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.
For more information, visit: www.orsiro.com or
www.biotronik.com
Twitter: @BIOTRONIK_News
LinkedIn: linkedin.com/company/BIOTRONIK
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SOURCE BIOTRONIK