Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Radboud University Medical Center, Nijmegen, The Netherlands.
Am Heart J. 2019 Feb;208:123-131. doi: 10.1016/j.ahj.2018.09.017. Epub 2018 Nov 22.
Patients with atrial fibrillation (AF) often have multi-morbidity, defined as ≥3 comorbid conditions. Multi-morbidity is associated with polypharmacy, adverse events, and frailty potentially altering response to anticoagulation. We sought to describe the prevalence of multi-morbidity among older patients with AF and determine the association between multi-morbidity, clinical outcomes, and the efficacy and safety of apixaban compared with warfarin.
In this post-hoc subgroup analysis of the ARISTOTLE trial, we studied enrolled patients age ≥ 55 years (n = 16,800). Patients were categorized by the number of comorbid conditions at baseline: no multi-morbidity (0-2 comorbid conditions), moderate multi-morbidity (3-5 comorbid conditions), and high multi-morbidity (≥6 comorbid conditions). Association between multi-morbidity and clinical outcomes were analyzed by treatment with a median follow-up of 1.8 (1.3-2.3) years.
Multi-morbidity was present in 64% (n = 10,713) of patients; 51% (n = 8491) had moderate multi-morbidity, 13% (n = 2222) had high multi-morbidity, and 36% (n = 6087) had no multi-morbidity. Compared with the no multi-morbidity group, the high multi-morbidity group was older (74 vs 69 years), took twice as many medications (10 vs 5), and had higher CHADS-VASc scores (4.9 vs 2.7) (all P < .001). Adjusted rates per 100 patient-years for stroke/systemic embolism, death, and major bleeding increased with multi-morbidity (Reference no multi-morbidity; moderate multi-morbidity 1.42 [1.24-1.64] and high multi-morbidity 1.92 [1.59-2.31]), with no interaction in relation to efficacy or safety of apixaban.
Multi-morbidity is prevalent among the population with AF; efficacy and safety of apixaban is preserved in this subgroup supporting extension of trial results to the most complex AF patients.
患有心房颤动(AF)的患者通常患有多种合并症,定义为≥3 种合并症。多种合并症与多药治疗、不良事件和虚弱有关,可能改变抗凝治疗的反应。我们旨在描述老年 AF 患者中多种合并症的流行情况,并确定多种合并症与临床结局之间的关系,以及与华法林相比,阿哌沙班的疗效和安全性。
在 ARISTOTLE 试验的这一事后亚组分析中,我们研究了年龄≥55 岁的入组患者(n=16800)。根据基线时的合并症数量将患者分为以下几类:无多种合并症(0-2 种合并症)、中度多种合并症(3-5 种合并症)和高度多种合并症(≥6 种合并症)。用中位数为 1.8(1.3-2.3)年的随访分析多种合并症与临床结局之间的关系。
64%(n=10713)的患者存在多种合并症;51%(n=8491)为中度多种合并症,13%(n=2222)为高度多种合并症,36%(n=6087)为无多种合并症。与无多种合并症组相比,高度多种合并症组年龄更大(74 岁 vs 69 岁),服用的药物数量是其两倍(10 种 vs 5 种),CHA2DS2-VASc 评分更高(4.9 分 vs 2.7 分)(所有 P<0.001)。每 100 名患者年的卒中/全身性栓塞、死亡和大出血发生率随合并症的增加而增加(参考无多种合并症;中度多种合并症为 1.42[1.24-1.64],高度多种合并症为 1.92[1.59-2.31]),阿哌沙班的疗效和安全性之间无交互作用。
多种合并症在 AF 人群中普遍存在;阿哌沙班在该亚组中的疗效和安全性得到保留,支持将试验结果扩展至最复杂的 AF 患者。