REDUCE FMR Evaluates Cardiac Dimensions' Carillon Mitral Contour System
September 23, 2018—Cardiac Dimensions, Inc. announced that results of the company’s landmark REDUCE FMR clinical trial were presented by Professor Horst Sievert, MD, at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California.
According to Cardiac Dimensions, the study met its primary endpoint with a statistically significant reduction in regurgitant volume at 1 year in patients who received the company's Carillon mitral contour system versus the control cohort, consisting of patients under guideline-directed medical therapy who underwent a sham procedure.
The reduction represented a 22% reduction in regurgitation in the treatment group compared to an overall increase of 8% in regurgitation in the control group (P = .03). Study patients, the imaging core lab, and the clinical assessors were blinded as to the patients’ randomization group through the 1-year follow-up period of the study.
In the announcement, Prof. Sievert commented, “I am impressed the trial results are consistent with the positive outcomes I’ve seen in my practice. When we designed this study, we knew a blinded, sham-controlled trial would be challenging, but the validity of the results would therefore be very compelling. And, it is.” Prof. Sievert is Director of the CardioVascular Center Frankfurt, Sankt Katharinen, and the Department of Internal Medicine, Cardiology, and Vascular Medicine of the Sankt Katharinen Hospital in Frankfurt, Germany.
Cardiac Dimensions recently announced that the first patient has been randomized in the CARILLON pivotal trial, which is evaluating the company's Carillon system for the treatment of functional mitral regurgitation (FMR) associated with heart failure as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines.
Marty Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital, who is Chairman of the CARILLON steering committee, stated in the press release, “The results of this unique but small, mechanistic trial are provocative. These data support and will inform the recently launched CARILLON trial, which is also a sham-controlled randomized trial, but it is a much larger pivotal trial with clinical endpoints.”
The company further stated that the REDUCE FMR study showed that those treated with the device experienced fewer major adverse events compared to the control group (16% vs 18%, respectively). In addition, only 11% of the implanted patients experienced recurrent heart failure hospitalizations, which was approximately half of the 21% rate observed in the control group. However, the trial was not powered to make statistical conclusions on these endpoints.
Secondary analyses of heart remodeling were also presented. The results showed a difference between those who received the Carillon system and those in the control group. Left ventricular end-diastolic volumes were reduced in the treatment group, while the control group had an overall increase in volumes at 12 months (-8.6 vs +6.5; P = .06). In addition, left ventricular end-systolic volumes were reduced in the treatment group, while the control group had an overall increase at 12 months (-4.8 vs +6.1; P = .07).
Klaus Witte, MD, commented, “Remodeling is important to patients as it has an impact on longer-term patient prognosis and mortality. The remodeling shown in the REDUCE FMR study is compelling and an important aspect to consider when contemplating treatment options for patients.” Dr. Witte is a heart failure physician from Leeds Teaching Hospital NHS Trusts, a top enroller in the REDUCE FMR study, in Leeds, United Kingdom.
The company advised that the REDUCE FMR trial included 120 heart failure patients who were randomized to treatment with the Carillon system (n = 87) or guideline-directed medical therapy (control) (n = 33). The primary endpoint of the study was to show a significant change in regurgitant volume between the Carillon system and the guideline-directed medical therapy group at 1 year, as assessed by a blinded, independent echo core lab. Additional analyses of heart failure hospitalizations and product safety data were also presented at TCT.