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New Landmark COAPT ™ Trial Issues Analysis Advantages of Abbott's MitraClip ™ Device

NJU ORLEANS, March 17, 2019 / PRNewsvire / – Abbott (NISE: ABT) today posted positive data from two separate COAPT analyzes A trial work showing additional key benefits from MitraClip treatmentfor patients with cardiac insufficiency with clinically significant secondary (or functional) mitral regurgitation (MR) or transmissive cardiac valve. Both sets of data were presented today at the 68th Annual Scientific Meeting of the American College of Cardiology (ACC). On Thursday, the US Food and Drug Administration (FDA) approved a new, extended indication for MitraClip for the treatment of secondary mitral regurgitation based on COAPT Trial data.

During the delays today in the ACC, MitraClip has been shown to be superior to medical therapy directed to guidelines in providing improved quality of life for selected patients with significant secondary MR resulting from advanced heart failure. These data are published at the same time Journal of the American College of Cardiology. The second sub-analysis measured the baseline characteristics of patients with cardiac insufficiency prior to enrollment in the COAPT Trial and showed that all subgroups of patients involved in the trial benefited from MitraClip therapy in the long-term.

"Following the revolutionary data from COAPT Trial presented in September last year, these analyzes further confirm that treatment with MitraClip is a great benefit for selected patients with advanced heart failure," says Gregg V. Why not, Chief Researcher COAPT Trial, Director of Cardiovascular Research and Education at Nevilleork Presbyterian /Columbia Universiti Irving Medical Center and Professor of Medicine at Columbia Universiti Vagelos College of Phisicians and Surgeons. "In patients who remained symptomatic with moderate to severe or severe MR, despite all the best medical treatments, MitraClip has prolonged its survival and significantly reduced the need for hospitalization, while improving their everyday life – despite age and comorbidity."

People with heart failure may develop a secondary MR when the left heart chamber is enlarged, preventing the closure of the mitral leaflets and allowing the blood to flow back through the heart.1 Significant secondary MR is difficult to manage, it is associated with poor prognosis,2 and can lead to a decrease in quality of life, repeated hospitalization and reduced survival.3, 4 Most patients with cardiac insufficiency with clinically significant secondary MR are only treated with medication and have several treatment options.5 However, on the basis of recent authorization, these patients can now benefit from treatment with MitraClip for their secondary MR.

MitraClip is a small piston device that fixes MR without the need for open-heart surgery. It is delivered to the heart through a small cut in the leg. The device works by collecting part of the mitral valve leaflet in order to reduce the return of blood flow, which allows the heart to pump more efficiently. Approximately one in 10 adults aged 75 and over in the US, or four million Americans, suffer from MR.6, 7.8 It is estimated that two to three times more patients can now benefit from MitraClip treatment for secondary MR as a result of basic cardiac insufficiency than those treated for the primary form of the disease that is usually associated with a deterioration in the valve structure.9

"These additional analyzes from a significant COAPT study indicate the benefits of MitraClip treatment for patients with severe MR who do not benefit from medical therapy," says Michael Dale, vice president of Abbott's structural heart. "The data point to our recent approval to help these people who desperately need treatment, giving them the ability to do what many of us take for granted: things like normal breathing, sleeping and walking to the mailbox."

Data on quality of life
The COAPT quality of life analysis showed that patients with cardiac insufficiency and secondary MR received maximum tolerated medical therapy and treated with MitraClip showed a significant improvement in health status (≥10 points) compared to medical therapy (36.4) . percentage vs. 16.6%; p <0.001). Although the quality of life remained unchanged over time in the medical therapeutic group, patients treated with MitraClip showed a significant improvement in the KCCK-OS score, self-evaluation of social abilities, symptoms and quality of life, as soon as a month after the procedure (mean difference between groups of 15.9 points , p <0.001), a difference that lasted up to 24 months. The quality of life of MitraClip was consistent in all subgroups in 24 months.

Examination of COAPT randomized patients with ASE (American Societies of Echocardiographi) classification 3-4 + (moderate to severe to severe) secondary MR to treatment MitraClip plus medical therapy (n = 302) or only medical therapy (n = 312). Initially, patients in both groups significantly damaged the quality of life due to their advanced heart failure. The quality of life was estimated at the beginning and for one, six, 12 and 24 months.

Echocardiographic sub-analysis of COAPT trial data
In the COAPT image sub-analysis, patients were screened to evaluate the severity of the secondary MR prior to enrollment in the examination, and to determine which patient characteristics best predicted favorable long-term outcomes with MitraClip. A specific recording protocol has been developed and used to select patients with severe MR that could benefit from the MitraClip device. A significant reduction in the number of hospitalization due to death and cardiac insufficiency was recorded in all subgroups regardless of the basic characteristics of patients.

In the sub-analysis, 614 patients with cardiac insufficiency and ASE class 3+ or 4+ secondary MR included and randomized 1: 1 on MitraClip and medical therapy or medical therapy alone based on an integrated assessment of the severity of regurgitation using multiple measures and parameters. Control cardiac recordings were obtained on discharge, one, six, 12, 18 and 24 months, and annually for five years. Clinical follow-up is currently completed in one year in all patients and in two years in many patients.

About the COAPT trial
In COAPT (Cardiovascular Outcome Assessment of MitraClip Percutaneous Therapy for Patients with Functional Mitral Regurgitation), 614 patients with symptomatic cardiac insufficiency with moderate to severe or severe secondary MR were randomized to receive treatment with MitraClip plus medical guidance. therapy or medical therapy directed at guidelines at 78 locations in the US and the US Canada. Acceptable patients were suffering from a heart muscle, more commonly known as dilated cardiomyopathy, which reduced the amount of blood pumped from the left ventricle; and moderate to severe or severe MRI assessed by the American Association for Echocardiographic Guidelines that remained symptomatic despite maximum tolerated medical therapy and cardiac resynchronization (if necessary).10,11 The average age of the patients was 72.2 years and 64% of men.

The primary endpoint of effectiveness in the COAPT trial was all hospitalization of cardiac insufficiency over two years, and the primary safety endpoint was the freedom from complications associated with the device in one year compared to the target of 88 percent. Secondary endpoints included the mortality of all causes for two years, the change in quality of life in one year, the change in functional capacity (six minutes of walking) in one year, the weight of MR in one year and the size of the left ventricle in one year. The COAPT trial filled out its primary endpoints and all 10 secondary endpoints, as presented during the TCT cardiac meeting in Sept. 2018 and published in New England Journal of Medicine.12

About MitraClip
MitraClip received the CE mark in Europe in 2008 and was approved by the FDA of 2013 for primary patients at risk of excessive risk (patients who do not meet the requirements for open-heart surgery). The FDA has approved an extended indication for MitraClip to treat a secondary MR March 2019. Delivered through a minimally invasive catheter, MitraClip provides a part of the mitral valve leaflet with an implanted piston, allowing the heart to pump blood more efficiently throughout the body, thereby relieving MR symptoms and improving the quality of life of the patient.

Patients with MR often do not meet the standard care requirements due to advanced age, weakness, multiple comorbidities, or other complicated factors, and the therapy offers a minimally invasive alternative. Therapy based on transcatheter pistons, now on the third generation of product innovation, has been used to treat over 80,000 people with MR over the world for more than 10 years.

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2 Dvivedi A, Vainrib A, Saric M. Functional mitral regurgitation in patients with cardiac insufficiency and depressive ejection fraction. Current Opinion in Cardiology. September 2016 – Volume 31 – Issue 5 – p. 483-492.
3 Sannino A, Smith II RL, Schiattarrella GG, et al. Survival and cardiovascular outcomes of patients with secondary mitral regurgitation: meta-analysis of 53 studies. JAMA Cardiologi 2017; 2: 1130-39.
4 Goliasch G, Bartko PE, Pavo N, et al. Improvement of the prognosis of the effect of functional mitral regurgitation on chronic cardiac insufficiency. Eur Heart J 2018; 39: 39-46.
5 Goel SS, Bajaj N, Aggarval B, et al. Prevalence and outcomes of patients with severe symptomatic mitral regurgitation and cardiac insufficiency: a comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014; 63: 185-6.
6 Dziadzzko et al., "Outcome and non-treatment of mitral regurgitation: cohort study of the community", Lancet 2018: 391: 960-69.
7 Update AHA of heart disease and stroke statistics, circulation 2017.
8 Ianci CV, Jessup M, Bozkurt B, et al. 2017 ACC / AHA / HFSA focused on updating the ACCF / AHA guidelines for the treatment of cardiac insufficiency for 2013: a report by the American College of Cardiology on the guidelines for clinical practice and the American Society of Failure. J Am Coll Caridol. 2017; 70: 776-803.
9 Goel SS, Bajaj N, Aggarval B, et al. Prevalence and outcomes of patients with severe symptomatic mitral regurgitation and cardiac insufficiency: a comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014; 63: 185-6.
10 Pecini and others EHJ 2011; Asgar et al, JACC 2015; Nieminen et al, EHJ 2006; Patel et al., Journal of Cardiac Failure 2004.
11 Nishimura RA, Otto CM, Bonov RO, et al. 2017 AHA / ACC focused updates of the AHA / ACC Guidelines for Managing Valvular Disease Patients for 2014: A report of the American Heart Association Task Force on Guidance on Clinical Practice. J Am Coll Cardiol. 201; 70: 252-289.
12 Stone GV, et al. Transcatheter Mitral-Valve Repair in the Patients with Heart Failure. N Engl J Med. 2018 Dec 13; 379 (24): 2307-2318.


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