Abbott’s TriClip and MitraClip Evaluated in Late-Breaking Clinical Science Presentations

October 24, 2023—Abbott announced data from late-breaking presentations of studies evaluating its minimally invasive heart devices in treating mitral and tricuspid valve disease.

According to the company, findings from the TRILUMINATE pivotal trial reinforce the safety and effectiveness of the TriClip transcatheter edge-to-edge repair (TEER) system for patients with symptomatic, severe tricuspid regurgitation (TR) despite optimal medical therapy.

Additionally, data from the MitraClip EXPAND G4 real-world registry demonstrated the device’s benefits across a broad group of patients with mitral regurgitation (MR).

The studies were presented as late-breaking clinical science at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

The randomized, controlled TRILUMINATE pivotal trial is evaluating the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy in patients with severe TR. TriClip, which is approved for use in Europe and Canada, is an investigational device in the United States, advised the company.

Abbott stated that the outcomes to date for all randomized patients (N=572) and those enrolled in the concurrent single-arm group (patients with more complex tricuspid valve anatomy) were presented for the first time at TCT and illustrated the device’s safety, effectiveness, and benefits.

As summarized by the company, key findings from the TRILUMINATE pivotal trial through 1 year include:

• TriClip therapy demonstrated significant improvements in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score for the full randomized group, along with an excellent safety profile. This finding is consistent with and reinforcing the findings in the primary randomized population (N=350, presented in March 2023 at the American College of Cardiology’s annual scientific session.
• The single-arm group with more complex anatomies and advanced disease met its primary endpoint. The data demonstrated that TriClip was safe, with 81% of patients achieving TR reduction to moderate or less and reporting a similar degree of KCCQ improvement 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,” commented David Adams, MD, in Abbott’s press release. “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.” Dr. Adams, who served as coprimary investigator of the trial, is chairman 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 in New York, New York.

The EXPAND G4 is a prospective, multicenter, global, real-world study of more than 1,100 patients that is evaluating the safety and effectiveness of the MitraClip G4 system in patients with a broad range of anatomies. The 1-year results were simultaneously published by Ralph Stephan von Bardeleben, MD, et al online in JACC: Cardiovascular Interventions.

Abbott reported that key findings from the EXPAND G4 study at 1 year include:

• MR reduction to mild or less (≤ grade 1+ on a five-point scale) achieved in 93% of patients, and trace or less MR achieved in 44% of patients, sustained through 1 year.
• Significant clinical improvements, including 82% of patients achieving New York Heart Association Functional Class I/II, an improvement from 36% at baseline; and a 19-point improvement in KCCQ score.
• Rates of all-cause mortality of 12% and hospitalization for heart failure of 17%.

Abbott subsequently noted that a prospective imaging substudy of the TRILUMINATE pivotal trial investigated the impact of TR reduction on cardiac remodeling and reported the following:

• High-quality of cardiac CT and magnetic resonance imaging (MRI) of the right heart is possible in patients with severe TR, atrial fibrillation and implanted devices.
• MRI confirms a significant TR reduction after TriClip treatment.
• Reduction in TR is accompanied by significant reverse remodeling and increased forward flow.
• Future work will investigate the impact of TR reduction and cardiac remodeling on clinical outcomes.

Additionally, the company advised that TRILUMINATE provided further support of quality-of-life improvements in patients treated with TriClip. The company reported:

• TriClip improved TR symptoms, functional status, and quality-of-life within the first month of treatment and were maintained through at least 1 year after treatment.
• Patients with severe TR saw substantial benefits in symptoms, functional status, and quality of life.
• Patients who reported improvement in health status at 1 month after treatment were less likely to die or be hospitalized for heart failure in the year after TriClip intervention.
• Patients with worse health status at baseline were most likely to benefit.