RESUMEN
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.
RESUMEN
BACKGROUND: The association between epicardial fat and coronary in-stent restenosis has not been evaluated. The objective of the present study was to evaluate the relationship of echocardiographic epicardial fat thickness (EFT) with restenosis in drug eluting stents (DES). METHODS: In this study, 117 patients who underwent coronary angiography due to recurrent clinical symptoms or findings of non-invasive cardiac tests one year after stent implantation were selected. According to angiographic results, they were divided into two groups, 65 patients with in-stent restenosis (case group) and 52 patients without such finding (control group). EFT was measured perpendicularly on the free wall of the right ventricle at the end of systole in two echocardiographic views (parasternal short and long axis) at least in three cardiac cycles. The average of obtained values was determined and recorded as EFT. Furthermore, the history of hypertension, smoking and diabetes, age and sex were investigated and body mass index (BMI) of each patient was also calculated. RESULTS: There were no significant differences in the baseline characteristics (P=0.812). Patients with in-stent restenosis did not have statistically significant difference (4.6±1.8 mm) in EFT compared to subjects with patent stents (4.5±1.8 mm; P=0.88). The above results were also confirmed using multiple linear regressions. No significant correlation was found between EFT and other clinical variables (P >0.05). CONCLUSION: In this selected population, the risk of restenosis was not correlated with epicardial fat thickness. Future studies for determining the role of epicardial fat in development of in-stent restenosis are warranted.
