Thoraxcenter, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
Catheter Cardiovasc Interv. 2012 Jul 1;80(1):18-26. doi: 10.1002/ccd.23199. Epub 2012 Apr 17.
There is few information on the long-term efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS) in all-comer percutaneous coronary intervention (PCI)-patients complicated by renal insufficiency (RI).
Our aim was to assess the 6-year clinical outcome of PCI-patients with RI treated exclusively with BMS, SES, or PES in our academic hospital.
A total of 1382 patients, included in three cohorts of consecutive PCI-patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft-Gault formula (normal kidney function ≥ 90; mild RI = 60-89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE).
Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan-Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox-regression analysis, SES and PES decreased the occurrence of target-vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28-0.84; aHR = 0.75, 95% CI: 0.57-0.97, respectively] with no significant effect on mortality. Safety- and efficacy end points were comparable for the three stent types in patients with mild- and moderate renal function.
Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES- or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug-eluting stents over BMS in safety and efficacy end points for patients with impaired renal function.
在所有经皮冠状动脉介入治疗（PCI）患者中，与裸金属支架（BMS）相比，西罗莫司洗脱支架（SES）和紫杉醇洗脱支架（PES）的长期疗效和安全性数据较少，这些患者并发肾功能不全（RI）。
我们旨在评估我们学术医院中 RI 经皮冠状动脉介入治疗（PCI）患者单独使用 BMS、SES 或 PES 的 6 年临床结果。
总共纳入了 1382 例连续 PCI 患者（BMS = 392；SES = 498；PES = 492），根据 Cockroft-Gault 公式计算的肌酐清除率分为三组（正常肾功能≥90；轻度 RI = 60-89；中度 RI < 60），并对主要不良心脏事件（MACE）的发生进行系统随访。
6 年时，中度 RI 患者的死亡率明显高于轻度 RI 和正常肾功能患者（Kaplan-Meier 估计：中度 RI（34%）比轻度 RI（12%），P < 0.001；中度 RI（34%）比正常肾功能（8%），P < 0.001）。多变量 Cox 回归分析后，SES 和 PES 降低了肌酐清除率正常患者 6 年时的靶血管血运重建（TVR）和 MACE 的发生，与 BMS 相比[校正后的危险比（aHR）= 0.48，95%CI：0.28-0.84；aHR = 0.75，95%CI：0.57-0.97]，死亡率无显著影响。在轻度和中度肾功能患者中，三种支架类型的安全性和有效性终点相似。
与 BMS 相比，SES 或 PES 植入后 6 年时，肌酐清除率正常的患者 TVR 和 MACE 发生率显著降低。然而，在肾功能受损的患者中，两种药物洗脱支架在安全性和有效性终点方面均无优于 BMS。
