Efficacy And Safety Of Different Doses Of Rosuvastatin On Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Purpose: The study was designed to investigate efficacy and safety of different doses of rosuvastatin on patients with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention(PCI).Method:A total of 79 ACS patients who accepted PCI treatment in the second hospital of Hebei Medical University from September 2013 to December 2014 were enrolled in this study, including 44 male and 35 female. All patients were randomly divided into two groups. 39 cases with 22 males and 17 females, age ranging from 40 to 71(average age was 58.97±4.78 years old) were enrolled into intensive group(group A). 40 cases with 22 male and 18 famale, age ranging from 42 to 70 years(average age was 57.00±7.86 years old) were enrolled into standard group(group B). The patients were given standard treatment with aspirin, clopidogrel, angiotensin-converting enzyme inhibitors(ACEI)/angiotensin II recepter antagonists(ARB), β-blocker and nitrates. Patients in Group A were given rosuvastatin 20mg/d preoperatively, until one month after PCI, with a long-term sequential treatment at a dose of 10mg/d. Patients in Group B were given rosuvastatin 10mg/d continuouely pre/post- PCI. Baseline data and the following data were observed: 1 Efficacy indicators(1) Difference between the lipid levels: low Density Lipoprotein(LDL-C), high density lipoprotein(HDL-C) and Non-HDL-C before PCI, 24 hours and one month after operation.(2) Changes of levels of inflammatory factors: high-sensitivity c-reactive protein(hs CRP) before PCI, 24 hours and one month after operation.(3) Levels of Troponin(c Tn I) before PCI, and 24 hours after operation.(4) Left ventricular ejection fraction(LVEF) detected by cardiac ultrasound before and 3-month after operation.(5) Creatinine clearance rate(Ccr) before, 24 hours and one month after operation.2 Safety indicators:(1) Alanine transaminase and Aspartate aminotransferase level before medication, 24 hours and one month after operation.(2) Reactions of skin rash, gastrointestinal reactions such as nausea, vomiting and so on were observed between two groups.(3) Myalgia, myopathy, changes of myohemoglobin and incidence of major adverse cardiac events(MACEs),etc were observed between two groups.Results:1 Differences of baseline data between group A and group BThere was no statistical difference between group A and B in baseline clinical characteristics(P>0.05), including gender, age, weight, the rate of NSTE-ACS, hypertension, diabetes melitus, family history of coronary disease, smoking and drinking. There was no significant difference betweeen the two groups in levels of blood lipid, blood glucose, hs CRP, Serum kalium, D-Dimer, transaminases, renal function and LVEF.2 Changes of lipid level before and after PCIThere was no statistical difference between two groups in blood lipid level before PCI(P>0.05), and there were no significant changes in levels of Non-HDL-C,LDL-C and HDL-C between the baseline level and lipid level 24 hours postoperatively. However, there was a statistically significant decrease of lipid level one month after PCI in non-HDL-C and LDL-C, and the decrease was more prominent in group A. There was a increase of HDL-C compared with that of baseline, however, there was no statistical difference between of therm(P>0.05).3 Changes of inflammatory factorThere was no statistical difference between group A and group B in the level of hs CRP. However there was a significant increase in 24 hours postoperatively. The increase was more significant in group B than that in group A(P<0.05). There was a significant decrease in one month postoperatively. The decrease was more significant in group A than that in group B(P<0.05).4 Changes of the myocardial injury markers before and after PCIThere were no statistical difference between group A and group B in level of c Tn I(P>0.05). The levels of c Tn I in two groups increased in 24 hours postoperatively compared with baseline level respectively(P<0.05). The increase of c Tn I in group B was significantly higher than that of group A(P<0.05).5 Changes of left ventricular ejection fraction(LVEF)There was no statistical difference between group A and group B in LVEF before treatment. LVEF detected after three month treatment in two groups increased compared to baseline, however, there was no statistical difference between of therm(P>0.05).6 Changes of creatinine clearance rateThere was no statistical difference in creatinine clearance rate(Ccr) between group A and group B before treatment. The level of Ccr was lower in both groups at 72-hour postoperatively than baseline(P<0.05). The value of Ccr decreased more obviously in group B than that in group A(P<0.05). The levels of Ccr increased in both groups one month after PCI, and it increased more significantly in group A than that in group B(P<0.05).7 Changes of aminotransferasesNo statistical difference was observed in aminotransferases before treatment in two groups. Aminotransferases increased moderately in both groups at 24-hour postoperatively and there was no statistical significance between two groups(P>0.05). There was no significant difference in transaminases one month after treatment compared with the baseline in both groups(P>0.05).8 Postoperative blood flowNo no-reflow phenomenon occurred in both groups. There was one case slow-flow in each group. There was no statistical significance between two groups.9 Drug adverse reactionsThere was no statistical difference between group A and group B in MYO before treatment. The MYO of two groups increased 24 hours postoperative compared with baseline levels respectively, but there was no statistical significance between two groups(P>0.05). The levels of MYO increased in both groups, and there was no statistical significance between two groups(P>0.05). No patient suffered from myalgia, myopathy or rhabdomyolysis, no skin rash, gastrointestinal reactions such as nausea, vomiting in either group in three month follow-up. There was no statistical significance between two groups(P>0.05).10 Incidences of MACEsNo incidence of MACE was observed in 3 month follow-up, a case of AMI occurred in the control group. There was no statistical significance between two groups(P>0.05).Conclusion:To ACS patients undergoing selective PCI treatment, perioperative intensified rosuvastation treatment for one month could reduce myocardial damage, decrease inflammation induced by PCI, improve heart function. The treatment was safe and effective.