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The New England Journal of MedicineTranscatheter or Surgical Treatment of Aortic-Valve Stenosis

Comparative Efficacy of TAVI and SAVR in Low-Risk Aortic Stenosis Patients

This randomized noninferiority trial investigates the outcomes of transcatheter aortic-valve implantation (TAVI) versus surgical aortic-valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis who are considered low or intermediate surgical risk. Conducted across 38 sites in Germany, the study provides critical insights into the comparative efficacy and safety of these two treatment modalities over a one-year period.

Study Design:

  • Participants: 1,414 patients with severe aortic stenosis, mean age 74±4 years; 57% male.
  • Risk Profile: Patients were classified as low or intermediate surgical risk, with a median Society of Thoracic Surgeons risk score of 1.8%.
  • Settings: Trial conducted at 38 sites across Germany, accommodating both TAVI and SAVR procedures.
  • Procedures: Patients randomly assigned to undergo either TAVI (701 patients) or SAVR (713 patients). Valve prostheses selection was based on operator discretion.

Key Findings:

  • Primary Outcome: One-year incidence of death from any cause or fatal/nonfatal stroke was 5.4% in the TAVI group compared to 10.0% in the SAVR group; hazard ratio of 0.53 (95% CI, 0.35 to 0.79; P<0.001 for noninferiority).
  • Mortality Rate: Death from any cause occurred in 2.6% of the TAVI group versus 6.2% of the SAVR group.
  • Stroke Incidence: Stroke rates were 2.9% for TAVI and 4.7% for SAVR.
  • Procedural Complications: Occurred in 1.5% of TAVI patients and 1.0% of SAVR patients.

HCN Medical Memo
This study stresses personalized treatment planning in aortic stenosis, suggesting that TAVI, when used in appropriate patient cohorts, offers a potentially safer alternative with fewer adverse outcomes compared to SAVR. As clinical practices evolve, integrating such evidence-based comparisons will be crucial in optimizing patient outcomes.

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