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MITRA-FR: No change in death, unplanned HF hospitalization at 2 years
PARIS — In patients with HF with reduced ejection fraction and secondary mitral valve regurgitation, percutaneous mitral valve repair with MitraClip plus medical therapy offered no advantage over medical therapy alone for the outcomes of death and unplanned hospitalization for HF at 2 years.
Two-year data reported at the European Society of Cardiology Congress show no difference in the primary composite endpoint of all-cause death or first unplanned HF hospitalization, with a rate of 64.2% among patients assigned percutaneous mitral valve repair with the MitraClip device (Abbott) vs. 68.6% among patients assigned only medical therapy (HR = 1.04; 95;% CI, 0.76-1.42).
“There was no surprise; we expected that,” Jean-Francois Obadia, MD, PhD, from Hopital Cardiovasculaire Louis Pradel, Lyon, France, said during a press conference. “This treatment does not add any benefit in this group of patients.”
When assessing secondary outcomes at 2 years in the percutaneous mitral valve repair and medical therapy groups, there were no significant differences for all-cause death (33.9% vs. 35%, respectively; HR = 0.99; 0.64-1.52), CV death (31.2% vs. 32.1%; HR = 0.99; 95% CI, 0.63-1.55), unplanned HF hospitalization (58.7% vs. 63.5%; HR = 1.03; 95% CI, 0.74-1.43) and MACE (66.1% vs. 68.6%; HR = 1.09; 95% CI, 0.8-1.48), according to Obadia.
An exploratory analysis of events between 12 months and 24 months found that the intervention group may have had a lower rate of first HF hospitalization (HR = 0.87; 95% CI, 0.56-1.35).
“We have some interest because the results today are not completely neutral,” Obadia said during the press conference. “We have this signal [of a lower rate of first hospitalization], and we have been surprised by this. We keep in mind [to] be careful, but at least when you see this chart, you see that the curves start to diverge after 1 year [for HF hospitalization].”
In this analysis, 246 patients with severe secondary mitral regurgitation and HF with an EF between 15% and 40% were assigned either percutaneous repair (n = 109) or medical treatment (n = 137). The 1-year results that were previously presented included 304 patients.
Two-year results from the MITRA-FR trial were simultaneously published in the European Journal of Heart Failure.
As Cardiology Today’s Intervention previously reported at ESC 2018, percutaneous mitral valve repair plus medical therapy offered no advantage over medical therapy alone in patients with HFrEF at 1 year.
In contrast, results of the COAPT trial were presented and published nearly a month later at TCT 2018, in which patients with HF with moderate-to-severe or severe functional mitral regurgitation who underwent percutaneous mitral valve repair with the MitraClip device had reduced risk for HF hospitalization and mortality compared with patients treated with medical therapy alone.
“After these two presentations, which [were] published in the same issue of The New England Journal of Medicine, we have created one of the most important controversies in cardiology,” Obadia said during the press conference. “During the last 10 months, we have had more than 200 citations of these two [trials] in literature. Also 70 editorials have been written trying to explain and to tell us what were the reasons why we have such a difference between the two [trial results].”
Next steps, according to Obadia, are follow-up for up to 5 years in MITRA-FR and a meta-analysis of individual data. – by Darlene Dobkowski
References:
Obadia J-F. Hot Line Session 4. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.
Iung B, et al. Eur J Heart Fail. 2019;doi:10.1002/ejhf.1616.
Disclosures: The study was funded mainly by the French Ministry of Health and in part by Abbott Vascular. Obadia reports he has personal conflicts with Delacroix-Chevalier, Edwards Lifesciences, Landanger, Medtronic, St. Jude Medical (Abbott) and Sorin. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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The 2-year data really did not change much from the initial data that the MITRA-FR investigators presented. As you can see, the curves start to bifurcate at about 18 months, but they don’t have enough data to determine long term whether there’s going to be a significant change. Right now, they can only talk about trends, but they don’t have enough data to talk about long-term impact.
As has been reported in the press multiple times, the COAPT and MITRA-FR trials were completely different in that the selection of subgroups of patients and timing of therapy. All of these things appear to make a big difference in outcomes.
Other issues about MITRA-FR were that the investigators only enrolled 300 patients vs. 600 patients in COAPT, so the size of the study may have made a difference, but most point to patient selection and timing as the critical difference between the two.
The next steps for MITRA-FR are to go out to 5 years and see if there is a 5-year difference. Many of these patients are quite ill, and if you look at what the impact will be at 5 years, it does look like the curves are changing.
The real lessons learned in this are that patient selection and the timing of the therapy with regards to this are very important in the success of percutaneous mitral valve therapies.
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