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经皮冠状动脉介入治疗中使用紫杉醇洗脱支架相关的支架内血栓形成风险是多少?一项荟萃分析。

What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: a meta-analysis.

作者信息

Bavry Anthony A, Kumbhani Dharam J, Helton Thomas J, Bhatt Deepak L

机构信息

Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.

出版信息

J Am Coll Cardiol. 2005 Mar 15;45(6):941-6. doi: 10.1016/j.jacc.2004.11.064.

Abstract

OBJECTIVES

This study investigated the risk of stent thrombosis associated with the use of paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS).

BACKGROUND

Clinical experience with coronary drug-eluting stents (DES) is relatively limited. There is concern that DES used for percutaneous coronary intervention may result in subsequent thrombosis.

METHODS

We conducted a meta-analysis on eight trials (total of 13 study arms) in 3,817 patients with coronary artery disease who were randomized to either PES or BMS.

RESULTS

As compared with BMS, PES do not increase the hazard for thrombosis up to 12 months (risk ratio [RR] = 1.06, 95% confidence interval [CI] 0.55 to 2.04, p = 0.86]). There was no evidence of heterogeneity among the studies (chi-square value for Q-statistic = 5.90 [10 degrees of freedom], p = 0.82). Similar results were obtained when the analysis was restricted to trials with a polymeric stent platform (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI) (RR = 1.01, 95% CI 0.40 to 2.53, p = 0.99), trials with longer lesions (TAXUS-IV and -VI) (RR = 0.62, 95% CI 0.2 to 1.91, p = 0.41), and trials that used a higher dose of paclitaxel (ASian Paclitaxel-Eluting Stent Clinical trial [ASPECT], European evaLUaTion of paclitaxel Eluting Stents [ELUTES], and DELIVER-I) (RR = 1.87, 95% CI 0.52 to 6.81, p = 0.34).

CONCLUSIONS

Current evidence suggests that standard dose PES do not increase the hazard of stent thrombosis compared to BMS.

摘要

目的

本研究调查了与裸金属支架(BMS)相比,使用紫杉醇洗脱支架(PES)相关的支架血栓形成风险。

背景

冠状动脉药物洗脱支架(DES)的临床经验相对有限。人们担心用于经皮冠状动脉介入治疗的DES可能会导致随后的血栓形成。

方法

我们对八项试验(共13个研究组)进行了荟萃分析,这些试验涉及3817例冠状动脉疾病患者,他们被随机分配接受PES或BMS。

结果

与BMS相比,在长达12个月的时间里,PES不会增加血栓形成的风险(风险比[RR]=1.06,95%置信区间[CI]为0.55至2.04,p=0.86)。研究之间没有异质性的证据(Q统计量的卡方值=5.90[10个自由度],p=0.82)。当分析仅限于使用聚合物支架平台的试验(使用单一紫杉醇洗脱支架[TAXUS]-I、-II、-IV和-VI治疗初发冠状动脉疾病)(RR=1.01,95%CI为0.40至2.53,p=0.99)、病变较长的试验(TAXUS-IV和-VI)(RR=0.62,95%CI为0.2至1.91,p=0.41)以及使用较高剂量紫杉醇的试验(亚洲紫杉醇洗脱支架临床试验[ASPECT]、欧洲紫杉醇洗脱支架评估[ELUTES]和DELIVER-I)(RR=1.87,95%CI为0.52至6.《81》,p=0.34)时,也得到了类似的结果。

结论

目前的证据表明,与BMS相比,标准剂量的PES不会增加支架血栓形成的风险。

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