Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München (J.J.C., S.K., A.A., A.K., S.C.), Technische Universität München, Munich, Germany.
Department of Cardiology, Inselspital (L.R., S. Bär, S.W.), Bern University Hospital, University of Bern, Switzerland.
Circulation. 2023 Feb 14;147(7):575-585. doi: 10.1161/CIRCULATIONAHA.122.062049. Epub 2023 Feb 13.
Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up.
Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed.
Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HR], 0.94 [95% CI, 0.80-1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HR, 0.80 [95% CI, 0.74-0.87]), target vessel (HR, 0.81 [95% CI, 0.76-0.87]), and nontarget vessels (HR, 0.69 [95% CI, 0.62-0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HR, 1.65 [95% CI, 1.24-2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HR, 1.14 [95% CI, 0.89-1.47]).
Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.
虽然一些研究已经调查了经皮冠状动脉介入治疗（PCI）后长达 5 年的与性别相关的结果，但缺乏在大队列中对仅接受药物洗脱支架（DES）平台治疗的患者进行更长随访（即 10 年）的分析。因此，本研究旨在确定在 DES 时代和更长的随访时间内，PCI 后长期结局的性别差异是否仍然存在。
汇总了 5 项随机对照试验中接受 DES 治疗的患者的个体数据，这些试验均进行了 10 年随访。根据性别将患者分为两组。通过在所有单变量和多变量模型中按父研究输入聚类效应，对个体参与者数据进行了 1 期分析，重点关注性别。本分析的主要终点包括 PCI 后 10 年内的心血管死亡、心肌梗死、再次血运重建和确定的支架血栓形成。通过 Kaplan-Meier 法分析生存情况，以估计首次事件的时间，并通过对数秩检验检验两组之间的差异。使用 Cox 比例风险模型计算风险比（HR）和 95%置信区间。进行了常规多变量分析，并对相关变量进行了调整。
在本分析中纳入的 9700 例接受 DES 植入的 PCI 患者中，2296 例为女性，7404 例为男性。随访至 10 年时，2296 例女性患者中有 407 例发生心血管死亡，7404 例男性患者中有 1012 例发生心血管死亡（校正 HR [HR]，0.94 [95%CI，0.80-1.11]）。女性发生靶病变（HR，0.80 [95%CI，0.74-0.87]）、靶血管（HR，0.81 [95%CI，0.76-0.87]）和非靶血管（HR，0.69 [95%CI，0.62-0.77]）的再次血运重建风险较低。与男性患者相比，女性患者在 DES 置入后 30 天内发生心肌梗死的风险增加（HR，1.65 [95%CI，1.24-2.19]），但此后风险相当。女性患者与男性患者的明确支架血栓形成风险无显著差异（HR，1.14 [95%CI，0.89-1.47]）。
在 DES 置入后的 10 年随访中，与男性患者相比，女性患者发生早期心肌梗死的风险增加，接受再次血运重建的次数较少，但心血管死亡率无差异。
