在接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中慢性肾脏病的长期影响：HORIZONS-AMI（急性心肌梗死中血运重建和支架与优化结果的临床试验）研究。
Long-term impact of chronic kidney disease in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention: the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial.
机构信息
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.
出版信息
JACC Cardiovasc Interv. 2011 Sep;4(9):1011-9. doi: 10.1016/j.jcin.2011.06.012.
OBJECTIVES
This study sought to investigate the impact of chronic kidney disease (CKD) in patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) with different antithrombotic strategies.
BACKGROUND
CKD is associated with increased risk of adverse ischemic and hemorrhagic events after primary PCI for STEMI.
METHODS
HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial was a multicenter, international, randomized trial comparing bivalirudin monotherapy or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) during primary PCI in STEMI. CKD, defined as creatinine clearance <60 ml/min, was present at baseline in 554 of 3,397 patients (16.3%). Patients were followed for 3 years. Net adverse cardiac event (NACE) was defined as the composite of death, reinfarction, ischemia-driven target vessel revascularization (TVR), stroke or non-coronary artery bypass grafting (CABG)-related major bleeding.
RESULTS
Patients with CKD compared with patients without had higher rates of NACE (41.4% vs. 23.8%, p < 0.0001), death (18.7% vs. 4.4%, p < 0.0001), and major bleeding (19.3% vs. 6.7%, p < 0.0001). Multivariable analysis identified baseline creatinine as an independent predictor of death at 3 years (hazard ratio: 1.51, 95% confidence interval: 1.21 to 1.87, p < 0.001). Patients with CKD randomized to bivalirudin monotherapy versus heparin plus GPI had no significant difference in major bleeding (19.0% vs. 19.6%, p = 0.72) or death (19.0% vs. 18.4%, p = 0.88) at 3 years. In patients with CKD, there was no difference in the rates of TVR in bare-metal stents (BMS) versus drug-eluting stents (DES) at 3 years (14.1% vs. 15.1%, p = 0.8).
CONCLUSIONS
STEMI patients with CKD have significantly higher rates of death and major bleeding compared with those without CKD. In patients with CKD, there appears to be no benefit of bivalirudin compared with heparin + GPI, or DES versus BMS during primary PCI in improving clinical outcomes.
目的
本研究旨在探讨不同抗栓策略下，慢性肾脏病（CKD）患者行经皮冠状动脉介入治疗（PCI）治疗 ST 段抬高型心肌梗死（STEMI）的影响。
背景
CKD 与 STEMI 患者行直接 PCI 后不良缺血和出血事件风险增加相关。
方法
HORIZONS-AMI（急性心肌梗死中经皮冠状动脉介入治疗与血管重建和支架的协调结果）试验是一项多中心、国际、随机试验，比较了在 STEMI 患者中行直接 PCI 时，比伐卢定单药治疗或肝素加糖蛋白 IIb/IIIa 抑制剂（GPI）的疗效。554/3397 例（16.3%）患者在基线时患有 CKD，定义为肌酐清除率<60 ml/min。患者接受了 3 年的随访。净不良心脏事件（NACE）定义为死亡、再梗死、缺血驱动的靶血管血运重建（TVR）、卒中和非冠状动脉旁路移植术（CABG）相关的大出血的复合终点。
结果
与无 CKD 的患者相比，有 CKD 的患者 NACE 发生率更高（41.4%比 23.8%，p<0.0001），死亡率更高（18.7%比 4.4%，p<0.0001），大出血发生率更高（19.3%比 6.7%，p<0.0001）。多变量分析确定基线肌酐是 3 年死亡的独立预测因素（风险比：1.51，95%置信区间：1.21 至 1.87，p<0.001）。在 CKD 患者中，随机接受比伐卢定单药治疗与肝素加 GPI 治疗的患者，3 年时大出血（19.0%比 19.6%，p=0.72）或死亡（19.0%比 18.4%，p=0.88）无显著差异。在 CKD 患者中，3 年时裸金属支架（BMS）与药物洗脱支架（DES）的 TVR 发生率无差异（14.1%比 15.1%，p=0.8）。
结论
与无 CKD 的患者相比，CKD 的 STEMI 患者的死亡率和大出血发生率明显更高。在 CKD 患者中，与肝素+GPI 相比，或与 DES 相比，BMS 在直接 PCI 中改善临床结局似乎没有获益。
Zotero 插件