Salukhe T V, Francis D P, Sutton R
Int J Cardiol. 2003 Feb;87(2-3):119-20. doi: 10.1016/s0167-5273(02)00585-5.
The COMPANION trial was terminated prematurely after recruiting 1600 patients, as initial results clearly and for the first time demonstrated survival benefit of resynchronisation and combined device (biventricular pacemaker with defibrillator capacity) therapy in heart failure. The combined primary end-points of all-cause mortality and all-cause hospitalisation in patients with dilated cardiomyopathy and heart failure of poor functional class was reduced by 20% with cardiac resynchronisation therapy (CRT) with or without defibrillator capacity. More importantly, mortality was reduced by 40% (from 19% to 11%) in patients implanted with combined devices, while CRT alone gave an intermediate mortality of 15%.
COMPANION试验在招募了1600名患者后提前终止,因为初步结果首次明确显示了再同步化和联合装置(具有除颤功能的双心室起搏器)治疗对心力衰竭患者的生存益处。对于扩张型心肌病且心功能分级较差的心力衰竭患者,无论是否具备除颤功能,心脏再同步化治疗(CRT)都使全因死亡率和全因住院率这两个联合主要终点降低了20%。更重要的是,植入联合装置的患者死亡率降低了40%(从19%降至11%),而单纯CRT治疗的患者死亡率为中间值15%。