BARCELONA, Spain, Aug. 28, 2017 /PRNewswire/ -- BIOTRONIK today 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 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 US investigational device exemption (IDE) trial included a large, complex patient population and was designed in collaboration with the FDA to support an upcoming premarket approval submission. Orsiro is currently commercially available in more than 100 countries worldwide.
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)
- 2.0 percent versus 2.4 percent clinically driven target lesion revascularization (cd-TLR) rate
- 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 US principal investigator Dr. David Kandzari, Piedmont Heart Institute, Atlanta, Georgia, US. "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. 50.8 percent of patients presented with an acute coronary syndrome, 35.0 percent of patients were diabetic and 73.8 percent of lesions were ACC/AHA Class B2/C. Patients will be followed for five years.
"At BIOTRONIK, we're committed to bringing proven innovation to market because we care about positively impacting lives. The data from the BIOFLOW-V study is evidence of the potential for Orsiro to enter the US DES market and become the standard of care in PCI," said Marlou Janssen, President of BIOTRONIK, Inc. "Where Orsiro is available around the world, hospitals, physicians and patients can confidently rely on this drug-eluting stent to deliver exceptional results."
A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris***, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar-18, the world's first 4F compatible stent for treating long lesions; Orsiro*, the ultrathin 60 micron drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI technology.
* CAUTION – Investigational device in the United States. Limited by US law to investigational use.
** Xience is a registered trademark of Abbott Cardiovascular Systems.
*** Not currently available in the United States.