NEW ORLEANS, March 17, 2019 / PRNewswire / – Abbott (NYSE: ABT) today announced positive delay data with two separate COAPT analyzes™ The trial shows additional key benefits from MitraClip treatment™ for patients with heart failure with clinically significant secondary (or functional) mitral regurgitation (MR) or bypass heart valve. The two words were presented today at the 68th annual scientific session of the American College of Cardiology (ACC). On Thursday, the US Food and Drug Administration (FDA) approved a new, extended MitraClip indication for treating secondary mitral regurgitation based on COAPT test data.
During the late violation of today's session in the ACC, MitraClip proved to be superior to medical therapy directed to guidelines in providing quality of life improvements in selected patients with significant secondary MR resulting from advanced heart failure. These data were published at the same time Journal of the American College of Cardiology. The second sub-analysis measures the essential characteristics of patients with heart failure before enrolling in the COAPT study and indicated that all subgroups of patients enrolled in the trial benefited from MitraClip therapy in the long run.
"Following the excellent data from the COAPT survey presented last September, these analyzes further confirm that treatment with MitraClip provides great benefit to selected patients with advanced heart failure," said Greg V. Stone, MD, co-lead investigator of the COAPT trial, director of cardiovascular research and education of New York Presbyterian /University of Columbia Irving Medical Center and Professor of Medicine University of Columbia Vagelos College of Physicians and Surgeons. "In patients who remained symptomatic with moderate to severe or severe MR, despite all the best medical treatments, MitraKlip continued its survival and significantly reduced the need for hospitalization, while improving their daily lives – despite advanced age and co-morbidity."
People with heart failure may develop a secondary MR when the left ventricle increases, preventing mitral leaflets from closing and allowing blood to flow back through the heart.1 Significant secondary MR is difficult to manage, is associated with a poor prognosis,2 and can lead to a decrease in quality of life, recurrent inpatients and reduced survival.3, 4 Most patients with heart failure with clinically significant secondary MR are only treated with medication and have few treatment options.5 However, on the basis of recent approval, these patients can now benefit from treatment with MitraClip for their secondary MR.
MitraClip is a small clip-based device that fixes the MR without the need for an open heart surgery. It is delivered to the heart through a small incision in the leg. The device works by clipping together a portion of the mitral valve leaflet to reduce the blood pressure backflow, which allows the heart to pump more easily. About one in 10 adults aged 75 and older in the United States, or four million Americans, suffer from MR.6, 7.8 It is estimated that two to three times more patients can now benefit from the MitraClip treatment for secondary MR due to underlying heart failure than those treated for the primary form of the disease most commonly associated with worsening of the valve structure.9
"These additional analyzes from the COAPT Court indicate the benefits of MitraClip treatment in patients with severe MR which are not beneficial in medical therapy," said Michael Dale, vice president of Abbott's structural heart business. "The data emphasize our recent approval to help those people who desperately need treatment, giving them the opportunity to do things that many of us take for granted: things like breathing normally, lying for sleep and walking to the inbox. "
Data on quality of life
The quality of life analysis of COAAPT showed that in 24 months, patients with heart failure and secondary MR receiving maximum tolerated medical therapy and treated with MitraClip showed significant and sustained health status (≥10 points) compared to medical therapy (36.4 per cent versus 16.6 percent, p <0.001). While quality of life was unchanged over time in the medical therapy group, patients treated with MitraClip showed significant improvement in the KCCQ-OS result, self-evaluation of social abilities, symptoms and quality of life as soon as a month after the procedure between the group 15.9 points, p <0.001), a difference that lasted 24 months. The MitraClip quality of life benefit was consistent across all subgroups over 24 months.
Clinical trials of COAPT were randomized patients with a classification of 3-4 + (moderate to severe and severe) secondary MR treatment with MitraClip plus medical therapy (n = 302) or only with medical therapy (n = 312). Initially, patients in both groups had significantly impaired quality of life due to their advanced heart failure. The quality of life was estimated at the beginning of one, six, 12 and 24 months.
Echocardiographic data sub-analysis for the COAPT test
In the sub-analysis of COAPT images, patients were screened to assess the severity of the secondary MR before they enrolled in the test and to determine which characteristics of the patient best predicted favorable long-term results with MitraClip. A specific recording protocol was developed and employed to select patients with severe MR that could benefit from the MitraClip device. Significant reduction in mortality and heart failure were observed in all subgroups of images, regardless of the basic characteristics of patients.
In sub-analyzes, there were 614 patients with heart failure and ASE class 3+ or 4 + secondary MR enrolled and randomized 1: 1 to MitraClip and medical therapy or only medical therapy based on an integrated assessment of the severity of regurgitation using several measures and parameters . The following cardiac imaging was obtained during discharge, one, six, 12, 18 and 24 months, and annually over five years. Clinical follow-up is currently completed in one year in all patients and over two years in many patients.
In COAPT (Assessment of MitraClip Percutaneous Cardiovascular Therapy in Patients with Heart Failure with Functional Mitral Regurgitation) A trial of 614 symptomatic patients with heart failure with moderate to severe or severe secondary MR were randomized to receive treatment with MitraKip plus medical therapy or guidance-directed medical therapy only at 78 locations in the United States and the United States Canada. Similar patients had heart muscle diseases, known as dilated cardiomyopathy, which reduced the amount of blood pumped from the left ventricle; and moderate to severe or severe MR evaluated by the American Association of Echocardiography, which remained symptomatic despite maximum tolerated therapy and cardiac resynchronization therapy (if appropriate).10,11 The average age of the patient was 72.2 years, and 64 percent were men.
The primary end point of effectiveness in the COAPT study was all of the hospitalization of cardiac heart disease over two years, and the primary safety endpoint was releasing the complications associated with devices in one year, compared to the target of a 88 per cent performance. Secondary endpoints include mortality from all causes of two years, a change in the quality of life per year, a change in functional capacity (six minutes distance from a walk) in one year, the severity of an MRI in one year and the size of the left ventricle a year . The COAPT check met its primary endpoints and all 10 secondary endpoints presented during a TCT cardiology meeting in September 2018 and published in New England Journal of Medicine.12
MitraClip received CE mark in Europe in 2008 and was approved by the FDA in 2013 for primary MR patients (patients who do not meet open heart surgery requirements). The FDA approved an extended indication for MitraClip to treat secondary MR in March 2019. Supplied via a minimally invasive catheter, MitraClip provides part of mitral valve leaflets with an implanted clip, allowing the heart to pump blood more easily throughout the body, releasing the symptoms of MR and improving the quality of the patient in life.
Patients with MR often do not fulfill the requirements for surgical intervention due to standard care due to advanced age, fatigue, multiple comorbidities or other complications, and therapy offers a minimally invasive alternative. Transcriptor clip-based therapy, now the third-generation product innovation, has been used to treat more than 80,000 people with MR in the world for more than 10 years.
For more information on MitraClip, visit: www.structuralheartsolutions.com.
For the important US security information for MitraClip, visit: https://www.structuralheartsolutions.com/us/mitraclip-isi.
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2 Dwivedi A, Vainrib A, Saric M. Functional mitral regurgitation in patients with heart failure and depressive ejection fraction. Current opinion in cardiology. September 2016 – Volume 31 – Number 5 – p. 483-492.
3 Sanino A, Smith II RL, Schiattarrella GG, et al. Survival and cardiovascular outcomes for patients with secondary mitral regurgitation: meta-analysis of 53 studies. JAMA Cardiology 2017; 2: 1130-39.
4 Goliasch G, Bartko PE, Pavo N, et al. Refining the impact of prognosis on functional mitral regurgitation in chronic heart failure. Eur Heart J 2018; 39: 39-46.
5 Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unaffected patients with severe symptomatic mitral regurgitation and heart failure: a comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014; 63: 185-6.
6 Dziaddzko et al, "Outcome and insufficient processing of mitral regurgitation: a joint cohort study", Lancet 2018: 391: 960-69.
7 AHA disease of the heart and recovery of statistical data, circulation 2017.
8 Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC / AHA / HFSA focused on updating ACCF / AHA / 2013 for heart failure management: a report by the American College of Cardiology / American Heart Association Association for Clinical Practice Guidelines and the American Heart Failure Association. J Am Coll Caridol. 2017; 70: 776-803.
9 Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unaffected patients with severe symptomatic mitral regurgitation and heart failure: a comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014; 63: 185-6.
10 Pecini et al EHJ 2011; Asgar et al, JACC 2015; Nieminen et al, EHJ 2006; Patel et al, Journal of Cardiac Failure 2004.
11 Nishimura RA, Otto KM, Boneu RO, and others. 2017 AHA / ACC Focused update of the AHA / ACC 2014 Guidelines for Managing Valvular Disease Patients: A report by the American College of Cardiology / American Association for Clinical Practice Guidelines. J Am Coll Cardiol. 201; 70: 252-289.
12 Stone GW, et al. Transcripteter Mitral valve repair in patients with heart failure. N Engl J Med. December 13, 2018; 379 (24): 2307-2318.