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药物洗脱支架时代前经皮冠状动脉介入治疗中血管内超声与血管造影引导的随机对照研究的荟萃分析。

Meta-analysis of randomized studies comparing intravascular ultrasound versus angiographic guidance of percutaneous coronary intervention in pre-drug-eluting stent era.

机构信息

Columbia University Medical Center, New York, New York, USA.

出版信息

Am J Cardiol. 2011 Feb 1;107(3):374-82. doi: 10.1016/j.amjcard.2010.09.030.

Abstract

We conducted a formal meta-analysis of peer-reviewed, published, randomized studies comparing intravascular ultrasound (IVUS)-guidance and angiographic-guided bare metal stent implantation. A total of 8 studies were identified. Because the Balloon Equivalent to Stent (BEST) study was a noninferiority trial designed to compare 2 very different percutaneous coronary intervention strategies-IVUS-guided aggressive balloon angioplasty (with bail-out stenting) and angiographic-guided deliberate bare metal stent implantation-it was eliminated. An unadjusted random-effects meta-analysis was used to compare the IVUS-guided and non-IVUS-guided stenting in the 7 remaining studies. A total of 2,193 patients were randomized in 5 multicenter and 2 single-center studies. IVUS guidance was associated with a significantly larger postprocedure angiographic minimum lumen diameter. The mean difference was 0.12 mm (95% confidence interval [CI] 0.06 to 0.18, p <0.0001). IVUS guidance was also associated with a significantly lower rate of 6-month angiographic restenosis (22% vs 29%, odds ratio 0.64, 95% CI 0.42 to 0.96, p = 0.02), a significant reduction in the revascularization rate (13% vs 18%, odds ratio 0.66, 95% CI 0.48 to 0.91, p = 0.004), and overall major adverse cardiac events (19% vs. 23%, odds ratio 0.69, 95% CI 0.49 to 0.97, p = 0.03). However, no significant effect was seen for myocardial infarction (p = 0.51) or mortality (p = 0.18). In conclusion, IVUS guidance for bare metal stent implantation improved the acute procedural results (angiographic minimum lumen diameter) and thereby reduced angiographic restenosis and repeat revascularization and major adverse cardiac events, with a neutral effect on death and myocardial infarction during a follow-up period of 6 months to 2.5 years.

摘要

我们对比较血管内超声(IVUS)指导与血管造影指导的金属裸支架植入的同行评审、已发表的随机研究进行了正式的荟萃分析。共确定了 8 项研究。由于 Balloon Equivalent to Stent(BEST)研究是一项旨在比较 2 种非常不同的经皮冠状动脉介入治疗策略(IVUS 指导的积极球囊血管成形术[伴有紧急支架置入]与血管造影指导的审慎金属裸支架植入)的非劣效性试验,因此将其排除在外。使用未调整的随机效应荟萃分析比较了其余 7 项研究中的 IVUS 指导和非 IVUS 指导支架置入。共有 2193 例患者在 5 项多中心和 2 项单中心研究中被随机分组。IVUS 指导与术后血管造影最小管腔直径显著增大相关。平均差值为 0.12mm(95%置信区间为 0.06 至 0.18,p<0.0001)。IVUS 指导还与 6 个月时的血管造影再狭窄率显著降低相关(22%对 29%,比值比为 0.64,95%置信区间为 0.42 至 0.96,p=0.02),血运重建率显著降低(13%对 18%,比值比为 0.66,95%置信区间为 0.48 至 0.91,p=0.004),以及整体主要不良心脏事件发生率降低(19%对 23%,比值比为 0.69,95%置信区间为 0.49 至 0.97,p=0.03)。然而,心肌梗死(p=0.51)或死亡率(p=0.18)无显著影响。总之,金属裸支架植入时的 IVUS 指导改善了急性手术结果(血管造影最小管腔直径),从而降低了血管造影再狭窄和再次血运重建以及主要不良心脏事件的发生率,在 6 个月至 2.5 年的随访期间,对死亡和心肌梗死的影响为中性。

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