Pache Jürgen, Dibra Alban, Mehilli Julinda, Dirschinger Josef, Schömig Albert, Kastrati Adnan
Deutsches Herzzentrum, Lazarettstrasse 36, 80636 Munich, Germany.
Eur Heart J. 2005 Jul;26(13):1262-8. doi: 10.1093/eurheartj/ehi098. Epub 2005 Feb 28.
Drug-eluting stents have considerably reduced restenosis. Their relative merits have been assessed on the basis of comparisons made with control bare stents with thick struts. However, increased strut thickness negatively affects restenosis. No direct comparisons between drug-eluting stents and bare stents with thin struts have been performed. The aim of this study was to evaluate the relative efficacy of sirolimus-eluting stents (Cypher) as compared with that of bare stents with thin struts (BeStent 2).
A total of 500 patients with coronary artery disease were randomly assigned to receive a Cypher stent or BeStent. The primary endpoint was angiographic restenosis defined as a stenosis diameter > or = 50% at 6-month angiographic follow-up. The secondary endpoint was the need for target vessel revascularization (TVR) during the year following the procedure. Follow-up angiography was performed in 81.8% of the patients. Patients treated with Cypher stents had a lower angiographic restenosis rate [8.3 vs. 25.5%, relative risk, 0.33 (95% confidence interval, 0.19-0.56), P<0.001] and a lower incidence of TVR [7.2 vs. 18.8%, relative risk, 0.38 (0.22-0.66), P<0.001]. For smaller vessels (< 2.8 mm), the angiographic restenosis rates were 7.0% with the Cypher stent and 34.2% with the BeStent (P<0.001). For larger vessels (> or = 2.8 mm), angiographic restenosis rates were 10.0% with the Cypher stent and 13.1% with the BeStent (P=0.52).
The drug-eluting stent, Cypher, is associated with a significantly lower risk of restenosis compared with the bare thin-strut BeStent. The advantage of the Cypher stent is vastly reduced in large vessels.
药物洗脱支架已显著降低再狭窄率。其相对优点是基于与厚支撑结构的对照裸支架比较而评估的。然而，支撑结构厚度增加对再狭窄有负面影响。尚未对药物洗脱支架与薄支撑结构裸支架进行直接比较。本研究的目的是评估西罗莫司洗脱支架（Cypher）与薄支撑结构裸支架（BeStent 2）相比的相对疗效。
总共500例冠心病患者被随机分配接受Cypher支架或BeStent支架。主要终点是血管造影再狭窄，定义为在6个月血管造影随访时狭窄直径≥50%。次要终点是术后一年内靶血管血运重建（TVR）的必要性。81.8%的患者进行了随访血管造影。接受Cypher支架治疗的患者血管造影再狭窄率较低[8.3%对25.5%，相对风险，0.33（95%置信区间，0.19 - 0.56），P<0.001]，TVR发生率也较低[7.2%对18.8%，相对风险，0.38（0.22 - 0.66），P<0.001]。对于较小血管（<2.8 mm），Cypher支架的血管造影再狭窄率为7.0%，BeStent支架为34.2%（P<0.001）。对于较大血管（≥2.8 mm），Cypher支架的血管造影再狭窄率为10.0%，BeStent支架为13.1%（P = 0.52）。
与薄支撑结构裸支架BeStent相比，药物洗脱支架Cypher与显著更低的再狭窄风险相关。Cypher支架在大血管中的优势大幅降低。
