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美国冠状动脉搭桥手术患者使用纤维蛋白密封剂相关的出血并发症及再入院率

Bleeding-Related Complications and Readmission Rates Associated With Fibrin Sealant Use in Patients Undergoing Coronary Artery Bypass Graft Surgery in the United States.

作者信息

Wan Yin, Lim Sangtaeck, Gao Xin, Danker Walter A, Kocharian Richard, Gangoli Gaurav, DeAnglis Ashley P, Hart James

机构信息

Pharmerit International, Bethesda, MD.

Ethicon Inc, Somerville, NJ.

出版信息

J Cardiothorac Vasc Anesth. 2017 Jun;31(3):876-882. doi: 10.1053/j.jvca.2016.11.015. Epub 2016 Nov 10.

DOI:10.1053/j.jvca.2016.11.015
PMID:28320573
Abstract

OBJECTIVES

To compare the clinical and economic outcomes of EVICEL (Ethicon, Inc., Somerville, NJ) and TISSEEL (Baxter Healthcare Corporation, Westlake Village, CA) use in patients undergoing primary coronary artery bypass graft (CABG) surgery.

DESIGN

Retrospective database analysis.

SETTING

Premier prospective hospital database (June 2009 through March 2014) covering approximately 20% of hospital discharges in the United States.

PARTICIPANTS

Adults undergoing primary CABG surgery who received either EVICEL or TISSEEL on the day of surgery (index date).

INTERVENTIONS

Two intervention groups were formed, EVICEL and TISSEEL. Clinical outcomes compared included postoperative bleeding complications (International Classification of Diseases, Ninth Revision, Clinical Modification code: 998.1) and number of blood transfusions received on the index day. Economic outcomes compared included hospital length of stay, hospital costs, and 30-day readmission rates. Propensity-score matching was used to control for patient and hospital characteristics.

MEASUREMENTS AND MAIN RESULTS

A total of 129,014 primary CABG surgery patients were identified; 986 patients (mean age: 64 years, 73% male) received EVICEL and 6,340 patients (mean age: 65 years, 75% male) received TISSEEL on the index day. After propensity-score matching, patients who received EVICEL compared with TISSEEL had significantly fewer postoperative bleeding complications (3.0% v 5.0%, p = 0.0197), index-day blood transfusion rates (19% v 34%, p<0.0001), readmission rates (18% v 32%, p<0.0001), and costs ($40,736 [standard deviation $19,465] v $46,005 [standard deviation $24,049], p<0.0001). Results from a sensitivity analysis using a generalized linear model to control for other hemostatic agent use also favored EVICEL over TISSEEL.

CONCLUSION

Results from this real-world retrospective database analysis showed fewer bleeding complications and lower costs in patients undergoing primary CABG surgery who received EVICEL compared with TISSEEL.

摘要

目的

比较在接受初次冠状动脉搭桥术(CABG)的患者中使用EVICEL(Ethicon公司,新泽西州萨默维尔)和TISSEEL(百特医疗保健公司,加利福尼亚州西湖村)的临床和经济结局。

设计

回顾性数据库分析。

设置

Premier前瞻性医院数据库(2009年6月至2014年3月),涵盖美国约20%的出院病例。

参与者

在手术当天(索引日期)接受EVICEL或TISSEEL的接受初次CABG手术的成年人。

干预措施

形成两个干预组,EVICEL组和TISSEEL组。比较的临床结局包括术后出血并发症(国际疾病分类第九版临床修订版代码:998.1)和索引日接受输血的次数。比较的经济结局包括住院时间、住院费用和30天再入院率。采用倾向评分匹配法来控制患者和医院特征。

测量指标及主要结果

共识别出129,014例初次CABG手术患者;986例患者(平均年龄:64岁,73%为男性)在索引日接受了EVICEL,6,340例患者(平均年龄:65岁,75%为男性)在索引日接受了TISSEEL。倾向评分匹配后,接受EVICEL的患者与接受TISSEEL的患者相比,术后出血并发症显著更少(3.0%对5.0%,p = 0.0197),索引日输血率(19%对34%,p<0.0001),再入院率(18%对32%,p<0.0001),且费用更低(40,736美元[标准差19,465美元]对46,005美元[标准差24,049美元],p<0.0001)。使用广义线性模型控制其他止血剂使用情况的敏感性分析结果也显示EVICEL优于TISSEEL。

结论

这项真实世界回顾性数据库分析结果显示,与TISSEEL相比,接受EVICEL的初次CABG手术患者出血并发症更少且成本更低。

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