Thomas Kevin L, Al-Khatib Sana M, Lokhnygina Yuliya, Solomon Scott D, Kober Lars, McMurray John J V, Califf Robert M, Velazquez Eric J
Duke Clinical Research Institute, Duke University Medical Center, Durham NC 27710, USA.
Am Heart J. 2008 Jan;155(1):87-93. doi: 10.1016/j.ahj.2007.09.010. Epub 2007 Oct 25.
We sought to assess the association of amiodarone use with mortality during consecutive periods in patients with post-acute myocardial infarction with left ventricular systolic dysfunction and/or HF treated with a contemporary medical regimen.
This study used data from VALIANT, a randomized comparison of valsartan, captopril, or both in patients with acute myocardial infarction with HF and/or left ventricular systolic dysfunction. We compared baseline characteristics of 825 patients treated with amiodarone at randomization with 13,875 patients not treated with amiodarone. Using Cox models, we examined the association of amiodarone use with subsequent mortality during consecutive periods after randomization (days 1-16, 17-45, 46-198, and 199-1096).
Patients treated with amiodarone were older, had higher Killip class, and were more likely to have a history of diabetes mellitus and hypertension. Adjusting for baseline predictors of mortality, we found that amiodarone use was associated with a significant increase in mortality during 3 of the 4 periods: hazard ratio 1.5, 95% CI (1.1-2.0), P = .02, for days 1 to 16; 2.1 (1.5-2.9), P < .001, for days 17 to 45; 1.1 (0.83-1.46), P = .51, for days 46 to 198; and 1.4 (1.2-1.6), P < .001, for days 199 to 1096.
In this study, amiodarone use was associated with excess early and late all-cause and cardiovascular mortality. These observational findings are in contrast to earlier randomized trials of amiodarone and need to be validated prospectively.
我们试图评估在接受当代药物治疗方案的急性心肌梗死后左心室收缩功能不全和/或心力衰竭患者中,连续各阶段使用胺碘酮与死亡率之间的关联。
本研究使用了VALIANT研究的数据,该研究对急性心肌梗死合并心力衰竭和/或左心室收缩功能不全患者随机使用缬沙坦、卡托普利或两者联合进行比较。我们将随机分组时接受胺碘酮治疗的825例患者的基线特征与未接受胺碘酮治疗的13,875例患者进行了比较。使用Cox模型,我们研究了随机分组后连续各阶段(第1 - 16天、第17 - 45天、第46 - 198天和第199 - 1096天)使用胺碘酮与随后死亡率之间的关联。
接受胺碘酮治疗的患者年龄更大,Killip分级更高,更有可能有糖尿病和高血压病史。在对死亡率的基线预测因素进行校正后,我们发现,在4个阶段中的3个阶段,使用胺碘酮与死亡率显著增加相关:第1至16天,风险比1.5,95%可信区间(1.1 - 2.0),P = 0.02;第17至45天,2.1(1.5 - 2.9),P < 0.001;第46至198天,1.1(0.83 - 1.46),P = 0.51;第199至1096天,1.4(1.2 - 1.6),P < 0.001。
在本研究中,使用胺碘酮与全因死亡率和心血管死亡率的早期及晚期增加有关。这些观察结果与早期胺碘酮的随机试验结果相反,需要进行前瞻性验证。