A Gender-based analysis from the RAIN-CARDIOGROUP VII study (veRy thin stents for patients with left mAIn or bifurcatioN in real life) on Left-main stenting

Introduction. There is a lack of data on clinical outcomes of percutaneous coronary intervention (PCI) with ultrathin stents on unprotected left main (ULM) coronary artery both in women and men.
Methods. All patients treated with ULM PCI with ultrathin stents (struts thinner than 81 µm) enrolled in the RAIN-cardiogroup VII Study were analysed according to a gender-assessment evaluation. Major adverse cardiovascular events (MACE: a composite of all cause death, myocardial infarction, target lesion revascularization [TLR] and stent thrombosis) were the primary end-point, whereas single components of MACE were the secondary end-points.
Results. Out of a cohort of 793 patients, 172 (21.7%) women and 621 (78.3%) men were included. Compared to men, women were older and less frequently smokers, had more frequently a history of previous PCI and presented more frequently with an acute coronary syndrome. Among women, ostial lesions were more prevalent and mean diameter stent was lower compared to men. After 13.4 (8.4-21.6) months, 32 (18.6%) women and 106 (17.1%) men experienced MACE (p=0.64). Censoring follow-up data at 3 years, no differences were observed in MACE (16.9 vs 14.7 per 100*pts/years, log-rank p=0.61) and their single components between women and men. At multivariate analysis, chronic kidney disease (HR 1.91: 1.23 -2.95, p=0.004) and acute coronary syndrome presentation (HR 1.84: 1.22-2.77, p=0.013) were independent predictors of MACE overall. Larger stent size (HR 0.65, 95% CI 0.48-0.89, p=0.007) and longer double antiplatelet therapy duration (HR 0.95, 95% CI 0.90-0.99, p=0.032) were associated with a reduced risk of MACE during the subsequent follow-up
Conclusion. Ultrathin stents offer low rates of MACE and TLR in the overall population without significant differences between sexes.

引言。针对使用超薄支架（支架直径小于81微米）进行冠状动脉介入治疗（PCI）的无保护左主干冠状动脉（ULM）的临床结果数据，无论是男性还是女性，均存在匮乏之态。方法。根据性别评估标准，对所有纳入RAIN-cardiogroup VII研究的采用超薄支架进行ULM PCI治疗的病人进行了分析。主要不良心血管事件（MACE：包括全因死亡、心肌梗死、靶病变血运重建[TLR]和支架内血栓形成的复合指标）为研究的首要终点，而MACE的单个组成部分则为次要终点。结果。在793名患者队列中，包括172名（21.7%）女性和621名（78.3%）男性。与男性相比，女性年龄更大，吸烟者比例更低，既往PCI病史更为常见，且更频繁地出现急性冠状动脉综合征。在女性患者中，开口病变更为普遍，且平均支架直径低于男性。经过13.4个月（8.4-21.6）的随访后，32名（18.6%）女性和106名（17.1%）男性经历了MACE（p=0.64）。在3年的随访截止时，女性与男性在MACE（每100*pts/years 16.9 vs 14.7，log-rank p=0.61）及其单一路径上未观察到显著差异。在多变量分析中，慢性肾病（HR 1.91：1.23-2.95，p=0.004）和急性冠状动脉综合征的发作（HR 1.84：1.22-2.77，p=0.013）是MACE的独立预测因素。较大的支架尺寸（HR 0.65，95% CI 0.48-0.89，p=0.007）和更长的双重抗血小板治疗持续时间（HR 0.95，95% CI 0.90-0.99，p=0.032）与后续随访期间MACE风险降低相关。结论。超薄支架在总体人群中提供了低MACE和TLR发生率，且在性别之间未见显著差异。