PARTNER 3: TAVI and SAVR Matched for Health Status at 7 Years

WASHINGTON, DC—New data from the PARTNER 3 low-risk trial of patients with symptomatic, severe aortic stenosis show that TAVI and SAVR are matched in terms of how patients feel at 7 years, mirroring the long-term clinical outcomes that have already been reported, according to a presentation last week at CRT 2026.

While TAVI held an edge in health status in the early years, by 7 years patients treated with either procedure were equally apt to have a favorable outcome as defined by a Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score of 60 or greater without a decline of more than 10 points from baseline. The metric captures physical limitations, the frequency and burden of symptoms, social limitations, and quality of life.

“It’s really reassuring to tell a patient that if we could have a crystal ball and look 7 years out in the future, you have nearly a 60% chance of feeling really good and being alive,” presenter Michael I. Brener, MD (New York-Presbyterian/Columbia University Irving Medical Center, New York, NY), told TCTMD. “For most patients with aortic stenosis who are in their early to mid 70s, that’s a pretty good vote of confidence and a stamp of approval for either transcatheter or surgical valve replacement.”

Late last year, the PARTNER 3 investigators reported 7-year clinical follow-up, with the primary endpoint of death from any cause, stroke, or rehospitalization occurring in 37.2% of patients randomized to the surgery arm and 34.6% of those treated with TAVI (HR 0.87; 95% CI 0.70-1.08). The long-term data reassured about durability of the balloon-expandable bioprosthetic valve (Sapien 3; Edwards Lifesciences).

One unusual difference seen in the health status outcomes, specifically in an analysis of key patient subgroups, was that those older than 74 years appeared to have more benefit with SAVR than TAVI (P for interaction = 0.053). 

“I think that this definitely falls into the bucket of a surprising finding,” Brener noted. “In older individuals, what we need to prioritize are obviously durability of hard endpoints [like] death, rehospitalization, et cetera, and we need to also prioritize the short-term recovery. The fact that we see a difference in long-term health status is not something that should persuade our clinical course of action [or] what we recommend to patients.”

He added that while intriguing, the finding comes from an underpowered subgroup within a secondary analysis of the overall PARTNER 3 cohort.

“Even though it is an interesting finding, one that we don’t truly have a clear mechanistic understanding or explanation for, it shouldn’t overwhelm common sense and very clear clinical data that we have that would suggest that surgery should not be the primary therapy for older individuals with aortic stenosis, even if they’re at low surgical risk.”

No Meaningful Differences

The PARTNER 3 investigators randomized 1,000 low surgical risk patients (mean age 73.4 years; 70% male) with an STS predicted risk of mortality of less than 4% (mean STS-PROM score 1.9%) at 71 centers between March 2016 and October 2017.

The mean baseline KCCQ-OS summary scores were 71.0 and 70.8 in the TAVI and surgery arms, respectively. The investigators also looked at the impact of TAVI and surgery on domains of the KCCQ, and on generic health status using the short form-36 (SF-36) physical component summary and mental component summary.

 Compared with the baseline, TAVI patients had moderate to large improvements in health status within 1 month of treatment, which was significantly greater than in surgery patients and clinically meaningful.

The mean treatment difference in the KCCQ-OS score at 30 days was 15.5 points higher with TAVI versus SAVR (P < 0.001), a difference that was attenuated by 6 months but remained statistically significant through 2 years of follow-up. The individual components of the KCCQ-OS followed a similar trend, being higher earlier on in the TAVI versus SAVR group.

“Beyond 2 years, the cardiovascular health status remained substantially improved compared with baseline, but there were no meaningful differences between TAVR and SAVR through 7 years of follow-up,” Brener noted.

He added that health status was observed to decline “gradually and modestly” over the long-term follow-up, driven by changes in the physical limitations’ domain, which peaked at 6 months and then gradually regressed. The SF-36 scores favored TAVI over surgery only through 1 month of follow-up before showing similar improvements from baseline between the two treatments.

A categorical analysis of health status showed no statistically significant differences in the proportion of TAVI or SAVR patients who experienced a favorable or excellent outcome through the long-term follow-up. Brener also noted that there has been very little loss to follow-up over the study period, with 98% of participants having KCCQ-OS data at baseline and 80% at 7 years.

Another unexpected difference seen in the key subgroups analysis was that the estimated treatment difference favored TAVI over surgery in patients with LVEF ≤ 55% (P for interaction = 0.027). Brener urged caution in interpreting this finding, as well, given the small number of patients in the trial who had low LVEF.

“I think mechanistically, it makes sense that patients with compromised LV systolic function would fare better with transcatheter aortic valve replacement as opposed to surgical valve replacement,” Brener told TCTMD. “They’re already a sick sort of patient subgroup to begin with, and TAVI relative to SAVR is obviously an easier procedure in the sense that the short-term recovery is typically quicker, and from a hemodynamics standpoint it puts less strain on the whole body.”

Panelist Thomas MacGillivray, MD (MedStar Washington Hospital Center, DC), noted that there also appeared to be some differences in the mental component of the SF-36 at certain time points in the follow-up, causing him to wonder about post-TAVI neurocognitive decline, a subject that was debated often in the early years of TAVI.

Brener acknowledged that the analysis does show statistically significant lower mental component scores at years 4 and 5 with TAVI, with no difference between groups by years 6 and 7.

“I think that’s just a natural variation in scores,” he added. “I don’t think that’s really a significant difference between the treatment groups.”