SAN DIEGO and BUELACH, Switzerland, Sept. 24, 2018 /PRNewswire/ — Today, BIOTRONIK announced two-year data from the BIOFLOW-V randomized trial comparing the Orsiroa and Xienceb drug-eluting stents (DES). The data shows statistically improved outcomes for patients treated with Orsiro across a range of clinical endpoints including 24-month target lesion failure (TLF).
This pivotal US investigational device exemption trial included a large, complex patient population (n=1,334) and was designed to rigorous FDA premarket approval standards. The results showed a 7.5% versus 11.9% 24-month TLF rate (p-value=0.015), demonstrating significantly improved outcomes with Orsiro in percutaneous coronary intervention.
Patients treated with Orsiro in BIOFLOW-V benefited from a significant reduction of events across a wide range of clinical endpoints1 including:
- 37% lower TLF rate (p=0.015)
- 44% lower TV-MI (target vessel myocardial infarction) rate (p=0.01)
- 47% lower TLR rate (ischemia driven target lesion revascularization) (p= 0.04)
Highlights of the BIOFLOW-V study include the following 24-month data points comparing Orsiro to Xience:
|
Orsiro |
Xience |
||
|
Target Lesion Failure |
7.5% |
11.9% |
p=0.015 |
|
TV-MI |
5.3% |
9.5% |
p=0.01 |
|
Target Lesion Revascularization |
2.6% |
4.9% |
p=0.04 |
|
Stent Thrombosis (Late/Very Late/Definite/Probable) |
0.1% |
1.0% |
p=0.045 |
“These two-year results confirm the superior outcomes for Orsiro we identified at one year, now across an even broader range of clinical endpoints,” said US principal investigator Dr. David Kandzari, Piedmont Heart Institute, Atlanta, Georgia, US. “Results from this trial establish a new standard for safety and efficacy among contemporary drug-eluting stents, demonstrating both maintenance of superior outcomes compared with the Xience stent at one year and emergence of new differences in both safety and efficacy events that favor Orsiro over what has been a benchmark for comparison.”
BIOFLOW-V is the first large randomized trial to show improved outcomes of any DES over Xience. The international study included 1,334 patients, of which a sizable percentage were complex: 50.8% of patients presented with acute coronary syndrome, 35.0% of patients were diabetic and 73.8% of lesions were ACC/AHA Class B2/C.1 Patients will be followed for five years.
“These results confirm that Orsiro’s unique combination of ultrathin struts and a bioresorbable polymer can deliver consistent, superior patient outcomes,” said Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK.
The BIOFLOW-V 24-month data has been published by the Journal of the American College of Cardiology (JACC). Further information is available at www.clinicaltrials.gov (identifier NCT02389946).
References:
1 Kandzari D, BIOFLOW-V: Two-Year Results of a Randomized Trial Evaluating an Ultra-thin Strut Bioresorbable Polymer-Based Drug-Eluting Stent. Presented at TCT, San Diego USA, September 2018.
a CAUTION – Investigational device in the United States. Limited by US law to investigational use.
b Xience is a trademark of Abbott Cardiovascular Systems.
About BIOTRONIK
BIOTRONIK is a medical technology company that develops trusted and innovative cardiovascular and endovascular solutions. Driven by purpose and integrity, BIOTRONIK has partnered with hospitals and health systems for more than 50 years, helping to deliver care that saves and improves the lives of millions of patients with heart and blood vessel diseases. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.
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SOURCE BIOTRONIK
