药物洗脱支架与金属裸支架置入术后对糖尿病患者远期死亡、心肌梗死和支架血栓发生情况的影响

Comparison of mortality,myocardial infarction,and stent thrombosis following drug eluting versus bare metal stenting in unselected diabetic patients at long-term followup

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。

This observational study compared the rates of death, myocardial infarction（MI）, repeat revascularization and stent thrombosis after implantation of drug eluting stents （ DES ） versus bare metal stents （ BMS ） in unselected patients with diabetes mellitus to evaluate the long-term efficacy and safety of DES. Methods We consecutively included 834 diabetic patients who underwent either DES （n = 583 ） or BMS（ n = 251 ） in our institution from July 2003 to December 2005. The primary end point was all-cause mortality at 24 months, the secondary end points were the occurrence of nonfatal MI, cerebrovascular events and repeat revascularization and major adverse cardiac events（MACE） at 24 months. Results After adjusting with Cox regression, the risk of mortality in the DES group was significantly lower than that in the BMS group （3.2% vs 5.1%, hazard ratio [HR] of DES vs BMS 0.58, 95% confidence interval [ CI] 0.12 to 0.94, P=O. 038）, similar outcome had also been found in the adjusted risk of cardiac mortality（2.2% vs 4.4% , HR=O. 29,95 % CI： 0.13 - 0.87, P = 0. 027 ） at 24 months, although the adjusted risk of nonfatal MI and the composite of the cardiac mortality and nonfatal MI was similar. DESs was not associated with increased risk of stent thrombosis（2.7% vs 3.2% , HR=O. 61, 95% CI： O. 17 1.32, P=0. 144）. The MACE rate was also lower in the DES group（ 15.8% vs 27.9%, HR =0.19, 95% CI： O. 09 ~ O. 85, P〈O. 001 ） due to less mortality and less repeat revaseularization with DES （ 10.5% vs 20.7%, HR = 0.24, 95% CI： 0.11 ~ 0.78, P〈0.001 ）. Conehtsion In a real-world diabetic patient population, DES was related to reduced mortality, repeat revaseularization and MACE rates at long-term follow-up compared with BMS without increased risk of stent thrombosis, or nonfatal MI. The survival benefits of DES resulted from reducing revaseularization procedures for restenosis which could account for the reduction in mortality and MI, higher rate of complete revaseularization and no additional risk of stent thrombosis.