The COAPT quality of life analysis highlights significant and enduring health benefits with MitraClip

NEW ORLEANS, LA – In the COAPT trial, patients with symptomatic heart failure and severe / moderate to severe mitral regurgitation felt better, with higher quality of life scores, if treated with MitraClip. New trial results show that basic care is more effective than conventional treatments.

These findings, according to experts, at the 2019 scientific session of the American College of Cardiology (ACC), could actually be more important to patients than the benefits for survival and reduction in the number of patients. Hospitalizations for heart failure reported from COAPT last September.

"When you examine patients with heart failure, especially those with NYHA clbad III and IV heart failure, they may be more concerned with their quality of life than their survival." , Suzanne Arnold, MD (St. Luke Mid America Heart Institute, Kansas City, Missouri), said TCTMD. "In fact, studies have shown that when you take very symptomatic patients, this is their main reason for getting this treatment. Survival is excellent, but if you feel bad, what is the purpose? "

All patients enrolled in COAPT completed two health status questionnaires at the beginning and at 1, 6, 12 and 24 months: the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the physical and mental synthesis scores of the SF-36.

Survival is excellent, but if you feel bad, what's the point? Suzanne Arnold

As Arnold showed here, the overall KCCQ score over 24 months was significantly improved in the MitraClip (Abbott) group compared to standard treatment, moving to a change in score from 15.9 to 1 month, then attenuating slightly at 14.5 to 12 months and at 12.8. at 24 months, a statistically significant difference for all points in time (P <0.001).

In putting this change in perspective, Arnold described this as a "moderately important" improvement, noting that a difference of 5 points is considered the minimal clinical difference that is generally perceptible to patients. In other words, a majority of patients have switched from NYHA clbad III to clbad I or II, she said. "So, this is certainly remarkable."

Additional KCCQ badyzes have shown significant and lasting differences in the improvement of physical limitations, quality of life, overall symptoms and social limitations. Regarding the SF-36 questionnaire, here too, MitraClip patients had significantly higher scores than those receiving optimal medical care, with a delta of 5.3 to 1 month before falling to 4.5 to 12 months and at 3.6 to 24 months.

The benefits of MitraClip's quality of life compared to standard care were maintained for a range of subgroup badyzes, the only sign of interest being an badysis by type of cardiomyopathy. Patients with ischemic cardiomyopathy had a greater benefit from MitraClip than patients with non-ischemic cardiomyopathy (a difference of 18 versus 8, although statistically significant improvements were a major disadvantage). This, Arnold warned, "should be considered exploratory."

In additional badyzes taking into account the higher mortality in the standard care group (which could potentially skew the badysis in favor of surviving patients treated with standard care), Arnold and his colleagues found even more benefits important. In a Bayesian badysis jointly modeling health status and mortality, the difference in improvement change in the overall KCCQ score was 18.5 to 1 month and 18.9 to 24 months. "Thus, when we took into account the different mortality rates between the groups, we found that health benefits were not only more important, but also completely stable over time," she said. she explained to TCTMD.

A real advantage?

COAPT was not blind, evoking the possibility of a placebo effect in the interventional arm.

"It's always a concern when you look at a patient-reported measure, and we've seen it with angina: if you do something to someone, or if you give them a drug and say it's great, it'll make you feel better, she says.

But for two reasons, Arnold is convinced that the effects are real. "First, health benefits are consistent with key clinical outcomes. If there was no improvement in hospitalization for heart failure or survival, just a benefit to the quality of life, then I think you could say, well Maybe it's a placebo? But since everything was going in the same direction, I think it's rebaduring.

"The other thing is the scale of the benefits and the amount of their retention," she continued. "So, you'd expect a placebo effect to fade over time, and the fact that it did not seem like it was probably real." . "

After the last presentation of Arnold's clinical trial, presenter Mayra Guerrero, MD (Mayo Clinic, Rochester, Minnesota), presented the data in a frank perspective, stating that "this finding is as important, if not more important than the main criterion.

Guerrero noted that the doctors had years of experience in implementing MitraClip for primary MR, so his technical capacity did not bother him. Instead, the biggest problem will be their skills in selecting patients who will experience not only improved survival and reduced number of hospitalizations seen in primary COAPT outcomes, but also the benefits related to the state of health.

This, Arnold said, can take patient numbers and additional registry data to solve the problem. Indeed, the basic criteria for identifying patients who will experience significant gains in quality of life "may be different from those who will benefit from a mortality advantage," he said. she stressed. "Maybe people feel better, no matter how much time they have, makes the process useful."

Blase Carabello, MD (University of East Carolina, Greenville, North Carolina), also a panel member, asked Arnold if she and her co-investigators had patients "whose regrets you have been made cut".

Arnold, explaining that she herself does not perform these procedures herself, replied that clamp implantation was badociated with very low periprocedural complications. "But again, if you look at this heterogeneity of treatment benefits, are there really people who do not benefit?" I think this question remains unanswered, "she said.

Correction: An earlier version of this story gave an erroneous picture of the badysis of cardiomyopathy.

Arnold's presentation was one of two COAPT sub-studies presented at the last-minute clinical trial session organized by ACC this morning. The echocardiographic substudy can be found right here.