ATRIAL FIBRILLATION FOLLOW UP INVESTIGATION OF RHYTHM MANAGEMENT (AFFIRM)

667 AFFIRM研究将比较优化的抗肿瘤药物是否 试图维持正常窦性心律的治疗 与优化治疗相比， 仅仅控制主泵室的心率 心房颤动 本研究将根据意向治疗分析 基础假设在房颤患者中， 主要治疗旨在维持窦性心律的总死亡率 等于主要治疗旨在控制的总死亡率 心率 因为中风是如此重要的一个终点， 终点将包括1）总死亡率和致残性卒中， 致残性缺氧性脑病; 2）总死亡率，致残性中风， 或缺氧性脑病大出血和心脏骤停 第三 目的是确定每种治疗的成本。 有200个站点 参加1996年5月至1999年4月进行的主要试验。 五十- 该研究中心已入组4例患者，预计 我们将继续每年招募30-40名患者。

667 The AFFIRM Study will compare whether optimized antiarrhythmic drug therapy administered in an attempt to maintain normal sinus rhythm has an impact on total mortality when compared to optimized therapy which merely controls the heart rate of the main pumping chambers during atrial fibrillation. The study will be analyzed on an intent-to-treat basis. The hypothesis is that in patients with atrial fibrillation, total mortality with primary therapy intended to maintain sinus rhythm is equal to total mortality with primary therapy intended to control heart rate. Because stroke is such an important endpoint, composite endpoints will include 1) total mortality and disabling stroke and disabling anoxic encephalopathy; 2) total mortality, disabling stroke, or anoxic encephalopathy, major bleeding, and cardiac arrest. A third objective is to ascertain the cost of each therapy. There are 200 sites participating in the main trial which will run from 5/96-4/99. Fifty- four patients have been enrolled at this site and it is anticipated that we will continue to enroll 30-40 patients per year.