Cardiovascular Division, King's College London, London SE1 7EH, UK.
JAMA. 2010 Aug 25;304(8):867-74. doi: 10.1001/jama.2010.1190.
Observational studies have previously reported that elective intra-aortic balloon pump (IABP) insertion may improve outcomes following high-risk percutaneous coronary intervention (PCI). To date, this assertion has not been tested in a randomized trial.
To determine whether routine intra-aortic balloon counterpulsation before PCI reduces major adverse cardiac and cardiovascular events (MACCE) in patients with severe left ventricular dysfunction and extensive coronary disease.
DESIGN, SETTING, AND PATIENTS: The Balloon Pump-Assisted Coronary Intervention Study, a prospective, open, multicenter, randomized controlled trial conducted in 17 tertiary referral cardiac centers in the United Kingdom between December 2005 and January 2009. Patients (n = 301) had severe left ventricular dysfunction (ejection fraction < or = 30%) and extensive coronary disease (Jeopardy Score > or = 8/12); those with contraindications to or class I indications for IABP therapy were excluded.
Elective insertion of IABP before PCI.
Primary end point was MACCE, defined as death, acute myocardial infarction, cerebrovascular event, or further revascularization at hospital discharge (capped at 28 days). Secondary end points included all-cause mortality at 6 months, major procedural complications, bleeding, and access-site complications.
MACCE at hospital discharge occurred in 15.2% (23/151) of the elective IABP and 16.0% (24/150) of the no planned IABP groups (P = .85; odds ratio [OR], 0.94 [95% confidence interval {CI}, 0.51-1.76]). All-cause mortality at 6 months was 4.6% and 7.4% in the respective groups (P = .32; OR, 0.61 [95% CI, 0.24-1.62]). Fewer major procedural complications occurred with elective IABP insertion compared with no planned IABP use (1.3% vs 10.7%, P < .001; OR, 0.11 [95% CI, 0.01-0.49]). Major or minor bleeding occurred in 19.2% and 11.3% (P = .06; OR, 1.86 [95% CI, 0.93-3.79]) and access-site complications in 3.3% and 0% (P = .06) of the elective and no planned IABP groups, respectively.
Elective IABP insertion did not reduce the incidence of MACCE following PCI. These results do not support a strategy of routine IABP placement before PCI in all patients with severe left ventricular dysfunction and extensive coronary disease.
isrctn.org Identifier: ISRCTN40553718; clinicaltrials.gov Identifier: NCT00910481.
先前的观察性研究报告称，选择性主动脉内球囊泵（IABP）置入术可能改善高危经皮冠状动脉介入治疗（PCI）后的结局。迄今为止，这一观点尚未在随机试验中得到验证。
确定在严重左心室功能障碍和广泛冠状动脉疾病患者中，PCI 前常规使用主动脉内球囊反搏是否降低主要不良心脏和心血管事件（MACCE）。
设计、地点和患者：2005 年 12 月至 2009 年 1 月，在英国 17 个三级转诊心脏中心进行的前瞻性、开放、多中心、随机对照试验。患者（n=301）有严重左心室功能障碍（射血分数≤30%）和广泛的冠状动脉疾病（危险评分>8/12）；有 IABP 治疗禁忌证或 I 类适应证的患者被排除在外。
在 PCI 前选择性插入 IABP。
主要终点为 MACCE，定义为出院时死亡、急性心肌梗死、脑血管事件或进一步血运重建（最多 28 天）。次要终点包括 6 个月时的全因死亡率、主要手术并发症、出血和入路部位并发症。
出院时 MACCE 在选择性 IABP 组为 15.2%（23/151），无计划 IABP 组为 16.0%（24/150）（P=0.85；比值比[OR]，0.94[95%置信区间{CI}，0.51-1.76]）。6 个月时的全因死亡率分别为 4.6%和 7.4%（P=0.32；OR，0.61[95%CI，0.24-1.62]）。与无计划 IABP 组相比，选择性 IABP 插入组的主要手术并发症发生率较低（1.3%对 10.7%，P<0.001；OR，0.11[95%CI，0.01-0.49]）。主要或轻微出血分别发生在 19.2%和 11.3%（P=0.06；OR，1.86[95%CI，0.93-3.79]），入路部位并发症分别发生在 3.3%和 0%（P=0.06）。
PCI 后选择性 IABP 插入并不能降低 MACCE 的发生率。这些结果不支持在所有严重左心室功能障碍和广泛冠状动脉疾病患者中常规放置 IABP 的策略。
isrctn.org 标识符：ISRCTN40553718；clinicaltrials.gov 标识符：NCT00910481。
