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经皮冠状动脉腔内血管成形术(PTCA)和支架置入术治疗初发冠状动脉狭窄的随机试验:1994年6月现有数据综述

Randomized trials on PTCA and stenting in the treatment of De Novo coronary artery stenosis: an overview on existing data in June 1994.

作者信息

Debbas N M, Eeckhout E, Goy J J

机构信息

Cardiology Division, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

出版信息

J Interv Cardiol. 1995 Dec;8(6 Suppl):752-5. doi: 10.1111/j.1540-8183.1995.tb00926.x.

DOI:10.1111/j.1540-8183.1995.tb00926.x
PMID:10159765
Abstract

This is a review on prospective randomized comparisons of PTCA and stents in the treatment of de novo native coronary artery lesions. BENESTENT and STRESS, two multicentric studies, used the articulated Palmaz-Schatz stent. In Lausanne, a single center trial limited to right coronary artery lesions, was conducted using the Wiktor stent. During the in-hospital phase. BENESTENT and STRESS showed the composite clinical end point to be less in the stent than in the PTCA groups (p < 0.05). In Lausanne, there was no difference between groups. The incidence of subacute closure was similar with both treatments in three trials. Angiographically, both postprocedural minimal luminal diameter (MLD) and percentage stenosis were larger in the stent group (P < 0.05). At 6 months, in both BENESTENT and STRESS, a composite clinical end point was reached by less stent patients than PTCA patients, with a reduced need for repeat nonsurgical reintervention by stenting. However, in Lausanne, there was no difference between stent and PTCA groups. At 6 months in both BENESTENT and STRESS, a persistent lower MLD, a larger percentage of stenosis, and a higher incidence of angiographic restenosis were found in the PTCA groups (P < 0.05). In Lausanne, no differences in MLD, percentage stenosis and angiographic restenosis were found between groups. Effective stenting of de novo lesions does improve immediate results compared to conventional balloon PTCA. The long-term outcome of stenting with Palmaz-Scharz stents is also improved compared to PTCA.

摘要

这是一篇关于经皮冠状动脉腔内血管成形术(PTCA)与支架置入术治疗初发原位冠状动脉病变的前瞻性随机对照研究的综述。两项多中心研究BENESTENT和STRESS使用了可弯曲的帕尔马兹-施查茨支架。在洛桑,一项仅限于右冠状动脉病变的单中心试验使用了维克托支架。在住院期间,BENESTENT和STRESS研究显示,支架置入组的复合临床终点低于PTCA组(p<0.05)。在洛桑,两组之间没有差异。在三项试验中,两种治疗方法的亚急性闭塞发生率相似。血管造影显示,支架置入组术后最小管腔直径(MLD)和狭窄百分比均较大(P<0.05)。6个月时,在BENESTENT和STRESS研究中,支架置入组患者达到复合临床终点的人数少于PTCA组,且通过支架置入术进行重复非手术再干预的需求减少。然而,在洛桑,支架置入组和PTCA组之间没有差异。在BENESTENT和STRESS研究中,6个月时,PTCA组的MLD持续较低、狭窄百分比更大、血管造影再狭窄发生率更高(P<0.05)。在洛桑,两组之间在MLD、狭窄百分比和血管造影再狭窄方面没有差异。与传统球囊PTCA相比,初发病变的有效支架置入确实改善了即刻效果。与PTCA相比,使用帕尔马兹-施查茨支架进行支架置入术的长期预后也有所改善。

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