September 1, 2017 — Biotronik recently announced data from the BIOFLOW-V randomized trial comparing Orsiro and Xience drug-eluting stents (DES) with 12-month target lesion failure (TLF) as the primary endpoint proving non-inferiority. Results presented at the European Society of Cardiology’s ESC Congress 2017, August 26-30 in Barcelona, Spain, and published by The Lancet show 6.2 percent versus 9.6 percent 12-month TLF rate, demonstrating statistically significant improved clinical outcomes with Orsiro in percutaneous coronary intervention (PCI).
This pivotal U.S. investigational device exemption (IDE) trial included a large, complex patient population and was designed in collaboration with the U.S. Food and Drug Administration (FDA) to support an upcoming premarket approval submission.
Highlights of the BIOFLOW-V study include the following 12-month data points comparing Orsiro to Xience:
- 6.2 percent versus 9.6 percent TLF rate (p=0.04);
- 4.7 percent versus 8.3 percent target vessel myocardial infarction (MI) rate (p=0.02);
- 2 percent versus 2.4 percent clinically driven target lesion revascularization (cd-TLR) rate; and
- 0.5 percent versus 0.7 percent Academic Research Consortium (ARC) definite/probable stent thrombosis rate.
In a pooled analysis with prior Orsiro randomized control trials versus Xience, BIOFLOW-II and BIOFLOW-IV, Orsiro demonstrated statistically significant improved outcomes and clear non-inferiority. Mean estimates of TLF at 12 months are 6.3 percent with Orsiro versus 8.9 percent with Xience, resulting in a mean difference of -2.6 percent, demonstrating a 100 percent probability of Orsiro being non-inferior to the control. A post-hoc superiority analysis showed a 96.9 percent probability of Orsiro being superior to the control.
“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,” said U.S. principal investigator David Kandzari, M.D., Piedmont Heart Institute, Atlanta. “Orsiro also notably has exceptional deliverability that is essential for PCI procedures. We believe Orsiro’s ultrathin 60 micron struts, bioresorbable polymer and proven antiproliferative drug are the key elements to its superior performance.”
BIOFLOW-V is the first large randomized trial to show improved outcomes of any DES over Xience. The international study 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. Fifty-point-eight (50.8) percent of patients presented with an acute coronary syndrome, 35 percent of patients were diabetic and 73.8 percent of lesions were ACC/AHA Class B2/C. Patients will be followed for five years.
The BIOFLOW-V study design was published by the American Heart Journal.
Read the February 2019 article FDA Clears Biotronik Orsiro Stent That Outperforms Xience
For more information: www.thelancet.com
April 22, 2024 
