At 6 years, transcatheter aortic valve replacement (TAVR) appears to rival surgery for major adverse events in low-risk patients with severe aortic stenosis, but it may come at the cost of more reinterventions.

In the Evolut Low Risk Trial comparing the two treatments in patients with low surgical risk, which has a planned 10-year follow-up, there was a strong trend for more reinterventions in the TAVR group (5.5% vs 3.3%; P = .07). This finding led to a post hoc analysis that further supported the validity of the observed difference, according to a multicenter team of investigators led by John K. Forrest, MD.

At this point in the follow-up, there were no statistically significant differences in the primary composite endpoint of all-cause mortality and disabling stroke, but the emerging difference in the reintervention rate is already relevant to patient counseling, noted Forrest, who is director of the Interventional Cardiology and Structural Heart Programs at Yale University School of Medicine in New Haven, Connecticut.

Reintervention: An Important Secondary Endpoint

“The finding of a higher rate of reintervention is a very important secondary endpoint,” Forrest told Medscape Medical News. “The early benefits of TAVR might outweigh a modestly higher risk of intervention, especially if that difference remains small. However, if in the years to come we begin to see a significant difference in survival or quality of life, then that would change the conversation.”

The 6-year Evolut Low-Risk Trial results were published online in the Journal of the American College of Cardiology on February 16. Seven-year follow-up data from the PARTNER 3 trial, which also evaluated TAVR vs surgery in low-risk patients, were also recently published in The New England Journal of Medicine.

Unlike the Evolut Low Risk Trial, the PARTNER 3 results, initially presented at the Transcatheter Therapeutics (TCT) 2026 meeting, TAVR did not differ from surgery at 7 years for the first and second primary composite endpoints. The rate of reinterventions, a secondary endpoint, was slightly higher in the TAVR group but the difference did not approach statistical significance (6.7% vs 6.0%; 95% CI, 0.63-1.94).

In the Evolut Low Risk Trial, 1414 low-risk patients with aortic stenosis were randomized at 87 sites to TAVR with an Evolut (Medtronic) valve or surgery. The researchers defined low risk based on standardized criteria as a predicted surgical mortality of less than 3%. In considering the new results, it is important to note that the TAVR valves employed in the Evolut Low Risk Tral are no longer commercially available and have been replaced by newer models.

In the PARTNER 3 trial, 1000 low-risk patients with aortic stenosis were randomized at 71 sites to TAVR with the Sapien 3 (Edwards Lifesciences) valve or surgery. Low risk was defined as a predicted surgical mortality of less than 4%.

In both trials, TAVR relative to surgery was associated with lower procedural mortality, lower stroke rates, and lower mortality at 1 year. Until now, the devices in subsequent follow-up have performed similarly with respect to primary and secondary endpoints. 

Given the strong trend for a higher reintervention rate at 6 years, the Evolut Low Risk Trial investigators engaged in an exploratory post hoc analysis incorporating data through 7 years of follow-up (available for most but not all of the study population). Reintervention rates in this additional year of follow-up climbed from 3.3% to 6.0% in the surgery group and from 5.5% to 9.8% in the TAVR group. The between-group difference at 7 years reached significance (P = .02).

‘A Moving Target’

In a further analysis, there was no meaningful difference between TAVR and SAVR, for reinterventions due to valve stenosis (3.6% vs 3.5%). Rather, the difference in reinterventions was largely confined to reinterventions for aortic regurgitation (5.6% vs 1.6%; P < .001).

The Evolut Low Risk trial must be considered in context, according to Michael Reardon, MD, professor of cardiothoracic surgery at Houston Methodist Hospital, Houston.

Reardon, who was also a study co-author, suggested both the Evolut valve and the implantation strategies have evolved meaningfully since the trial was initiated.

“Further follow-up of this trial to its 10-year completion as well as TAVR using the current generation valve and on guidance post-dilatation will be necessary to fully inform both the patients as well as the implanting physicians,” Reardon told Medscape Medical News.

In addition to advances in the Evolut valve design, he pointed out that postimplant dilatation in a trial “that began a decade ago” was conducted with a balloon larger than the current recommended size and pressure. These and other modifications in device and technique might well explain the increased relative risk for aortic regurgitation.

In an accompanying editorial published in JACC, Ziad A. Ali, MD, director of investigational interventional cardiology at the St. Francis Hospital and Heart Center in Roslyn, New York, noted that trials like this “capture a moment in time.” The data are informative but not definitive.

“The late divergence in reintervention between TAVR and SAVR, the predominance of regurgitation-related failure, and the contribution of specific valve sizes and procedural patterns all represent signals that merit continued surveillance, further study, and careful consideration in contemporary practice,” he wrote.

Forrest echoed this sentiment. “As we move into longer-term follow-up, the most important question is, will there be survival and quality-of-life differences between the two groups?”

So far, survival after TAVR and SAVR in low-risk patients is similar, meaning faster recovery after TAVR might motivate patients to select this option — even if modest differences in the reintervention rate are shared by other TAVR devices relative to SAVR when long-term follow-up is available for contemporary devices.

As devices and techniques improve, the relative safety and efficacy of TAVR and SAVR long-term will be a moving target, Forrest suggested.

“This is why it is so critical that there is open and transparent reporting of this data,” he said.

Forrest reported a financial relationship with Medtronic, which provided funding for this trial as well as with Edwards Lifesciences. Reardon reported financial relationships with Abbott, Boston Scientific, W.L. Gore Medical, and Medtronic. Ali reported financial relationships with Abiomed, Acist, Amgen, AstraZeneca, Boston Scientific, Canon, Cathworks, Conavi, Heartflow, Inari, Medtronic, Nipro, Opsens, Medisi, Philips, Shockwave, Siemens, Spectrawave, and Teleflex.