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Abstract：
BACKGROUND: In post-stroke atrial fibrillation (AF) patients who have indications for both oral anticoagulant (OAC) and antiplatelet agent (AP), e.g., those with carotid artery stenosis, there is debate over the best antithrombotic strategy. We aimed to compare the risks of ischemic stroke, composite of ischemic stroke/major bleeding and composite of ischemic stroke/intracranial hemorrhage (ICH) between different antithrombotic strategies.
METHODS: This study included post-stroke AF patients with and without extracranial artery stenosis (ECAS) (n = 6390 and 28,093, respectively) identified from the Taiwan National Health Insurance Research Database. Risks of clinical outcomes and net clinical benefit (NCB) with different antithrombotic strategies were compared to AP alone.
RESULTS: The risk of recurrent ischemic stroke was higher for patients with ECAS than those without (12.72%/yr versus 10.60/yr; adjusted hazard ratio [aHR] 1.104, 95% confidence interval [CI] 1.052-1.158, p < 0.001). For patients with ECAS, when compared to AP only, non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy was associated with lower risks for ischaemic stroke (aHR 0.551, 95% CI 0.454-0.669), the composite of ischaemic stroke/major bleeding (aHR 0.626, 95% CI 0.529-0.741) and the composite of ischaemic stroke/ICH (aHR 0.577, 95% CI 0.478-0.697), with non-significant difference for major bleeding and ICH. When compared to AP only, warfarin monotherapy was associated with higher risks of major bleeding (aHR 1.521, 95% CI 1.231-1.880), ICH (aHR 2.045, 95% CI 1.329-3.148), and the composite of ischaemic stroke and major bleeding. With combination of AP plus warfarin, there was an increase in ischaemic stroke, major bleeding, and the composite outcomes, when compared to AP only. NOAC monotherapy was the only approach associated with a positive NCB, while all other options (warfarin, combination of AP-OAC) were associated with negative NCB.
CONCLUSIONS: For post-stroke AF patients with ECAS, NOAC monotherapy was associated with lower risks of adverse outcomes and a positive NCB. Combination of AP with NOAC or warfarin did not offer any benefit, but more bleeding especially with AP-warfarin combination therapy.
METHODS: This study included post-stroke AF patients with and without extracranial artery stenosis (ECAS) (n = 6390 and 28,093, respectively) identified from the Taiwan National Health Insurance Research Database. Risks of clinical outcomes and net clinical benefit (NCB) with different antithrombotic strategies were compared to AP alone.
RESULTS: The risk of recurrent ischemic stroke was higher for patients with ECAS than those without (12.72%/yr versus 10.60/yr; adjusted hazard ratio [aHR] 1.104, 95% confidence interval [CI] 1.052-1.158, p < 0.001). For patients with ECAS, when compared to AP only, non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy was associated with lower risks for ischaemic stroke (aHR 0.551, 95% CI 0.454-0.669), the composite of ischaemic stroke/major bleeding (aHR 0.626, 95% CI 0.529-0.741) and the composite of ischaemic stroke/ICH (aHR 0.577, 95% CI 0.478-0.697), with non-significant difference for major bleeding and ICH. When compared to AP only, warfarin monotherapy was associated with higher risks of major bleeding (aHR 1.521, 95% CI 1.231-1.880), ICH (aHR 2.045, 95% CI 1.329-3.148), and the composite of ischaemic stroke and major bleeding. With combination of AP plus warfarin, there was an increase in ischaemic stroke, major bleeding, and the composite outcomes, when compared to AP only. NOAC monotherapy was the only approach associated with a positive NCB, while all other options (warfarin, combination of AP-OAC) were associated with negative NCB.
CONCLUSIONS: For post-stroke AF patients with ECAS, NOAC monotherapy was associated with lower risks of adverse outcomes and a positive NCB. Combination of AP with NOAC or warfarin did not offer any benefit, but more bleeding especially with AP-warfarin combination therapy.
摘要：
背景：在有口服抗凝药（OAC）和抗血小板药（AP）适应症的卒中后房颤（AF）患者中，例如，颈动脉狭窄患者,关于最佳抗血栓策略存在争议.我们的目的是比较缺血性中风的风险，不同抗血栓策略之间的缺血性卒中/大出血和缺血性卒中/颅内出血（ICH）的复合。
方法：本研究包括来自台湾国家健康保险研究数据库的有和没有颅外动脉狭窄（ECAS）的卒中后房颤患者（分别为6390和28,093）。将不同抗血栓策略的临床结果和净临床获益（NCB）的风险与单纯AP进行比较。
结果：ECAS患者发生复发性缺血性卒中的风险高于无ECAS患者（12.72%/年对10.60/年；校正风险比[aHR]1.104，95%置信区间[CI]1.052-1.158，p<0.001）。对于ECAS患者，与仅AP相比，非维生素K拮抗剂口服抗凝剂（NOAC）单药治疗与缺血性卒中风险降低相关（aHR0.551,95%CI0.454-0.669），缺血性卒中/大出血的复合（aHR0.626，95％CI0.529-0.741）和缺血性卒中/ICH的复合（aHR0.577，95％CI0.478-0.697），大出血和ICH无显著差异。与仅AP相比，华法林单药治疗与较高的大出血风险相关(aHR1.521,95%CI1.231-1.880),ICH（AHR2.045，95%CI1.329-3.148），以及缺血性中风和大出血的复合物。联合AP加华法林,缺血性中风增加,大出血,以及综合结果，与仅AP相比。NOAC单药治疗是唯一与NCB阳性相关的方法，而所有其他选择(华法林，AP-OAC组合）与NCB阴性相关。
结论：对于有ECAS的卒中后房颤患者，NOAC单药治疗与较低的不良结局风险和阳性NCB相关。AP与NOAC或华法林的组合没有任何好处，但出血更多，尤其是AP-华法林联合治疗。
方法：本研究包括来自台湾国家健康保险研究数据库的有和没有颅外动脉狭窄（ECAS）的卒中后房颤患者（分别为6390和28,093）。将不同抗血栓策略的临床结果和净临床获益（NCB）的风险与单纯AP进行比较。
结果：ECAS患者发生复发性缺血性卒中的风险高于无ECAS患者（12.72%/年对10.60/年；校正风险比[aHR]1.104，95%置信区间[CI]1.052-1.158，p<0.001）。对于ECAS患者，与仅AP相比，非维生素K拮抗剂口服抗凝剂（NOAC）单药治疗与缺血性卒中风险降低相关（aHR0.551,95%CI0.454-0.669），缺血性卒中/大出血的复合（aHR0.626，95％CI0.529-0.741）和缺血性卒中/ICH的复合（aHR0.577，95％CI0.478-0.697），大出血和ICH无显著差异。与仅AP相比，华法林单药治疗与较高的大出血风险相关(aHR1.521,95%CI1.231-1.880),ICH（AHR2.045，95%CI1.329-3.148），以及缺血性中风和大出血的复合物。联合AP加华法林,缺血性中风增加,大出血,以及综合结果，与仅AP相比。NOAC单药治疗是唯一与NCB阳性相关的方法，而所有其他选择(华法林，AP-OAC组合）与NCB阴性相关。
结论：对于有ECAS的卒中后房颤患者，NOAC单药治疗与较低的不良结局风险和阳性NCB相关。AP与NOAC或华法林的组合没有任何好处，但出血更多，尤其是AP-华法林联合治疗。
