COAPT: Benefits of MitraClip sustained to 5 years; death, HF events high
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NEW ORLEANS — Transcatheter mitral valve repair for patients with HF and severe secondary mitral regurgitation reduced HF hospitalization and improved survival and functional status at 5 years vs. medical therapy alone, a speaker reported.
Reflecting the high-risk status of the patient population, nearly three-quarters of those who underwent transcatheter mitral valve repair and more than nine out of 10 of those in the control group died or were hospitalized for HF at 5 years.
In addition, the benefits of transcatheter mitral valve repair (MitraClip, Abbott) were consistent across prespecified subgroups, according to the final results of the COAPT trial presented at the American College of Cardiology Scientific Session.
“In patients with heart failure and severe secondary [mitral regurgitation] who remain symptomatic despite optimal medical therapy, [transcatheter edge-to-edge repair] with the MitraClip was safe, reduced the rate of heart failure hospitalizations and improved survival during 5-year follow up. These outcomes were consistent across all prespecified subgroups regardless of patient age, sex, [mitral regurgitation] severity, [left ventricular] function and volume, cardiomyopathy etiology and surgical risk,” Gregg W. Stone, MD, director of academic affairs for the Mount Sinai Health System and professor of medicine (cardiology) and population health science and policy at Icahn School of Medicine at Mount Sinai, said during a presentation. “Symptomatic status was also improved throughout 5-year follow-up and MitraClip treatment provided durable repair mitral regurgitation. The treatment effects were reduced after 2 to 3 years, in large part due to MitraClip treatment in 45% of control group patients surviving to this time period. The prognosis of control group patients so treated was substantially improved similar to that of patients originally assigned to the MitraClip. However, and importantly, nearly half of the control group patients died before becoming eligible for crossover at 2 years.”
For the COAPT trial, 614 patients with HF with reduced ejection fraction, moderate LV dilatation, secondary moderate to severe or severe mitral regurgitation and who were symptomatic despite receiving optimal medical therapy and cardiac resynchronization therapy, if appropriate, were assigned to transcatheter mitral valve repair plus medical therapy or medical therapy alone.
As Healio previously reported, transcatheter mitral valve repair plus medical therapy reduced risk for HF hospitalization and mortality compared with patients treated with medical therapy alone and also had improved exercise tolerance and quality of life.
The 5-year results of the COAPT trial were simultaneously published in The New England Journal of Medicine.
Stone and colleagues reported that at 5 years, HF hospitalizations occurred at a rate of 33.1% per year among COAPT participants assigned to transcatheter mitral valve repair compared with 57.2% per year in the control group, translating to an approximately 47% lower risk in the device arm (HR = 0.53; 95% CI, 0.41-0.68).
During 5 years of follow-up, only four device-related adverse safety events were reported, all of which occurred within the first 30 days of device implantation, according to the study.
For the composite outcome of death and HF hospitalization at 5 years, researchers observed lower risk among patients assigned to transcatheter mitral valve repair compared with medical therapy alone (device arm, 73.6%; control arm, 91.5%; HR = 0.53; 95% CI, 0.44-0.64), an observation that was consistent across all subgroups.
In an analysis of time to first HF hospitalization out to 5 years, HF hospitalizations occurred at a rate of 83% in the medical therapy arm compared with 61% in the device arm (HR = 0.49; 95% CI, 0.4-0.61), according to the presentation. However, to put this difference in context, Stone said the rate of HF hospitalization from baseline to 3 years was 76.4% in the medical therapy arm and 46.8% in the device arm (HR = 0.46; 95% CI, 0.36-0.57), whereas from year 3 to year 5, the rate of HF hospitalization was 34.3% in the medical therapy arm compared with 30.7% in the device arm (HR = 0.85; 95% CI, 0.55-1.33), a shift that was explained by the crossover nature of the trial.
Similarly, the mortality rate from baseline to 3 years was 42.7% in the medical therapy arm and 28.1% in the device arm (HR = 0.62; 95% CI, 0.47-0.82), whereas from year 3 to year 5, the mortality rate was 42.8% in the medical therapy arm compared with 40.6% in the device arm (HR = 0.88; 95% CI, 0.64-1.23).
In a multivariable analysis of patients who crossed over to the device group, the researchers observed a significant reduction of death and HF hospitalization compared with medical therapy alone (HR after transcatheter mitral valve repair = 0.53; 95% CI, 0.36-0.78).
In addition, Stone and colleagues observed improved NYHA class throughout the 5-year follow-up, and durable repair of mitral regurgitation, according to the presentation.
“These data strongly support the belief that heart failure patients appropriate for [transcatheter edge-to-edge repair] with the MitraClip should be identified and considered for treatment as early as possible,” Stone said during the presentation. “Despite the favorable risk-benefit profile of the MitraClip in this setting, adverse outcomes continue to accrue in both groups such that 91.5% of control group patients and 73.6% of device group patients had either died or had been hospitalized for heart failure within 5 years. These findings emphasize the need for further therapies to address the underlying LV dysfunction in this high-risk population.”
Reference:
Perspective
Back to TopAllison Dupont, MD, FACC, FSCAI
Results from the COAPT 5-year follow-up study presented at ACC.23 showed encouraging data that patients receiving transcatheter edge-to-edge repair for functional mitral regurgitation with the MitraClip device have durable outcomes with lower mortality and lower rate of hospitalization (all-cause, CV and HF mortality and hospitalizations) compared to patients treated with guideline-directed medical therapy (GDMT) alone. As the publication outlined, the treatment effect did decrease over time (after 2 years) as patients in the control arm began to cross over into the treatment arm (as permitted by the study protocol). It is important to point out, however, that a large proportion (42.7%) of those in the control group had already died at 2 years, before crossover was permitted.
This study indicates that patients with symptomatic moderate-to-severe or severe functional mitral regurgitation receive durable benefit with MitraClip as compared to GDMT alone.
Perspective
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In terms of COAPT, what a study. It is so exciting for the 5-year data to be released. Again, confirmatory in what we know about patients receiving mitral therapy. Decreased HF hospitalizations, improved quality of life metrics and you could see that in the medical therapy arm, patients did not do as well, clearly, in terms of mortality and repeat hospitalizations and HF and so on. I did find it interesting that 44.9% of patients in the control arm did decide to move forward with therapy after their 2-year mark, and did well after that point.
It’s a sick patient population in terms of functional mitral regurgitation. This is illuminating in terms of the 5-year data. It shows that this is a phenomenal therapy and has its place in our portfolio of options for patients who are high or prohibitive risk, and it’ll be interesting to see as time goes on how all these indications and technologies continue to advance. The iterations have been amazing to this point.
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Stone GW, et al. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials (Session 405). Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).
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