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依维莫司洗脱支架治疗钙化性冠状动脉罪犯病变患者的疗效:SPIRIT II 研究两年的血管造影和三年的临床结果。

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study.

机构信息

Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

出版信息

Catheter Cardiovasc Interv. 2010 Nov 1;76(5):634-42. doi: 10.1002/ccd.22541.

DOI:10.1002/ccd.22541
PMID:20690152
Abstract

BACKGROUND

Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions.

METHODS

The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed.

RESULTS

The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12).

CONCLUSIONS

The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

摘要

背景

关于药物洗脱支架(DES)治疗对钙化冠状动脉病变的影响知之甚少。本分析旨在评估依维莫司洗脱支架(EES)在钙化或非钙化罪犯病变患者中的安全性和疗效。

方法

研究人群包括 212 名患者的 247 处病变,他们单独接受 EES 治疗。靶病变的血管造影分级为无/轻度、中度或重度钙化。人群分为两组:至少有一个靶病变中度或重度钙化(钙化组:68 例 75 处钙化病变)和所有靶病变均为轻度或无钙化(非钙化组:144 例)。完成 6 个月和 2 年的血管造影随访以及 3 年的临床随访。

结果

两组间基线特征无显著差异。与非钙化组相比,钙化组 6 个月时支架内血管造影二进制再狭窄(ABR,4.3%比 0%,P = 0.03)和缺血驱动的靶病变血运重建(ID-TLR,5.9%比 0%,P = 0.01)发生率显著更高,导致主要心脏不良事件(MACE,5.9%比 1.4%,P = 0.09)发生率更高。2 年时,与非钙化组相比,钙化组支架内 ABR 更高(7.4%比 0%,P = 0.08)和 ID-TLR 更高(7.8%比 1.5%,P = 0.03),导致 MACE 发生率更高(10.9%比 4.4%,P = 0.12)。3 年时,ID-TLR 在钙化组比非钙化组有升高趋势(8.6%比 2.4%,P = 0.11),导致 MACE 发生率更高(12.1%比 4.7%,P = 0.12)。

结论

EES 治疗钙化病变患者的 MACE 发生率高于非钙化病变患者,但仍低于先前报告的支架研究结果。EES 植入钙化罪犯病变患者是安全的,并可降低再狭窄和再次血运重建的发生率。© 2010 约翰威立父子公司

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