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【medical-news】初次PCI中使用药物洗脱支架
Drug-eluting stent use possible in primary PCI
初次PCI中使用药物洗脱支架
14 September 2006
N Engl J Med 2006; 355: 1093-1104, 1105-1113
新英格兰医学杂志 2006；355 1093-1104，1105-1113
Two trials published in the New England Journal of Medicine indicate that drug-eluting stents may reduce the need for repeated revascularization after primary percutaneous coronary intervention for ST-elevation myocardial infarction (STEMI).
两项发表在《新英格兰医学杂志》上的临床试验表明，药物洗脱支架可能减少初次经皮冠脉介入术治疗（PCI）ST段抬高心肌梗塞（STEMI）后再次血运重建。
However, only the TYPHOON trial involving the sirolimus-eluting stent significantly reduced its primary endpoint of target vessel failure compared with an uncoated stent.
但是，只有关于西罗莫司洗脱支架的TYPHOON试验表明，与裸支架组相比显著降低了作为主要终点的靶血管障碍率
A favorable, but not significant trend, towards benefits with the paclitaxel-eluting stent in the primary endpoint of serious adverse cardiac events was seen in the PASSION trial.
PASSION试验显示，在严重心脏事件为主要终点方面使用紫杉醇洗脱支架可以获得较好效果，但未达统计学显著性。
Commenting on the findings in an accompanying editorial, Frans Van Der Werf (University of Leuven, Belgium) said: "It would be dangerous to conclude from these data that one drug-eluting stent is better than the other in primary PCI, since direct comparisons of the two stents for this indication are not available."
Frans Van Der Werf（比利时Leuven大学）在配发的一篇社论中评论说：“从这些数据就得出药物洗脱支架在初次PCI中优于其他支架是危险的，因为并没有针对这种适应症的两种支架的直接比较”
The Trial to Assess the Use of the Cypher Stent in acute MI Treated with Balloon Angioplasty (TYPHOON) was a single-blind, multicenter study in which 712 STEMI patients were randomly assigned to a sirolimus-eluting stent or any commercially available uncoated stent.
评价在急性心肌梗塞的气囊血管成形术中使用Cypher支架的试验（TYPHOON）为单盲、多中心研究，712名ST段抬高心肌梗塞患者被随机分配接受西罗莫司洗脱支架或者任何可用的裸支架。
Christian Spaulding (INSERM U780, Paris, France) and colleagues report that the primary endpoint of target vessel failure at 1 year, defined as target-vessel-related death recurrent MI, or target vessel revascularization (TVR) was significantly less common with the sirolimus stent than the bare stent, at 7.3% versus 14.3% (p=0.004).
Christian Spaulding（法国国家健康与医学研究院）和同事们报告了1年时的主要终点靶血管障碍，定义为靶血管相关的再次心肌梗塞，或者靶血管再次血运重建（TVR），在西罗莫司显著低于裸支架组，分别为7.3%和14.3%（p=0.004）
The reduction was driven by a decrease in TVR, with this endpoint seen in 5.6% versus 13.4% of the groups, respectively (p<0.001), with deaths and reinfarction occurring similarly. Stent thrombosis was also nearly identical in the two groups.
主要终点降低的主要原因为靶血管再次血运重建降低了，该终点两组发生率分别为5.6%和13.4%（p<0.001），两组死亡和心肌梗塞发生率类似。支架血栓发生率在两组也近于相同。
"The results of the angiographic follow-up study suggest that the mechanism of benefit involves the suppression of neointimal proliferation among patients receiving sirolimus-eluting stents," the researchers add.
研究人员补充说，研究随访的血管造影结果提示获益的机制为西罗莫司洗脱支架抑制了新生内膜增殖。
Neointimal proliferation, assessed from the mean in-stent late luminal loss among 174 participants who underwent angiography at 8 months, was 0.14 mm in the sirolimus-stent group versus 0.83 mm in the uncoated-stent group (p<0.001).
新生内膜增殖，从174名在8个月接受造影检查的患者中得到支架内迟发管腔径丢失的均数，在西罗莫司洗脱支架为0.14mm，而裸支架组为0.83mm（p<0.001）。
The Paclitaxel-Eluting Stent versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation (PASSION) trial included 619 STEMI patients who were randomly assigned either a paclitaxel-eluting stent or uncoated stent.
比较紫杉醇洗脱支架与传统支架治疗ST段抬高的心肌梗塞试验（PASSION）入选了619名患者，随机分配接受紫杉醇洗脱支架或者裸支架。
The primary endpoint of death from cardiac causes, MI, or target lesion revascularization at 1 year was reduced from 12.8% with the bare stent to 8.8% with the paclitaxel-eluting stent - an adjusted relative risk of 0.63 with the coated stent that did not register as statistically significant (p=0.09) - with similar results for the individual endpoints. Stent thrombosis at 1 year also occurred similarly.
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作者:admin@医学,生命科学 2011-02-12 17:14
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