Holmes D R, Lansky A, Kuntz R, Bell M R, Buchbinder M, Fortuna R, O'Shaughnessy C D, Popma J
Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
Am J Cardiol. 2000 Nov 15;86(10):1073-9. doi: 10.1016/s0002-9149(00)01162-0.
A new martensitic nitinol stent with improved flexibility and radiopacity was tested to evaluate whether these differences improve initial or long-term outcome. Patients who underwent percutaneous revascularization of a discrete native coronary lesion were randomly assigned to the new stent (PARAGON, n = 349) or to the first-generation Palmaz-Schatz (PS) stent (n = 339). The primary end point was target vessel failure at 6 months (a composite of cardiac or noncardiac death, any infarction in the distribution of the treated vessel, or clinically indicated target vessel revascularization). Secondary end points were, among others, device and procedural success and angiographic restenosis. Mean age was 62 years; diabetes was present in 21% of patients, prior bypass surgery in 6%, and recent infarction in 22% (p = NS for comparison between the 2 randomized arms). The PARAGON stent group had smaller reference vessels (2.97 vs 3.05 mm, p = 0.05), more prior restenosis (8.0% vs 4.5%, p = 0.07), and a longer average stent length (21.3 vs 19.4 mm, p < 0.05). Device success was significantly higher in the PARAGON arm (99.1% vs 94.3%, p < 0.05). Death and infarction at 6-month follow-up were infrequent in both groups. There was no significant difference in death (2.0% vs 1.2%, p = 0.546), but a higher rate of infarction for the PARAGON cohort (9.2% vs 4.7%, p = 0.025). Although target vessel failure (20.3% vs 12.4%, p = 0.005) and target lesion revascularization (12.0% vs 5.9%, p = 0.005) were higher in the PARAGON group, there was no significant difference in 6-month follow-up in in-stent minimal lumen diameter or in the rate of binary angiographic restenosis. Both PARAGON and PS stents are safe and associated with infrequent adverse events. The PARAGON stent can be delivered more frequently than the first-generation PS stent. Although there was no significant difference in in-stent minimal lumen diameter or the frequency of angiographic restenosis, clinical restenosis was more frequent in the PARAGON group.
一种具有更好柔韧性和显影性的新型马氏体镍钛合金支架接受了测试，以评估这些差异是否能改善初始或长期疗效。对接受孤立性原生冠状动脉病变经皮血管重建术的患者进行随机分组，分别植入新型支架（PARAGON，n = 349）或第一代帕尔马兹 - 施瓦茨（PS）支架（n = 339）。主要终点是6个月时的靶血管失败（包括心源性或非心源性死亡、治疗血管供血区域内的任何梗死或临床指征的靶血管再血管化的复合指标）。次要终点包括器械和手术成功率以及血管造影再狭窄等。平均年龄为62岁；21%的患者患有糖尿病，6%的患者曾接受过搭桥手术，22%的患者近期发生过梗死（两组随机分组之间比较，p = 无显著差异）。PARAGON支架组的参考血管较小（2.97 vs 3.05 mm，p = 0.05），既往再狭窄情况更多（8.0% vs 4.5%，p = 0.07），平均支架长度更长（21.3 vs 19.4 mm，p < 0.05）。PARAGON组的器械成功率显著更高（99.1% vs 94.3%，p < 0.05）。两组在6个月随访时死亡和梗死情况均不常见。死亡情况无显著差异（2.0% vs 1.2%，p = 0.546），但PARAGON队列的梗死发生率更高（9.2% vs 4.7%，p = 0.025）。尽管PARAGON组的靶血管失败率（20.3% vs 12.4%，p = 0.005）和靶病变再血管化率（12.0% vs 5.9%，p = 0.005）更高，但在6个月随访时，支架内最小管腔直径或二元血管造影再狭窄率并无显著差异。PARAGON和PS支架均安全，且不良事件发生率较低。PARAGON支架的输送频率比第一代PS支架更高。尽管支架内最小管腔直径或血管造影再狭窄频率无显著差异，但PARAGON组的临床再狭窄更常见。
