Gastrointestinal bleeding risk with rivaroxaban vs aspirin in atrial fibrillation: A multinational study

被引：4

作者：

Fanning, Laura ^{[1
,2
]}

Wong, Ian C. K. ^{[1
,3
]}

Li, Xue ^{[3
,4
,5
]}

Chan, Esther W. ^{[3
,6
]}

Mongkhon, Pajaree ^{[1
,7
,8
]}

Man, Kenneth K. C. ^{[1
,3
]}

Wei, Li ^{[1
]}

Leung, Wai K. ^{[9
]}

Darzins, Peteris ^{[2
]}

Bell, Simon ^{[10
,11
]}

Ilomaki, Jenni ^{[10
,11
]}

Lau, Wallis C. Y. ^{[1
,3
]}

机构：

[1] UCL, Sch Pharm, Res Dept Practice & Policy, Mezzanine Floor,British Med Assoc House,, London WC1H 9JP, England

[2] Monash Univ, Eastern Hlth Clin Sch, Fac Med Nursing & Hlth Sci, Melbourne, Vic, Australia

[3] Univ Hong Kong, Dept Pharmacol & Pharm, Li Ka Shing Fac Med, Ctr Safe Medicat Practice & Res, Hong Kong, Peoples R China

[4] Univ Hong Kong, Dept Paediat & Adolescent Med, Li Ka Shing Fac Med, Hong Kong, Peoples R China

[5] Univ Hong Kong, Dept Social Work & Social Adm, Fac Sci, Hong Kong, Peoples R China

[6] Univ Hong Kong Shenzhen Inst Res & Innovat, Shenzhen, Peoples R China

[7] Chiang Mai Univ, Pharmacoepidemiol & Stat Res Ctr PESRC, Fac Pharm, Chiang Mai, Thailand

[8] Univ Phayao, Sch Pharmaceut Sci, Muang, Thailand

[9] Univ Hong Kong, Dept Med, Hong Kong, Peoples R China

[10] Monash Univ, Fac Pharm & Pharmaceut Sci, Ctr Med Use & Safety, Melbourne, Vic, Australia

[11] Monash Univ, Dept Epidemiol & Prevent Med, Fac Med Nursing & Hlth Sci, Melbourne, Vic, Australia

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2020年 / 29卷 / 12期

基金：

英国医学研究理事会;

关键词：

anticoagulant; antiplatelet; atrial fibrillation; gastrointestinal bleeding; pharmacoepidemiology; ORAL ANTICOAGULANTS; STROKE; ASSOCIATION; DABIGATRAN; METAANALYSIS; PREVENTION; WARFARIN; THERAPY; NETWORK;

D O I：

10.1002/pds.5130

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Purpose Comparative gastrointestinal bleeding (GIB) risk between rivaroxaban and low-dose aspirin is unknown in patients with atrial fibrillation (AF). This study investigated GIB risk with rivaroxaban vs aspirin among two separate AF cohorts in Hong Kong and the United Kingdom, using a common protocol approach. Methods This was a population-based cohort study using separate data from the Clinical Data Analysis and Reporting System (CDARS) of the Hong Kong Hospital Authority (2010-2018) and The Health Improvement Network (THIN) database in the United Kingdom (2011-2017). Patients with AF newly prescribed aspirin or rivaroxaban were included. Cox proportional hazards regression was used to compare GIB risks for rivaroxaban vs aspirin, accounting for confounders using propensity score fine stratification approach. Results In CDARS, 29 213 patients were included; n = 1052 (rivaroxaban), n = 28 161 (aspirin). Crude GIB event rates per 100 patient-years in CDARS were 3.0 (aspirin) and 2.6 (rivaroxaban). No difference in GIB risk was observed between rivaroxaban and aspirin overall (HR = 1.04, 95%CI = 0.76-1.42), and in dose-stratified analyses (HR = 1.21, 95%CI = 0.84-1.74 [20 mg/day]; HR = 0.80, 95%CI = 0.44-1.45 [<= 15 mg/day]). In THIN, 11 549 patients were included, n = 3496 (rivaroxaban) and n = 8053 (aspirin). Crude GIB event rates were 1.3 (aspirin) and 2.4 (rivaroxaban) per 100 patient-years. No difference in GIB risk was observed between rivaroxaban and aspirin overall (HR = 1.40, 95%CI = 1.00-1.98) and low-dose rivaroxaban (<= 15 mg/day) (HR = 1.00, 95%CI = 0.56-1.30), but increased GIB risk was observed for rivaroxaban 20 mg/day vs aspirin (HR = 1.57, 95%CI = 1.08-2.29). Conclusion In patients with AF, GIB risk was comparable between aspirin and rivaroxaban <= 15 mg/day. GIB risk for rivaroxaban 20 mg/day vs aspirin remains uncertain and warrants further investigation.

引用

页码：1550 / 1561

页数：12

共 29 条

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