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Transcatheter aortic valve replacement shows comparable mortality to surgery in severe symptomatic aortic stenosisTrial compares TAVR and surgery for aortic stenosis

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Key Takeaway
Note that while mortality rates are comparable, TAVR may involve higher risks of regurgitation requiring reintervention.

The trial evaluated patients with severe symptomatic aortic stenosis at low surgical risk to compare transcatheter aortic valve replacement (TAVR) against traditional surgical aortic valve replacement. The primary endpoint was a composite of all-cause mortality or disabling stroke over a multi-year follow-up period.

Results indicated no statistically significant difference between TAVR and surgery regarding the primary composite outcome or all-cause mortality. However, the study observed higher reintervention rates for TAVR compared to surgical intervention at later follow-up points. Specifically, these higher reintervention rates in the TAVR cohort were primarily driven by issues related to regurgitation rather than stenosis.

The authors noted limitations regarding the consistency of long-term data across all patients. While the primary outcomes showed high certainty due to the study design, the evidence for longer-term reintervention trends is more limited. Clinicians may consider these findings when weighing immediate procedural success against potential long-term requirements for reintervention in patients undergoing TAVR.

For many people living with severe aortic stenosis, the heart's main valve becomes narrowed and stiff, making it harder for blood to flow through. This condition can cause serious symptoms like fatigue or shortness of breath. When it is time to treat the valve, doctors often choose between two main methods: traditional open-heart surgery or a less invasive procedure called TAVR (transcatheter aortic valve replacement). Because both options are common, patients and their families often want to know which one offers better long-term results.

A large study followed 1,414 patients who were at low risk for surgery but had severe symptoms. The researchers split these patients into two groups: 730 received the TAVR procedure, and 684 underwent traditional surgery. They tracked the patients for up to six years to see how well each treatment worked over time.

The primary goal was to see if one method resulted in fewer deaths or strokes compared to the other. The results showed that both methods were very similar in this regard. At the six-year mark, the rate of death or disabling stroke was 23.3% for those who had TAVR and 20.4% for those who had surgery. This small difference was not considered statistically significant, meaning both procedures performed well at keeping patients safe from major events.

However, the study did find a difference in how often patients needed more procedures later on. At the six-year mark, about 5.5% of TAVR patients needed a follow-up procedure compared to 3.3% of surgery patients. When looking at data available for seven years, this gap became clearer: nearly 10% of TAVR patients needed a second procedure, while only 6% of surgery patients did. Most of these extra procedures for the TAVR group were specifically to fix issues with blood leaking backward (regurgitation).

It is important to keep these findings in perspective. While the data suggests that TAVR might require more follow-up work over several years, it does not mean the procedure is less effective at treating the initial problem. The difference in survival rates was very small. Furthermore, because this study only looked at a specific group of low-risk patients, the results may not apply to everyone. Patients should talk with their doctors about these findings to decide which path best fits their personal health needs and preferences.

What this means for you:
TAVR and surgery show similar survival rates, but TAVR may require more follow-up procedures for leaking.

Study Details

Study typeRct
Sample sizen = 1,414
EvidenceLevel 2
Follow-up120.0 mo
PublishedJun 2026
View Original Abstract ↓
BACKGROUND: The Evolut Low Risk trial enrolled patients with severe aortic stenosis at low surgical risk. Annual follow-up is planned for 10 years, evaluating the composite of all-cause mortality or disabling stroke and key secondary endpoints. OBJECTIVES: Our prespecified objective was to report the 6-year clinical outcomes of transcatheter aortic valve replacement (TAVR) vs surgery from the Evolut Low Risk trial. Given an increase in reintervention rates at 6 years, we performed additional analyses in available 7-year data. METHODS: Low-risk patients with severe symptomatic aortic stenosis were randomized to TAVR or surgery from 2016-2019. Prespecified analyses at 6 years included annual follow-up of clinical outcomes reported as Kaplan-Meier estimates with log-rank test. Because the trial enrolled patients over several years, at the time of data lock, a majority of patients had completed 7-year follow-up. Given an increased reintervention rate at 6 years in the TAVR arm, we performed additional analysis of 7-year data available at the time of the database lock. Reintervention rates are reported as cumulative incidence. RESULTS: A total of 1,414 patients underwent an attempted implantation (730 TAVR, 684 surgery). At 6 years, the composite endpoint of all-cause mortality or disabling stroke was 23.3% for TAVR and 20.4% for surgery (difference: 2.8% [95% CI: -1.9% to 7.6%]; P = 0.43). All-cause mortality with vital status sweep at 6 years was 23.3% (95% CI: 20.6%-26.4%) for TAVR and 20.2% (95% CI: 17.4%-23.3%) for surgery (P = 0.24). The reintervention rate at 6 years was 5.5% for TAVR and 3.3% for surgery (sHR: 1.66 [95% CI: 0.96-2.86]; P = 0.07). Using available 7-year follow-up (555 TAVR and 480 surgery), the reintervention rate for TAVR was 9.8% and for surgery was 6.0% (sHR: 1.68 [95% CI: 1.10-2.58]; P = 0.02). In the TAVR and surgery groups, the rate of reintervention for regurgitation was 5.6% vs 1.6% (sHR: 3.39 [95% CI: 1.62-7.07]; P < 0.001) and the rate of reintervention for stenosis was 3.6% vs 3.5% (sHR: 1.14 [95% CI: 0.61-2.15]; P = 0.70). CONCLUSIONS: The 6-year results from the Evolut Low Risk trial show no significant difference in the composite endpoint of all-cause mortality or disabling stroke. At 6 and 7 years, the TAVR arm had a higher reintervention rate compared with surgery, driven by an increased incidence of aortic regurgitation. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
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