The New England Journal of MedicineTranscatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

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A large-scale randomized trial involving 901 patients across 75 North American centers has provided evidence comparing early transcatheter aortic-valve replacement (TAVR) with clinical surveillance in patients with asymptomatic severe aortic stenosis. The study addresses a significant clinical question regarding optimal timing of intervention in these patients.

Study Design:

• Multicenter RCT across 75 centers in US and Canada
• 901 patients randomized 1:1 (455 TAVR, 446 clinical surveillance)
• Patient characteristics:
  • Mean age: 75.8 years
  • Mean STS mortality score: 1.8%
  • 83.6% classified as low surgical risk
• Primary endpoint: Composite of death, stroke, or unplanned cardiovascular hospitalization
• Median follow-up: 3.8 years

Key Findings:

• Primary endpoint occurred in:
  • TAVR group: 26.8% of patients
  • Clinical surveillance group: 45.3% of patients
  • (HR 0.50; 95% CI, 0.40-0.63; P<0.001)
• Individual outcomes:
  • Death: 8.4% TAVR vs 9.2% surveillance
  • Stroke: 4.2% TAVR vs 6.7% surveillance
  • Unplanned CV hospitalization: 20.9% TAVR vs 41.7% surveillance
• 87% of surveillance group eventually underwent valve replacement
• No significant differences in procedure-related adverse events between groups

HCN Medical Memo
The results suggest that physicians should consider early TAVR intervention in eligible patients with asymptomatic severe aortic stenosis, rather than waiting for symptom development. The significant reduction in adverse events, particularly unplanned cardiovascular hospitalizations, supports a more proactive approach to management in this population.

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