Medizinische Klinik III, Eberhard Karls Universität Tübingen, Germany.
Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.
Stents eluting antiproliferative drugs reduce the incidence of restenosis but delay healing of the vascular wall. We assessed the safety and efficacy of catheter-based local delivery of fluid paclitaxel in patients with coronary de novo stenoses after implantation of a bare metal stent.
We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (group I) with the implantation of a bare metal stent (group II) and the implantation of a paclitaxel-eluting stent (group III) in 204 patients. The primary end point was in-stent late lumen loss. Secondary end points included binary restenosis rate >50%, minimal lumen diameter, diameter stenosis, and a composite clinical end point (major adverse cardiac events and revascularization of the target lesion) 6 months after intervention. At 6 months, angiography showed an in-stent late lumen loss of 0.61+/-0.44 mm in group I versus 0.99+/-0.72 mm in group II (I versus II, P=0.0006) and 0.44+/-0.48 mm in group III (noninferiority of I versus III, P=0.023). The 1-sided 95% CI for the true difference of the means of in-stent late lumen loss in groups I and III was -infinity to 0.3174188. The cumulative overall rate of major cardiac events was 13.4% in group I, 26.8% in group II, and 14.9% in group III. Target lesion revascularization rate was 13.4% (group I), 22.1% (group II), and 13.4% (group III).
Additional antiproliferative treatment of de novo lesions in native coronary arteries with catheter-based delivery of fluid paclitaxel after bare metal stenting was safe and significantly reduced neointimal proliferation, restenosis, and clinical events compared with bare metal stent implantation alone.
载有抗增殖药物的支架可降低再狭窄发生率，但会延迟血管壁愈合。我们评估了经皮冠状动脉腔内成形术后裸金属支架植入患者冠状动脉新发病变局部应用紫杉醇溶液的安全性和有效性。
我们前瞻性、随机比较了裸金属支架植入后局部应用紫杉醇溶液（I 组）、裸金属支架植入（II 组）和紫杉醇洗脱支架植入（III 组）的 204 例患者。主要终点为支架内晚期管腔丢失。次要终点包括：二元再狭窄率>50%、最小管腔直径、直径狭窄率和复合临床终点（主要心脏不良事件和靶病变血运重建）。6 个月时，血管造影显示 I 组支架内晚期管腔丢失为 0.61±0.44mm，II 组为 0.99±0.72mm（I 组与 II 组，P=0.0006），III 组为 0.44±0.48mm（I 组与 III 组，非劣效性 P=0.023）。I 组和 III 组支架内晚期管腔丢失的均值差值的 1 侧 95%CI 为-无穷大至 0.3174188。I 组、II 组和 III 组的主要心脏不良事件发生率分别为 13.4%、26.8%和 14.9%。靶病变血运重建率分别为 13.4%（I 组）、22.1%（II 组）和 13.4%（III 组）。
与单独裸金属支架植入相比，经皮冠状动脉腔内成形术后裸金属支架植入患者冠状动脉新发病变局部应用紫杉醇溶液可显著减少新生内膜增生、再狭窄和临床事件。
