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目的本研究通过比较糖尿病患者置入金属裸支架(bare metal stents,BMS)vs药物洗脱支架(drug eluting stents,DES)后发生死亡、心肌梗死(myocardial infarction,MI)、再次血运重建和支架血栓的情况,以评价糖尿病患者置入DES后的远期安全性和有效性。方法本研究于2003年7月～2005年12月连续入选了834例因冠心病合并糖尿病在首都医科大学附属北京安贞医院心内科行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者,按置入支架类型将患者分为DES组(n=583)和BMS组(n=251)。主要终点事件为24个月时全因病死率;次要终点事件为24个月时非致死性MI、再次血运重建以及主要不良心血管事件(major adverse cardiac events,MACE)的发生率。结果本研究结果经多因素回归分析显示,DES组明显降低了24个月时死亡[3.2%vs 5.1%,危险比(hazard ratio,HR)0.34,95%可信区间(confidential interval,CI)0.12～0.94,P=0.038]和心性死亡的风险(2.2%vs 4.4%,HR=0.29,95%CI:0.13～0.87,P=0.027),非致死性MI和心性死亡与非致死性MI复合终点发生风险比较差异无统计学意义;明确和可能的支架血栓的发生风险比较差异也没有统计学意义(1.9%vs 2.0%,HR=0.96,95%CI:0.51～2.17,P=0.351)。DES明显降低了再次血运重建的风险(10.5%vs 20.7%,HR=0.24,95%CI:0.11～0.78,P<0.001)和靶血管再次血运重建的风险(8.9%vs 17.1%,HR=0.33,95%CI:0.16～0.87,P<0.001);与BMS组比较DES组的MACE的风险也明显降低,差异有统计学意义(15.8%vs 27.9%,HR=0.19,95%CI:0.09～0.85,P<0.001);其主要与DES组患者的死亡和靶血管再次血运重建的风险降低有关。结论与BMS相比,DES可显著降低糖尿病患者的24个月时死亡、再次血运重建和MACE的风险,而未增加非致死性MI和支架血栓的风险。置入DES后死亡风险的降低原因,主要与DES降低再狭窄后的死亡和MI风险,获得更高的完全血运重建率以及未增加支架血栓的风险相关。
OBJECTIVE: In this study, we compared mortality, myocardial infarction (MI), revascularization and stent placement in patients with diabetes after implantation of bare metal stents (BMS) vs drug eluting stents (DES) Thrombosis, to evaluate the long-term safety and effectiveness of diabetic patients after DES insertion. Methods From July 2003 to December 2005, 834 consecutive patients with coronary artery disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI) at the Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Patients were divided into DES group (n = 583) and BMS group (n = 251) according to the type of stent placement. The primary endpoint was all-cause mortality at 24 months; the secondary endpoint was non-fatal MI, revascularization, and major adverse cardiac events (MACE) at 24 months. Results The multivariate regression analysis showed that the DES group significantly reduced the death rate at 24 months [3.2% vs 5.1%, hazard ratio (HR) 0.34, 95% confidential interval (CI) 0.12 ~ 0.94, P = 0.038] and the risk of death from cardiac death (2.2% vs 4.4%, HR = 0.29, 95% CI: 0.13 to 0.87, P = 0.027) There was no statistically significant difference in risk of occurrence; the risk of definite and probable stent thrombosis was not statistically different (1.9% vs 2.0%, HR = 0.96, 95% CI: 0.51-2.17, P = 0.351). DES significantly reduced the risk of revascularization (10.5% vs 20.7%, HR = 0.24, 95% CI: 0.11-0.78, P <0.001) and the risk of target revascularization (8.9% vs 17.1%, HR = 0.33, 95% CI: 0.16-0.87, P <0.001). The risk of MACE in DES group was significantly lower than that in BMS group (15.8% vs 27.9%, HR = 0.19, 95% CI: 0.09-0.85, P <0.001), which was mainly associated with the decreased risk of death and target revascularization in DES patients. Conclusion Compared with BMS, DES significantly reduced the risk of death, revascularization and MACE at 24 months in diabetic patients without increasing the risk of non-fatal MI and stent thrombosis. The reason for the decreased risk of death after DES implantation was mainly associated with DES reduction of mortality and MI risk after restenosis, higher rates of complete revascularization, and no increased risk of stent thrombosis.