New York–Presbyterian Hospital, Columbia University Medical Center, The Cardiovascular Research Foundation, New York, NY 10022, USA.
Circulation. 2011 Aug 23;124(8):893-900. doi: 10.1161/CIRCULATIONAHA.111.031070. Epub 2011 Aug 8.
Some (but not all) prior trials have reported differential outcomes after percutaneous coronary intervention with paclitaxel-eluting stents versus stents eluting rapamycin analogs according to the presence of diabetes mellitus. These studies lacked sufficient power to examine individual safety and efficacy end points.
To determine whether an interaction exists between the presence of diabetes mellitus and treatment with everolimus-eluting stents compared with paclitaxel-eluting stents, we pooled the databases from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) II, SPIRIT III, SPIRIT IV, and A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice (COMPARE) trials in which percutaneous coronary intervention was performed in 6780 patients, 1869 (27.6%) of whom had diabetes mellitus. Patients without diabetes mellitus treated with everolimus-eluting stents compared with paclitaxel-eluting stents had significantly reduced 2-year rates of mortality (1.9% versus 3.1%; P=0.01), myocardial infarction (2.5% versus 5.8%; P<0.0001), stent thrombosis (0.3% versus 2.4%; P<0.0001), and ischemia-driven target lesion revascularization (3.6% versus 6.9%; P<0.0001). In contrast, among patients with diabetes mellitus, there were no significant differences between the 2 stent types in any measured safety or efficacy parameter. Significant interactions were present between diabetic status and stent type for the 2-year end points of myocardial infarction (P=0.01), stent thrombosis (P=0.0006), and target lesion revascularization (P=0.02).
We have identified a substantial interaction between diabetes mellitus and stent type on clinical outcomes after percutaneous coronary intervention. In patients without diabetes mellitus, everolimus-eluting stents compared with paclitaxel-eluting stents resulted in substantial 2-year reductions in death, myocardial infarction, stent thrombosis, and target lesion revascularization, whereas no significant differences in safety or efficacy outcomes were present in diabetic patients.
一些（但不是全部）先前的试验报告称，根据糖尿病的存在，紫杉醇洗脱支架与雷帕霉素类似物洗脱支架经皮冠状动脉介入治疗的结果存在差异。这些研究缺乏足够的能力来检查个别安全性和疗效终点。
为了确定糖尿病的存在与依维莫司洗脱支架与紫杉醇洗脱支架治疗之间是否存在相互作用，我们合并了 Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) II、SPIRIT III、SPIRIT IV 和 A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice (COMPARE) 试验中的数据库，其中经皮冠状动脉介入治疗在 6780 例患者中进行，其中 1869 例（27.6%）患有糖尿病。与紫杉醇洗脱支架相比，无糖尿病的患者接受依维莫司洗脱支架治疗的 2 年死亡率（1.9%比 3.1%；P=0.01）、心肌梗死（2.5%比 5.8%；P<0.0001）、支架血栓形成（0.3%比 2.4%；P<0.0001）和缺血驱动的靶病变血运重建（3.6%比 6.9%；P<0.0001）明显降低。相比之下，在糖尿病患者中，两种支架类型在任何测量的安全性或疗效参数上均无显著差异。支架类型与糖尿病状态之间存在显著的相互作用，在 2 年终点上表现为心肌梗死（P=0.01）、支架血栓形成（P=0.0006）和靶病变血运重建（P=0.02）。
我们已经确定了经皮冠状动脉介入治疗后糖尿病与支架类型之间的显著相互作用。在无糖尿病的患者中，与紫杉醇洗脱支架相比，依维莫司洗脱支架可显著降低 2 年死亡、心肌梗死、支架血栓形成和靶病变血运重建的发生率，而在糖尿病患者中，安全性或疗效结果无显著差异。
