MODE SELECTION TRIAL IN SINUS NODE DYSFUNCTION (MOST)

MOST项目是NIH于2000年发起的一项为期5年的多中心研究 患者，设计有三个不可分割且同等重要的目标：1） 为了确定双腔、速率调节的初始策略是否 所有病窦综合征（SSS）患者的DDDR起搏改善 无事件生存期; 2）确定随机分配至DDDR组的患者是否 起搏患者的生活质量比随机分配至 心室频率调制（VVIR）起搏，以及3）确定在 纵向随访1.5- 4.5年，DDDR起搏成本更高- 比VVIR起搏更有效。 本研究的主要终点是 复合临床终点包括卒中或全因死亡率。 总死亡率和复合终点，包括第一个 发生卒中、心力衰竭住院或死亡将 构成重要的次要临床终点。 生活质量 (QOL)在随机选择的1400个亚组中进行子研究 患者，提供数据，以扭转目前的实践模式， 似乎限制了女性和老年人使用双腔起搏。 这项QOL研究针对女性和老年人，以确定DDDR起搏是否 上级。 因此，MOST试图确定 DDDR起搏器更高的初始成本被防止不良反应所抵消 事件和生活质量的改善（患者受益），如果 所有SSS患者的DDDR起搏包括社会效益（平衡 DDDR起搏的技术成本增加， 临床节约）。

The MOST project is an NIH-sponsored, multicenter, 5-year study in 2000 patients, designed with three, indivisible and equally important aims: 1) to determine whether an initial strategy for dual-chamber, rate-modulated (DDDR) pacing in all patients with sick sinus syndrome (SSS) improves event-free survival; 2) to determine whether patients randomized to DDDR pacing have a better quality of life than do patients randomized to ventricular, rate-modulated (VVIR) pacing, and 3) to determine if, after 1.5--4.5 years of longitudinal followup, DDDR pacing is more cost- effective than VVIR pacing. The primary endpoint of the study will be a composite clinical endpoint consisting of stroke or all-cause mortality. Total mortality and a composite endpoint consisting of the first occurrence of stroke, heart failure hospitalization, or death will constitute important secondary clinical endpoints. A Quality of Life (QOL) substudy is being conducted, in a randomly selected subset of 1400 patients, to provide data to reverse current practice patterns which appear to restrict access to dual chamber pacing in women and the aged. This QOL study targets women and the elderly to determine if DDDR pacing in superior in these two subgroups. Thus, MOST seeks to determine if the greater initial cost of DDDR pacemakers is offset by preventing adverse events and by improvement in quality of life (patient Benefits), and if DDDR pacing of all patients with SSS includes societal benefits (balancing the increased technological costs of DDDR pacing with potential long-term clinical savings).