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Randomized Controlled Trial
. 2021 Aug 7;42(30):2912-2919.
doi: 10.1093/eurheartj/ehab375.

Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement

Troels Højsgaard Jørgensen  1 , Hans Gustav Hørsted Thyregod  2 , Nikolaj Ihlemann  3 , Henrik Nissen  3 , Petur Petursson  4 , Bo Juel Kjeldsen  5 , Daniel Andreas Steinbrüchel  6 , Peter Skov Olsen  2 , Lars Søndergaard  1
Affiliations
Randomized Controlled Trial

Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement

Troels Højsgaard Jørgensen et al. Eur Heart J. .

Abstract

Aims: The aims of the study were to compare clinical outcomes and valve durability after 8 years of follow-up in patients with symptomatic severe aortic valve stenosis at low surgical risk treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).

Methods and results: In the NOTION trial, patients with symptomatic severe aortic valve stenosis were randomized to TAVI or SAVR. Clinical status, echocardiography, structural valve deterioration, and failure were assessed using standardized definitions. In total, 280 patients were randomized to TAVI (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean STS score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction was 54.5% after TAVI and 54.8% after SAVR (P = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%; P = 0.90), stroke (8.3% vs. 9.1%; P = 0.90), or myocardial infarction (6.2% vs. 3.8%; P = 0.33) were similar after TAVI and SAVR. The risk of structural valve deterioration was lower after TAVI than after SAVR (13.9% vs. 28.3%; P = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%; P = 0.61).

Conclusions: In patients with severe aortic valve stenosis at low surgical risk randomized to TAVI or SAVR, there were no significant differences in the risk for all-cause mortality, stroke, or myocardial infarction, as well as the risk of bioprosthetic valve failure after 8 years of follow-up.

Clinical trial registration: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

Keywords: Bioprosthetic aortic valve durability; Mortality; Stroke; Surgical aortic valve replacement; Transcatheter aortic valve implantation.

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Figures

None
Clinical and aortic bioprosthetic valve failure 8 years after transcatheter and surgical aortic valve replacement. CI, confidence interval; HR, hazard ratio.
Figure 1
Figure 1
Estimated risk of all-cause mortality. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Figure 2
Figure 2
Estimated risk of all-cause mortality, stroke or myocardial infarction. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Figure 3
Figure 3
Mean gradient and effective orifice area during follow-up. EOA, effective orifice area; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation. *P < 0.05.
Figure 4
Figure 4
Structural valve deterioration. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Figure 5
Figure 5
Bioprosthetic valve failure. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
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