Department of Cardiology, Heart Center Balatonfüred, Balatonfüred, Hungary.
Heart Institute, University of Pécs, Pécs, Hungary.
J Am Coll Cardiol. 2014 Mar 25;63(11):1061-70. doi: 10.1016/j.jacc.2013.12.023. Epub 2014 Jan 30.
This study sought to evaluate the impact of treatment with prasugrel and high-dose clopidogrel on the basis of platelet function testing in patients with acute coronary syndrome (ACS) who are undergoing percutaneous coronary intervention (PCI).
The clinical impact of treatment with prasugrel in patients with ACS who have high platelet reactivity (HPR) is unknown.
Patients with ACS who were pre-treated with clopidogrel and undergoing successful PCI were enrolled in a single-center, prospective registry. Platelet function was measured 12 to 36 h after PCI with the Multiplate device (Roche Diagnostics GmbH, Mannheim, Germany). Patients with HPR (>46 U) were switched to prasugrel or treated with high-dose clopidogrel, and those without HPR continued treatment with 75 mg of clopidogrel.
A total of 741 consecutive patients were enrolled in the study between September 2011 and August 2012, and 219 of these patients (29.5%) had HPR. Although platelet reactivity decreased after treatment adjustments in those with HPR, prasugrel provided significantly more potent platelet inhibition compared with high-dose clopidogrel (p < 0.0001). Compared with patients without HPR, the risk of all-cause death, myocardial infarction, stent thrombosis, or stroke at 1 year was significantly higher in the high-dose clopidogrel group (hazard ratio [HR]: 2.27; 95% confidence interval [CI]: 1.45 to 3.55; p < 0.0001), and patients who were switched to prasugrel had similar outcomes (HR: 0.90; 95% CI: 0.44 to 1.81; p = 0.76). Bleeding Academic Research Consortium (BARC) type 3/5 bleeding was also more frequent in patients treated with high-dose clopidogrel (HR: 2.09; 95% CI: 1.05 to 4.17; p = 0.04) than in patients switched to prasugrel (HR: 0.45; 95% CI: 0.11 to 1.91; p = 0.28). In a multivariate model, HPR with high-dose clopidogrel, but not with prasugrel, was an independent predictor of the composite ischemic endpoint (HR: 1.90; 95% CI: 1.17 to 3.08; p = 0.01).
Switching patients with ACS who have HPR to treatment with prasugrel reduces thrombotic and bleeding events to a level similar to that of those without HPR; however, there is a higher risk of both thrombotic and bleeding complications with high-dose clopidogrel.
本研究旨在评估在接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）患者中，根据血小板功能检测结果，使用普拉格雷和高剂量氯吡格雷治疗的效果。
目前尚不清楚在血小板高反应性（HPR）的 ACS 患者中使用普拉格雷治疗的临床影响。
在本单中心前瞻性登记研究中，纳入了预先使用氯吡格雷治疗且 PCI 成功的 ACS 患者。在 PCI 后 12 至 36 小时，使用 Multiplate 设备（Roche Diagnostics GmbH，德国曼海姆）测量血小板功能。对于 HPR（>46 U）的患者，将其转换为普拉格雷或接受高剂量氯吡格雷治疗，而没有 HPR 的患者继续接受 75 mg 氯吡格雷治疗。
2011 年 9 月至 2012 年 8 月期间，共纳入了 741 例连续患者，其中 219 例（29.5%）存在 HPR。尽管 HPR 患者在调整治疗后血小板反应性降低，但与高剂量氯吡格雷相比，普拉格雷提供了更有效的血小板抑制作用（p < 0.0001）。与没有 HPR 的患者相比，高剂量氯吡格雷组的全因死亡、心肌梗死、支架血栓形成或卒中的 1 年风险显著更高（风险比 [HR]：2.27；95%置信区间 [CI]：1.45 至 3.55；p < 0.0001），而转换为普拉格雷的患者具有相似的结局（HR：0.90；95%CI：0.44 至 1.81；p = 0.76）。高剂量氯吡格雷治疗组也更常发生出血学术研究联合会（BARC）3/5 型出血（HR：2.09；95%CI：1.05 至 4.17；p = 0.04），而转换为普拉格雷的患者出血风险较低（HR：0.45；95%CI：0.11 至 1.91；p = 0.28）。在多变量模型中，HPR 与高剂量氯吡格雷而非普拉格雷相关，是复合缺血终点的独立预测因素（HR：1.90；95%CI：1.17 至 3.08；p = 0.01）。
将 HPR 的 ACS 患者转换为普拉格雷治疗可将血栓形成和出血事件降低至与无 HPR 患者相似的水平；然而，高剂量氯吡格雷治疗的血栓形成和出血并发症风险更高。
