Khosravi Ali Reza, Pourmoghadas Masoud, Ostovan Mohammad, Mehr Gilda Kiani, Gharipour Mojgan, Zakeri Habib, Soleimani Bahram, Namdari Mehrdad, Hassanzadeh Mehdi, Tavassoli Ali Akbar, Ghaffari Samad, Khaledifar Arsalan, Roghani Farshad, Khosravi Mohammad Reza, Sarami Shahrooz, Kojouri Javad, Nori Fatemeh, Khosravi Elham, Jozan Mahnaz, Sarrafzadegan Nizal
Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
J Res Med Sci. 2011 May;16(5):640-50.
To compare the early and late cardiovascular events as well as side effects of Osvix, a generic form of Clopidogrel versus Plavix regimens in patients with chronic stable angina, undergoing bare metal stent (BMS) or drug eluting stent (DES) placement, this study was carried out.
A total of 442 patients with chronic stable angina who were scheduled for elective percutaneous coronary intervention (PCI) were included in a randomized, double blind, multi-centric clinical trial being performed in 6 distinct university hospitals in 5 cities of Iran from March 2007 to November 2009. Baseline, demographic and history of risk factors were recorded using the patients' medical charts. Stenting procedure was performed via transfemoral approach using low osmolar contrast agents. Patients underwent BMS or DES placements based on the physician selection and were randomly assigned to Osvix or Plavix groups. Patients were followed by telephone in 0 and 6 months intervals regarding the major adverse cardiovascular events (MACE) including death, myocardial infarction, in-stent thrombosis, stroke, target lesion revascularization, and target vascular revascularization. Angina episodes, bleeding, liver enzymes, neutrophils and platelets count were also assessed in these intervals.
There was not any significant difference between these two groups regarding the baseline characteristics. In the DES group, the 6-month mortality rate and the incidence of MACE in Osvix and Plavix groups were 0.9% and 1.9% (p = 0.61) and 1.8% and 4.9% (p = 0.26), respectively. During the follow up period after DES or BMS placement, there wasn't any significant difference regarding neutrophil and platelet counts or liver enzymes between study groups.
Using Osvix and Plavix are followed by similar major cardiovascular events and side-effect profile in patients undergoing PCI.
为比较氯吡格雷仿制药Osvix与波立维方案在慢性稳定型心绞痛患者接受裸金属支架（BMS）或药物洗脱支架（DES）置入时的早期和晚期心血管事件以及副作用，开展了本研究。
2007年3月至2009年11月期间，在伊朗5个城市的6家不同大学医院进行了一项随机、双盲、多中心临床试验，共纳入442例计划进行择期经皮冠状动脉介入治疗（PCI）的慢性稳定型心绞痛患者。使用患者病历记录基线、人口统计学和危险因素病史。采用低渗造影剂经股动脉途径进行支架置入手术。根据医生的选择，患者接受BMS或DES置入，并随机分为Osvix组或波立维组。通过电话随访患者0个月和6个月时的主要不良心血管事件（MACE），包括死亡、心肌梗死、支架内血栓形成、中风、靶病变血管重建和靶血管血管重建。在此期间还评估心绞痛发作、出血、肝酶、中性粒细胞和血小板计数。
两组在基线特征方面无显著差异。在DES组中，Osvix组和波立维组的6个月死亡率和MACE发生率分别为0.9%和1.9%（p = 0.61）以及1.8%和4.9%（p = 0.26）。在DES或BMS置入后的随访期间，研究组之间在中性粒细胞和血小板计数或肝酶方面无显著差异。
接受PCI的患者使用Osvix和波立维后的主要心血管事件和副作用情况相似。
