Connolly Stuart J, Dorian Paul, Roberts Robin S, Gent Michael, Bailin Steven, Fain Eric S, Thorpe Kevin, Champagne Jean, Talajic Mario, Coutu Benoit, Gronefeld Gerian C, Hohnloser Stefan H
Department of Medicine, McMaster University, Hamilton, Ontario.
JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.
Implantable cardioverter defibrillator (ICD) therapy is effective but is associated with high-voltage shocks that are painful.
To determine whether amiodarone plus beta-blocker or sotalol are better than beta-blocker alone for prevention of ICD shocks.
DESIGN, SETTING, AND PATIENTS: A randomized controlled trial with blinded adjudication of events of 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously occurring ventricular tachycardia or fibrillation.
Patients were randomized to treatment for 1 year with amiodarone plus beta-blocker, sotalol alone, or beta-blocker alone.
Primary outcome was ICD shock for any reason.
Shocks occurred in 41 patients (38.5%) assigned to beta-blocker alone, 26 (24.3%) assigned to sotalol, and 12 (10.3%) assigned to amiodarone plus beta-blocker. A reduction in the risk of shock was observed with use of either amiodarone plus beta-blocker or sotalol vs beta-blocker alone (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28-0.68; P<.001). Amiodarone plus beta-blocker significantly reduced the risk of shock compared with beta-blocker alone (HR, 0.27; 95% CI, 0.14-0.52; P<.001) and sotalol (HR, 0.43; 95% CI, 0.22-0.85; P = .02). There was a trend for sotalol to reduce shocks compared with beta-blocker alone (HR, 0.61; 95% CI, 0.37-1.01; P = .055). The rates of study drug discontinuation at 1 year were 18.2% for amiodarone, 23.5% for sotalol, and 5.3% for beta-blocker alone. Adverse pulmonary and thyroid events and symptomatic bradycardia were more common among patients randomized to amiodarone.
Despite use of advanced ICD technology and treatment with a beta-blocker, shocks occur commonly in the first year after ICD implant. Amiodarone plus beta-blocker is effective for preventing these shocks and is more effective than sotalol but has an increased risk of drug-related adverse effects.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00257959.
植入式心脏复律除颤器（ICD）治疗有效，但会带来令人痛苦的高压电击。
确定胺碘酮联合β受体阻滞剂或索他洛尔在预防ICD电击方面是否优于单独使用β受体阻滞剂。
设计、设置和患者：一项随机对照试验，对来自加拿大、德国、美国、英国、瑞典和奥地利的39个门诊ICD临床中心的412例患者的事件进行盲法判定，研究时间为2001年1月13日至2004年9月28日。如果患者在21天内因可诱导或自发发生的室性心动过速或颤动而接受了ICD，则符合入选标准。
患者被随机分配接受为期1年的胺碘酮联合β受体阻滞剂、单独使用索他洛尔或单独使用β受体阻滞剂治疗。
主要结局是因任何原因发生的ICD电击。
单独使用β受体阻滞剂的41例患者（38.5%）发生了电击，使用索他洛尔的26例患者（24.3%）发生了电击，使用胺碘酮联合β受体阻滞剂的12例患者（10.3%）发生了电击。与单独使用β受体阻滞剂相比，使用胺碘酮联合β受体阻滞剂或索他洛尔可降低电击风险（风险比[HR]，0.44；95%置信区间[CI]，0.28 - 0.68；P <.001）。与单独使用β受体阻滞剂相比，胺碘酮联合β受体阻滞剂显著降低了电击风险（HR，0.27；95% CI，0.14 - 0.52；P <.001），与索他洛尔相比也有降低（HR，0.43；95% CI，0.22 - 0.85；P =.02）。与单独使用β受体阻滞剂相比，索他洛尔有降低电击的趋势（HR，0.61；95% CI，0.37 - 1.01；P =.055）。1年时研究药物停药率分别为：胺碘酮18.2%，索他洛尔23.5%，单独使用β受体阻滞剂5.3%。在随机接受胺碘酮治疗的患者中，肺部和甲状腺不良事件以及症状性心动过缓更为常见。
尽管使用了先进的ICD技术并联合β受体阻滞剂进行治疗，但ICD植入后的第一年仍经常发生电击。胺碘酮联合β受体阻滞剂可有效预防这些电击，且比索他洛尔更有效，但药物相关不良反应的风险增加。临床试验注册ClinicalTrials.gov标识符：NCT00257959。
