One-Year Data Presented From BIOFLOW-V Pivotal Trial of Biotronik's Orsiro DES
August 28, 2017—Biotronik announced data from the BIOFLOW-V randomized trial comparing the company's Orsiro drug-eluting stent (DES) and the Xience DES (Abbott Vascular) for the primary endpoint noninferiority in 12-month target lesion failure (TLF). The results were presented at the European Society of Cardiology's ESC Congress 2017, held August 26–30 in Barcelona, Spain, and published by David E. Kandzari, MD, et al online ahead of print in The Lancet.
BIOFLOW-V is a pivotal United States investigational device exemption trial of the Orsiro DES that included a large, complex patient population and was designed in collaboration with the US Food and Drug Administration to support an upcoming premarket approval submission. Orsiro is an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent. In the United States, Orsiro is an investigational device limited by law to investigational use only; it is commercially available in more than 100 countries worldwide, advised Biotronik.
According to the company, Orsiro had a 6.2% TLF rate at 12 months versus 9.6% for Xience, demonstrating statistically significant (P = .04) improved clinical outcomes with Orsiro in percutaneous coronary intervention (PCI). Other findings of the BIOFLOW-V study comparing Orsiro to Xience at 12 months include a target vessel myocardial infarction (MI) rate of 4.7% versus 8.3% (P = .02), a clinically driven target lesion revascularization rate of 2% versus 2.4%, and an Academic Research Consortium definite/probable stent thrombosis rate of 0.5% versus 0.7%.
The investigators also reported that in a pooled analysis with previous Orsiro randomized controlled trials versus Xience, BIOFLOW-II and BIOFLOW-IV, Orsiro demonstrated statistically significant improved outcomes and clear noninferiority. Mean estimates of TLF at 12 months are 6.3% with Orsiro versus 8.9% with Xience, resulting in a mean difference of -2.6%, demonstrating a 100% probability of Orsiro being noninferior to the control. A post hoc superiority analysis showed a 96.9% probability of Orsiro being superior to the control.
In Biotronik's announcement, Dr. Kandzari, who is Principal Investigator of the BIOFLOW-V trial in the United States, commented, "Orsiro's rate of TLF shows an unprecedented improvement in DES outcomes compared with a control stent that has served as a standard in interventional cardiology. Orsiro also notably has exceptional deliverability that is essential for PCI procedures. We believe Orsiro's ultrathin 60-μm struts, bioresorbable polymer and proven antiproliferative drug are the key elements to its superior performance."
Biotronik stated that the international BIOFLOW-V randomized trial included 1,334 patients (884 Orsiro; 450 Xience) and showed that Orsiro outcomes were statistically better for TLF and target vessel MI rates than Xience in a sizable, complex population. In the study, 50.8% of patients presented with an acute coronary syndrome, 35% of patients were diabetic, and 73.8% of lesions were American College of Cardiology/American Heart Association class B2/C. Patients will be followed for 5 years. The design of the BIOFLOW-V study was published online ahead of print by Gheorghe Doros, PhD, et al in American Heart Journal, noted the company.