| Part 1Comparison of effectiveness and safety among bare-metal stent, and first and second generation drug-eluting stent in Chinese patients diagnosed with ST-segment elevated acute myocardial infarctionBackgroundCoronary artery disease (CAD) is a quite common cardiovascular disorder that threatens public health worldwide. Percutaneous coronary intervention (PCI) technique remarkably improved outcomes in patients with CAD. Coronary stents experienced continuous development in these years, and the emerging drug-eluting stents (DES) further increased the effectiveness and safety of PCI as compared with bare-metal stents (BMS). Acute myocardial infarction (AMI) is the end-stage malignant event of CAD. Pathologically the unstable atherosclerotic plaque breaks and promotes platelets to aggregate around the lesion site, forming an acute thrombus and thoroughly blocking the blood flow in the coronary artery. Thus the cardiac tissue necrosis occurs due to acute ischemia, which severely worsens prognosis in patients and is supposed to be prevented. Implantation with BMS or DES in the culprit coronary artery has been a standardized approach to treat ACS. Nevertheless it has not been fully elucidated whether BMS is different from DES, or whether G1-DES is significantly different from G2-DES in respect to effectiveness and safety in Chinese patients diagnosed as STEMI.ObjectThe study aims to demonstrate and compare the effectiveness and safety among BMS, G1-DES and G2-DES in patients diagnosed as STEMI and receiving PCI treatment, and provide real-world evidence to refine the practice of coronary artery stent implantation.MethodA consecutive group of patients who were diagnosed as STEMI and received emergency PCI between April 2004 and May 2014 in Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China were retrospectively enrolled in the study. The exclusion criteria included (1) STEMI due to intra-stent restenosis or stent thrombosis (95 cases) and (2) patients who received stent implantation other than BMS, G1-DES or G2-DES, or received more than 1 type of stents (305 cases). Finally 1,248 cases remained in the study. Patients were divided into 3 groups according to the type of implanted stent, namely BMS group, G1-DES group and G2-DES group. The endpoints included effective and safety outcomes. The effective endpoint is defined as MACE (major adverse cardiac events) including a composition of target vessel-related myocardial infarction (TV-MI), target vessel revascularization (TVR), target lesion revascularization (TLR) and cardiogenic death, as well as these individual events. The safety endpoint id defined as definite and probable stent thrombosis based on the Academic Research Consortium criteria. The follow up lasted for 1 year. The occurrence of TV-MI, TVR, TLR, cardiogenic death and stent thrombosis were compared by Chi-square test and Kaplan-Meier method. Besides multivariate Cox proportional-hazard regression analysis and Logistic regression methods were applied to compare the hazard/odd ratio of the above mentioned adverse events among the 3 groups.ResultsIn the 1,248 consecutive patients diagnosed as STEMI and receiving emergency PCI treatment, the 1-year-follow-up data revealed that the occurrence of MACE was higher in the BMS group as compared with DES-1 and DES-2 groups (BMS 20.4%, G1-DES 4.2% and G2-DES 4.1%, P< 0.001; BMS vs. G1-DES, P< 0.001; BMS vs G2-DES, P< 0.001), while it was not different between G1-DES and G2-DES groups (P= 0.969). The occurrence of TV-MI in BMS, G1-DES and G2-DES groups were 2.6%,0.3% and 1.0% respectively, and differed among the 3 groups (P= 0.017). By post-hoc Chi-square analysis we found that TV-MI was reduced in the G1-DES group compared to BMS group (P= 0.017), while it was similar between BMS and G1-DES (P= 0.070) and between G1-DES and G2-DES groups (P=0.216). Furthermore compared BMS both G1-DES and G2-DES reduced the occurrence of TVR (10.4%,2.5% and 1.8%), TLR (7.8%, 1.1% and 1.2%) and cardiogenic death (9.2%,1,7% and 1.8%) (all P values< 0.001) while the occurrence rate of these events were not different between the G1-DES and G2-DES group (P values were 0.458,> 0.999 and 0.908). The stent thrombosis rates were not differed among the 3 groups within 1 year (P= 0.354). It was demonstrated by Kaplan-Meier analysis that the TLR-and cardiogenic free survival rates were both higher in the DES groups as compare to that in the BMS group (all P values< 0.001), and did not show statistical difference between G1-and G2-DES groups. By further analysis with multivariate Cox proportional hazard regression model, it was elucidated that both G1-and G2-DES were predictive of reduced TVR (G1-DES, HR 0.24,95% CI [0.11-0.50], P< 0.001; G2-DES, HR= 0.40,95% CI [0.27-0.58], P< 0.001) and TLR (G1-DES, HR= 0.15,95% CI [0.05-0.43], P< 0.001; G2-DES, HR= 0.39,95% CI [0.25-0.61], P< 0.001), while the hazard ratios of TV-MI, TLR or cardiogenic death were not different between G1-and G2-DES groups. In addition the Logistic regression analysis revealed that stent type was not predictive of stent thrombosis.Conclusion(1) In patients diagnosed as STEMI and receiving PCI treatment, MACE occurred more frequently in the BMS group, and did not differ in occurrence between G1-DES and G2-DES groups.(2) G1-DES and G2-DES were protective factors of TVR and TLR within 1 year, while the risk of these events were not different between the 2 groups.(3) The occurrence and risk of TV-MI thrombosis were similar among BMS, G1-DES and G2-DES groups, and the risk of TV-MI or cardiogenic death were not different among the 3 groupsPart 2Comparison of effectiveness and safety between first and second generation drug-eluting stent in Chinese patients diagnosed with acute coronary syndromeBackgroundAcute coronary syndrome (ACS) consists of ST-segment elevated acute myocardial infarction, non-ST-segment elevated acute myocardial infarction and unstable angina pectoris. The common pathological mechanism underlying ACS is complete or incomplete coronary thrombosis caused by ruptured or eroded atherosclerotic plaque, leading to an acute decrease in coronary blood flow. ACS usually presents with sudden onset and potential lethality, and therefore should be cautiously prevented. According to previous reports ACS increases hazard ratio of stent thrombosis after PCI treatment as compared with stable coronary disorder. Thus due attention should be pay to the selection of stent type during the PCI treatment in patients with ACS. Yet there are controversies on the effectiveness and safety issues between G1-DES and G2-DES in the therapy of ACS, and it has not been reported whether G2-DES is superior to Gl-DES in the setting of ACS in Chinese patients.ObjectiveThe current study aims to compare the effectiveness and safety between Gl-DES and G2-DES in Chinese patients diagnosed as ACS and receiving PCI treatment, and to provided theoretical evidence of appropriate selection of stent type in the PCI treatment in ACS patients.MethodsA consecutive group of patients who received PCI treatment between January 2013 to December 2013 in Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China were retrospectively enrolled in the study, and those diagnosed as ACS were screened and identified. The exclusion criteria included (1) patients who received percutaneous transluminal coronary angioplasty (PTCA) without stent implantation, (2) patients who had stent implantation other than Gl-DES or G2-DES or had more than 1 type of stent implanted, and (3) patients who were not diagnosed as ACS. A total of 3,929 patients were enrolled, including 862 cases with STEMI,284 cases with NSTEMI and 2,783 cases with unstable angina pectoris. All patients were divided in to G1-DES and G2-DES group according to the implanted stent type. The follow up lasted for 2 years, and the outcomes are described in Part 1 in this paper. Stent thrombosis were defined as definite, probable or possible thrombosis according to the Academic Research Consortium criteria. A propensity score matching method was applied to match the patients in a 1:1 manner. The Chi-square test, Kaplan-Meier analysis and multivariate Cox proportional hazard regression analysis were applied to compare the occurrence rate and hazard ratio of outcome events.ResultsFrom all the patients who receiving PCI treatment due to ACS,2,248 cases were selected by propensity score matching. After 2 years follow up, there was no significant difference on the occurrence of MACE between G1-DES and G2-DES groups (4.8% vs. 3.9%, P= 0.302). The occurrence of TV-MI did not differ between the 2 groups (0.7 vs. 0.7, P> 0.999). Meanwhile statistical differences on TVR (5.5% vs.3.5%, P= 0.019), TLR (4.1% vs.2.5%, P=0.033) and cardiogenic death (0.5% vs.1.4%, P= 0.033) were detected. we found that the TLR-free survival rate increased and cardiogenic death-free survival rate decreased in the G2-DES group (P= 0.038 and 0.039). The multivariate Cox proportional hazard regression analysis identified that G2-DES is predictive of reduced TLR as compared with G1-DES (HR= 0.592,95% CI [0.370-0.947], P= 0.029), while the risks of TV-MI, cardiogenic death or cumulative stent thrombosis were similar between G1-and G2-DES groups (TV-MI, HR= 1.121,95% CI [0.380-3.303], P=0.836; cardiogenic death, HR= 2.469,95% CI [0.883-7.057], P= 0.084; cumulative stent thrombosis, HR= 1.197, 95% CI [0.471-3.041], P= 0.706).Conclusion(1) In patients receiving PCI due to ACS, the occurrence of MACE was not significantly different between G1-DES and G2-DES groups.(2) G2-DES was identified as a protective factor of TLR as compared to G1-DES.(3) The occurrence and risk of TV-MI, cardiogenic death or cumulative stent thrombosis were not statistically different between G1-DES and G2-DES groups.
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