A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.
A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.
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DOI：
10.1056/nejmoa012843
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发表时间：
2002-06-06
影响因子：
158.5
通讯作者：
Falotico, R
中科院分区：
文献类型：
--
作者：
Morice, M;Serruys, PW;Falotico, R
背景：经皮冠状动脉血运重建术的主要局限性是需要对已治疗血管的再狭窄进行重复治疗。由于西罗莫司（雷帕霉素）抑制淋巴细胞和平滑肌细胞的增殖，我们比较了西罗莫司洗脱支架与标准的无涂层支架在patients with angina pectors.Methods：我们进行了一项随机，双盲试验，比较两种类型的支架在自体冠状动脉的单一，原发性病变的血运重建。该试验包括19个医疗中心的238名患者。主要终点是支架内晚期管腔丢失（术后即刻最小管腔直径与6个月时直径之间的差异）。次要终点包括支架内狭窄占管腔直径的百分比和再狭窄率（管腔狭窄50%或以上）。我们还分析了一个复合临床终点，包括1个月、6个月和12个月时的死亡、心肌梗死和经皮或手术血运重建。在6个月时，新生内膜增殖的程度，表现为平均（+/-SD）晚期管腔丢失，西罗莫司支架组（-0.01+/-0.33 mm）显著低于标准支架组（0.80+/-0.53 mm，P
Background: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris.Methods: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months.Results: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P