Charité Campus Benjamin Franklin, Berlin, Germany.
Circ Cardiovasc Interv. 2011 Apr 1;4(2):130-8. doi: 10.1161/CIRCINTERVENTIONS.110.960245. Epub 2011 Mar 1.
In the prospective, randomized Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, implantation of paclitaxel-eluting stents (PES) safely reduced the rates of ischemic target lesion revascularization (TLR) compared with bare metal stents (BMS) in patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention. Diabetes mellitus is a known predictor of adverse outcomes after percutaneous intervention in STEMI. We therefore sought to assess the impact of PES in diabetic patients with STEMI from the HORIZONS-AMI trial.
A total of 478 patients with diabetes and 2527 without diabetes were randomly assigned to receive PES versus BMS. The 12-month rates of ischemic TLR were significantly reduced by PES compared with BMS in both diabetic (11.2% versus 5.2%; hazard ratio [95% confidence interval]=0.45 [0.21 to 0.93]; P=0.03) and nondiabetic (6.8% versus 4.3%, hazard ratio [95% confidence interval]=0.63 [0.44 to 0.92]; P=0.02) patients. In patients with insulin-treated diabetes, PES compared with BMS reduced the 12-month TLR rate from 21.4% to 7.3% (hazard ratio [95% confidence interval]=0.35 [0.12 to 1.03]; P=0.046). Angiographic late loss and binary restenosis at 13 months were also significantly reduced in PES-treated diabetic patients. There were no significant differences between the BMS and PES groups in the 12-month rates of death, reinfarction, stroke, or stent thrombosis in either diabetic or nondiabetic patients.
In the large-scale, prospective, randomized HORIZONS-AMI trial, implantation of PES compared with BMS in patients with STEMI and diabetes mellitus resulted in significant reductions in ischemia-driven TLR and angiographic restenosis at 1 year, with comparable safety outcomes, including stent thrombosis. These results suggest that PES can safely be used to reduce restenosis in high-risk diabetic patients presenting with STEMI.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.
在前瞻性、随机的 Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction（急性心肌梗死血管重建和支架置入的协调结果）试验中，与裸金属支架（BMS）相比，紫杉醇洗脱支架（PES）在接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死（STEMI）患者中安全降低了缺血性靶病变血运重建（TLR）的发生率。糖尿病是经皮冠状动脉介入治疗后发生不良结局的已知预测因素。因此，我们试图从 HORIZONS-AMI 试验中评估 PES 在糖尿病合并 STEMI 患者中的影响。
共有 478 例糖尿病患者和 2527 例非糖尿病患者被随机分配接受 PES 或 BMS 治疗。与 BMS 相比，PES 显著降低了糖尿病（11.2%对 5.2%；风险比[95%置信区间]=0.45[0.21 至 0.93]；P=0.03）和非糖尿病（6.8%对 4.3%，风险比[95%置信区间]=0.63[0.44 至 0.92]；P=0.02）患者的 12 个月 TLR 发生率。在胰岛素治疗的糖尿病患者中，与 BMS 相比，PES 将 12 个月 TLR 率从 21.4%降至 7.3%（风险比[95%置信区间]=0.35[0.12 至 0.93]；P=0.046）。13 个月时 PES 治疗的糖尿病患者的血管造影晚期丢失和二元再狭窄也显著减少。在糖尿病或非糖尿病患者中，12 个月时 BMS 和 PES 组之间的死亡率、再梗死、卒中和支架血栓形成发生率均无显著差异。
在大规模、前瞻性、随机的 HORIZONS-AMI 试验中，与 BMS 相比，在 STEMI 和糖尿病患者中植入 PES 可显著降低 1 年时缺血驱动的 TLR 和血管造影再狭窄，且安全性结局相当，包括支架血栓形成。这些结果表明，在 STEMI 合并糖尿病的高危患者中，PES 可安全用于减少再狭窄。
