PROTECTED TAVR
Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Paciente / Población Intervención / Exposición Comparación Desenlace
In 3,000 patients undergoing transcatheter aortic-valve replacement, the Sentinel cerebral embolic protection device did not reduce periprocedural stroke compared with no embolic protection.
N
3000
Diseño
Multicentre RCT
Desenlace
Stroke within 72 hours of TAVR or before discharge
Relevancia
3
ResultadoCerebral embolic protection 2.3% vs no protection 2.9% (difference -0.6 pp, 95% CI -1.7 to 0.5, P=0.30); neutral. Disabling stroke numerically lower (0.5% vs 1.3%) but exploratory.
Kapadia SR, et al. N Engl J Med. 2022;387(14):1253-63. 10.1056/NEJMoa2204961
Discusión y crítica
Observed overall stroke rate (~2.5%) far below the assumed 4%, leaving the trial underpowered; disabling-stroke signal only hypothesis-generating. Did not establish routine embolic protection.