MODE SELECTION TRIAL IN SINUS NODE DYSFUNCTION (MOST)

MOST项目是2000年由美国国立卫生研究院赞助的一项为期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) 要确定初始策略是否为双腔、调频 所有病态窦房结综合征(SSS)患者的(DDDR)起搏均有改善 无事件生存；2)确定患者是否随机接受DDDR 起搏患者的生活质量比随机选择的患者要好 心室，调频(VVIR)起搏，以及3)以确定是否在 经过1.5-4.5年的纵向随访，DDDR起搏的成本更高- 比VVIR起搏有效。研究的主要终点将是 由中风或全因死亡率组成的综合临床终点。 总死亡率和由第一个 发生中风、心力衰竭住院，或死亡遗嘱 构成重要的次要临床终点。一种生活质量 (QOL)子研究正在进行中，随机选择1400人 患者，提供数据以扭转当前的实践模式， 似乎限制了妇女和老年人使用双腔起搏的机会。 这项生活质量研究的目标是妇女和老年人，以确定DDDR起搏是否 在这两个亚组中处于优势地位。因此，大多数人试图确定 DDDR起搏器的更大初始成本可通过预防不良反应来抵消 事件和生活质量的改善(患者的利益)，如果 所有SSS患者的DDDR起搏包括社会效益(平衡 DDDR起搏增加的技术成本具有潜在的长期效应 临床储蓄)。

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).