Abstract：
OBJECTIVE: Sex is associated with clinical outcome in stroke. The present study aimed to determine the effect of sex on efficacy of dual antiplatelet (DAPT) versus alteplase in ischemic stroke based on Antiplatelet versus recombinant tissue plasminogen activator (R-tPA) for Acute Mild Ischemic Stroke (ARAMIS) trial.
METHODS: In this secondary analysis of the ARAMIS study, eligible patients aged 18 years or older with minor nondisabling stroke who received dual antiplatelet therapy or intravenous alteplase within 4.5 h of stroke onset were divided into two groups: men and women. The primary endpoint was an excellent functional outcome, defined as a modified Rankin Scale (mRS) 0-1 at 90 days. Binary logistic regression analyses and generalized linear models were used.
RESULTS: Of the 719 patients who completed the study, 31% (223) were women, and 69% (496) were men. There were no significant sex differences in excellent functional outcome (unadjusted p = 0.304 for men and p = 0.993 for women; adjusted p = 0.376 for men and p = 0.918 for women) and favorable functional outcome (mRS score of 0-2; unadjusted p = 0.968 for men and p = 0.881 for women; adjusted p = 0.824 for men and p = 0.881 for women). But for the secondary outcomes, compared with alteplase, DAPT was associated with a significantly decreased proportion of early neurological deterioration within 24 h in men {unadjusted odds ratio [OR] = 0.440 [95% confidence interval (CI), 0.221-0.878]; p = 0.020; adjusted OR = 0.436 [95% CI, 0.216-0.877]; p = 0.020}, but not in women [unadjusted OR = 0.636 (95% CI, 0.175-2.319), p = 0.490; adjusted OR = 0.687 (95% CI, 0.181-2.609), p = 0.581]. For the safety outcomes, compared with the DAPT group, alteplase was associated with a significantly increased proportion of any bleeding events in men [unadjusted OR = 3.110 (95% CI, 1.103-8.770); p = 0.032], but not in women [unadjusted OR = 5.333 (95% CI, 0.613-46.407), p = 0.129; adjusted OR = 5.394 (95% CI, 0.592-49.112), p = 0.135].
CONCLUSIONS: Sex did not influence the effect of dual antiplatelet therapy versus intravenous alteplase in minor nondisabling stroke, but more early neurological deterioration and bleeding events occurred in men who received alteplase.
METHODS: In this secondary analysis of the ARAMIS study, eligible patients aged 18 years or older with minor nondisabling stroke who received dual antiplatelet therapy or intravenous alteplase within 4.5 h of stroke onset were divided into two groups: men and women. The primary endpoint was an excellent functional outcome, defined as a modified Rankin Scale (mRS) 0-1 at 90 days. Binary logistic regression analyses and generalized linear models were used.
RESULTS: Of the 719 patients who completed the study, 31% (223) were women, and 69% (496) were men. There were no significant sex differences in excellent functional outcome (unadjusted p = 0.304 for men and p = 0.993 for women; adjusted p = 0.376 for men and p = 0.918 for women) and favorable functional outcome (mRS score of 0-2; unadjusted p = 0.968 for men and p = 0.881 for women; adjusted p = 0.824 for men and p = 0.881 for women). But for the secondary outcomes, compared with alteplase, DAPT was associated with a significantly decreased proportion of early neurological deterioration within 24 h in men {unadjusted odds ratio [OR] = 0.440 [95% confidence interval (CI), 0.221-0.878]; p = 0.020; adjusted OR = 0.436 [95% CI, 0.216-0.877]; p = 0.020}, but not in women [unadjusted OR = 0.636 (95% CI, 0.175-2.319), p = 0.490; adjusted OR = 0.687 (95% CI, 0.181-2.609), p = 0.581]. For the safety outcomes, compared with the DAPT group, alteplase was associated with a significantly increased proportion of any bleeding events in men [unadjusted OR = 3.110 (95% CI, 1.103-8.770); p = 0.032], but not in women [unadjusted OR = 5.333 (95% CI, 0.613-46.407), p = 0.129; adjusted OR = 5.394 (95% CI, 0.592-49.112), p = 0.135].
CONCLUSIONS: Sex did not influence the effect of dual antiplatelet therapy versus intravenous alteplase in minor nondisabling stroke, but more early neurological deterioration and bleeding events occurred in men who received alteplase.
摘要：
目的：性别与卒中的临床预后相关。本研究旨在基于抗血小板与重组组织型纤溶酶原激活剂（R-tPA）治疗急性轻度缺血性卒中（ARAMIS）的试验，确定性别对双联抗血小板（DAPT）与阿替普酶治疗缺血性卒中疗效的影响。
方法：在对ARAMIS研究的二次分析中，在卒中发病4.5h内接受双联抗血小板治疗或静脉注射阿替普酶的18岁或以上轻度非致残性卒中患者被分为两组:男性和女性.主要终点是出色的功能结局，定义为90天时的改良Rankin量表(mRS)0-1。使用二元逻辑回归分析和广义线性模型。
结果：在完成研究的719名患者中，31%(223)是女性，69%(496)是男性。在出色的功能结局（男性未调整p=0.304，女性p=0.993；男性调整p=0.376，女性p=0.918）和良好的功能结局（mRS评分为0-2；男性未调整p=0.968，女性p=0.881；男性调整p=0.824，女性p=0.881）没有显着的性别差异。但对于次要结果，与阿替普酶相比，DAPT与男性24小时内早期神经系统恶化的比例显著降低相关{未调整比值比[OR]=0.440[95%置信区间(CI),0.221-0.878]；p=0.020；调整后的OR=0.436[95%CI，0.216-0.877]；p=0.020}，但不是女性[未调整OR=0.636（95%CI，0.175-2.319），p=0.490；调整后OR=0.687（95%CI，0.181-2.609），p=0.581]。对于安全结果，与DAPT组相比，阿替普酶与男性出血事件的比例显着增加相关[未调整OR=3.110（95％CI，1.103-8.770）;p=0.032]，但不是女性[未调整OR=5.333（95％CI，0.613-46.407），p=0.129；调整后OR=5.394（95%CI，0.592-49.112），p=0.135]。
结论：性别不影响双重抗血小板治疗与阿替普酶静脉治疗对轻度非致残性卒中的效果，但在接受阿替普酶治疗的男性中,早期神经系统恶化和出血事件更多.
方法：在对ARAMIS研究的二次分析中，在卒中发病4.5h内接受双联抗血小板治疗或静脉注射阿替普酶的18岁或以上轻度非致残性卒中患者被分为两组:男性和女性.主要终点是出色的功能结局，定义为90天时的改良Rankin量表(mRS)0-1。使用二元逻辑回归分析和广义线性模型。
结果：在完成研究的719名患者中，31%(223)是女性，69%(496)是男性。在出色的功能结局（男性未调整p=0.304，女性p=0.993；男性调整p=0.376，女性p=0.918）和良好的功能结局（mRS评分为0-2；男性未调整p=0.968，女性p=0.881；男性调整p=0.824，女性p=0.881）没有显着的性别差异。但对于次要结果，与阿替普酶相比，DAPT与男性24小时内早期神经系统恶化的比例显著降低相关{未调整比值比[OR]=0.440[95%置信区间(CI),0.221-0.878]；p=0.020；调整后的OR=0.436[95%CI，0.216-0.877]；p=0.020}，但不是女性[未调整OR=0.636（95%CI，0.175-2.319），p=0.490；调整后OR=0.687（95%CI，0.181-2.609），p=0.581]。对于安全结果，与DAPT组相比，阿替普酶与男性出血事件的比例显着增加相关[未调整OR=3.110（95％CI，1.103-8.770）;p=0.032]，但不是女性[未调整OR=5.333（95％CI，0.613-46.407），p=0.129；调整后OR=5.394（95%CI，0.592-49.112），p=0.135]。
结论：性别不影响双重抗血小板治疗与阿替普酶静脉治疗对轻度非致残性卒中的效果，但在接受阿替普酶治疗的男性中,早期神经系统恶化和出血事件更多.
