GISSIAF研究-幻灯片概要.ppt

Prospective, multicenter, randomized, double-blind, placebo-controlled study Patients with a history of AF were centrally randomized in a 1:1 ratio to receive either valsartan or placebo Participating centers:cardiology centers without need of special facilities Study design 研究设计 Inclusion criteria Male or female patients ≥40 years of age Sinus rhythm At least 2 ECG documented episodes of symptomatic AF in the previous 6 months or After a successful cardioversion for AF performed between 14 days and 48 hours before randomization Written informed consent to participate in the study prior to any study procedure Inclusion criteria At least one of the following underlying cardiovascular diseases/co-morbidities : Heart failure/documented history of LV dysfunction (defined as an EF40%) History of hypertension ≥6 months with/without LVH Type II diabetes mellitus Documented history of stroke or preipheral vascular disease Documented history of coronary artery disease Lone AF with documented LA dilation (LA diameter ≥45 mm for men and ≥40 mm for women Patient, centers, study duration 1142 patients from 114 centers FPFV : November 2004 LPLV : December 2007 Mean follow-up period 223 +/- 152 days Median follow-up 233 days TIME TO FIRST RECURRENCE OF AF GISSI-AF试验的基本原理与 设计研究 （Rationale and design of the GISSI-Atrial Fibrillation trial） 研究背景： 心房颤动是心律失常最常见的类型 传统药物治疗房颤复发率高 前研究表明，血管紧张素ⅡAT1受体阻滞剂能改善房颤的复发 研究目的 针对AF患者，缬沙坦是否可以降低总复发率 进一步评估药物的安全性 患者入选标准： 年龄：40岁 窦性心率 至少两次心电图出现AF特征，间隔时间≥6个月 至少存在下列一项： 心力衰竭（或左心功能障碍，射血分数40%） 高血压病史6m（合并或不合并左心室肥厚） Ⅱ型糖尿病史 中风（或周围血管病）史 冠心病史 单次AF伴左心房扩张（男性≥45mm,女性≥40mm） 患者认可知情同意书 缬沙坦:降低AF的首次复发 研究小结 缬沙坦能显著减少AF患者复发率 减少首次复发率 针对单次AF复发患者,缬沙坦能是AF患者首次复发减少17.6 % 减少多次复发率 针对多次AF复发患者，缬沙坦能使每次AF复发率减少17.6 % * * GISSI-Atrial Fibrillation trial Disertori et al. 80mg valsartan placebo Study Drug Treatment Randomization Week Days Day GISSI-Atrial Fibrillation trial Disertori et al. 研究背景 GISSI-Atrial Fibrillation trial Disertori et al. 一级终点 随访一年 AF患者首次复发 二级复合终点 随访一年 AF患者多次复