PRAETORIAN
Subcutaneous vs Transvenous Defibrillator Therapy
Patient / Population Intervention / Exposure Comparison Outcome
In 849 patients needing a defibrillator but no pacing, a subcutaneous ICD was non-inferior to a transvenous ICD for device complications and inappropriate shocks.
N
849
Design
RCT, non-inferiority
Endpoint
Device complications + inappropriate shocks
Relevance
2
ResultNon-inferior; primary endpoint 15.1% vs 15.7% (68 vs 68 pts), HR 0.99 (95% CI 0.71–1.39), P=0.01 for non-inferiority; P=0.95 superiority.
Knops RE, et al. N Engl J Med. 2020;383(6):526-536. 10.1056/NEJMoa1915932
Discussion & critique
Trades lead complications for more inappropriate shocks and no pacing or anti-tachycardia therapy. Suits patients with no pacing or resynchronisation indication.