非ST段抬高急性冠状动脉综合征患者介入治疗的性别差异

目的 比较非ST段抬高急性冠状动脉综合征患者介入治疗的性别差异.方法 为多中心随机研究,在全国24家医院,根据入选标准将非ST段抬高的急性冠状动脉综合征患者随机分配至早期介入组(24 h内接受冠状动脉造影)和延迟介入组(36 h后接受冠状动脉造影).分别观察介入治疗后不同性别的主要终点事件(180 d随访时死亡、心肌梗死、卒中的复合终点),次要终点事件(180 d随访时死亡、心肌梗死、难治性缺血、卒中、再次血运重建).结果 共有815例患者入选,其中男性545例,女性270例.男性和女性患者主要终点和次要终点事件发生率差异无统计学意义(P＞0.05).男性患者早介入组主要终点事件发生率明显低于延迟介入组(分别为7.1%、14.8%,P=0.00);两组次要终点事件发生率,即180 d随访时死亡、心肌梗死或难治性心肌缺血发生率分别为12.5%、21.2%,差异有统计学意义(P=0.00);另一个次要终点事件发生率,即180 d随访时死亡、心肌梗死、卒中、难治性心肌缺血或再次血运重建发生率分别为26.8%、32.4%,两组差异无统计学意义(P＞0.05).女性早期介入组和延迟介入组间主要终点事件发生率(分别为12.6%、14.3%,P＞0.05)和两个次要终点事件发生率(分别为18.5%、23.5%,P＞0.05;28.5%、27.7%,P＞0.05)差异均无统计学意义.结论 男性和女性非ST段抬高急性冠状动脉综合征患者介入治疗的疗效和安全性无明显差异;但男性患者早期介入治疗可减少心肌梗死的发生率,女性患者早期和延迟介入治疗均无明显差异.

Gender-based analyses of intervention outcome in non-ST segment elevation acute coronary syndrome

Objective To investigate the impact of gender on outcomes in patients with non-ST segment elevation acute coronary syndrome undergoing intervention treatment. Methods In a multi-center randomized trial, the patients diagnosed as non-ST segment elevation acute coronary syndrome were randomly assigned to undergo early intervention ( coronary angiography ≤ 24 h after randomization) or delayed intervention ( coronary angiography ≥ 36 h after randomization) . The primary outcome was a composite of death, myocardial infarction or stroke at 180 days. The secondary outcomes were death, myocardial infarction, refractory ischemia, stroke or revascularization at 180 days. Results Among 815 patients (545 males, 270 females) , the incidences of primary and secondary outcome were equivalent for both genders ( P > 0. 05). Males of the early intervention group had a greater incidence of the primary outcome (7. 1 % vs 14. 8% , P=0. 00). The secondary outcome was a composite of death, myocardial infarction or refractory ischemia occurring in 12. 5% of males in early intervention group and 21. 2% in delayed intervention group. Significant difference existed ( P = 0. 00 ). The incidence of another secondary outcome as a composite of death, myocardial infarction, refractory ischemia, stroke or revascularization was equivalent for males in early intervention group and delayed intervention group (26.8% vs 32.4% , P>0. 05). The incidences of primary outcome ( 12. 6% vs 14. 3% , P > 0. 05 ) and secondary outcome ( 18. 5% vs 23. 5% P > 0. 05 ; 28. 5% vs 27. 7% P > 0. 05 ) were equivalent for females in early intervention group and delayedintervention group (P > 0.05). Conclusion Patients with non-ST segment elevation acute coronary syndrome undergoing intervention demonstrate no significant gender differences in efficacy and safety. Early intervention reduces the rate of myocardial infarction for males, but it is not superior to delayed intervention for females.