In cases where it is difficult to demonstrate the improvement of a drug or a device in hard endpoints such as mortality, we should look for softer and easier to prove endpoints. The problem is that these soft endpoints are often subjective (such as sensation of shortness of breath or angina pectoris) and they could be biased by a drug or device placebo effect.
That is how invasive sham procedures emerged, almost as a fashion. In these procedures, patients leave the cath lab without knowing if they have received a stent (e.g., ORBITA Trial), if they have effectively undergone renal denervation (e.g., SPYRAL HTN-ON MED Trial), or —in the study we are analyzing today, which will soon be published in J Am Coll Cardiol HF— if they have effectively received a device to treat functional mitral regurgitation.
The REDUCE FMR Trial included 120 patients and randomized them to optimal medical treatment for heart failure plus Carillon device implantation into the coronary sinus to reduce the mitral annulus vs. optimal medical treatment plus a sham procedure.
The primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis.
About 87 patients were randomized to receive the device. In this group, 73 (84%) actually received the device and the remaining patients underwent a sham procedure.
The primary endpoint was met, with an effective reduction in mitral regurgitant volume with the Carillon device vs. the placebo (a decrease of 7.1 mL/beat vs. an increase of 3.3 mL/beat, respectively; p = 0.049).
There was also a reduction in the end-diastolic volume and the end-systolic volume.
As regards symptoms, the shortness of breath significantly improved during one year of treatment and so did the quality of life and the distance covered in 6 minutes.
The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes, and improved the symptoms of patients with functional mitral regurgitation receiving optimal medical therapy.
Original title: The REDUCE FMR Trial. A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.
Reference: Klaus K. Witte et al. J Am Coll Cardiol HF 2019, article in press.
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