ATLANTA, June 11, 2018 /PRNewswire/ -- CryoLife,
Inc. (NYSE: CRY), a leading cardiac and vascular surgery
company focused on aortic disease, today announces the publication
of our clinical study entitled "Anticoagulation and Antiplatelet
Strategies After On-X Mechanical Aortic Valve Replacement" in a
peer-reviewed medical journal, the Journal of the American
College of Cardiology. The publication reports outcomes
from a multicenter, non-inferiority, two-arm study (the PROACT
clinical trial) testing whether, after an On-X mechanical aortic
valve replacement (AVR), patients in a High Risk Arm could be
safely managed with lower-intensity warfarin plus aspirin or in a
Low Risk Arm could be safely managed with dual antiplatelet therapy
(DAPT).
High Risk Arm - Patients with one or more thromboembolic (TE)
risk factors were randomized to a High Risk study group with
lower-intensity warfarin plus aspirin (international normalized
ratio [INR] 1.5-2.0) compared to standard warfarin plus aspirin
(INR 2.0-3.0). Patients randomized to the lower-intensity
warfarin plus aspirin group experienced a greater than 60%
reduction in bleeding, at up to 8.7 years follow-up, with no
differences in TE and all-cause mortality. Based on the
results of this study, the U. S. Food and Drug Administration (FDA)
approved a labeling recommendation for the On-X mechanical aortic
valve with an INR of 1.5-2.0 plus aspirin (81 mg/day), beginning 3
months after surgery.
John D. Puskas, M.D., Professor
of Cardiovascular Surgery at the Icahn School of Medicine at Mount
Sinai in New York, Chairman of the
Department of Cardiovascular Surgery at Mount Sinai Saint Luke's
Hospital, and International Principal Investigator for the PROACT
clinical trial, said, "We are honored that the Journal of the
American College of Cardiology has recognized our clinical work
in their publication. Our findings support an important lower
warfarin threshold advantage specifically for the On-X valve, which
decreases the risks and health concerns associated with long-term
anticoagulation. These findings led the FDA and other
professional societies to support an Indication for Use related
only to On-X. We consider the On-X valve to be
state-of-the-art for aortic valve replacement as it offers a
one-time surgical solution with proven low gradients, resistance to
pannus formation, and outstanding durability."
Low Risk Arm - Patients without TE risk factors undergoing AVR
were randomized to a Low Risk study group with DAPT (aspirin 325mg
and clopidogrel 75mg) compared to standard warfarin plus
aspirin. In the Low Risk study group, patients randomized to
DAPT experienced significantly more TE events and a statistically
similar rate of bleeding events compared to patients maintained on
standard warfarin plus aspirin. As a result, the study was
terminated early. Since antiplatelet strategies were
unsuccessful in this study group, warfarin is still required with
mechanical valves, but with a lower-intensity INR for the On-X
mechanical aortic valve as shown by the results for the High Risk
study group.
On-X Mechanical Heart Valve
On-X mechanical heart valves are made with the most advanced
design and materials in the industry including length-to-diameter
ratio similar to a native valve, an inlet flared orifice, a leaflet
opening up to 90 degrees, an actuated pivot, and pure pyrolytic
carbon. These key features translate into laminar flow, low
gradients, and reduced thrombogenicity making it the most
clinically beneficial lifelong heart valve replacement option
available for patients today.
About CryoLife
Headquartered in suburban Atlanta,
Georgia, CryoLife is a leader in the manufacturing,
processing, and distribution of medical devices and implantable
tissues used in cardiac and vascular surgical procedures focused on
aortic repair. CryoLife markets and sells products in more
than 90 countries worldwide. For additional information about
CryoLife, visit our website, www.cryolife.com.
Contacts:
CryoLife
|
The Ruth
Group
|
D. Ashley
Lee
|
Tram Bui / Emma
Poalillo
|
Executive Vice
President, Chief Financial Officer and
|
646-536-7035 /
7024
|
Chief Operating
Officer
|
tbui@theruthgroup.com
/
|
Phone:
770-419-3355
|
epoalillo@theruthgroup.com
|
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SOURCE CryoLife, Inc.