Cardiovascular Center, Beijing Tongren Hospital, Capital Medical University, Beijing 100176, China.
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University; National Clinical Research Center for Cardiovascular Diseases, Beijing 100029, China.
Chin Med J (Engl). 2020 Dec 1;134(3):309-317. doi: 10.1097/CM9.0000000000001270.
Post hoc analysis of the landmark atrial fibrillation follow-up investigation of rhythm management trial revealed that amiodarone was associated with higher risks of mortality, intensive care unit admission, and non-cardiovascular death. We aim to evaluate the association between amiodarone use and patient survival under updated medical mode and level using data from the China Atrial Fibrillation (China-AF) Registry study.
Clinical data of 8161 non-valvular atrial fibrillation (NVAF) patients who were antiarrhythmic drug (AAD)-naive before enrollment into the China-AF Registry, recruited between August 2011 and February 2017, were collected. The primary outcome was all-cause mortality. A Cox proportional hazard regression model was used to evaluate the association between amiodarone use and the outcome. We also calculated the rate of sinus rhythm maintenance at the penultimate follow-up.
Compared with 6167 patients of non-AAD group, 689 patients of the amiodarone group were younger (mean age 65.6 vs. 68.6 years), more frequently completed high school education, had fewer comorbidities such as chronic heart failure, prior bleeding, and stroke, and were more likely to be treated in tertiary hospitals while less hospitalization. The proportion of persistent AF was much lower among users of amiodarone, who were also less likely to be taking oral anticoagulants. The patients in the amiodarone group had a statistically insignificant lower incidence of all-cause mortality (2.44 vs. 3.91 per 100 person-years) over a mean follow-up duration of 300.6 ± 77.5 days. After adjusting for potential confounders, amiodarone use was not significantly associated with a lower risk of all-cause mortality (adjusted hazard ratio, 0.79; 95% confidence interval, 0.42-1.49). Sub-group analysis revealed the consistent results. The rate of sinus rhythm maintenance at the penultimate follow-up in the amiodarone group was significantly higher than in the non-AAD group.
Our study indicated that amiodarone use was not significantly associated with a lower risk of 1-year all-cause mortality compared with a non-AAD strategy in "real-world" patients with NVAF.
对标志性的心房颤动随访调查心律管理试验的事后分析显示，胺碘酮与更高的死亡率、重症监护病房入院率和非心血管死亡风险相关。我们旨在使用中国心房颤动（China-AF）注册研究的数据，根据更新的医疗模式和水平评估胺碘酮使用与患者生存之间的关系。
收集了 2011 年 8 月至 2017 年 2 月期间纳入 China-AF 注册研究的 8161 例非瓣膜性心房颤动（NVAF）患者的临床数据，这些患者在入组前均未使用抗心律失常药物（AAD）。主要结局是全因死亡率。采用 Cox 比例风险回归模型评估胺碘酮使用与结局之间的关系。我们还计算了最后一次随访前的窦性心律维持率。
与 6167 例非 AAD 组患者相比，689 例胺碘酮组患者年龄较小（平均年龄 65.6 岁比 68.6 岁），受教育程度较高，合并症较少，如慢性心力衰竭、既往出血和中风，更可能在三级医院治疗，住院次数较少。胺碘酮使用者持续性房颤的比例明显较低，服用口服抗凝剂的可能性也较低。在平均随访 300.6±77.5 天后，胺碘酮组的全因死亡率（每 100 人年 2.44 比 3.91）统计上显著较低。调整潜在混杂因素后，胺碘酮使用与全因死亡率降低无关（调整后的危险比，0.79；95%置信区间，0.42-1.49）。亚组分析显示结果一致。胺碘酮组最后一次随访时窦性心律维持率明显高于非 AAD 组。
我们的研究表明，与非 AAD 策略相比，在“真实世界”NVAF 患者中，胺碘酮的使用与 1 年全因死亡率降低无关。
