TCT
TCT
September 24, 2018
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REDUCE-FMR: Regurgitant volume reduced with catheter-based mitral annuloplasty in HF

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Horst Sievert
Horst Sievert

SAN DIEGO — Patients with HF and functional mitral regurgitation who received a device for transcatheter indirect mitral annuloplasty during a double-blind, sham controlled study had a reduction in regurgitant volume at 1 year, according to data from the REDUCE-FMR trial presented at TCT 2018. This was the first blinded, randomized study in the field of valve therapy.

The reduction was seen in both the per-protocol (actually implanted) and intention-to-treat analyses.

Safety was similar in patients assigned the device (Carillon Mitral Contour System, Cardiac Dimensions) and the sham control.

“From a heart failure perspective and from an implanter’s perspective, the REDUCE-FMR trial has shown that a percutaneous device that is inserted through the coronary sinus has the ability to reduce functional mitral regurgitation in a population of patients with important heart failure, but also that doing so can improve the structure of the heart and can improve the structure of the heart,” Klaus Witte, MD, senior lecturer of cardiology at the University of Leeds in the United Kingdom, a consultant cardiologist at Leeds Teaching Hospital Trust and a top enroller in the REDUCE-FMR study, told Cardiology Today’s Intervention.

Horst Sievert, MD, founder and director of the CardioVascular Center Frankfurt, and colleagues analyzed data from 120 patients with dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional mitral regurgitation. Patients also had NYHA class II, III or IV, left ventricular ejection fraction < 50%, LV end diastolic diameter > 55 mm or LV end diastolic diameter/body surface area > 3 cm/m2 and were on stable HF medication for at least 3 months.

Patients were randomly assigned to either the treatment (n = 87) or sham control (n = 33) groups and were analyzed by intention to treat, as-treated and per-protocol. The Carillon device is not yet available for commercial use in the United States.

“To some extent, how you see the results depends upon perspective,” Witte said in an interview. “The Carillon device used in REDUCE-FMR requires a very straightforward implantation procedure through a puncture in the neck that does not require complex imaging. Implantation is also incredibly safe. A reduction in MR creates a powerful impression, but the potential impact of the favorable remodeling that we saw, given its reliability as a predictor of improved outcomes, must also not be underplayed.”

The primary efficacy endpoint for the intention-to-treat analysis was change in regurgitant volume at 1 year. Secondary efficacy endpoints were defined as HF hospitalization at 1 year, change in LV end-diastolic volume and LV end-systolic volume from baseline to 1 year and change in regurgitant volume at 1 year. Secondary safety endpoints were major adverse events at 1 month and 1 year, which were defined as MI, death, vessel perforation that required intervention, device embolization and either surgery or PCI associated with device failure.

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The rate of major adverse events at 1 year was similar in the treatment group and the sham-control group (16.1% vs. 18.2%, respectively).

In the intention-to-treat analysis, the primary efficacy endpoint was met, with a 22% reduction in the treatment group and an 8% increase in the control group (absolute difference = 10.4 mL; P = .03) at 1 year.

In the as-treated analysis, the P value for change in regurgitant volume RV at 1 year in the as-treated analysis was .02; it was .06 in the intention-to-treat analysis.

“As expected, there was a larger effect in the as-treated and per-protocol cohorts, but due to the smaller number, it was not statistically significant,” Sievert said during the press conference.

The secondary endpoint in the as-treated analysis — change in LV end diastolic and systolic volumes at 1 year — favored the device-therapy group vs. the sham-control group.

“This sham-controlled study in functional mitral regurgitation patients should inform future clinical research,” Sievert said during the press conference. “Sham-controlled trials in valve therapy can be performed. Careful echo prescreening of patient by a core lab is necessary.”

“We are pleased with these positive results, which come on the heels of enrollment of the first patient in our CARILLON Pivotal Trial, announced last week — the next step toward bringing the Carillon device to patients in the United States,” Steve Goldberg, MD, chief medical officer of Cardiac Dimensions, said in a press release. “We look forward to gathering further clinical evidence to increase our understanding of the benefits of the Carillon device.” – by Darlene Dobkowski

Reference:

Sievert H, et al. Late-Breaking Trials 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Disclosure s : The trial was supported by Cardiac Dimensions. Goldberg is an employee of Cardiac Dimensions. Sievert reports he or his institution received consultant fees, travel expenses and study honoraria from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Cibiem, CGuard, Comed B.V., Contego, CVRx, Edwards, Endologix, Hemoteq, InspireMD, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, Vivasure Medical, Venus and Veryan. Witte reports he is a proctor for and received speaker fees from Cardiac Dimensions.