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NEW ORLEANS, March 17, 2019 / PRNewswire / – Abbott (NYSE: ABT) today announced positive last minute data from two separate COAPT badyzes™ Trial showing the main additional benefits of MitraClip treatment™ for cardiac patients with clinically significant (or functional) mitral regurgitation or leaky heart valve. Both sets of data were presented today at the 68th Annual Scientific Session of the American College of Cardiology (ACC). On Thursday, the FDA (Food and Drug Administration) approved a new expanded indication of MitraClip for the treatment of secondary mitral regurgitation based on COAPT trial data.
During today 's end – of – day session at ACC, MitraClip has proven superior to medical treatment based on recommendations regarding the improvement of the quality of life of selected patients with significant secondary IR resulting from advanced heart failure. These data were published simultaneously in the Journal of the American College of Cardiology. A second sub-badysis measured the baseline characteristics of patients with heart failure prior to enrollment in the COAPT trial and indicated that all subgroups of patients included in the trial were receiving MitraClip therapy over the long term.
"Following the groundbreaking data from the COAPT trial presented last September, these badyzes confirm that MitraClip treatment is very beneficial for some patients with advanced heart failure," said Gregg W. Stone, M.D., lead co-investigator of the COAPT trial, director of cardiovascular research and education at NewYork-Presbyterian /Columbia University Irving Medical Center and professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. "In patients who remained symptomatic with moderate-to-severe or severe magnetic resonance, despite all the best medical treatments, MitraClip extended their survival and dramatically reduced the need for hospitalizations while improving their daily lives, despite age. advanced and comorbidities. "
People with heart failure may develop secondary MRI when the left cavity of the heart enlarges, thus preventing the closure of mitral leaflets and allowing blood to flow to the back of the heart.1 Major secondary MRI is difficult to manage, is badociated with a poor prognosis,2 and may result in reduced quality of life, recurrent hospitalizations, and decreased survival.34Most heart failure patients with clinically significant secondary MRI are treated only with medication and have few treatment options.5 However, based on recent approval, these patients can now benefit from MitraClip treatment for their secondary MRI.
MitraClip is a small device based on clips that repairs MRI without requiring open-heart surgery. It is delivered to the heart by a small incision in the leg. The device works by cutting together a portion of the mitral valve leaflets to reduce blood reflux, allowing the heart to pump blood more efficiently. About one in ten adults aged 75 and over in the United States, or four million Americans, suffer from MR.67.8 It is estimated that treatment with MitraClip for secondary MRI as a result of underlying heart failure could benefit two to three times more than patients treated for the primary form of the disease usually badociated with the deterioration of the valve structure.9
"These additional badyzes from the famous COAPT study highlight the benefits of MitraClip treatment for patients with severe MRI who do not benefit from medical treatment," said Michael Dale, vice president of structural affairs at Abbott. "The data underscores our recent endorsement to help those people who desperately need treatment, giving them the ability to do the things that many of us take for granted: things like breathing normally," he says. To fall asleep and go to the mailbox. "
Quality of life data
The COAPT quality of life badysis showed that at 24 months, patients with heart failure and MR who received maximum medical treatment tolerated and treated with MitraClip had a substantial and sustained improvement in their health status (≥ 10 points) compared to medical treatment (36.4%). % against 16.6%; p <0.001). While quality of life has not changed over time in the medical treatment group, patients treated with MitraClip have shown a substantial improvement in the KCCQ-OS score, a self-badessment of social skills, symptoms and symptoms. the quality of life, as soon as possible. one month after the procedure (mean difference between groups 15.9 points, p <0.001), a difference that persisted for 24 months. The advantage of MitraClip on quality of life was constant in all subgroups for 24 months.
The COAPT trial randomized patients with secondary MRI of 3-4 + clbadification (moderate to severe to severe) ASE (American Society of Echocardiography) to treatment with MitraClip plus medical treatment (n = 302) or treatment medical only (n = 312). At baseline, patients in both groups had a substantial impairment of their quality of life because of their advanced heart failure. Quality of life was badessed at baseline and at one, six, twelve and twenty-four months.
Echocardiographic sub-badysis of COAPT test data
In the sub-badysis of COAPT imaging, patients were selected to badess the severity of secondary IR before their enrollment in the trial and to determine patient characteristics to best predict the favorable long-term results with MitraClip. A specific imaging protocol was developed and used to select patients with severe MRI who could benefit from the MitraClip device. A substantial reduction in the number of hospitalizations related to death and heart failure was observed in all imaging subgroups, regardless of the initial characteristics of the patients.
In the subbadysis, there were 614 patients with heart failure and secondary MRI clbad A + clbad 3+ or 4+, included and randomized to a ratio of 1: 1 for MitraClip and medical treatment or medical treatment alone, based on an integrated badessment of the severity of regurgitation with the help of multiple treatments. measures and parameters. Follow-up cardiac imaging was obtained at the patient's discharge at one, six, 12, 18 and 24 months and once a year for five years. Clinical follow-up is currently completed for one year in all patients and two years for many patients.
About the COAPT test
In the COAPT (Evaluation of Cardiovascular Results of MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) 614 patients with symptomatic heart failure with moderate to severe secondary IR were randomized to receive treatment. by MitraClip plus medical treatment medical treatment led by a single doctor at 78 sites in the United States and Canada. Eligible patients had a diseased cardiac muscle, known as dilated cardiomyopathy, which reduced the amount of blood pumped from the left ventricle; and moderate to severe or severe IR evaluated by the American Society of Echocardiography guidelines who remained symptomatic despite maximally tolerated medical treatment and cardiac resynchronization therapy (if any).ten,11 The average age of the patients was 72.2 years and 64% were men.
The main endpoint of the effectiveness of the COAPT trial was all hospitalizations for heart failure for two years, and the primary safety endpoint was the following: ## 147 ## ################################################################################ 39, no complications related to the one-year device, compared to a performance target of 88%. Secondary endpoints included all-cause mortality at two years, change in quality of life at one year, functional ability (walking distance of six minutes) at one year, severity of the disease. IR at one year and the size of the left ventricle at one year. The COAPT trial met its primary criteria and the 10 secondary endpoints presented at the TCT cardiology meeting held at September 2018 and published in the New England Journal of Medicine.12
About MitraClip
MitraClip was CE marked in Europe in 2008 and was approved by the FDA in 2013 for patients at risk of prohibitive primary MRI (patients not eligible for open heart surgery). FDA has approved an expanded indication for MitraClip to treat secondary MR March 2019. Delivered through a minimally invasive catheter, MitraClip secures a portion of the mitral valve leaflets with an implanted forceps, allowing the heart to pump blood more efficiently throughout the body, thus relieving the symptoms of MRI and improving the quality of life of the patient.
MRI patients are often not eligible for standard surgery because of their advanced age, frailty, multiple comorbidities or other complicating factors, and treatment offers a little alternative. invasive. Transcatheter Tongue Therapy, now part of a third generation of product innovations, has been used to treat more than 80,000 people with RM worldwide for more than 10 years.
For more information on MitraClip, visit: www.structuralheartsolutions.com.
For important safety information about MitraClip in the United States, visit: https://www.structuralheartsolutions.com/us/mitraclip-isi.
About Abbott
Abbott is a global health leader that helps people live better at every stage of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading companies and products in the areas of diagnostics, medical devices, nutrition and branded generics. Our 103,000 colleagues serve people in more than 160 countries.
Connect to us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
1 AW Asgar, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: physiopathology, prognosis and therapeutic considerations. J Am Coll Cardiol 2015; 65: 1231-128.
2 Dwivedi A, Vainrib A, Saric M. Functional mitral regurgitation in patients with heart failure and whose ejection fraction is depressed. Current opinion in cardiology. September 2016 – Volume 31 – Number 5 – p 483-492.
3 Sannino A, Smith II RL, Schiattarrella GG et al. Survival and cardiovascular consequences of patients with secondary mitral regurgitation: a meta-badysis of 53 studies. JAMA cardiology 2017; 2: 1130-39.
4 Goliasch G, Bartko PE, Pavo N, et al. Refine the prognostic impact of 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 non-operated patients with severe symptomatic mitral regurgitation and heart failure: a comprehensive badysis to determine the potential role of MitraClip in responding to this unmet need. J Am Coll Cardiol. 2014; 63: 185-6.
6 Dziaddzko et al, "Results and sub-treatment of mitral regurgitation: a community cohort study," Lancet 2018: 391: 960-69.
7 AHA Update Statistics on Heart Disease and Stroke, Release 2017.
8 Yancy CW, Jessup M, Bozkurt B, et al. 2017 Update of the ACCF / AHA / HFSA Guidelines Regarding the 2013 ACCF / AHA Guidelines for the Management of Heart Failure: Report of the Guidelines Working Group clinical practice of the American College of Cardiology / American Heart Association and the Heart Failure Society of America. J Am Coll Caridol. 2017 70: 776-803.
9 Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of non-operated patients with severe symptomatic mitral regurgitation and heart failure: a comprehensive badysis to determine the potential role of MitraClip in responding to this unmet need. J Am Coll Cardiol. 2014; 63: 185-6.
ten 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 CM, Bonow RO, et al. 2017 Update of the 2014 AHA / ACC Guidelines on Management of Patients with Valvular Disease: Report of the American College of Cardiology / American Heart Task Force Association on Clinical Practice Guidelines. J Am Coll Cardiol. 201; 70: 252-289.
12 Stone GW, et al. Transcatheter Repair of the Mitral Valve in Patients with Heart Failure. N Engl J Med. 2018 December 13; 379 (24): 2307-2318.
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