News | Stents Drug Eluting | September 01, 2017

Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial

Landmark data published by The Lancet demonstrates statistically significant lower event rates with Orsiro

Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial

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.

For more information: www.thelancet.com

Related Content

CorInnova Awarded 2017 InnoSTARS Prize for EpicHeart Soft Robotic Heart Assist Device
News | Artificial Heart| December 11, 2017
CorInnova Inc. recently announced it was awarded second prize in the “2017 InnoSTARS” life science competition for its...
ECG Study of NBA Players Shows Need for Sport-Specific Normative Data and Guidelines
News | ECG| December 08, 2017
Cardiologists at NewYork-Presbyterian/Columbia University Irving Medical Center compared electrocardiographic findings...
New Study Suggests Protein Could Protect Against Coronary Artery Disease

Patients with no obstructed blood flow in the coronary arteries had higher levels of CXCL5 (blue) compared to patients with moderate levels (green) or lower levels (yellow) of CXCL5, who had increased severity of coronary obstructions (indicated by the arrows). Credit: Schisler lab

News | Cardiac Diagnostics| December 07, 2017
December 7, 2017 — The buildup of plaque in the heart’s arteries is an unfortunate part of aging.
Edwards Acquires Harpoon Medical
News | Heart Valve Technology| December 07, 2017
December 7, 2017 — Edwards Lifesciences Corp.
Robocath Receives $1.5 Million in Capital for Advancement of R-One Robotic System
News | Robotic Systems| December 06, 2017
December 6, 2017 — French company Robocath, which designs and develops...
New data on the Corvia intra-atrial shunt to treat diastolic heart failure were presented at the recent 2017 American Heart Association (AHA) Scientific Sessions. It was the most popular story in November.

New data on the Corvia intra-atrial shunt to treat diastolic heart failure were presented at the recent 2017 American Heart Association (AHA) Scientific Sessions. It was the most popular story in November.

Feature | December 06, 2017 | Dave Fornell
Here is the list of the most popular articles and videos on the Diagnostic and Interventional Cardiology (DAIC) magaz
New Tool Predicts Risk of Heart Attack in Older Surgery Patients
News | Cardiac Diagnostics| December 05, 2017
A tool designed to more accurately predict the risk of heart attack in older patients undergoing non-cardiac surgery...
Screening for Critical Congenital Heart Disease at Birth Saves Lives
News | Congenital Heart| December 05, 2017
Infant deaths from critical congenital heart disease (CCHD) decreased more than 33 percent in eight states that...
Toshiba Medical Rolls Out Interactive Learning Tools for Ultrasound and Vascular Training
News | Ultrasound Imaging| December 04, 2017
Toshiba Medical, a Canon Group company, introduced new educational tools and interactive learning resources to help...
Philips Azurion Platform Improves Clinical Workflow and Staff Experience Benefits
News | Angiography| December 04, 2017
Philips recently announced the results of a comprehensive, independent, two-year study demonstrating the clinical...
Overlay Init