Evolute Low Risk at 3 Years: Promising Outcomes

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. 

TAVI bajo riesgo

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.

Read also: CLOUT Registry: Thrombectomy in TVP with ClotTriever.

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).

Read also: Retrograde Tibial Access for Endovascular Treatment of Femoropopliteal Occlusions: Is it a Safe Strategy?

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 - Consejo Editorial SOLACI

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. 


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

More articles by this author

Severe Tricuspid Regurgitation: Surgical vs. Transcatheter Edge-to-Edge Repair

While highly prevalent, tricuspid regurgitation is a notably undertreated valvulopathy. Its progression has been associated with higher mortality and significant disability. According to the...

ACCESS-TAVI: Comparing Post TAVR Vascular Closure Devices

Transcatheter aortic valve replacement (TAVR) is a well-established option to treat elderly patients with severe symptomatic aortic valve stenosis. Technical advances and device development...

Coronary Artery Disease in Aortic Stenosis: CABG + SAVR vs. TAVR + PCI: Data from Spanish Centers

Multiple randomized studies have shown comparable or superior efficacy of transcatheter aortic valve replacement (TAVR) vs. coronary artery bypass graft (CABG).  However, many of...

TCT 2024 | TRISCEND II: A New Hope in Percutaneous Tricuspid Valve Replacement

Advanced tricuspid regurgitation (TR) is a debilitating disease associated with heart failure and increased mortality.  Edge-to-edge repair has been shown to improve both clinical condition...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

Severe Tricuspid Regurgitation: Surgical vs. Transcatheter Edge-to-Edge Repair

While highly prevalent, tricuspid regurgitation is a notably undertreated valvulopathy. Its progression has been associated with higher mortality and significant disability. According to the...

ACCESS-TAVI: Comparing Post TAVR Vascular Closure Devices

Transcatheter aortic valve replacement (TAVR) is a well-established option to treat elderly patients with severe symptomatic aortic valve stenosis. Technical advances and device development...

Endovascular Treatment of Iliofemoral Disease for the Improvement of Heart Failure with Preserved Ejection Fraction

Peripheral artery disease (PAD) is a significant risk factor in the development of difficult-to-treat conditions, such as heart failure with preserved ejection fraction (HFpEF)....