ATRIAL FIBRILLATION FOLLOW UP INVESTIGATION OF RHYTHM MANAGEMENT (AFFIRM)

这项肯定研究将比较为保持正常窦性心律而进行的优化抗心律失常药物治疗与仅控制房颤期间主要泵房的心率的优化治疗相比，是否对总死亡率有影响。这项研究将在意向治疗的基础上进行分析。假设在房颤患者中，旨在维持窦性心律的初级治疗的总死亡率与旨在控制心率的初级治疗的总死亡率相等。由于中风是如此重要的终点，因此复合终点将包括1)总死亡率和致残性中风和致残性缺氧性脑病；2)总死亡率、致残性中风或缺氧性脑病、大出血和心脏骤停。第三个目标是确定每种疗法的成本。有200个站点参与了主试验，从1996年5月到1999年10月，目标是5000名入选患者。这个网站已经招收了62名患者，预计我们每年将继续招收30-40名患者。

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 5/96-10/99 with the goal of 5000 enrolled patients. Sixty-two patients have been enrolled at this site and it is anticipated that we will continue to enroll 30-40 patients per year.