Partner 3 Study Showing Long-Term Safety Profile of Transcatheter Aortic Valves Could Lead to Even Further Adoption Over Surgery

Edwards Lifesciences has presented new long-term data from the PARTNER 3 trial that highlights the sustained success of transcatheter aortic valve replacement (TAVR) in low surgical risk patients over five years. The findings, which represent the most extended clinical follow-up of a low surgical risk cohort of TAVR patients, were disclosed during a late-breaking clinical trials session at the 35th Transcatheter Cardiovascular Therapeutics (TCT) symposium and were simultaneously published in The New England Journal of Medicine.

TAVR now surpasses surgical aortic valve replacement as the dominant procedure performed in the United States. Close to one hundred thousand aortic valve replacement procedures are performed every year in the United States.

In a comprehensive analysis of the five-year data from the PARTNER 3 trial, it was revealed that the rates of all-cause mortality, disabling stroke, and rehospitalization remained low. Notably, all secondary endpoints remained stable and statistically consistent with the surgical control arm, in which more than 70% of patients received an Edwards surgical heart valve.

In the TAVR arm of the study, all-cause mortality at five years was recorded at 10%, cardiovascular mortality at 5.5%, and the incidence of disabling stroke at 2.9%. Moreover, rehospitalization for this elderly patient population remained below 3% per year over five years. Importantly, valve durability indicators were stable over time, with no significant differences in the incidence of bioprosthetic valve failure related to structural valve deterioration or reintervention rates between TAVR and surgical aortic valve replacement (SAVR).

The results have far-reaching implications for patients with severe, symptomatic aortic stenosis (AS) who are considered to be at low risk for surgical treatment. Dr. Martin Leon, Professor of Medicine at Columbia University Irving Medical Center and co-principal investigator of PARTNER 3, highlighted the significance of these findings, stating, “The five-year follow-up findings from the PARTNER 3 trial reaffirm the clinical outcome benefits and bioprosthetic valve durability of SAPIEN 3 TAVR as a meaningful alternative to surgical therapy for low-risk severe, symptomatic AS patients.”

The PARTNER 3 trial initially randomized 1,000 low surgical risk patients at 71 centers between March 2016 and October 2017. These patients were divided into two groups, one undergoing TAVR with the SAPIEN 3 valve and the other opting for surgery with any commercially available surgical valve. The primary endpoint was set to measure all-cause mortality, all-stroke, and rehospitalization.