction in the risk for stent thrombosis. Also, in the BIOSCIENCE trial, Orsiro was found to be noninferior to the Xience family of stents (Abbott Vascular) in a patient population designed to reflect routine clinical practice.
David E. Kandzari
“Based on the encouraging previous study results, I am very excited that enrollment in the BIOFLOW-V study has started,” principal investigator David E. Kandzari, MD, Piedmont Heart Institute, Atlanta, said in the release. “As a treatment option, I have no doubt Orsiro will benefit both patients and physicians in the U.S. as it has for the past 4 years in Europe.”
Disclosure: Kandzari reports receiving research/grant support from Abbott Vascular, Biotronik, Boston Scientific and Medtronic, and minor consultant honoraria from Boston Scientific and Medtronic.