经皮冠状动脉介入治疗后获得性血小板减少症的发生率、预测因素和结局：CHAMPION 试验（替卡格雷与标准治疗以实现血小板抑制最佳管理）的汇总、患者水平分析。
Incidence, Predictors, and Outcomes of Acquired Thrombocytopenia After Percutaneous Coronary Intervention: A Pooled, Patient-Level Analysis of the CHAMPION Trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition).
机构信息
From the Division of Cardiology, Scripps Clinic, La Jolla, CA (E.M.G., M.J.P.); Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.); FACT (French Alliance for Cardiovascular clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique-Hôpitaux de Paris, France (P.G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Science and Strategy Consulting Group, Basking Ridge, NJ (E.N.D.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York City, NY (G.W.S.); Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.M.G.); Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany (C.W.H.); Division of Cardiology (K.W.M.), Department of Medicine, Division of Cardiology (R.A.H.), Stanford University Medical School, CA; Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.); Division of Cardiology, University of Florida, Jacksonville (D.A.); and Elysis, Llc, Carlisle, MA (J.P.).
出版信息
Circ Cardiovasc Interv. 2018 Apr;11(4):e005635. doi: 10.1161/CIRCINTERVENTIONS.117.005635.
BACKGROUND
The influence of cangrelor on the incidence and outcomes of post-percutaneous coronary intervention (PCI) thrombocytopenia is not defined. We aimed to explore the incidence, predictors, and clinical impact of thrombocytopenia after PCI in cangrelor-treated patients.
METHODS AND RESULTS
This was a pooled, patient-level analysis of the CHAMPION trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition), which compared cangrelor with clopidogrel for prevention of thrombotic complications during and after PCI. Acquired thrombocytopenia was defined as either a drop in platelet count to <100 000 after PCI or a drop of >50% between baseline and a follow-up. The main efficacy outcome was major adverse cardiac events. The primary safety outcome was noncoronary artery bypass grafting-related Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries-defined severe bleeding at 48 hours. Patients (23 783) were enrolled, and 3009 (12.7%) received a GPI (glycoprotein IIb/IIIa inhibitor). Acquired thrombocytopenia occurred in 200 patients (0.8%). The adjusted rate of major adverse cardiovascular events at 48 hours was significantly higher in patients who developed thrombocytopenia compared with those who did not (odds ratio, 3.00; 95% confidence interval, 1.89-4.69; <0.001), as was major bleeding (odds ratio, 14.71; 95% confidence interval, 5.96-36.30; <0.001). GPI use was the strongest independent predictor of acquired thrombocytopenia (odds ratio, 2.93; 95% confidence interval, 2.15-3.97; <0.0001). There was no difference in the rate of acquired thrombocytopenia in patients randomized to cangrelor or clopidogrel.
CONCLUSIONS
Acquired thrombocytopenia after PCI is strongly associated with substantial early morbidity and mortality, as well as major bleeding. GPI use is a significant predictor of thrombocytopenia. Cangrelor is not associated with acquired thrombocytopenia, and its clinical efficacy and safety is consistent irrespective of thrombocytopenia occurrence.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00305162, NCT00385138, and NCT01156571.
背景
目前尚不清楚坎格雷洛对经皮冠状动脉介入治疗（PCI）后血小板减少症的发生率和结局的影响。本研究旨在探讨接受坎格雷洛治疗的患者 PCI 后血小板减少症的发生率、预测因素和临床影响。
方法和结果
这是对 CHAMPION 试验（坎格雷洛与标准疗法治疗血小板抑制优化管理的比较）的患者水平汇总分析，该试验比较了坎格雷洛与氯吡格雷在 PCI 期间和之后预防血栓并发症的效果。获得性血小板减少症定义为 PCI 后血小板计数降至<100 000/μL，或基线至随访时血小板计数下降>50%。主要疗效结局是主要不良心脏事件。主要安全性结局是 48 小时内非冠状动脉旁路移植术相关的全球使用链激酶和组织型纤溶酶原激活剂治疗闭塞冠状动脉定义的严重出血。共纳入 23 783 例患者，其中 3009 例（12.7%）接受了糖蛋白 IIb/IIIa 抑制剂（GPI）治疗。200 例（0.8%）患者发生获得性血小板减少症。与未发生血小板减少症的患者相比，发生血小板减少症的患者在 48 小时时主要心血管不良事件的调整发生率显著更高（比值比，3.00；95%置信区间，1.89-4.69；<0.001），大出血的发生率也更高（比值比，14.71；95%置信区间，5.96-36.30；<0.001）。GPI 治疗是获得性血小板减少症的最强独立预测因素（比值比，2.93；95%置信区间，2.15-3.97；<0.0001）。随机接受坎格雷洛或氯吡格雷治疗的患者获得性血小板减少症发生率无差异。
结论
PCI 后获得性血小板减少症与早期严重发病率和死亡率以及大出血密切相关。GPI 治疗是血小板减少症的显著预测因素。坎格雷洛与获得性血小板减少症无关，且其临床疗效和安全性不受血小板减少症发生与否的影响。
临床试验注册
网址：https://www.clinicaltrials.gov。唯一标识符：NCT00305162、NCT00385138 和 NCT01156571。
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