Halkin Amir, Mehran Roxana, Casey Christopher W, Gordon Paul, Matthews Ray, Wilson B Hadley, Leon Martin B, Russell Mary E, Ellis Stephen G, Stone Gregg W
Cardiovascular Research Foundation, New York, NY 10022, USA.
Am Heart J. 2005 Dec;150(6):1163-70. doi: 10.1016/j.ahj.2005.01.032.
Mortality and restenosis may be increased in patients with mild to moderate renal insufficiency (RI) after coronary stent implantation. Whether drug-eluting stents safely reduce restenosis and enhance event-free survival in these patients is unknown. We sought to evaluate the impact of baseline RI on clinical and angiographic outcomes in patients undergoing elective percutaneous coronary intervention using either bare metal or paclitaxel-eluting stents.
In the TAXUS-IV trial, 1314 patients were randomized to either the polymer-based paclitaxel-eluting TAXUS stent or an identical-appearing bare metal stent. Outcomes were stratified on the basis of the presence of RI, defined as a baseline creatinine clearance < 60 cm3/min calculated by the Cockcroft-Gault formula.
Baseline RI was present in 223 (17.2%) patients, in whom the mean creatinine clearance was 49.6 +/- 8.5 cm3/min. Compared with bare metal stents, treatment with the TAXUS stent resulted in lower rates of 9-month angiographic restenosis rates in both patients with (2.1% vs 20.5%, P = .009) and without (9.2% vs 27.8%, P < .0001) baseline RI. Similarly, 1-year target lesion revascularization rates were reduced with the TAXUS stent in patients with (3.3% vs 12.2%, P = .01) and without (4.7% vs 15.8%, P < .0001) baseline RI. The occurrence of death, myocardial infarction, and stent thrombosis at 1 year were similar in both randomization groups, independent of renal function.
The polymer-based paclitaxel-eluting TAXUS stent safely reduces clinical and angiographic restenosis in patients with preserved as well as moderate impairment of baseline renal function.
冠状动脉支架植入术后，轻至中度肾功能不全（RI）患者的死亡率和再狭窄率可能会升高。药物洗脱支架能否安全降低这些患者的再狭窄率并提高无事件生存率尚不清楚。我们试图评估基线RI对接受裸金属支架或紫杉醇洗脱支架的择期经皮冠状动脉介入治疗患者的临床和血管造影结果的影响。
在TAXUS-IV试验中，1314例患者被随机分为基于聚合物的紫杉醇洗脱TAXUS支架组或外观相同的裸金属支架组。根据RI的存在情况进行分层，RI定义为根据Cockcroft-Gault公式计算的基线肌酐清除率<60 cm³/min。
223例（17.2%）患者存在基线RI，其平均肌酐清除率为49.6±8.5 cm³/min。与裸金属支架相比，TAXUS支架治疗使有（2.1%对20.5%，P = 0.009）和无（9.2%对27.8%，P < 0.0001）基线RI的患者9个月时的血管造影再狭窄率均降低。同样，TAXUS支架使有（3.3%对12.2%，P = 0.01）和无（4.7%对15.8%，P < 0.0001）基线RI的患者1年时的靶病变血运重建率降低。两个随机分组组1年时死亡、心肌梗死和支架血栓形成的发生率相似，与肾功能无关。
基于聚合物的紫杉醇洗脱TAXUS支架可安全降低基线肾功能正常以及中度受损患者的临床和血管造影再狭窄率。
