TAVR vs isolated SAVR in low-risk patients: 5-year comparative outcomes from the Evolut Low Risk trial

Post hoc subanalysis of the Evolut Low Risk trial comparing 5-year outcomes in 1164 low-risk patients with severe aortic stenosis undergoing isolated aortic valve replacement, either transcatheter (TAVR) or surgical (SAVR).

Transcatheter aortic valve replacement (TAVR) has progressively expanded from its initial indication in inoperable or high-risk patients to its current use in low-risk and potentially younger populations. In this setting, long-term durability and comparative performance against conventional surgery (SAVR) in patients with longer life expectancy have become critical issues. However, the frequent coexistence of coronary artery disease (CAD) and aortic stenosis adds another layer of complexity when comparing both strategies, as outcomes may be influenced not only by valve treatment itself but also by the modality and completeness of coronary revascularization.

To isolate the effect of the valve procedure per se, Ramlawi et al. present this post hoc subanalysis of the Evolut Low Risk trial, which used the self-expanding supra-annular CoreValve®, Evolut R®, and Evolut PRO® bioprostheses (Medtronic®). Of the 1414 patients initially randomized, 250 were excluded: those undergoing concomitant procedures, mainly percutaneous coronary intervention or coronary artery bypass grafting, and the 5 patients who crossed over between treatment arms. This yielded an “isolated” cohort of 1164 patients (667 TAVR, 497 SAVR), with a low burden of CAD by design (mean SYNTAX score 1.5 vs 1.3) and an overall low-risk baseline profile (mean age 74 years; STS-PROM 1.9% in both groups). At 5 years, follow-up data were available for 92.1% of patients in the TAVR group and 86.7% in the SAVR group.

Clinical outcomes were largely comparable. The 5-year composite end point of all-cause mortality or disabling stroke was similar between groups (15.5% TAVR vs 14.6% SAVR; 𝑝 = .84), as were all-cause mortality (13.5% vs 12.8%; 𝑝 = .85), cardiovascular mortality (6.9% vs 8.3%; 𝑝 = .36), and noncardiovascular mortality (7.1% vs 5.0%; 𝑝 = .19). Valve durability also appeared comparable, with similarly low rates of thrombosis, endocarditis, and reintervention (3.0% TAVR vs 2.2% SAVR; 𝑝 = .51).

Differences were mainly confined to procedure-specific events. TAVR was associated with a higher rate of new permanent pacemaker implantation (27.3% vs 8.9%; 𝑝 < .001) and, notably, a higher incidence of myocardial infarction (5.9% vs 3.0%; 𝑝 = .03). In contrast, SAVR was associated with a markedly higher risk of atrial fibrillation (39.9% vs 16.9%; 𝑝 < .001). Echocardiographically, TAVR consistently showed superior hemodynamics, with lower mean transvalvular gradients and larger effective orifice areas at all follow-up time points, although at the cost of a higher incidence of mild paravalvular regurgitation (14.2% vs 0.7% at 5 years). Moderate or greater paravalvular regurgitation, however, remained similarly uncommon in both groups (0.5% TAVR vs 0% SAVR; 𝑝 = .52).

A particularly interesting finding concerns CAD. Although more than 95% of the cohort was classified as not requiring revascularization during pre-valve treatment screening, among patients in whom revascularization had been planned but ultimately was not performed because concomitant procedures were excluded from this analysis, the incidence of myocardial infarction was numerically much higher after TAVR (16.3% vs 0%; 𝑝 = .26). The authors place these findings in the context of other low-risk trials, including PARTNER 3 at 7 years and NOTION at 10 years, as well as evidence addressing coronary revascularization from NOTION-3 and TCW, highlighting that both the favorable hemodynamic profile of TAVR and the absence of a clear adverse prognostic impact of paravalvular regurgitation have also been observed in these series.

𝐂𝐎𝐌𝐌𝐄𝐍𝐓𝐀𝐑𝐘:

This subanalysis, with mid- to long-term follow-up, further supports the concept that self-expanding TAVR represents a valid alternative to surgery in carefully selected low-risk patients undergoing isolated aortic valve replacement, with comparable mortality, valve durability, and rates of clinically significant paravalvular regurgitation. The superior hemodynamic performance of the supraannular device is consistent with its design and persists over time, whereas the trade-off remains a greater need for permanent pacemaker implantation, an issue that newer-generation prostheses and optimized implantation techniques are progressively mitigating.

Nevertheless, the relevance of this study lies as much in what it demonstrates as in the boundaries it defines. By deliberately excluding concomitant procedures, the authors achieve a relatively “clean” comparison of the valve intervention itself, but at the cost of creating a population artificially stripped of much of the coronary complexity encountered in clinical practice, thereby limiting the generalizability of the findings to real-world patients. The signal toward a higher incidence of myocardial infarction after TAVR (both overall and, particularly, among patients in whom revascularization had been planned but was not performed) deserves attention and is consistent with previous evidence associating higher SYNTAX scores and incomplete coronary revascularization with worse outcomes after TAVR. The authors’ conclusion therefore appears reasonable: at present, low-risk patients with higher SYNTAX scores or extensive CAD remain better candidates for SAVR with concomitant coronary artery bypass grafting.

The limitations inherent to the study design should also be emphasized. This was an exploratory, non-prespecified post hoc analysis that disrupted the original randomization and reduced statistical power; therefore, its findings should be regarded as hypothesis-generating rather than confirmatory. Furthermore, these results cannot be extrapolated to patients younger than 65 years or to those with high-risk TAVR anatomy, such as excessive left ventricular outflow tract calcification or bicuspid aortic valve morphology, who were systematically excluded from these trials. Planned follow-up through 10 years, together with dedicated prospective studies, will be essential to confirm long-term durability in a population with prolonged life expectancy.

𝐑𝐄𝐅𝐄𝐑𝐄𝐍𝐂𝐄:

Ramlawi B, Deeb GM, Yakubov SJ, Mumtaz M, Chu MWA, et al. Isolated Transcatheter and Surgical Aortic Valve Replacement in the Evolut Low-Risk Trial: 5-Year Comparative Outcomes. Ann Thorac Surg. 2026;122(1):57-66. doi: 10.1016/j.athoracsur.2026.03.070.

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