- Question
- Can transcatheter aortic valve replacement (TAVR) be safely used in lower surgical risk patients compared with conventional surgery, in an all-comers population with severe aortic stenosis?
- Design
- 1:1 randomized trial, open-label with single masking per the registry, conducted at 3 Nordic centers with 280 patients. The primary analysis was at 1 year of follow-up.
- Population
- Patients aged 70 years or older with severe aortic valve stenosis and no significant coronary artery disease. Mean age was 79.1 years and 81.8% were considered low risk.
- Intervention
- TAVR with a self-expanding bioprosthesis.
- Control
- Surgical aortic valve replacement (SAVR).
- Primary outcome
- Composite of death from any cause, stroke, or myocardial infarction at 1 year.
- Results
- In the intention-to-treat population, the primary endpoint occurred in 13.1% with TAVR vs. 16.3% with SAVR (p = 0.43 for superiority), with no significant difference; results were unchanged in the as-treated population. There were also no differences in cardiovascular death or prosthesis reintervention.
- Safety
- TAVR was associated with more conduction abnormalities requiring pacemaker implantation, more total aortic regurgitation and a higher NYHA functional class at 1 year, with a larger improvement in effective orifice area. Surgery had more major or life-threatening bleeding, cardiogenic shock, acute kidney injury (stage II or III) and new-onset or worsening atrial fibrillation at 30 days.
- Conclusion
- At 1 year there was no significant difference between TAVR and surgery in the composite of death, stroke or MI in this mostly low-risk population.
- Why it matters
- It was one of the first randomized trials to compare TAVR with surgery in lower-risk patients, providing early evidence to extend TAVR beyond high-risk patients and fueling the debate on long-term durability.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026