Abbott touts data from Mitraclip sub-analyses
Abbott (NYSE:ABT) yesterday presented data from two separate analyses of the COAPT trial of its MitraClip device, touting benefits of the device in treating patients with clinically significant secondary mitral regurgitation.
Data from the analyses were presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the Journal of the American College of Cardiology, the Chicago-area medical company said.
A total of 614 patients with heart failure and moderate to severe secondary mitral regurgitation were recruited for the COAPT trial at 78 U.S. and Canadian medical centers, Abbott said.
In its first analysis, exploring improvements in patient’s treated with the Mitraclip’s quality of life, researchers reported that patients with heart failure and a leaking heart valve reported feeling better and fewer heart failure symptoms after treatment with the device.
Study investigators assessed participant quality of life using the Kansas City Cardiomyopathy Questionnaire. At the start of the trial, participants scored on average a 52 out of 100 on the KCCQ summary score, reflecting a “relatively poor quality of life,” according to the study data.
At one month post-treatment, patients who were treated with the Mitraclip reported a 16-point grater improvement on their average KCCQ score compared to those treated with standard therapy, which researchers said is considered a moderate-to-large improvement.
At two years, TMVR patients reported an average KCCQ score 13 points higher on average than those treated with standard therapy, study researchers reported.
While deaths were common in both treatment groups due to advanced age, co-morbidities and underlying heart failure, investigators said that a higher proportion of Mitraclip patients survived with significant improvements in health status at every follow-up time point.
Limitations of the study included that it was non-blinded, and that the loss of a relatively large proportion o the patients before the end of the two-year follow up may have biased the average quality of life upwards, study researchers said.
“In patients with heart failure and secondary mitral regurgitation, TMVR resulted in early, substantial and sustained improvement in health status compared with standard care. These outcomes are incredibly important to patients. Showing that TMVR improves patients’ symptoms and quality of life adds further support to the use of TMVR in these patients. The durability of the finding was a bit surprising given that these patients had pretty severe heart failure at baseline. You might expect that the benefit might wane over time, and the fact that we didn’t see much reduction over time was encouraging,” study lead author Dr. Suzanne Arnold of the University of Missouri–Kansas City said in a prepared release.
In a separate analysis, researchers explored how the use of echocardiography can help diagnose secondary mitral regurgitation based on data from the COAPT trial, as well as the use of a multi-parametric algorithm used for patient selection and to track the valve function.
Researchers in the study said that while ECGs are often used to assess mitral regurgitation, there is no worldwide standard for diagnosing it using ECG, which limits its application.
In the trial, study investigators used ECG to image participants’ hearts before enrollment and during follow-up visits extended out to two years. An algorithm was developed and used by expert echocardiographers to interpret the images and evaluate the functioning of the valve to determine whether patients were appropriate candidates for the MitraClip procedure, researchers said.
Study investigators said that the use of ECG was helpful in identifying patients with secondary mitral regurgitation, and that ECG was beneficial in predicting which patients would have better or worse responses to TMVR.
“We found echocardiography is valuable for assessing patients with secondary mitral regurgitation on multiple levels. Echocardiography should be used to determine which patients are candidates for TMVR, and it should also be used after MitraClip implantation to see the results of the procedure,” study lead author Dr. Federico Asch of the MedStar Health Research Institute said in a press release.
Researchers concluded that TMVR was equally beneficial across all subgroups analyzed, which included size, function and heart chamber pressure. They added that patients with similar characteristics should be considered for future interventions.
“MitraClip was shown to be beneficial in the study population in all sub-groups analyzed, regardless of patients’ echocardiographic characteristics. While we learned that patients with higher pulmonary hypertension are at higher risk after they receive the MitraClip, they still do better than if they would not have had the intervention done. Doing an echocardiogram is critical in determining if a patient is a good candidate for MitraClip and in following these patients to evaluate results of the procedure in the long run,” Asch said in a prepared statement.
“These additional analyses from the landmark COAPT Trial point to the advantages of MitraClip treatment for patients with severe MR who are not benefitting from medical therapy. The data underscore our recent approval to help these people who desperately need treatment, giving them the ability to do the things many of us take for granted: things like breathing normally, lying down to sleep and walking to the mailbox,” Abbott structural heart biz VP Michael Dale said in a press release.