Department of Cardiology, Shenyang Northern Hospital, Shenyang, Liaoning 110016, China.
Chin Med J (Engl). 2013 Mar;126(6):1039-45.
The gender difference on long-term outcome in unselected patients after percutaneous coronary intervention (PCI) has not yet been fully investigated. This study aimed to evaluate the gender difference on five-year outcomes following EXCEL biodegradable polymer-coated sirolimus-eluting stenting in patients with coronary disease.
A total of 2077 "all comers", consisting of 1528 (73.6%) men and 549 (26.4%) women, who were exclusively treated with EXCEL coronary stents were enrolled in the prospective CREATE study at 59 centers from four countries. After propensity score matching, the baseline characteristics of the two groups were well matched. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The primary outcome that was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac mortality, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR), and stent thrombosis (ST) at five years were compared between the two gender groups.
In the two groups, women had higher proportions of clinical risk factors, such as being elderly, diabetes mellitus, hypertension and hyperlipidemia, compared to men. Besides, the mean target vessel number per patient was higher and the mean reference vessel diameter smaller for women. Men had higher risks of cardiac death (3.7% vs. 1.6%, P = 0.021) and MACE (8.4% vs. 4.7%, P = 0.004) at five years compared with women. However, the cumulative hazards of non-fatal MI and TLR were similar between men and women. The incidence of Academic Research Consortium (ARC) definite or probable stent thrombosis was similar between the two groups (1.3% vs. 1.0%, P = 0.639). Prolonged clopidogrel therapy (>6 months) did not reduce the cumulative hazards of ST from six months to five years in both men (χ(2) = 0.098, log rank P = 0.754) and women (χ(2) = 2.043, log rank P = 0.153) patients.
Women had a lower MACE and cardiac death rate than men after biodegradable polymer-coated sirolimus-eluting stenting in long term follow-up. Effects of prolonged dual antiplatelet therapy (DAPT) in preventing stent thrombosis was similar with six-month DAPT after EXCEL stent implantation in both men and women groups.
经皮冠状动脉介入治疗（PCI）后，未选择患者的性别对长期结果的影响尚未得到充分研究。本研究旨在评估在患有冠状动脉疾病的患者中，EXCEL 可生物降解聚合物涂层西罗莫司洗脱支架五年后，性别对结局的影响。
共有 2077 名“所有患者”，包括 1528 名（73.6%）男性和 549 名（26.4%）女性，仅接受 EXCEL 冠状动脉支架治疗，他们来自四个国家的 59 个中心参与了前瞻性 CREATE 研究。经倾向评分匹配后，两组的基线特征匹配良好。推荐的抗血小板治疗方案为氯吡格雷和阿司匹林 6 个月，然后长期服用阿司匹林。两组之间的主要终点是主要不良心脏事件（MACE）的发生率，定义为心脏死亡、非致死性心肌梗死（MI）和靶病变血运重建（TLR）和支架血栓形成（ST）的复合终点，随访 5 年。
两组中，女性的临床危险因素（如年龄较大、糖尿病、高血压和高脂血症）比例高于男性。此外，女性患者的平均靶血管数/患者更高，参考血管直径更小。与女性相比，男性在 5 年内的心脏死亡（3.7% vs. 1.6%，P = 0.021）和 MACE（8.4% vs. 4.7%，P = 0.004）的风险更高。然而，男性和女性之间非致死性 MI 和 TLR 的累积危险相似。两组之间 ARC 确定或可能的支架血栓形成发生率相似（1.3% vs. 1.0%，P = 0.639）。延长氯吡格雷治疗（>6 个月）并不能降低男性（χ(2) = 0.098，log rank P = 0.754）和女性（χ(2) = 2.043，log rank P = 0.153）患者从 6 个月到 5 年的 ST 累积危险。
在长期随访中，与男性相比，女性在接受可生物降解聚合物涂层西罗莫司洗脱支架后，MACE 和心脏死亡率较低。在 EXCEL 支架植入后，延长双联抗血小板治疗（DAPT）对预防支架血栓形成的效果与 6 个月 DAPT 相似。
