Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Am J Cardiol. 2010 Nov 15;106(10):1436-42. doi: 10.1016/j.amjcard.2010.07.011.
Whether drug-eluting stents are effective and safe in patients with moderate renal insufficiency (RI) is unknown. We performed a pooled analysis of data from 3 blinded randomized trials of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs; SIRIUS, C-SIRIUS, E-SIRIUS) that included 1,510 patients. Clinical and angiographic outcomes were stratified by the presence of RI defined by creatinine clearance calculated by the Cockcroft-Gault formula (normal ≥ 90, mild 60 to 89, moderate < 60 ml/min). Patients with baseline creatinine > 3.0 mg/dl were excluded from these trials. Baseline mild RI was present in 517 patients (34.7%, mean creatinine clearance 75.7 ml/min) and moderate RI in 228 patients (15.3%, mean creatinine clearance 47.2 ml/min). Treatment with SESs resulted in lower rates of 8-month angiographic restenosis rates in patients with RI (mild RI 6.7% vs 42.6%, p < 0.001; moderate RI 9.7% vs 39.7%, p < 0.001) and without baseline RI (7.7% vs 37.2%, p < 0.001). One-year target vessel revascularization rates were similarly decreased with SESs in patients with (mild RI 4.7% vs 24.2%, p < 0.001; moderate RI 5.5% vs 26.9%, p < 0.001) and without (8.1% vs 22.4%, p < 0.001) RI, and this benefit was maintained at 5 years. Compared to patients with normal or mild RI, patients with moderate RI had higher rates of overall mortality and cardiac death at 1 year and 5 years (death 2.6% vs 0.6%, p <0.01, and 17.5% vs 6.3%, p < 0.01, at 1 year and 5 years, respectively; cardiac death 1.3% vs 0.2%, p = 0.05, and 6.6% vs 3.4%, p = 0.04, at 1 year and 5 years, respectively). However, there was no differential effect of SESs versus BMSs on any safety end point. In conclusion, patients with moderate RI have a nearly threefold increase in 5-year mortality after percutaneous coronary intervention compared to patients without RI. The effectiveness of SESs in decreasing restenosis compared to BMSs in patients with moderate RI was preserved and rates of death and myocardial infarction were not adversely affected.
在中度肾功能不全（RI）患者中，药物洗脱支架是否有效和安全尚不清楚。我们对 3 项依维莫司洗脱支架（SES）与裸金属支架（BMS）的盲法随机试验数据进行了汇总分析，共纳入 1510 例患者。根据 Cockcroft-Gault 公式计算的肌酐清除率（正常≥90，轻度 60-89，中度<60ml/min）将临床和血管造影结果分层。这些试验排除了基线肌酐>3.0mg/dl的患者。基线轻度 RI 患者 517 例（34.7%，平均肌酐清除率 75.7ml/min），中度 RI 患者 228 例（15.3%，平均肌酐清除率 47.2ml/min）。与 BMS 相比，SES 治疗可降低 RI 患者（轻度 RI 6.7% vs. 42.6%，p<0.001；中度 RI 9.7% vs. 39.7%，p<0.001）和无基线 RI 患者（7.7% vs. 37.2%，p<0.001）的 8 个月血管造影再狭窄率。与 BMS 相比，SES 治疗也可降低 RI 患者（轻度 RI 4.7% vs. 24.2%，p<0.001；中度 RI 5.5% vs. 26.9%，p<0.001）和无 RI 患者（8.1% vs. 22.4%，p<0.001）的 1 年靶血管血运重建率，且这种获益在 5 年内得以维持。与正常或轻度 RI 患者相比，中度 RI 患者在 1 年和 5 年时的全因死亡率和心脏死亡率更高（死亡率分别为 2.6% vs. 0.6%，p<0.01，17.5% vs. 6.3%，p<0.01；心脏死亡率分别为 1.3% vs. 0.2%，p=0.05，6.6% vs. 3.4%，p=0.04）。然而，SES 与 BMS 在任何安全性终点上均无差异。结论：与无 RI 患者相比，经皮冠状动脉介入治疗后，中度 RI 患者 5 年死亡率增加近 3 倍。SES 降低再狭窄的有效性与 BMS 相似，且死亡率和心肌梗死发生率未受不良影响。
