Department of Cardiology, Thoraxcentre, Erasmus Medical Centre, Rotterdam 3015 GD, the Netherlands.
First Department of Cardiology, Medical University of Warsaw, Warsaw 02-091, Poland.
Eur Heart J Cardiovasc Pharmacother. 2022 Jan 5;8(1):39-47. doi: 10.1093/ehjcvp/pvaa110.
The aim of this study was to investigate the efficacy and safety of ticagrelor monotherapy in patients undergoing percutaneous coronary intervention (PCI) stratified according to the baseline white blood cell (WBC) count.
This is a post hoc analysis of the GLOBAL LEADERS trial, a multi-centre, open-label, randomized all-comer trial in patients undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual anti-platelet therapy [DAPT]) with the reference strategy (12-month aspirin monotherapy following 12-month DAPT). Patients were stratified into two WBC groups, either < or ≥median WBC count of 7.8 × 109 cells/L (lower or higher WBC group, respectively). The primary endpoint was a composite of all-cause mortality or new Q-wave myocardial infarction at 2 years. Of 14 576 patients included in the present study, 7212 patients (49.5%) were classified as the lower WBC group, who had a significantly lower risk of both ischaemic and bleeding outcomes at 2 years. At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group [2.8% vs. 4.2%; hazard ratio (HR): 0.67; 95% confidence interval (CI): 0.52-0.86] but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82-1.25; Pinteraction=0.013). There were no significant differences in the risks of Bleeding Academic Research Consortium type 3 or 5 bleeding between two anti-platelet strategies regardless of the WBC groups.
Increased WBC counts, which may reflect degree of inflammation, at the time of index procedure may attenuate the anti-ischaemic benefits of ticagrelor monotherapy observed in patients with lower WBC counts.
本研究旨在探讨根据基线白细胞（WBC）计数对行经皮冠状动脉介入治疗（PCI）的患者进行替格瑞洛单药治疗的疗效和安全性。
这是 GLOBAL LEADERS 试验的事后分析，该试验为多中心、开放标签、随机、所有患者入组的 PCI 试验，比较了实验策略（1 个月双联抗血小板治疗[DAPT]后 23 个月替格瑞洛单药治疗）与参考策略（12 个月 DAPT 后 12 个月阿司匹林单药治疗）。患者按两个 WBC 组分层，WBC 中位数<或≥7.8×109 个细胞/L（分别为低 WBC 组和高 WBC 组）。主要终点为 2 年时全因死亡率或新发 Q 波心肌梗死的复合终点。在本研究纳入的 14576 例患者中，7212 例（49.5%）患者被归类为低 WBC 组，2 年时两组缺血和出血结局的风险均显著降低。2 年时，与参考策略相比，低 WBC 组中实验策略与较低的主要终点发生率相关[2.8%比 4.2%；风险比（HR）：0.67；95%置信区间（CI）：0.52-0.86]，但在高 WBC 组中则无相关性（4.8%比 4.7%；HR：1.01；95% CI：0.82-1.25；P 交互=0.013）。无论 WBC 组如何，两种抗血小板策略之间的 Bleeding Academic Research Consortium 3 型或 5 型出血风险均无显著差异。
在指数手术时白细胞计数的增加，可能反映炎症的程度，可能会削弱在低白细胞计数患者中观察到的替格瑞洛单药治疗的抗缺血益处。
