Author/Authors :
Khosravi, Ali Reza Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Soleimani, Bahram Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Roghani, Farshad Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Kojouri, Javad Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Khosravi, Elham Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Jozan, Mahnaz Isfahan Hypertension Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Pourmoghadas, Masoud Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Kiani Mehr, Gilda Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Gharipour, Mojgan Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Tavassoli, Ali Akbar Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Nori, Fatemeh Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Sarrafzadegan, Nizal Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences , Ostovan, Mohammad Shiraz University of Medical Sciences , Zakeri, Habib Fasa University of Medical Sciences , Namdari, Mehrdad Lorestan University of Medical Sciences, Khoramabad , Hassanzadeh, Mehdi Mashhad University of Medical Sciences , Khosravi, Mohammad Reza Tabriz University of Medical Sciences , Ghaffari, Samad Tabriz University of Medical Sciences , Khaledifar, Arsalan Shahrekord University of Medical Sciences , Sarami, Shahrooz Department of Pharmaceutics - School of Pharmacology, Tehran University of Medical Sciences
Abstract :
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Using Osvix and Plavix are followed by similar major cardiovascular events and side-effect profile in
patients undergoing PCI.
