ATRIAL FIBRILLATION FOLLOW UP INVESTIGATION OF RHYTHM MANAGEMENT (AFFIRM)

AFFIRM研究将比较为维持正常窦性心律而给予的优化抗心律药物治疗与仅控制房颤期间主泵室心率的优化治疗相比，是否对总死亡率产生影响。将在意向治疗基础上分析研究。 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心率的总死亡率。 由于卒中是如此重要的终点，复合终点将包括1）总死亡率和致残性卒中和致残性缺氧性脑病; 2）总死亡率、致残性卒中或缺氧性脑病、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家临床试验机构参与了主试验，试验将于1996年5月至1999年10月进行，目标是招募5000例患者。 该研究中心已入组62例患者，预计我们将继续每年入组30-40例患者。

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.