Duke University Medical Center, Duke Clinical Research Institute, Durham, NC.
Heart Institute, InCor, University of São Paulo Medical School, São Paulo, Brazil.
Am J Med. 2022 Jul;135(7):915-918. doi: 10.1016/j.amjmed.2022.02.016. Epub 2022 Mar 14.
Using data from the ODYSSEY OUTCOMES trial (NCT01663402), we sought to identify factors associated with the development of incident atrial fibrillation in patients with recent acute coronary syndrome without prior atrial fibrillation and to determine whether alirocumab treatment influenced risk of incident atrial fibrillation.
ODYSSEY OUTCOMES compared alirocumab treatment with placebo in 18,924 patients with recent acute coronary syndrome and dyslipidemia despite high-intensity or maximum-tolerated statin therapy. The primary outcome of major adverse cardiovascular events (MACE) comprised death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, or unstable angina requiring hospitalization. Patients were classified as having previous atrial fibrillation (present prior to or at randomization) or no previous atrial fibrillation. A multivariable model was used to determine factors associated with incident atrial fibrillation.
Among 18,262 participants without prior atrial fibrillation at baseline, 499 (2.7%) had incident atrial fibrillation during follow-up. Older age, history of heart failure or myocardial infarction, and higher body mass index were significantly associated with incident atrial fibrillation. Treatment with alirocumab or placebo did not influence the cumulative incidence of atrial fibrillation (hazard ratio 0.91; 95% confidence interval, 0.77-1.09). Patients with vs without a history of atrial fibrillation had a higher incidence of MACE (8.8 vs 3.7 events per 100 patient-years), without significant interaction between atrial fibrillation and randomized treatment on risk of MACE (P = .78).
While alirocumab did not modify risk of incident atrial fibrillation after acute coronary syndrome, it did reduce the risk of MACE, regardless of prior atrial fibrillation history. History of atrial fibrillation is an independent predictor of recurrent cardiovascular events after acute coronary syndrome.
利用 ODYSSEY OUTCOMES 试验(NCT01663402)的数据,我们旨在确定近期急性冠脉综合征且无既往心房颤动患者中与新发心房颤动相关的因素,并确定阿利西尤单抗治疗是否影响新发心房颤动的风险。
ODYSSEY OUTCOMES 比较了近期急性冠脉综合征且存在血脂异常的患者(尽管进行了高强度或最大耐受他汀类药物治疗)中阿利西尤单抗与安慰剂的治疗效果。主要不良心血管事件(MACE)的主要终点包括因冠心病、非致死性心肌梗死、致死性或非致死性缺血性卒中和需要住院治疗的不稳定型心绞痛而导致的死亡。患者被分为有既往心房颤动(在随机分组前或随机分组时存在)或无既往心房颤动。采用多变量模型确定与新发心房颤动相关的因素。
在基线时无既往心房颤动的 18262 名参与者中,499 名(2.7%)在随访期间发生了新发心房颤动。年龄较大、心力衰竭或心肌梗死病史以及较高的体重指数与新发心房颤动显著相关。与安慰剂相比,阿利西尤单抗治疗并未影响心房颤动的累积发生率(风险比 0.91;95%置信区间,0.77-1.09)。有既往心房颤动病史的患者与无既往心房颤动病史的患者相比,MACE 的发生率更高(每 100 例患者年分别为 8.8 例和 3.7 例事件),但心房颤动与随机治疗对 MACE 风险的交互作用无统计学意义(P=0.78)。
尽管阿利西尤单抗并未改变急性冠脉综合征后新发心房颤动的风险,但它降低了 MACE 的风险,而与既往心房颤动病史无关。心房颤动病史是急性冠脉综合征后复发心血管事件的独立预测因素。