接受药物洗脱支架植入术患者中氯吡格雷与质子泵抑制剂的安全性
Safety of clopidogrel and proton pump inhibitors in patients undergoing drug-eluting stent implantation.
作者信息
Rossini Roberta, Capodanno Davide, Musumeci Giuseppe, Lettieri Corrado, Lortkipanidze Nikoloz, Romano Michele, Nijaradze Tamar, Tarantini Giuseppe, Cicorella Nicola, Sirbu Vasile, Guagliumi Giulio, Rosiello Renato, Valsecchi Orazio, Gavazzi Antonello
机构信息
Cardiovascular Department, Ospedali Riuniti di Bergamo, Bergamo, Italy.
出版信息
Coron Artery Dis. 2011 May;22(3):199-205. doi: 10.1097/MCA.0b013e328343b03a.
OBJECTIVE
A pharmacodynamic interaction between clopidogrel and proton pump inhibitors (PPIs) has been suggested, leading to reduced clopidogrel-induced platelet inhibitory effects. However, data from clinical studies are conflicting. The aim of this study was to evaluate the safety of long-term clopidogrel and PPI therapy.
METHODS
A total of 1328 consecutive patients (age 63±11 years; 81% male) undergoing drug-eluting stent implantation and 1-year follow-up were included. All patients were treated with a standard aspirin and clopidogrel treatment regimen for 12 months. The concomitant PPI therapy for the same duration was at the discretion of the clinical cardiologist. PPI therapy included lansoprazole (30 mg/day), pantoprazole (20 mg/day), or omeprazole (20 mg/day). At 1-year follow-up, major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), acute coronary syndrome leading to hospitalization and nonfatal stroke, were recorded. All cause death, any stent thrombosis (ST), and bleeding (Thrombolysis in MI major and minor) were also assessed.
RESULTS
Lansoprazole, pantoprazole, and omeprazole were administered to 855, 178, and 125 patients, whereas 170 were not prescribed any PPI therapy. Among patients treated with PPIs, those on pantoprazole had more often prior MI, multivessel coronary artery disease, and chronic kidney disease, whereas earlier peptic ulcer was more frequent among patients treated with omeprazole. The incidence of 1-year MACE was not statistically different between patients in the PPI and no-PPI groups (7.5 vs. 5.0%; P=0.26). Similarly, 1-year rates of all cause death, ST, and Thrombolysis in MI major and minor bleedings did not significantly differ. After statistical adjustment for potential confounders, the concomitant use of clopidogrel and PPIs was not associated with the risk of 1-year MACE [odds ratio (OR) 1.54, P=0.38], death (OR: 0.97, P=0.961), and ST (OR: 1.01, P=0.998). No differences across the three PPI types were found.
CONCLUSION
The association of clopidogrel and PPIs after drug-eluting stent implantation, prescribed on clinical judgement, seems safe.
目的
已有研究提示氯吡格雷与质子泵抑制剂（PPI）之间存在药效学相互作用，可导致氯吡格雷诱导的血小板抑制作用减弱。然而，临床研究数据存在矛盾。本研究旨在评估氯吡格雷与PPI长期联合治疗的安全性。
方法
共纳入1328例连续接受药物洗脱支架植入并进行1年随访的患者（年龄63±11岁；81%为男性）。所有患者均接受标准阿司匹林和氯吡格雷治疗方案12个月。同时使用PPI治疗相同疗程由临床心脏病专家决定。PPI治疗包括兰索拉唑（30mg/天）、泮托拉唑（20mg/天）或奥美拉唑（20mg/天）。在1年随访时，记录主要不良心脏事件（MACE），定义为死亡、心肌梗死（MI）、导致住院的急性冠状动脉综合征和非致死性卒中。还评估全因死亡、任何支架血栓形成（ST）和出血（心肌梗死溶栓治疗的严重和轻微出血）情况。
结果
855例、178例和125例患者分别接受兰索拉唑、泮托拉唑和奥美拉唑治疗，170例未接受任何PPI治疗。在接受PPI治疗的患者中，接受泮托拉唑治疗的患者既往心肌梗死、多支冠状动脉疾病和慢性肾脏病更为常见，而接受奥美拉唑治疗的患者既往消化性溃疡更为常见。PPI组和非PPI组患者1年MACE发生率无统计学差异（7.5%对5.0%；P = 0.26）。同样，全因死亡、ST以及心肌梗死溶栓治疗的严重和轻微出血的1年发生率也无显著差异。在对潜在混杂因素进行统计学调整后，氯吡格雷与PPI联合使用与1年MACE风险[比值比（OR）1.54，P = 0.38]、死亡（OR：0.97，P = 0.961）和ST（OR：1.01，P = 0.998）无关。三种PPI类型之间未发现差异。
结论
基于临床判断在药物洗脱支架植入后联合使用氯吡格雷和PPI似乎是安全的。
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