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April 19, 2021
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COAPT: MitraClip improves outcomes regardless of mitral valve gradient

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Transcatheter mitral valve repair improved clinical outcomes in patients with HF across all quartiles of mitral valve gradient, according to new data from the COAPT trial.

As Healio previously reported, in the main results of COAPT, mitral valve repair with a transcatheter device (MitraClip, Abbott) plus medical therapy compared with medical therapy alone reduced 2-year risk for HF hospitalization and mortality in patients with HF and moderate to severe or severe functional mitral regurgitation. For the present analysis, researchers analyzed whether the results were consistent based on mitral valve gradient.

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‘Very reassuring’ data

Howard C. Herrmann

“This data is very reassuring for physicians who place MitraClips in patients with secondary mitral regurgitation. It demonstrates that the benefits of mitral regurgitation reduction in patients with heart failure were maintained even when mild to moderate mitral stenosis, which can be caused by a narrowing of the mitral valve, occurred after MitraClip,” Howard C. Herrmann, MD, the John Winthrop Bryfogle Professor of Cardiovascular Diseases in the Perelman School of Medicine at the University of Pennsylvania and health system director for interventional cardiology, said in a press release.

The researchers stratified 250 patients from COAPT who received the MitraClip device into quartiles based on mitral valve gradient as assessed by echocardiography.

Mean mitral valve gradient was 2.1 mm Hg in quartile 1, 3 mm Hg in quartile 2, 4.2 mm Hg in quartile 3 and 7.2 mm Hg in quartile 4.

The 2-year composite endpoint of HF hospitalization or all-cause mortality occurred in 43.2% of patients in quartile 1, 49.2% of quartile 2, 40.6% in quartile 3 and 40.3% in quartile 4 (P for trend = .78), the researchers wrote.

The groups also did not differ in improvement in NYHA class, Kansas City Cardiomyopathy Questionnaire score or 6-minute walk distance, according to the researchers.

After adjustment for baseline clinical and echocardiographic characteristics, post-procedure mitral regurgitation grade and number of clips, there was no difference in the 2-year composite endpoint between quartile 4 and quartiles 1 to 3 (adjusted HR = 1.23; 95% CI, 0.6-2.51; P = .57).

“The use of MitraClip to treat secondary mitral regurgitation has meant that physicians have a better way to help more of the population impacted by this kind of heart disease, specifically patients who would not be able to qualify for major surgery,” Herrmann said in the release. “It is paramount that we as researchers continue to study outcomes with new devices after they come to market so that patients can receive the greatest benefits of treatment.”

Caution about extrapolation

João L. Cavalcante
Paul Sorajja

In a related editorial, João L. Cavalcante, MD, scientific director of the Cardiovascular Imaging Research Center, and Paul Sorajja, MD, director of the Center for Valve and Structural Heart Disease, both at Minneapolis Heart Institute, Abbott Northwestern Hospital, wrote: “One needs to be cautious to extrapolate these COAPT findings to daily practice, where a fine art of balancing further functional mitral regurgitation reduction could be traded by worsening mitral stenosis. Given the small number of patients with mean mitral valve gradient > 5 mm Hg, and even less so those with mitral valve gradient 5 mm Hg or more and residual mitral regurgitation 2+ (n = 10), one cannot be certain that the presence of higher gradients post-MitraClip in functional mitral regurgitation patients are innocuous, particularly when associated with more residual mitral regurgitation.”

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