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You’re listening to Heart Matters on ReachMD. On this episode, we’ll hear from cardiologist Dr. Paul Sorajja, who’s serves as the Director of the Center for Valve and Structural Heart Disease at the Minneapolis Heart Institute Foundation. Dr. Sorajja will be sharing data from the TRILUMINATE trial and taking a look at transcatheter tricuspid valve repair. Let’s hear from him now.

Dr. Sorajja:
TRILUMINATE is the first pivotal clinical trial to test the impact of tricuspid regurgitation and its reduction on the outcomes of patients in a randomized trial. We enrolled patients who had severe symptomatic TR who are intermediate or greater risk of surgery, and we randomized them to either TriClip or GDMT or guideline-directed medical therapy.

So in the trial, it was actually quite remarkable that what we found in TRILUMINATE was that transcatheter paired with TriClip was associated with a really marked reduction in the severity of TR. The TR at 30 days was 87 percent at moderate or less in the TriClip group and only 5 percent in the control group, and that was a prespecified secondary endpoint, and that was the really marked reduction in TR severity. And, importantly, that was also observed with a very favorable safety profile. The major adverse event rate was only 1.7 percent, so really quite remarkable for patients with TR who usually are at high risk for surgery. And then the primary endpoint was met in the trial. We found the device to be superior to GDMT, and that superiority was driven mainly by a difference in quality of life.  There wasn’t a marked difference between the two groups in terms of survival free or death or heart failure hospitalization but these patients actually did quite well on medical therapy. And so, you know, the quality of life while that was the main driver of the primary endpoint, was still a very meaningful finding in the study.

Well, I think the TRILUMINATE trial is really a landmark study because it’s the first trial to test the impact of TR reduction in these patients. And as a first trial, we found what I think is the correct message in that TR reduction leads to improvements in quality of life, and that is the main message for these patients who are in need. These patients do not have good options. The options of surgery are often high-risk. Medical therapy is not established and usually consists of simple loop diuretics or decongestion, which can have side effects in their own. And so I think the trial is really impactful because for the first time we have something that can treat patients who historically have been untreated. They have been known as a forgotten bow, and I believe this trial shines a light on these patients who are forgotten no longer.

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