| Objective: to study intermediate-term the efficacy and safety of XIENCE V(EES) or PARTNER(SES) for treating the coronary heart disease and preventing the cardiovascular event.Methods: 648 patients with coronary heart disease who needed operation were randomly divided into the EES(XIENCE V) and SES(PARTNER) groups. After the clinical follow-up for at least 24 months, observed the primary end point was major adverse cardiac events; the secondary end point were stent thrombosis events, all-cause mortality, and readmission and bleeding events.Results: there were 327 cases in EES group with 539 XIENCE V, and 321 cases in SES group with 415 PARTNER. There was no statistical difference between the two groups in the age, gender, hypertension, hyperlipidemia, diabetes, smoking, family history of coronary heart disease, previous PCI and previous CABG, EF %, stable angina pectoris and acute coronary syndrome(P>0.05). The previous myocardial infarction history of EES was more than that of SES(9.17%: 4.67%, P=0.02), and the difference was statistically significant, indicating that the illness condition of EES was more severe and complex than that of SES. The average target lesion length of both groups was(20.58±6.22) mm and(20.73±5.61) mm, and the stent implantation length was(24.19±10.33) mm and(24.77±14.47) mm, and there was no statistically significant difference(P>0.05). The average stent implantation number of EES was more than that in SES,(1.65±0.85) and(1.29±0.56) respectively, and there was statistically significant difference(P<0.001). The single vessel disease of EES was less than that in SES,(15.90%: 33.33%,P<0.001), the triple vessel disease and lesion type B2/ C of EES was more than that in SES,(41.59%: 31.15%, P=0.006)and(76.99%: 66.34%, P=0.04)respectively, and there was statistically significant difference, further indicating that the coronary artery lesions in EES was more serious and complex than that in SES. The non-inferiority margin was defined as 0.05 in the research design, and the MACE non-inferiority test was conduced for EES and SES during the two years. After the clinical follow-up for 26.64±7.48 months, the MACE of EES relative to SES was(6.25%: 7.24%, non-inferiority test=0.025); the 95% CI unilateral lower limit was-0.050 obtained through the non-inferiority test with no statistical difference, and the EES was not inferior to the SES group. There was no statistical difference between the two groups in the total rate of stent thrombosis(2.30%: 1.97%, P>0.05), all-cause mortality(2.29%: 3.29%, P>0.05) and bleeding events(6.54%: 3.62%, P>0.05). The readmission rate of EES group was relatively higher than that in SES group(17.32%: 11.51%, P=0.008), and the difference of CHD admission rate(9.80%: 6.91%, P=0.04) was statistically significant; the difference of non-CHD admission rate(7.52%: 4.61%, P > 0.05) was not statistically significant. There was no statistical difference for patients in EES and SES groups taking Aspirin, Clopidogrel and other antiplatelet drugs for 24 months(90.83%: 94.70%, P>0.05),(28.75%: 27.73%, P>0.05).Conclusion: in this single-center, randomized and controlled clinical trial, the coronary heart disease situation of EES group was more complex and serious than that in SES group, but the incidence rate of intermediate-term MACE of the coronary heart disease treatment(2-year clinical outcomes) was not inferior to that of SES group. Both groups have good safety and effectiveness in the coronary heart disease treatment. Of course, the long-time multicenter follow-up with larger sample size based on the similar vascular lesions and stent implantation is also very necessary. |
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