Comparative Clinical Study Between Alpha Stent And Excel Stent

Background and Objective：Coronary heart disease(CHD) has seriously endangeredpeople’s health. There are some treatment aims about CHD, such as preventing myocardialinfarction and sudden death, improving prognosis, prolonging survival of patients, reducingischemic attacks, relieving symptoms and improving quality of life. The treatment of CHD atpresent includes drug treatment, percutaneous coronary intervention (PCI), coronary arterybypass graft (CABG), and so on. Among them, PCI undoubtedly has the highest security.The main complication of PCI was postoperative In-stent restenosis （ISR）. And how tosolve this problem becomes to be a research hotspot. Undoubtedly drug-eluting stents(DES)are most widely used, becouse although some new stent has broad prospects, but thetechnology is not yet mature. In view of the problems existing in the coronary stent, people’sresearch focus in recent years turned to the DES which has better biocompatibility polymerand better drug release control. This study aims at evaluating the efficacy and safety ofdrug-eluting coronary stent system (Alpha Stent) in the treatment of patients with coronaryartery disease, through the comparative study.Methods：Selectsd44patients between18-75years old of coronary heart disease withobvious angina or clear ischemic evidence who came to our hospital from September2010toMarch2011. There were24cases of patients with unstable angina (UA),13with ST-segmentelevation myocardial infarction (STEMI),3with non-ST-segment elevation myocardialinfarction (NSTEMI),and4with ith old myocardial infarction. Depending on the differentstents placed, the patients were randomly divided into the Alpha Group and Excel group,22cases of each group. Patients were given conform diagnosis after assistant examination. Theywere given a loading dose of aspirin (300mg) and clopidogrel (300mg) by the oral24hoursbefore surgery for coronary revascularization. The two groups of patients were implantedwith32Alpha stent and27Excel stent through PCI. Postoperative patients were all routinelygiven low molecular heparin subcutaneous injection every12hours,3-5days; and aspirin100mg, clopidogrel75mg and statin drugs, once-daily oral of adjuvant therapy. Coronaryangiography and other relevant inspection would be re-examed in the9th month.Cardiovascular endpoint events and in-stent restenosis situation were observed after surgery.Besides some other data would be compared between the two groups,including basic information of the patients, data of nterventional treatment, results of coronaryangiography reviewed, and changes of ECG, echocardiography, and so on. In this research,all data were analyzed by statistical software SPSS13.0. Continuous variables were given asmean±SD, the student t test is used in determining differences between mean valuesbetween groups. Categorical variables were reported as percentages and were anlyzed byeither Chi-square or Fisher’s exact test, as appropriate. P<0.05was considered statisticallysignificant.Results：Basic information and data of interventional treatment of the patients had nostatistical significance(P>0.05). The two groups of patients all had no major adverse cardiacevents in the first9months. Changes of ECG and echocardiography also had no statisticalsignificance. In the experimental group, the recurrence of angina was10%(2/20), and therewas no myocardial infarction. In the control group, recurrence of angina was25%(5/20),one cases of myocardial infarction. There was no significant difference (P>0.05). Accordingto comparasion of the Coronary angiography re-examed, we found that the two groups hadthe same rate of ISR. Experimental group had no case with restenosis>50%. While thecontrol group had one case of restenosis by90%-95%. Also there was no significantdifference (P>0.05).Conclusions：Drug-eluting coronary stent system (Alpha Stent) has a good safety andefficacy in the treatment of coronary heart disease. Due to the limited sample size, it is notyet clear whether the Alpha Stent is superior to the ordinary rapamycin drug-eluting stents.