COAPT: MitraClip reduces hospitalization, mortality in HF, mitral regurgitation
SAN DIEGO — Patients with HF with moderate to severe or severe functional mitral regurgitation who underwent transcatheter mitral valve repair reduced the risk for HF hospitalization and mortality compared with patients treated with medical therapy alone, according to 2-year data from the COAPT trial presented at TCT 2018.
Patients who underwent the procedure with the transcatheter device (MitraClip, Abbott) also had improved exercise tolerance and quality of life.
The findings are contrary to the MITRA-FR trial, in which, as Cardiology Today’s Intervention previously reported, assignment to a procedure with a MitraClip did not improve survival or HF hospitalization in patients with severe secondary mitral regurgitation.
“This is really the first therapy that’s been shown to improve the prognosis in high-risk patients with secondary mitral regurgitation due to underlying left ventricular dysfunction,” Gregg W. Stone, MD, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Irving Medical Center, told Cardiology Today’s Intervention.
Researchers analyzed data from 614 patients from 78 sites in the United States and Canada.
“In this space, it’s the largest randomized trial ever done of any mitral valve technology,” Stone, a member of the Cardiology Today’s Intervention Editorial Board, said in an interview.
Patients had HF with reduced ejection fraction, moderate left ventricular dilatation, secondary mitral regurgitation graded moderate to severe or severe and were symptomatic despite receiving best medical therapies and cardiac resynchronization therapy if appropriate.
Patients were assigned transcatheter mitral valve repair with medical therapy (n = 302; mean age, 72 years; 67% men) or medical therapy alone (n = 312; mean age, 73 years; 62% men).
“The MitraClip is a much safer, less invasive therapy than is surgery,” Stone told Cardiology Today’s Intervention. “It works by basically attaching the tips of the two leaflets of the mitral valve to create ... a double orifice valve; therefore, it reduces mitral regurgitation.”
The primary effectiveness endpoint was HF hospitalization within 24 months. The primary safety endpoint was freedom from complications related to the device at 12 months, which was compared with a prespecified performance goal of 88%.
The rate of HF hospitalization per year was reduced in patients assigned the device vs. the control group (35.8% per year vs. 67.9% per year; HR = 0.53; 95% CI, 0.4-0.7).
At 1 year, the performance goal for the primary safety endpoint was exceeded with a rate of freedom from device-related complications at 96.6% (lower 95% confidence limit, 94.8%; P < .001).
At 2 years, 29.1% of patients in the device group died compared with 46.1% in the control group, which resulted in a 38% reduction in mortality (HR = 0.62; 95% CI, 0.46-0.82). The composite of death or first HF hospitalization was reduced by 43% in patients assigned the device (P < .001), according to a press release from Abbott.
Mitral regurgitation severity was significantly reduced in the device group at 1 year compared with the control group. More patients assigned the device had mitral regurgitation of grade 2 or less compared with those assigned medical therapy alone (94.8% vs. 46.9%; P < .001). Also at 1 year, 72.2% of the device group had NYHA class I or II HF vs. 49.6% in the control group (P < .001).
“Now the MitraClip has become a standard of care approach for these patients,” Stone said in an interview. “It can substantially make them feel better, improve their exercise capacity and quality of life, reduce their need for heart failure hospitalization and improve their survival. Heart failure is the No. 1 cause overall of morbidity and mortality in patients in the United States and in most Westernized countries and has tremendous cost implications for the health resource utilization. This really now has become the new standard of care for patients who fit these criteria.”
“This is one of the most difficult trials I have ever been involved in, ... and this is the most positive trial I’ve been involved in,” Michael J. Mack, MD, FACC, medical director of cardiovascular surgery at Baylor Health Care System in Dallas, chairman of the Heart Hospital Baylor Plano Research Center in Texas and Cardiology Today’s Intervention Editorial Board Member, said during a press conference.
Stone said there are several differences between the COAPT trial and the MITRA-FR trial recently presented at ESC.
In contrast, the MITRA-FR trial found that percutaneous mitral valve repair plus medical therapy offered no advantage over medical therapy alone in patients with HF with reduced ejection fraction and secondary mitral valve regurgitation.
The severity of mitral regurgitation enrolled in COAPT was substantially greater, and the ventricles were not severely dilated in the current trial, Stone said. The HF medications were allowed to vary in the MITRA-FR trial, whereas in COAPT, patients were on maximally tolerated guideline-directed medical therapy at baseline with few major changes during follow-up.
“Today we have two publications in The New England Journal of Medicine and apparently two different outcomes,” Jean-Francois Obadia, MD, PhD, from Hopital Cardiovasculaire Louis Pradel, Lyon, France, who presented data from the MITRA-FR trial at the European Society of Cardiology Congress in August, said during the presentation. “This is the best scenario we could have. ... This difference leads us to go deeper into the analysis ... to try to understand this complex disease. Therefore, we know with COAPT what to do, because it provides an accurate selection of the patients who could really benefit from the clip, and with MITRA-FR, which represents more the real world, in which patients should not receive a clip. The two studies are more complementary than controversial.” – by Darlene Dobkowski
Stone GW, et al. Late-Breaking Trials 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosures: The trial was funded by Abbott. Stone reports he received grants from Abbott to the Cardiovascular Research Foundation; personal fees from Ablative Solutions, Claret, Gore, HeartFlow, Matrizyme, Miracor, Neovasc, Reva, Robocath, Shockwave, TherOx, V-wave, Valfix and Vascular Dynamics; and other support from Ancora, Aria, Biostar, Cagent, Caliber, MedFocus, Qool Therapeutics, SpectraWave; and his employer, Columbia University, receives royalties from Abbott for sales of the MitraClip. Please see the study for all other authors’ relevant financial disclosures.