Abbott presented data from the TRILUMINATE pivotal trial on Saturday (scroll down for the latest findings). The randomized controlled trial is designed to compare transcatheter edge-to-edge repair with Abbott’s TriClip device (pictured above) to medical therapy in 700 patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for surgery. The primary outcome measure is a hierarchical composite of number of participants with all-cause mortality or number of participants with tricuspid valve surgery, rate of heart failure hospitalizations, and assessment of quality-of-life improvement using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months.
Abbott presented first results from the TRILUMINATE trial last September at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium of the Cardiovascular Research Foundation in Boston. The data from the roll-in cohort through 30 days showed a high implant success rate (99%), at least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74%. The data also showed patients achieving around a 17-point improvement in the KCCQ score, a 30% improvement from baseline score. An average of 2.3 clips were used per patient. The 30-day safety data showed one major adverse event and seven major bleeds (five of which were GI bleeds).
“We are encouraged by these findings and look forward to evaluating results from the full data readout with patient randomization and one-year outcomes,” Marie Thibault, a medtech analyst at BTIG, wrote in a report previewing ACC.23.
Thibault said she spoke with Abbott at BTIG’s recent Snowbird Conference, and that FDA approval for TriClip could potentially come in late 2023 or early 2024.
“Abbott pointed out that though the patient population in mitral regurgitation (MR) is larger than in tricuspid regurgitation, there are limited treatment options for patients with TR,” the analyst wrote. “They believe the serviceable patient populations for MR and TR are quite comparable in size and that the ramp in TriClip adoption could be quicker since physicians already have experience using clips.”
Key findings from TRILUMINATE, as Presented at ACC.23
The TRILUMINATE trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group (win ratio 1.48, p=0.02), primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year. Other positive findings include:
- Significant reduction in TR grade. Significant reduction in TR to moderate or less (grade < 2) was achieved in 87% of patients with the device at 30 days versus 4.8% in the control group, with TR reduction sustained and durable at one year.
- Significant improvement in quality of life. Abbott reported that 50% of patients who received the device achieved at least a 15-point improvement in the KCCQ score at one year versus 26% in the control group.
- A strong safety profile. At 30 days, only 1.7% of patients who received the device experienced major adverse events, with no urgent surgery or endocarditis. There were no occurrences of device embolization or device thrombus.
Analyst thoughts on the full read-out
In a report issued Sunday, BTIG's Thibault shared positive takeaways from the presentation of this trial data.
"In our view, TriClip is clearly an approvable device at the FDA, and we think these trial results will lead to enthusiastic adoption in the U.S. We expect FDA approval could come as soon as late 2023 or early 2024," Thibault wrote.