Amiodarone to prevent recurrence of atrial fibrillation
Amiodarone to prevent recurrence of atrial fibrillation
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DOI：
10.1056/nejm200003303421302
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发表时间：
2000-03-30
影响因子：
158.5
通讯作者：
Thibault, B
中科院分区：
文献类型：
--
作者：
Roy, D;Talajic, M;Thibault, B
背景资料：恢复和维持窦性心律是房颤患者的理想目标，因为预防复发可以改善心功能并缓解症状。非对照研究表明，胺碘酮在低剂量可能是更有效和更安全的比其他药物在预防复发，但这种药物还没有被测试在一个大的，随机trial.Methods：我们进行了一项前瞻性的，多中心的试验来测试的假设，即低剂量的胺碘酮将更有效地预防复发性房颤比治疗与索他洛尔或普罗帕酮。我们将在过去6个月内至少有一次房颤发作的患者随机分配到胺碘酮或索他洛尔或普罗帕酮，以开放标签的方式给药。分配到索他洛尔或普罗帕酮组的患者进行第二次随机化，以确定他们是否将首先接受索他洛尔或普罗帕酮;如果第一种药物不成功，则开具第二种药物。两组所有患者均在随机化后21天内给予负荷剂量药物并进行电击复律（如有必要）。随访期从随机化后21天开始。主要终点是首次复发房颤的时间长度。结果：在研究的403例患者中，201例被分配到胺碘酮组，202例被分配到索他洛尔组（101例）或普罗帕酮组（101例）。经过平均16个月的随访，71名接受胺碘酮治疗的患者（35%）和127名接受索他洛尔或普罗帕酮治疗的患者（63%）出现房颤复发（P
Background: The restoration and maintenance of sinus rhythm is a desirable goal in patients with atrial fibrillation, because the prevention of recurrences can improve cardiac function and relieve symptoms. Uncontrolled studies have suggested that amiodarone in low doses may be more effective and safer than other agents in preventing recurrence, but this agent has not been tested in a large, randomized trial.Methods: We undertook a prospective, multicenter trial to test the hypothesis that low doses of amiodarone would be more efficacious in preventing recurrent atrial fibrillation than therapy with sotalol or propafenone. We randomly assigned patients who had had at least one episode of atrial fibrillation within the previous six months to amiodarone or to sotalol or propafenone, given in an open-label fashion. The patients in the group assigned to sotalol or propafenone underwent a second randomization to determine whether they would receive sotalol or propafenone first; if the first drug was unsuccessful the second agent was prescribed. Loading doses of the drugs were administered and electrical cardioversion was performed (if necessary) within 21 days after randomization for all patients in both groups. The follow-up period began 21 days after randomization. The primary end point was the length of time to a first recurrence of atrial fibrillation.Results: Of the 403 patients in the study, 201 were assigned to amiodarone and 202 to either sotalol (101 patients) or propafenone (101 patients). After a mean of 16 months of follow-up, 71 of the patients who were assigned to amiodarone (35 percent) and 127 of those who were assigned to sotalol or propafenone (63 percent) had a recurrence of atrial fibrillation (P