Positive 9-Month Results From BIOFLOW-II and 12-Month Results From BIOFLOW-III Presented for Biotronik Orsiro DES

May 30, 2013—Primary endpoint results from the BIOFLOW-II clinical study demonstrating the noninferiority of the Orsiro hybrid drug-eluting stent (Biotronik, Inc.; Lake Oswego, OR) compared to Xience Prime (Abbott, Santa Clara, CA) were presented in a late-breaking clinical trials session at EuroPCR in Paris, France, by Principal Investigator Prof. Stephan Windecker, MD, of University Hospital in Bern, Switzerland.

According to the company's press release, BIOFLOW-II is a prospective, international, multicenter, randomized trial evaluating the safety and efficacy of Orsiro against Xience Prime. The primary endpoint is in-stent late lumen loss at 9 months. Secondary clinical endpoints include target lesion failure (a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction [MI], coronary artery bypass grafting [CABG], and clinically driven target lesion revascularization [TLR]). In addition to angiographic follow-up, intravascular ultrasound and optical coherence tomography imaging were performed at 9 months. Clinical follow-up took place at 1, 6, and 9 months and will continue annually for up to 5 years, the company stated.

Between July 2011 and March 2012, 452 patients were enrolled in a 2:1 (Orsiro:Xience Prime) randomization at 24 European sites. At 9 months, the results for the primary endpoint, in-stent late lumen loss, were .1 ±.32 mm in the Orsiro arm and .11 ± .29 mm in the Xience Prime arm as evaluated by an independent core laboratory and confirming the non-inferiority hypothesis.

"The Orsiro stent met the primary noninferiority endpoint of late loss at 9 months compared to the Xience Prime stent, demonstrating effectiveness of drug elution from this bioabsorbable polymer," commented Prof. Windecker in the company's press release. "The platform also appears to be safe, with low rates of myocardial infarction and revascularization and no reported stent thrombosis. The low strut thickness and good deliverability of Orsiro is advantageous during complex stenting, which is performed in current cath lab practice."

Primary endpoint results from the BIOFLOW-III registry were also presented at EuroPCR by Coordinating Investigator Prof. Johannes Waltenberger, MD of Universitätsklinikum Münster, Germany. BIOFLOW-III is an international, prospective, nonrandomized, multicenter, open-label clinical evaluation of the Orsiro hybrid drug-eluting stent. The primary endpoint is target lesion failure at 12 months, defined as a composite of cardiac death, target vessel Q-wave or non-Q wave MI, emergent CABG, and clinically driven TLR. Prespecified subgroups include diabetes, small vessels, chronic total occlusion, and acute myocardial infarction.

Between August 2011 and March 2012, 1,356 patients were enrolled at 43 sites in 14 countries. At 12 months, the result for the primary endpoint TLF was 4.7% (cardiac death, 1.3%; target vessel MI, 2%; emergent CABG, 0%; and clinically driven TLR 2.7%). "The results from this large all-comers registry confirms the efficacy and safety of Orsiro in a large and more complex patient population," commented Prof. Waltenberger in the press release.