Results from the ALIGN-AR pivotal trial came from an expanded cohort of 700 patients. Investigators shared results, simultaneously published in The Lancet, at PCR London Valves this week.
ALIGN-AR evaluates Trilogy in high-risk patients with symptomatic, severe aortic regurgitation (AR). This data builds on findings reported from an expanded cohort of 500 patients back in March of this year.
Trilogy is currently the only approved transcatheter valve indicated for AR in Europe. JenaValve, which reported the 1,000th patient implanted with the valve last week, is currently the subject of a planned acquisition by Edwards, which faces regulatory scrutiny from the FTC.
JenaValve says its expanded trial represents the largest ever prospective dataset of a dedicated TAVR device for AR. It provides critical insight into the procedural and longer-term outcomes of TAVR in that patient population.
In the latest findings from the trial, Trilogy achieved non-inferiority for the 30-day primary safety composite endpoint of 24%. That came in well below the performance goal of 40.5%. The study also achieved superiority on its one-year efficacy endpoint of all-cause mortality at 7.7%, surpassing the 25% performance benchmark. Overall technique success came in at 94.9%, compared to 74%-86% in studies using off-label devices.
JenaValve reports no intraprocedural deaths in the 700 patients enrolled in the study. Stroke rate and all-cause mortality came in at 0.6% and 1.6%, respectively, at 30 days. Almost all patients entered the trial with moderate-to-severe or graeter AR. At 30 days, moderate AR occurred in just three patients, with zero experiencing severe AR.
Commentary from JenaValve officials and the study’s principal investigator
Dr. Raj Makkar, ALIGN-AR principal investigator, said:
“These results confirm that TAVR for high-risk patients with severe AR is quickly becoming a reality, offering a much-needed treatment option for individuals who have had limited alternatives. We observed profound reductions in aortic regurgitation, excellent valve hemodynamics, and clear evidence of myocardial remodeling, along with meaningful improvements in functional status and quality of life sustained for up to two years. This therapy has the potential to change patients’ lives.”
Dr. Duane Pinto, chief medical officer at JenaValve, said:
“These outcomes exemplify the ALIGN-AR investigators’ commitment to excellence and highlight the performance of the Trilogy device. I am thrilled to see this validation of the years of extraordinary effort supporting the development of Trilogy system. In particular, I am appreciative of the patients, research coordinators, physicians, and the FDA who have contributed immensely to this effort and look forward to bringing the benefits of TAVR to this high-risk group of patients with aortic regurgitation.”
John Kilcoyne, CEO of JenaValve, said:
“We are incredibly proud to have presented the ALIGN-AR trial results at PCR London Valves, which represents a major advancement in treatment for patients with severe aortic regurgitation. The strength and consistency of these data demonstrate the need for a dedicated TAVR solution for AR patients, particularly in light of recent updates to the European ESC guidelines. As U.S. guidelines and regulatory evaluations continue to evolve, I believe a dedicated AR device, like the Trilogy, has the potential to expand access to effective therapy for this historically underserved population.”
