Dive Brief:
- Edwards Lifesciences and Medtronic reported new data on their transcatheter aortic-valve replacement (TAVR) devices that show no significant difference between the procedure and open-heart surgery in low-risk patients. Analysts predicted the market will continue on the same trajectory after the results were shared at TCT 2023.
- The rate of death, stroke or rehospitalization in low-risk patients was numerically lower in recipients of Edwards’ Sapien 3 than in their peers who underwent open-heart surgery. All-cause mortality was slightly higher in the TAVR arm, in large part because of non-cardiovascular deaths.
- With Medtronic also delivering four-year results that were in line with expectations, J.P. Morgan and Stifel analysts predicted the datasets will have little impact on clinical practice or market share.
Dive Insight:
Investors’ worries about the potential for open-heart surgery to outperform Edwards’ TAVR device in the five-year update from the PARTNER 3 trial have dragged on the stock. However, a set of analyst notes published ahead of the release of the data at TCT 2023 suggested the fears may be overblown, with physicians predicting TAVR would be statistically non-inferior.
The five-year PARTNER 3 data, which Edwards presented at TCT 2023 and published Tuesday in The New England Journal of Medicine, largely allays the investor fears. The gap between the TAVR and surgical aortic valve replacement (SAVR) rates of death, stroke and rehospitalization continued to close, but Sapien 3 retained a 4.4 percentage point advantage over the open-heart approach.
Breaking up the composite endpoint revealed the rate of all-cause death was higher in the TAVR group (10%) than the open-heart surgery cohort (8.2%). There were 26 deaths from cardiovascular causes in the TAVR arm, compared to 21 in the SAVR group, but the difference in all-cause mortality was largely driven by deaths unrelated to the heart, including cancer, COVID-19 and sepsis.
J.P. Morgan analysts wrote in a research note that while “some investors will likely pick at the curves crossing in the all-cause mortality endpoint,” the “non-inferior result overall alongside similar outcomes in cardiovascular mortality specifically should be enough to keep doctors excited about Sapien and drive future growth in this population.”
Medtronic shared four-year data on its rival TAVR device in a similar low-risk patient population. The research letter, which was published Tuesday in the Journal of the American College of Cardiology, showed that the rate of all-cause mortality or disabling stroke continued to be lower in the Evolut TAVR arm (10.7%) than the SAVR cohort (14.1%) after four years. With the results broken out, TAVR performed better than open-heart surgery in all-cause mortality and disabling stroke, although the difference was not statistically significant, William Blair analyst Margaret Kaczor wrote in a research note.
J.P. Morgan and Stifel are divided on whether the data favor Edwards or Medtronic, although neither expects the results to shift the balance of power in the TAVR market. While noting that cross-trial comparisons come with several caveats, the J.P. Morgan team said outcomes in the Medtronic trial “looked similar to PARTNER 3 at four years, with Edwards having the numerical edge.” In contrast, the Stifel analysts said that “on the surface, the data optics would appear to favor Medtronic.”
Attempts to compare data from the trials are complicated by the fact there are “different endpoints, different operators, different patients lost to follow-up and different SAVR group performance,” the Stifel analysts said. The data are also still immature too, with the Stifel analysts predicting it is the “seven-plus year low-risk TAVR data” that will be “truly critical for clinical practice implications.”