Quality-of-Life Analysis From COAPT Trial Compares TMVR and Medical Therapy
March 17, 2019—The American College of Cardiology (ACC) announced that findings from a quality-of-life analysis of the COAPT trial were presented by Lead Investigator Suzanne Arnold, MD, at the ACC 68th Annual Scientific Session, being held March 16–18 in New Orleans, Louisiana. This study was simultaneously published online in Journal of the American College of Cardiology.
The COAPT trial investigated transcatheter mitral valve repair (TMVR) with the MitraClip device (Abbott Structural Heart) in patients with secondary mitral regurgitation. In 2018, the COAPT investigators reported that patients undergoing TMVR with the MitraClip device had significantly better rates of survival at 2 years compared to those patients receiving standard medications alone. The study was funded by Abbott.
In the study presented at the 2019 ACC meeting, the investigators further analyzed data from the trial to determine whether the valve repair also improved patients’ quality of life. The patients who underwent TMVR reported feeling better and experiencing fewer heart failure symptoms than those who received standard treatment alone.
Dr. Arnold stated in the ACC announcement, “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.” Dr. Arnold is a cardiologist at Saint Luke's Mid America Heart Institute in Kansas City, Missouri, and Associate Professor of Medicine at the University of Missouri–Kansas City.
As summarized by ACC, 614 patients with heart failure and moderate-to-severe secondary mitral regurgitation were enrolled in COAPT at 78 medical centers in the United States and Canada. Investigators randomly assigned them to receive TMVR or standard medical therapy. Patients' quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ).
At the start of the trial, patients' average KCCQ summary score was 52 out of 100, which indicates a relatively poor quality of life. Patients’ heart failure symptoms significantly limited their daily activities, causing shortness of breath or fatigue when walking on level ground or doing light housework, noted Dr. Arnold.
The investigators found that after 1 month, patients who underwent TMVR reported a 16-point improvement in their average KCCQ score compared with those on standard therapy, an improvement considered moderate to large. Patients potentially still had shortness of breath or fatigue when walking briskly or up an incline but were no longer limited in their ability to engage in less vigorous activities, such as shopping or walking at a normal pace.
By the end of 2 years, those undergoing TMVR had an average KCCQ score that was, on average, 13 points higher than those on standard therapy.
Dr. Arnold commented in the announcement, “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.”
Deaths were common in both treatment groups because of advanced age, comorbidities, and underlying heart failure. However, a higher proportion of patients who were randomized to TMVR were alive with significant improvement in health status at every follow-up time point.
At 2 years, more patients treated with TMVR were alive with a moderate improvement in health status compared with patients treated with standard care (36% vs 17%).
Limitations of the study include that it was not a blinded trial, a relatively large proportion of patients died before the end of the 2-year follow-up, and the loss of the more severely ill patients, who likely had the poorest quality of life, may have biased the average quality of life over time in a slightly upward direction. It is also unclear whether the results are generalizable beyond the specific patient group included in the trial, advised Dr. Arnold in the ACC announcement.