胺碘酮预防心房颤动复发。加拿大心房颤动试验研究人员。

Amiodarone to prevent recurrence of atrial fibrillation. Canadian Trial of Atrial Fibrillation Investigators.

作者信息

Roy D, Talajic M, Dorian P, Connolly S, Eisenberg M J, Green M, Kus T, Lambert J, Dubuc M, Gagné P, Nattel S, Thibault B

机构信息

Montreal Heart Institute, QC, Canada.

出版信息

N Engl J Med. 2000 Mar 30;342(13):913-20. doi: 10.1056/NEJM200003303421302.

DOI:10.1056/NEJM200003303421302

PMID:10738049

Abstract

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<0.001). Adverse events requiring the discontinuation of drug therapy occurred in 18 percent of the patients receiving amiodarone, as compared with 11 percent of those treated with sotalol or propafenone (P=0.06).

CONCLUSIONS

Amiodarone is more effective than sotalol or propafenone for the prevention of recurrences of atrial fibrillation.

摘要

背景

恢复并维持窦性心律是心房颤动患者的理想目标，因为预防复发可改善心脏功能并缓解症状。非对照研究表明，低剂量胺碘酮在预防复发方面可能比其他药物更有效且更安全，但该药物尚未在大型随机试验中进行测试。

方法

我们进行了一项前瞻性多中心试验，以检验低剂量胺碘酮在预防房颤复发方面比索他洛尔或普罗帕酮治疗更有效的假设。我们将在过去六个月内至少有一次房颤发作的患者随机分配至胺碘酮组，或接受开放标签给药的索他洛尔或普罗帕酮组。分配至索他洛尔或普罗帕酮组的患者进行第二次随机分组，以确定他们是先接受索他洛尔还是普罗帕酮；如果第一种药物无效，则使用第二种药物。两组所有患者在随机分组后21天内给予药物负荷剂量，并（如有必要）进行电复律。随访期从随机分组后21天开始。主要终点是首次房颤复发的时间长度。

结果

在该研究的403例患者中，201例被分配至胺碘酮组，202例被分配至索他洛尔（101例患者）或普罗帕酮（101例患者）组。平均随访16个月后，分配至胺碘酮组的71例患者（35%）和分配至索他洛尔或普罗帕酮组的127例患者（63%）发生房颤复发（P<0.001）。需要停药的不良事件发生在18%接受胺碘酮治疗的患者中，而接受索他洛尔或普罗帕酮治疗的患者中这一比例为11%（P=0.06）。