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非缺血性收缩性心力衰竭患者除颤器置入研究
Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure


Lars Køber ... 心脑血管疾病 • 2016.09.29
相关阅读
• 关于心力衰竭管理方案的重点更新

摘要


背景

虽然置入型心律转复除颤器(ICD)对冠心病引起的有症状收缩性心力衰竭患者的益处已经得到充分证实,但是预防性ICD对非冠心病引起的收缩性心力衰竭患者获益的证据主要建立在亚组分析基础上。自从具有里程碑意义的ICD试验之后,心力衰竭的治疗有所改善,如今有许多患者接受心脏再同步化治疗(CRT)。

 

方法

在一项随机对照试验中,556例非冠心病引起的有症状性收缩性心力衰竭患者(左心室射血分数≤35%)被分配接受ICD,560例患者被分配接受常规临床治疗(对照组)。两个研究组中,58%的患者接受了CRT。试验的主要结局为任何原因死亡,次要结局为心脏性猝死和心血管性死亡。

 

结果

在中位数为67.7个月的随访期后,ICD组中的120例患者(21.6%)和对照组中的131例患者(23.4%)发生了主要结局(风险比为0.87;95%置信区间[CI]为0.68~1.12;P=0.28)。ICD组中的24例患者(4.3%)和对照组中的46例患者(8.2%)发生了心脏性猝死(风险比为0.59;95% CI为0.31~0.82;P=0.005)。ICD组中的27例患者(4.9%)和对照组中的20例患者(3.6%)发生了设备感染(P=0.29)。

 

结论

在本试验中,对非冠心病引起的有症状收缩性心力衰竭患者,预防性ICD置入并不能比常规临床治疗显著降低长期任何原因死亡率(由美敦力公司[Medtronic]等资助;DANISH试验在ClinicalTrails.gov注册号为NCT00542945)。





作者信息

Lars Køber, M.D., D.M.Sc., Jens J. Thune, M.D., Ph.D., Jens C. Nielsen, M.D., D.M.Sc., Jens Haarbo, M.D., D.M.Sc., Lars Videbæk, M.D., Ph.D., Eva Korup, M.D., Ph.D., Gunnar Jensen, M.D., Ph.D., Per Hildebrandt, M.D., D.M.Sc., Flemming H. Steffensen, M.D., Niels E. Bruun, M.D., D.M.Sc., Hans Eiskjær, M.D., D.M.Sc., Axel Brandes, M.D., Anna M. Thøgersen, M.D., Ph.D., Finn Gustafsson, M.D., D.M.Sc., Kenneth Egstrup, M.D., D.M.Sc., Regitze Videbæk, M.D., Christian Hassager, M.D., D.M.Sc., Jesper H. Svendsen, M.D., D.M.Sc., Dan E. Høfsten, M.D., Ph.D., Christian Torp-Pedersen, M.D., D.M.Sc., and Steen Pehrson, M.D., D.M.Sc., for the DANISH Investigators*
Address reprint requests to Dr. Køber at the Department of Cardiology, Rigshospitalet, University Hospital, Blegdamsvej 9, Copenhagen, Denmark, or at lars.koeber@regionh.dk. *A complete list of investigators in the Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH) is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

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