Navigation Links
Data From Landmark Clinical Trial of Abbott's MitraClip® System Demonstrate Durable Clinical Benefits for Patients With Mitral Regurgitation Two Years After Treatment

NEW ORLEANS, April 4, 2011 /PRNewswire/ -- 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® 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 YearsThe 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 ProcedureAbbott'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 VascularAbbott 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 AbbottAbbott 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 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.

    SOURCE Abbott
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Data From Landmark Study Evaluating Gender Differences in Response to an HIV Therapy Published in Annals of Internal Medicine
    2. Landmark National Survey Conducted by Harris Interactive® Sheds Light on Hidden Problem of Heavy Monthly Periods
    3. The New England Journal of Medicine Publishes Results of Landmark CREST Study, Showing Similar Positive Outcomes for Abbotts Carotid Stent System and Surgery
    4. US HIFU to Fund Landmark Investigation of Focal Therapy for Prostate Cancer
    5. BioMed Realty Trust Signs New Lease With Regeneron Pharmaceuticals for 131,000 Square Feet at Landmark
    6. Landmark Study in The Lancet Oncology Shows Capecitabine (Xeloda(R)) Combination Therapy Reduces Early Breast Cancer Recurrence
    7. ATS Medical Announces FDA Approval for a Landmark Clinical Investigation of the ATS 3f Aortic Bioprosthesis
    8. Landmark Study for GSKs Cervical Cancer Vaccine Published in The Lancet
    9. Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results
    10. Landmark Study in The New England Journal of Medicine Shows HPV Testing Significantly Reduces Deaths from Cervical Cancer, Compared to other Methods Including Pap
    11. New England Journal of Medicine Publishes Results from Boston Scientifics Landmark SYNTAX(TM) Trial
    Post Your Comments:
    (Date:10/12/2017)... Pa. , Oct. 12, 2017 ... leader in innovative solutions for injectable drug administration, today ... before the market opens on Thursday, October 26, 2017, ... the results and business expectations at 9:00 a.m. Eastern ... (U.S.) or 253-336-8738 (International). The conference ID is 94093362. ...
    (Date:10/11/2017)... -- Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an ... Puerto Rico , where the company ... Following a comprehensive onsite assessment, ... damage, temporary loss of power and minimal water damage ... operations have resumed, and the company expects to return ...
    (Date:10/5/2017)... 5, 2017  In response to the nationwide ... Maxillofacial Surgeons (AAOMS) released prescribing recommendations that urge ... used as a first-line therapy to manage a ... Recognizing the value and importance ... "Opioid Prescribing: Acute and Postoperative Pain Management" stresses ...
    Breaking Medicine Technology:
    (Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a ... utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the ... a CBD form that can be easily incorporated into liquid products, while reducing costs ...
    (Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
    (Date:10/13/2017)... ... 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of ... popular and least understood books in the Holy Scriptures, Revelation. The Book of Revelation ... scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins ...
    (Date:10/13/2017)... ... 13, 2017 , ... “America On The Brink”: the Christian history of the ... is the creation of published author, William Nowers. Captain Nowers and his wife, ... he spent thirty years in the Navy. Following his career as a naval ...
    (Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
    Breaking Medicine News(10 mins):