一般研究的亚分析：药物依从性差的日本心房颤动患者的临床特征和结局。
Clinical characteristics and outcomes of Japanese atrial fibrillation patients with poor medication adherence: A sub-analysis of the GENERAL study.
机构信息
Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Tsuji Clinic, Kyoto, Japan.
出版信息
J Cardiol. 2023 Feb;81(2):209-214. doi: 10.1016/j.jjcc.2022.07.022. Epub 2022 Aug 16.
BACKGROUND
Oral anticoagulation therapy is essential for preventing stroke in patients with atrial fibrillation (AF). However, poor anticoagulant adherence may hamper medication safety and effective prevention of stroke.
METHODS
GENERAL is a prospective cohort study of AF patients taking rivaroxaban prescribed by general practitioners in Japan. In this study, anticoagulant adherence was calculated as the proportion of days covered (PDC), and patients were retrospectively divided into two groups: good adherence (PDC ≥80 %) and poor adherence (<80 %).
RESULTS
Of 5680 patients in the GENERAL study, the poor adherence group consisted of 223 patients (3.9 %). Baseline clinical characteristics were almost comparable regarding age (PDC ≥80 % vs. <80 %: 73.9 vs. 74.0 years, p = 0.92) and sex (male 64.6 % vs. 66.8 %, p = 0.52). The PDC <80 % group more often had various co-morbidities, and had significantly higher CHADS (2.14 vs. 2.28, p = 0.04) and CHADS-VASc scores (3.12 vs. 3.31, p = 0.045). There was no significant difference in HAS-BLED score (1.41 vs. 1.47, p = 0.39). During 2-year follow-up, the incidences of stroke or systemic embolism (1.14 vs. 3.56 % per patient-year, p < 0.01), major bleeding (0.59 vs. 1.78 % per patient-year, p < 0.01), and net clinical outcome (the composite of stroke, systemic embolism, major bleeding, or death) (3.49 vs. 7.78 % per patient-year, p < 0.01) were significantly higher in the poor adherence group; however, there was no significant difference in all-cause (1.89 vs. 2.73 % per patient-year, p = 0.23) and cardiovascular mortality (0.86 vs. 1.49 % per patient-year, p = 0.18). Multivariate analysis revealed that the poor adherence group was independently associated with stroke or systemic embolism (adjusted hazard ratio 3.12, 95 % confidence interval 1.79-5.47), major bleeding (2.87, 1.31-6.34), and net clinical outcome, (2.02, 1.39-2.93), but not with all-cause (1.18, 0.64-2.17) or cardiovascular death (1.39, 0.60-2.93).
CONCLUSIONS
Poor anticoagulant adherence, as measured by PDC <80 %, was associated with higher incidence of stroke or systemic embolism and major bleeding in the GENERAL study.
背景
口服抗凝治疗对于预防心房颤动（AF）患者的中风至关重要。然而，抗凝药物依从性差可能会妨碍药物安全性和中风的有效预防。
方法
GENERAL 是一项在日本由全科医生为服用利伐沙班的 AF 患者进行的前瞻性队列研究。在这项研究中，抗凝药物依从性通过比例天数覆盖（PDC）来计算，患者被回顾性地分为两组：药物依从性好（PDC≥80%）和药物依从性差（<80%）。
结果
在 GENERAL 研究的 5680 名患者中，药物依从性差的患者有 223 名（3.9%）。在年龄（药物依从性好：73.9 岁；药物依从性差：74.0 岁，p=0.92）和性别（男性：64.6%；药物依从性差：66.8%，p=0.52）方面，两组的基线临床特征几乎相似。药物依从性差的患者更常患有各种合并症，并且 CHADS（2.14 与 2.28，p=0.04）和 CHADS-VASc 评分（3.12 与 3.31，p=0.045）明显更高。HAS-BLED 评分无显著差异（1.41 与 1.47，p=0.39）。在 2 年的随访期间，药物依从性差的患者中风或全身性栓塞（1.14 与每患者每年 3.56%，p<0.01）、大出血（0.59 与每患者每年 1.78%，p<0.01）和净临床结局（中风、全身性栓塞、大出血或死亡的复合结局）（3.49 与每患者每年 7.78%，p<0.01）的发生率明显更高；然而，全因死亡率（1.89 与每患者每年 2.73%，p=0.23）和心血管死亡率（0.86 与每患者每年 1.49%，p=0.18）无显著差异。多变量分析显示，药物依从性差与中风或全身性栓塞（调整后的危险比 3.12，95%置信区间 1.79-5.47）、大出血（2.87，1.31-6.34）和净临床结局（2.02，1.39-2.93）独立相关，但与全因死亡率（1.18，0.64-2.17）或心血管死亡率（1.39，0.60-2.93）无关。
结论
在 GENERAL 研究中，PDC<80%的抗凝药物低依从性与中风或全身性栓塞和大出血的发生率升高相关。
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