Transcatheter aortic valve replacement has shown important benefits but one of its biggest challenges is showing its safety and efficacy at followup in low risk patients. At present we have 2-year data from the Evolute Low Risk, but the we lack information at longer followup.
The study looked at 3-year followup of the Evolute Low Risk including 1414 patients, with 730 receiving TAVR (51.6%) and 630 surgical aortic valve replacement (SAVR, 48.4%).
Primary end point was all cause death or disabling stroke at 3 years.
There were no differences between the populations: mean age was 73, 65% were men, 30% presented diabetes, 85% hypertension, 16% COPD, 8% peripheral vascular disease, 2% prior CABG, 14% prior PCI, 5% prior AMI, 15% atrial fibrillation, 3.5% definite pacemaker implantation. Ejection fraction was 61%.
Mortality STS was 2% and SYNTAX I was 2.
Primary end point for TAVR and SABR resulted 7.4% vs. 10.4% (HR: 0.70; 95% CI: 0.49-1.00; log-rank P=0.051) respectively.
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At 3 years, there were no differences between TAVR and SAVR in mortality (6.3% vs. 8.3% HR: 0.75; 95% CI: 0.51-1.12; P=0.16) and disabling stroke (2.3% vs. 3.4% HR: 0.65; 95% CI: 0.34-1.24; P=0.19)
The combined end point of all-cause mortality, disabling stroke and valve related rehospitalization was 13,2% for TAVR vs. 16.2% for SAVR (HR: 0.76; 95% CI: 0.58-1.00; P=0.050).
Atrial fibrillation rate was higher in patients receiving SAVR (13% vs. 40%, p<0.01) and the need for definite pacemaker was higher among TAVR patients (23.2% vs. 9.1% p<0.01).
Moderate prosthetic mismatch was lower among TAVR patients (10.6 vs. 25.5, p=0.01).
There were no differences between the groups when it came to moderate or severe leaks, but TAVR showed more mild leaks.
There were no differences in AMI, major vascular complications, valve thrombosis or endocarditis.
Conclusion
At 3 years, the Evolute Low Risk showed the benefits of TAVR are durable as regards all-cause mortality or disabling stroke vs. SAVR.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.
Reference: John K. Forrest , et al. J Am Coll Cardiol 2023;81:1663–1674.
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