Division of Cardiology, Careggi Hospital, Florence, Italy.
Am J Cardiol. 2012 Jan 15;109(2):214-8. doi: 10.1016/j.amjcard.2011.08.034. Epub 2011 Oct 12.
Recent guidelines have recommended the use of aspirin and prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention. However, prasugrel use has been evaluated only in randomized trials. This study sought to evaluate bleeding rates and adherence to treatment in "real-world" patients treated with prasugrel. In total 298 consecutive patients 68 ± 10 years old (31% >75 years old) underwent stent implantation and received prasugrel therapy. Indications to prasugrel therapy were (1) ST-elevation acute myocardial infarction (41%), (2) drug-eluting stent implantation in diabetics (24%), (3) stent thrombosis (3%), (4) left main coronary artery drug-eluting stent implantation (6%), and (5) percutaneous coronary intervention in patients with high residual platelet reactivity on clopidogrel therapy (26%). All patients received a loading of prasugrel 60 mg. Patients ≥75 years old and with body weight ≤60 kg received a maintenance dose of 5 mg/day (10 mg/day for all the other patients). Follow-up data including adherence to prasugrel therapy were collected by telephone interviews or outpatient visits. Minimal follow-up length was 6 months (mean 9 ± 3). Major, minor, and minimal bleedings (Thrombolysis In Myocardial Infarction criteria) occurred in 2.7%, 4.7%, and 15.1% of enrolled patients. Low residual platelet reactivity (p = 0.001) and female gender (p = 0.29) were independent predictors of bleeding events. The most frequent minimal bleeding event was epistaxis. Only 8 patients (2.7%) permanently discontinued prasugrel therapy because of bleeding events (n = 4), possible side effects (n = 2), or medical decisions not associated with bleeding or side effects (n = 2). Fourteen patients (4.7%) temporarily discontinued prasugrel (average 6.5 days) mainly because of surgical procedures. No definite or probable stent thrombosis occurred, although 3 patients develop de novo myocardial infarction and 1 an ischemic stroke. There were 11 deaths because of heart failure or refractory cardiogenic shock in 9, pulmonary embolism in 1, and cancer in 1. In conclusion, in clinical practice, major and minor bleeding event rates associated with prasugrel therapy are comparable to those reported in controlled randomized trials. The minimal bleeding event rate is higher than reported but does not seem to affect adherence to treatment.
最近的指南建议，在接受经皮冠状动脉介入治疗的急性冠脉综合征患者中使用阿司匹林和普拉格雷。然而，普拉格雷的使用仅在随机试验中进行了评估。本研究旨在评估“真实世界”患者使用普拉格雷的出血率和治疗依从性。共有 298 例连续患者（68±10 岁，31%>75 岁）接受支架植入并接受普拉格雷治疗。普拉格雷治疗的适应证为：（1）ST 段抬高型急性心肌梗死（41%）；（2）糖尿病患者药物洗脱支架植入（24%）；（3）支架血栓形成（3%）；（4）左主干药物洗脱支架植入（6%）；（5）对氯吡格雷治疗后血小板反应性高的患者行经皮冠状动脉介入治疗（26%）。所有患者均接受普拉格雷 60mg 负荷量。年龄≥75 岁且体重≤60kg 的患者给予 5mg/天维持剂量（其余患者给予 10mg/天）。通过电话访谈或门诊随访收集包括普拉格雷治疗依从性在内的随访数据。最小随访时间为 6 个月（平均 9±3 个月）。纳入患者中有 2.7%、4.7%和 15.1%发生主要、次要和最小出血（血栓溶解心肌梗死标准）。低残余血小板反应性（p=0.001）和女性（p=0.29）是出血事件的独立预测因子。最常见的最小出血事件是鼻出血。仅 8 例患者（2.7%）因出血事件（n=4）、可能的副作用（n=2）或与出血或副作用无关的医疗决策（n=2）而永久停用普拉格雷治疗。14 例患者（4.7%）因手术（平均 6.5 天）暂时停用普拉格雷。尽管 3 例患者新发心肌梗死，1 例发生缺血性卒中，但未发生明确或可能的支架血栓形成。因心力衰竭或难治性心源性休克死亡 9 例（其中 1 例因癌症死亡），肺栓塞 1 例，癌症 1 例。总之，在临床实践中，与普拉格雷治疗相关的主要和次要出血事件发生率与对照随机试验报告的相似。最小出血事件发生率高于报告，但似乎不影响治疗的依从性。
