The first US patient—Biotronik has revealed—has been enrolled in the BIOFLOW-V clinical study of the Orsiro hybrid drug-eluting stent. The aim of the study is further demonstrate the safety and effectiveness of the device. The implant of the stent was successfully performed by David Trice at Thomas Hospital in Fairhope, Alabama, USA.
BIOFLOW-V is a prospective, international, multicentre, randomised, controlled investigational device exemption (IDE) trial. The primary endpoint is target lesion failure at 12 months post-index procedure. The study is aiming to enrol 1,334 prospective patients at up to 150 sites in the USA, Canada, Europe, Israel and the Asia Pacific region. Eligible patients with coronary artery disease will be randomized in a 2:1 ratio to receive either Orsiro or another currently marketed drug-eluting stent.
According to a press release, Orsiro is widely used in Europe and previous studies have consistently shown the device to be associated with good efficacy and safety. For example, the BIOSCIENCE trial, recently published in The Lancet, indicates that Orsiro is non-inferior to Xience stent family (Abbott Vascular) in a patient population reflective of routine clinical practice. Orsiro has also demonstrated angiographic and clinical non-inferiority to Xience Prime in BIOFLOW-II3, a prospective, international, multicentre, randomised trial, which evaluated the safety and efficacy of Orsiro. Subgroup analyses of BIOFLOW-II and BIOFLOW-III, an all-comers registry, also demonstrated low restenosis rates in small vessels and complex B2/C lesions.
More recently, the latest one-year data from the industry-independent SORT OUT VII trial presented at EuroPCR 2015 revealed Orsiro to be non-inferior to the Nobori stent in a large, all-comers population. In that trial, Orsiro demonstrated enhanced safety and a three-times reduced risk of stent thrombosis.
BIOFLOW-V US principal investigator David Kandzari (Piedmont Heart Institute, Atlanta, USA) says: “Based on the encouraging previous study results, I am very excited that enrolment in the BIOFLOW-V study has started and BIOTRONIK can begin the process of bringing this remarkable product to US patients. As a treatment option, I have no doubt Orsiro will benefit both patients and physicians in the US as it has for the past four years in Europe.”