缺血后处理对 ST 段抬高型心肌梗死患者直接经皮冠状动脉介入治疗的影响：一项随机临床试验。
Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial.
机构信息
Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Department of Cardiology, Roskilde Hospital, Roskilde, Denmark.
出版信息
JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.
IMPORTANCE
Ischemic postconditioning of the heart during primary percutaneous coronary intervention (PCI) induced by repetitive interruptions of blood flow to the ischemic myocardial region immediately after reopening of the infarct-related artery may limit myocardial damage.
OBJECTIVE
To determine whether ischemic postconditioning can improve the clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).
DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, randomized clinical trial, patients with onset of symptoms within 12 hours, STEMI, and thrombolysis in myocardial infarction (TIMI) grade 0-1 flow in the infarct-related artery at arrival were randomized to conventional PCI or postconditioning. Inclusion began on March 21, 2011, through February 2, 2014, and follow-up was completed on February 2, 2016. Analysis was based on intention to treat.
INTERVENTIONS
Patients were randomly allocated 1:1 to conventional primary PCI, including stent implantation, or postconditioning performed as 4 repeated 30-second balloon occlusions followed by 30 seconds of reperfusion immediately after opening of the infarct-related artery and before stent implantation.
MAIN OUTCOME AND MEASURES
A combination of all-cause death and hospitalization for heart failure.
RESULTS
During the inclusion period, 1234 patients (975 men [79.0%] and 259 women [21.0%]; mean [SD] age, 62 [11] years) underwent randomization in the trial. Median follow-up was 38 months (interquartile range, 24-58 months). The primary outcome occurred in 69 patients (11.2%) who underwent conventional primary PCI and in 65 (10.5%) who underwent postconditioning (hazard ratio, 0.93; 95% CI, 0.66-1.30; P = .66). The hazard ratios were 0.75 (95% CI, 0.49-1.14; P = .18) for all-cause death and 0.99 (95% CI, 0.60-1.64; P = .96) for heart failure.
CONCLUSIONS AND RELEVANCE
Routine ischemic postconditioning during primary PCI failed to reduce the composite outcome of death from any cause and hospitalization for heart failure in patients with STEMI and TIMI grade 0-1 flow at arrival.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01435408.
重要性
在经皮冠状动脉介入治疗（PCI）期间，通过在梗死相关动脉再通后立即重复中断血流来对缺血心肌区域进行缺血后处理，可能会限制心肌损伤。
目的
确定缺血后处理是否可以改善 ST 段抬高型心肌梗死（STEMI）患者的临床结局。
设计、地点和参与者：这是一项多中心、随机临床试验，纳入的患者在发病后 12 小时内，STEMI 患者，到达时梗死相关动脉的溶栓治疗心肌梗死（TIMI）血流为 0-1 级，随机分为常规 PCI 或后处理组。纳入始于 2011 年 3 月 21 日，至 2014 年 2 月 2 日，并于 2016 年 2 月 2 日完成随访。分析基于意向治疗。
干预措施
患者随机以 1:1 的比例分配到常规的直接 PCI 治疗组，包括支架植入，或后处理组，在梗死相关动脉再通后并在支架植入前立即进行 4 次 30 秒的球囊闭塞，随后进行 30 秒的再灌注。
主要结局和测量指标
全因死亡和因心力衰竭住院的联合结局。
结果
在纳入期间，1234 名患者（975 名男性[79.0%]和 259 名女性[21.0%]；平均[SD]年龄，62[11]岁）接受了随机分组。中位随访时间为 38 个月（四分位距，24-58 个月）。主要结局发生在 69 名接受常规直接 PCI 治疗的患者（11.2%）和 65 名接受后处理的患者（10.5%）中（风险比，0.93；95%CI，0.66-1.30；P=0.66）。全因死亡的风险比为 0.75（95%CI，0.49-1.14；P=0.18），心力衰竭的风险比为 0.99（95%CI，0.60-1.64；P=0.96）。
结论和相关性
在 STEMI 患者和 TIMI 血流 0-1 级到达时，直接 PCI 期间常规进行缺血后处理并不能降低全因死亡和因心力衰竭住院的复合结局。
试验注册
clinicaltrials.gov 标识符：NCT01435408。
Zotero 插件