Komarov A L, Shakhmatova O O, Muraseeva V G, Novikova E S, Guskova E V, Panchenko E P
Department of Clinical Problems of Atherothrombosis of the National Medical Research Center for Cardiology, Moscow, Russia.
Pirogov National Medical and Surgical Center, Moscow, Russia.
Ter Arkh. 2018 Sep 20;90(9):92-100. doi: 10.26442/terarkh201890992-100.
The urgency of the study is determined by the lack of data necessary in order to assess the safety of prolonged use of proton pump inhibitors (PPI) in patients with IHD combined with anti-aggregant therapy. The aim of the study was to study the relationship between the use of PPI and the risk of thrombotic complications in patients undergoing planned procedures of percutaneous coronary interventions (PCI) and receiving dual antiplatelet therapy.
The study is a prospective register of patients who successfully underwent planned percutaneous coronary intervention (PCI). The effect of PPI (omeprazole and pantoprazole) on the frequency of the combined end point cardiovascular death, ACS, AI, TIA, peripheral arterial thrombosis and PE was assessed using the Log-Rank criterion, as well as in a multivariate analysis (Cox proportional risk regression model).
A total of 391 patients were included in the study (23.1% women, mean age 61.2 years ± 10.4 years). The median duration of follow-up was 18 months. During this period of time, 34 adverse events were recorded. Log-Rank analysis showed that the proportion of patients without adverse events in the omeprazole group was significantly lower in comparison with patients who did not receive PPI (0.56 vs. 0.84, Log-Rank p=0.003), and for pantoprazole no such pattern was found (0.89 against 0.84, Log-Rank p=0.21). The average level of residual platelet reactivity (ORT), as well as the number of patients with high ORT (> 208 PRU), did not differ significantly between the groups of omeprazole, pantoprazole and the group of patients not receiving PPI. According to multivariate analysis, omeprazole was an independent predictor of thrombotic complications after a planned PCI (OR 3.75, 95% confidence interval 1.72-8.17, p=----0.0009).
Long-term use of omeprazole (at least 30 days) is an independent predictor of thrombotic complications in patients who underwent planned PCI.
本研究的紧迫性源于缺乏评估缺血性心脏病（IHD）患者在联合抗血小板治疗时长期使用质子泵抑制剂（PPI）安全性所需的数据。本研究的目的是探讨在接受经皮冠状动脉介入治疗（PCI）计划手术并接受双联抗血小板治疗的患者中，使用PPI与血栓形成并发症风险之间的关系。
本研究是一项成功接受计划经皮冠状动脉介入治疗（PCI）患者的前瞻性登记研究。使用对数秩检验标准以及多变量分析（Cox比例风险回归模型）评估PPI（奥美拉唑和泮托拉唑）对复合终点心血管死亡、急性冠状动脉综合征（ACS）、急性心肌梗死（AI）、短暂性脑缺血发作（TIA）、外周动脉血栓形成和肺栓塞（PE）发生频率的影响。
共有391例患者纳入本研究（女性占23.1%，平均年龄61.2岁±10.4岁）。随访的中位时间为18个月。在此期间，记录到34例不良事件。对数秩分析显示，与未接受PPI的患者相比，奥美拉唑组无不良事件患者的比例显著更低（0.56对0.84，对数秩p = 0.003），而泮托拉唑组未发现这种情况（0.89对0.84，对数秩p = 0.21）。奥美拉唑组、泮托拉唑组和未接受PPI的患者组之间，残余血小板反应性（ORT）的平均水平以及ORT高（> 208 PRU）的患者数量无显著差异。根据多变量分析，奥美拉唑是计划PCI术后血栓形成并发症的独立预测因素（比值比3.75，95%置信区间1.72 - 8.17，p = ----0.0009）。
长期使用奥美拉唑（至少30天）是接受计划PCI患者血栓形成并发症的独立预测因素。
