心脏手术患者远程缺血预处理和后处理结果（RISPO）试验的长期临床结局
Long-term clinical outcomes of Remote Ischemic Preconditioning and Postconditioning Outcome (RISPO) trial in patients undergoing cardiac surgery.
作者信息
Cho Youn Joung, Lee Eun-Ho, Lee Kanghee, Kim Tae Kyong, Hong Deok Man, Chin Ji-Hyun, Choi Dae-Kee, Bahk Jae-Hyon, Sim Ji-Yeon, Choi In-Cheol, Jeon Yunseok
机构信息
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
出版信息
Int J Cardiol. 2017 Mar 15;231:84-89. doi: 10.1016/j.ijcard.2016.12.146. Epub 2016 Dec 23.
BACKGROUND
Remote ischemic conditioning has been shown to confer myocardial protection. However, there is still no sufficient data on its long-term clinical outcomes. We analyzed the long-term results of the Remote Ischemic Preconditioning and Postconditioning Outcome (RISPO) trial in cardiac surgery patients.
METHODS
In the RISPO trial, 1280 patients were randomized to receive remote ischemic preconditioning (RIPC) with postconditioning (RIPostC, upper arm ischemia by four cycles of 5-min inflation followed by 5-min deflation of a pneumatic cuff, N=644) or sham (N=636) during cardiac surgery. Patient follow-up data were collected by review of medical records, telephone interviews, and from the National Statistical Office. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE; a composite of all-cause mortality, myocardial infarction (MI), stroke, and revascularization), and the secondary endpoints were the individual components of the primary endpoint.
RESULTS
At completion of follow-up (mean 44months), there was no difference in MACCE between the groups (90 [14.0%] versus 101 [15.9%] in the RIPC with RIPostC versus control groups; hazard ratio [HR], 0.893; 95% confidence interval [CI], 0.672-1.187; P=0.435). However, MI was reduced to half in the RIPC with RIPostC group (10 [1.6%] versus 23 [3.6%]; HR, 0.468; 95% CI, 0.222-0.984; P=0.045).
CONCLUSIONS
Remote ischemic preconditioning with RIPostC did not improve long-term MACCE after cardiac surgery. However, MI was reduced in the RIPC with RIPostC group compared with the control group during the follow-up period.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT00997217.
背景
远程缺血预处理已被证明可提供心肌保护。然而，关于其长期临床结局的资料仍然不足。我们分析了心脏手术患者远程缺血预处理和后处理结果（RISPO）试验的长期结果。
方法
在RISPO试验中，1280例患者被随机分组，在心脏手术期间接受远程缺血预处理（RIPC）及后处理（RIPostC，通过气动袖带四个周期的5分钟充气后接5分钟放气造成上臂缺血，n = 644）或假处理（n = 636）。通过查阅病历、电话访谈以及国家统计局收集患者随访数据。主要终点是主要不良心脑血管事件（MACCE；全因死亡率、心肌梗死（MI）、中风和血运重建的组合），次要终点是主要终点的各个组成部分。
结果
随访结束时（平均44个月），两组间MACCE无差异（RIPC联合RIPostC组与对照组分别为90例[14.0%]和101例[15.9%]；风险比[HR]，0.893；95%置信区间[CI]，0.672 - 1.187；P = 0.435）。然而，RIPC联合RIPostC组的MI减少了一半（10例[1.6%]对23例[3.6%]；HR，0.468；95%CI，0.222 - 0.984；P = 0.045）。
结论
RIPC联合RIPostC未改善心脏手术后的长期MACCE。然而，在随访期内，RIPC联合RIPostC组与对照组相比MI有所减少。
临床试验注册
ClinicalTrials.gov标识符，NCT00997217。
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