Results from the TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomatic, severe tricuspid regurgitation (TR). Abbott also shared data from the MitraClip EXPAND G4 real-world registry. Those results highlighted the device’s benefits across a broad group of patients with mitral regurgitation (MR).
The company presented its data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium in San Francisco.
“These late-breaking data at TCT offer further evidence that our innovative, minimally-invasive heart devices are having a positive impact on the lives and well-being of those with structural heart disease,” said Michael Dale, SVP of Abbott’s structural heart business. “For more than two decades, Abbott has continued to evolve and expand its minimally invasive treatment options for mitral and tricuspid regurgitation. Our portfolio of technologies to restore health and improve the quality of life of patients with leaky valves represents new standards of care and an example of our commitment to leadership in the treatment of structural heart disease.”
Findings from the TriClip trial
TRILUMINATE evaluates the TriClip system compared to medical therapy in people with severe TR. Outcomes for 572 randomized patients and those enrolled in the concurrent single-arm group illustrated safety, effectiveness and benefits for TriClip. Patients with more complex tricuspid valve anatomy went into the single-arm group.
Key findings through one year remained consistent and reinforced the findings in the primary randomized population. TriClip demonstrated significant improvements in quality of life along with an excellent safety profile.
The single-arm group with more complex anatomies and advanced disease met its primary endpoint. Data highlighted TriClip’s safety as 81% of patients achieved TR reduction to moderate or less. These patients also reported a similar quality of life improvement compared to the randomized population.
“The updated TRILUMINATE pivotal results confirm what has previously been shown – that TriClip is safe and effective for patients with severe tricuspid regurgitation,” said Dr. David Adams, chair of the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System, who served as co-primary investigator of the trial. “With the addition of the single-arm data that include people with more complex tricuspid anatomies, the takeaway is that TriClip is reducing TR effectively and patients are subsequently experiencing improvement in their quality of life.”
Abbott also has good MitraClip news
The EXPAND G4 study of more than 1,100 patients reinforced MitraClip G4’s safety and effectiveness in a broad range of anatomies. Abbott simultaneously published one-year results JACC: Cardiovascular Interventions.
Key findings included the highest reported MR reduction in a mitral TEER study to date, Abbott said. Patients sustained results through one year with MR reduction to mild or less achieved in 93% of patients. Trace or less MR came through in 44% of patients.
Abbott also reported significant clinical improvements, including 82% of patients achieving New York Heart Association (NYHA) Functional Class I/II. They reached a point of slight or no limitation of physical activity. That marked an improvement from 36% at baseline.
MitraClip also showed the lowest rates of all-cause mortality (12%) and hospitalization for heart failure (17%) in a global, real-world mitral TEER study.
