Data From Landmark Clinical Trial of Abbott's MitraClip(R) System Demonstrate Durable Clinical Benefits for Patients With Mitral Regurgitation Two Years After Treatment
By Abbott, PRNESunday, April 3, 2011
Positive EVEREST II Results Published in The New England Journal of Medicine and Presented at the American College of Cardiology Conference
NEW ORLEANS, April 4, 2011 - Abbott (NYSE: ABT) today announced data from its EVEREST II (Endovascular
Valve Edge-to-Edge REpair STudy) study showing that patients with significant
mitral regurgitation (MR) treated with the company's investigational
percutaneous catheter-based MitraClip(R) system continue to demonstrate the
clinical benefits of initial treatment shown at one year out to two years,
including improvements in heart function and reductions in symptoms. EVEREST
II is the first randomized clinical trial to compare a catheter-based mitral
valve device to mitral valve surgery. Data from the study were published in
The New England Journal of Medicine and presented in a late-breaking clinical
trial session at the American College of Cardiology's (ACC) 60th Annual
Scientific Session and i2 Summit 2011 in New Orleans.
At two years after treatment, data from 279 patients from the EVEREST II
trial demonstrated a clinical success rate of 51.7 percent for patients
treated with the MitraClip device compared to a clinical success rate of 66.3
percent for surgery patients (p=0.04) on an Intention-to-Treat (ITT) basis.
These results compare with the one-year data, which demonstrated a clinical
success rate of 55.2 percent for patients who received the MitraClip device,
compared to a clinical success rate of 73.0 percent for surgery patients
(p=0.0007). The clinical success rate is defined as freedom from death, from
surgery for valve dysfunction, and from moderate to severe MR (3+ or 4+).
In The New England Journal of Medicine, the study authors, who represent
a variety of specialties including cardiac surgery and interventional
cardiology, state that "although percutaneous repair was less effective at
reducing mitral regurgitation than surgery before hospital discharge, at 12
and 24 months the rates of reduction in mitral regurgitation were similar,
and percutaneous treatment was associated with increased safety, improved
left ventricular dimensions, and clinical improvements in NYHA class and
quality of life."
"These results reinforce that the MitraClip device continues to be
effective out to two years, confirming the durability of the clinical benefit
and the safety profile of the therapy. Surgery also performed well in the
trial," said Ted Feldman, M.D., FSCAI, director, Cardiac Catheterization
Laboratory, and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional
Cardiology, NorthShore University HealthSystem, Evanston, Ill. "The MitraClip
system offers an option that addresses the unmet need for a percutaneous
approach to treating MR, which may be especially important for many patients
who are considered high-risk surgical candidates."
Dr. Feldman served as co-principal investigator of the EVEREST II trial,
was the lead author of The New England Journal of Medicine publication, and
presented the two-year EVEREST II data during the late-breaking clinical
trial session at ACC.
"In the EVEREST II study, the MitraClip device demonstrated strong safety
and meaningful clinical benefits," said Donald Glower, M.D., professor of
surgery, Cardiovascular and Thoracic Surgery Division, Duke University School
of Medicine, Durham, N.C., co-principal investigator of the EVEREST II trial
and an author of The New England Journal of Medicine publication. "The
MitraClip system's positive risk-benefit profile supports its use as a
treatment choice for patients who are not good candidates for surgery and
have few other options, including elderly or frail patients, those who are at
high risk for surgery, and certain patients with functional MR."
The MitraClip system includes a catheter-based device that is delivered
to the heart through the femoral vein, a blood vessel in the leg. The
MitraClip therapy is designed to reduce significant MR by clipping together
the leaflets of the mitral valve, one of the four valves of the heart.
The most common type of heart valve insufficiency,(1) MR affects more
than 4 million people in the United States - a prevalence of 11.7 percent of
those aged 75 years and older.(2) Significant MR is a debilitating condition
in which the heart's ability to function continues to deteriorate over time
and may lead to irregular heartbeats, heart failure, stroke, heart attack or
death. The condition traditionally has been managed with medications (which
can relieve symptoms but do not address the underlying cause of the
condition) or open-heart surgery. Many people who suffer from MR are not
treated surgically(3) because they are not referred to surgery, are not sick
enough, or are too frail for an invasive procedure.
EVEREST II Data Demonstrate Durability Through Two Years
The EVEREST II pivotal trial is a multi-center, randomized clinical trial
of 279 patients in the United States and Canada with moderate-to-severe (3+)
or severe (4+) MR who were candidates for mitral valve surgery.
In addition to the clinical success rate at one and two years, data from
the EVEREST II study showed the following on an ITT basis:
- At 30 days, the MitraClip system demonstrated superior safety compared to surgery, with 15.0 percent of MitraClip patients and 47.9 percent of surgery patients experiencing a major adverse event (MAE) (p<0.001). Major adverse events are defined as a composite of 12 pre-specified adverse events. - At one and two years, both the MitraClip and surgery groups experienced a significant reduction (p<0.05) in the end systolic and end diastolic volume of the left ventricle heart chamber compared to baseline, indicating an improvement in heart function. In both groups, the decrease in end diastolic volume that was observed between baseline and one year continued to decrease between years one and two. - Both the MitraClip device and surgery experienced a statistically significant reduction in New York Heart Association (NYHA) Functional Class symptoms at one year that was sustained through two years. NYHA Functional Class provides a scale that assists in the determination of functional ability in patients with heart disease. - At two years, 78 percent of patients randomized to the MitraClip device were free from surgery.
Longer-term follow-up of patients in EVEREST II is planned and will
provide additional data to better understand the benefits of the MitraClip
device.
Two-year results from patients with functional MR and patients considered
at high risk for mitral valve surgery were also featured in presentations at
ACC. Results from both presentations demonstrated that positive one-year
clinical outcomes were sustained out to two years.
"The publication of the EVEREST II data in The New England Journal of
Medicine and today's data presentation at ACC represent significant
milestones in a nearly decade-long effort to develop a new treatment option
for patients with mitral regurgitation," said Charles A. Simonton, M.D.,
FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical
officer, Abbott Vascular. "Nearly 3,000 patients around the world have now
been treated with the MitraClip device. We look forward to an FDA Advisory
Panel to review the safety and effectiveness of the MitraClip device this
year, hopefully bringing the technology a step closer to being available to
U.S. physicians and patients."
About Mitral Regurgitation (MR)
MR occurs when the leaflets of the mitral valve do not close completely,
causing blood to flow backwards and leak into the left atrium of the heart
during the cardiac cycle. To maintain an adequate forward flow of blood
throughout the body, the heart compensates by increasing the size of the left
ventricle (the main pumping chamber of the heart) to accommodate the increase
in the volume of blood it is pumping. The chronic volume overload caused by
MR requires the heart to work harder and may ultimately lead to heart failure
and other complications. MR traditionally has been managed with drugs or
open-heart surgery, depending on an individual patient's severity of MR and
risk factors.
About the MitraClip Technology and Procedure
Abbott's proprietary MitraClip system is designed to reduce significant
MR by clipping together the leaflets of the mitral valve, one of the four
valves of the heart. The catheter-based MitraClip device is delivered to the
heart through the femoral vein, a blood vessel in the leg. The heart beats
normally during the procedure, and therefore does not require a heart-lung
bypass machine. After treatment, patients are usually home within two to
three days and have been observed to recover quickly. The safety and efficacy
of the MitraClip system were evaluated in EVEREST II, a study supported by
Abbott.
The MitraClip system received CE Mark in March 2008 and is commercially
available in Europe, Turkey, Israel and Australia. The first-in-man clinical
trial of the MitraClip system was conducted in the United States, where it is
an investigational device currently under review for approval by the U.S.
Food and Drug Administration.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart disease.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
(1) Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16; 368(9540):1005-11. (2) Ibid. (3) Bach DS, Awais M, Gurm HS, et al. Failure of guideline adherence for intervention in patients with severe mitral regurgitation. J Am Coll Cardiol 2009; 54:860-865.
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