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Effect of Single Loading Dose of Fluvastatin Sodium Extended Release Tablets on Periprocedural Myocardial Injury in Patients Undergoing Elective Percutaneous Coronary Intervention

Author: GaoCongHui
Tutor: CuiZuo
School: Hebei Medical University
Course: Internal Medicine
Keywords: Fluvastatin sodium extended release tablets HMG-CoAreductase inhibitors Myocardial injury Percutaneous coronary intervention Pleiotropic effects Statins Troponin Myocardial protection
CLC: R654.2
Type: Master's thesis
Year: 2013
Downloads: 15
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Objective: With the rise of the incidence of coronary heart disease(CHD), CHD has become one of the major diseases affecting human health.Percutaneous coronary intervention (PCI) treatment is one of the importantmethods for coronary revascularization. CHD is associated with unstableplaque rupture, vascular endothelial damage and inflammatory response. PCItherapy can cause damage to the vessel wall, inflammation, transient vascularocclusion, thereby might cause myocardial injury, which might lead to therelease of markers of myocardial injury. Perioperative myocardial injury (PMI)is a common complication of PCI and is associated with short-term andlong-term adverse outcomes. At present, it has been proved by a large numberof studies that statins before PCI may reduce the incidence of PMI andimprove prognosis. However it is unclear whether single loading dose offluvastatin sodium extended release tablets before elective PCI has protectiveeffects on PMI.Methods: From August2011to December2012, patients with coronaryheart disease undergoing elective PCI in our center were prospectivelyenrolled. Patients were randomly divided into3groups according to theirbaseline medications. Patients received no statins was designated as contorlgroup, those who had been given statins and received fluvastatin sodiumextended release tablets80mg the night before PCI as statin group1, and thosewho were statins naive and received fluvastatin sodium extended releasetablets80mg the night before PCI as statin group2. Standard medications ofCHD were given to all patients before PCI. Aspirin, clopidogrel were used atleast3-5days before PCI. Serum creatine kinase myocardial isoform (CK-MB)and serum cardiac troponin I (cTnI) levels were measured preoperatively and repeated at16-24h postoperatively, which were used as the assessment ofPMI indicators. Incidence of major adverse cardiovascular events during theindexed hospitalization was recorded.SPSS19.0software was used for statistical analysis. Data showed anormal distribution was described as mean±standard deviation (SD), and thecomparison among three groups was analyzed using one-way analysis ofvariance. Data showed a skewed distribution was described as median (lowerquartile, upper quartile), and the comparison among three groups wasanalyzed using nonparametric test. Count data was expressed as percentages,and the comparison among three groups was analyzed using Chi-square test. Ap value <0.05was considered statistically significant. Logistic regressionanalysis was used to identify risk factors of PMI [cTnI≥1×ULN(upper limit ofnormal)].Results: Totally96patients were enrolled,69of them were male(71.87%), and27were female (28.13%), aging38-77years (58.68±8.59years). Patients were randomly designated into control group of27patients,statin group1of39patients, and statin group2of30patients. The overallincidence of any cTnI elevation was23.96%(23/96), which was22.22%in thecontrol group,17.95%in statin group1, and33.33%in the statin group2.There was no significant difference among the three groups with respect toany elevation of cTnI (P=0.322). The overall incidence of cTnI elevation≥3×ULN was14.58%, which was18.52%,12.82%and13.33%in the controlgroup, statin group1, and statin group2, respectively. There was also nosignificant difference among the three groups with respect to cTnI elevation≥3×ULN (P=0.790). The overall incidence of cTnI elevation≥5×ULN was9.38%, which was14.81%,7.69%, and6.67%in control group, statin group1,and statin group2, respectively. There was no significant difference among thethree groups with respect to cTnI elevation≥5×ULN (P=0.514). The overallincidence of any CKMB elevation was17.71%(17/96), which was11.11%,20.51%, and20.00%in control group, statin group1, and statin group2, withno significant difference among the three groups (P=0.570). The incidence of CK-MB elevation≥3×ULN was1.04%(1/96), which was occurred in statingroup2, also with no significant difference among the three groups (P=0.329).Stepwise binary Logistic regression analysis was taken according to thepatient’s gender, age, smoking status, alcohol drinking history, body massindex (BMI), diabetes, hypertension, hypercholesterolemia, implanted stentlength, stent diameter and so on, as an independent variables of PMI. Theresults showed that the administration of nicorandil was a protective factor forPMI [(OR=0.085,95%CI:0.019to0.369, P=0.001)], while stent length wasan independent risk factors for PMI [(OR=7.045,95%CI:1.601to31.010,P=0.010)].No major adverse cardiac events such as recurrent angina, myocardialinfarction, urgent revascularization, cardiac death events took place in all the3groups during hospitalization.Conclusions: Administration of a single80mg loading dose offluvastatin sodium extended release tablets the night before elective PCIseems not enough to reduce the incidence of PMI, whether in statin use orstatin naive patients. This conclusion need to be confirmed by larger-scalerandomized clinical trials.

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