| Objective: To observe and compare the long-term safety and efficacy of the Endeavor resolute drug eluting stent and domestic sirolimus drug-eluting stent Firebird2 TM,Excel, partner in the treatment of coronary heart disease.Methods: The study included 285 patients with coronary heart disease after PCI.Endeavor resolute stent group(155 cases) and domestic sirolimus drug eluting stent group(130 cases). The endpoints included major adverse cardiovascular events(non fatal myocardial infarction, fatal myocardial infarction, target vessel revascularization),and secondary outcome events(cardiac causes of re admission, heart failure). Patients were followed up from December 15, 2014 to December 25, 2014, mean follow-up time was 35.95 +15.99 months and Final follow up of 252 cases, Endeavor resolute stent group(139 cases) and domestic sirolimus drug elution stent group(113 cases).Statistical analysis, The measurement data were expressed by mean plus or minus standard deviation, and the two groups were compared by t test or Wilcoxon rank sum test. Count data, the number of cases, the rate or composition, the comparison between the two groups using chi square test or Fisher exact probability method. The difference was statistically significant between P < 0.05. The non inferiority test of the main efficacy indexes of the two groups was conducted., MACE events did not occur to show good efficacy, Setting the non inferiority boundary value is 0.05result:1. Two groups of patients with coronary artery disease at baseline: Endeavor resolute stent group and domestic sirolimus stent group with the mean age, sex, hypertension,the number of patients with diabetes, dyslipidemia, smoking, drinking, brain vascular disease, peripheral vascular disease, previous PCI, coronary heart disease family history had no statistical significance(P > 0.05).2.Endeavor resolute stent group and domestic sirolimus stent group admission diagnosis of STEMI and NSTEMI, old of myocardial infarction, angina pectoris, unstable angina pectoris, and between the two groups had no statistical significance(P > 0.05).3.Both groups of patients were not statistically significant t test(P>0.05).4.laboratory tests between the two groups were no statistical significance(P>0.05).5. Coronary artery disease between the two groups were no statistical significance(P>0.05).6.the results of follow-up, Endeavor resolute stent group and domestic sirolimus drug-eluting stent group lost 16 cases and 17 cases, two groups of MACE were 9 cases,12 cases, each groups of fatal myocardial infarction were 1 cases, 6 cases, each groups of revascularization were 8 cases, 6 the cases, once again the PCI patients were 6cases, 3 cases, with coronary artery bypass graft revascularization patients were 2cases, 3 cases, each groups of patients with all-cause mortality were 3 cases, 8 cases,for patients with NYHA heart function gradeⅠof survival were 132 cases, 96 cases,with NYHA heart function grade II were 3 cases, 8 cases, NYHA cardiac function Ⅲgrade were 1 cases, 1 cases, heart cause readmission were 34 cases, 31 cases. The two groups of patients with MACE, the target vessel revascularization, all due to death,NYHA cardiac function II, heart cause readmission were no statistical significance(P>0.05). Among the two groups, cardiac causes Fisher exact probability, the P value was 0.0476, and the NYHA heart function gradeⅠP value was 0.0071, which was statistically significant(P<0.05).7. Two groups of patients with mace rate time curve: after two groups of stent implantation in patients with 20 months mace occurred there was no significant difference. After 20 months Endeavor resolute stent group mace, almost no longer increase,however domestic sirolimus eluting stent group mace is still growing.8. Non inferiority test of two groups, set the non inferiority boundary value of 0.05,statistical results: Z=2.5604, P=0.0052, the difference between the two groups was0.0414, and its 95% confidence interval was [-0.0286,0.1114].Conclusion: the long-term curative effect on patients with coronary heart disease Endeavor resolute stent is not inferior to the domestic sirolimus eluting stents. |
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