A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention The PROTECT II Study
A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention The PROTECT II Study
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DOI：
10.1161/circulationaha.112.098194
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发表时间：
2012-10-02
期刊：
影响因子：
37.8
通讯作者：
Ohman, Magnus
中科院分区：
文献类型：
--
作者：
O'Neill, William W.;Kleiman, Neal S.;Ohman, Magnus
尽管冠状动脉旁路移植术通常是有症状的严重、复杂的多支血管或左主干疾病患者的首选，但有些患者的临床特征使冠状动脉旁路移植术在临床上缺乏吸引力。经皮冠状动脉介入治疗结合血流动力学支持对这些患者是可行的。目前，方法和结果：我们将452例有症状的复杂3支血管疾病或无保护左主干冠状动脉疾病和左心室功能严重下降的患者随机分配到主动脉内球囊反搏（IABP）（n=226）或Impella 2.5（n=226）支持。经皮冠状动脉介入治疗的风险。主要终点是30天内主要不良事件的发生率。方案还要求进行90天随访。Impella 2.5提供了优于IABP的上级血流动力学支持，心输出功率较基线的最大降低为-0.04 +/- 0.24 W，而IABP为-0.14 +/- 0.27 W（P=0.001）。两组的主要终点（30天主要不良事件）无统计学差异：意向治疗人群中Impella 2.5组为35.1%，IABP组为40.1%，P=0.227;符合方案人群中为34.3%，IABP组为42.2%，P=0.092。在90天时，与IABP相比，在Impella 2.5支持的患者中观察到主要不良事件减少的强烈趋势：意向治疗人群中为40.6% vs 49.3%，P=0.066，符合方案人群中为40.0% vs 51.0%，P=0.023，结论：IABP或Impella 2.5血流动力学支持患者的30天主要不良事件发生率没有差异。然而，在90天时观察到Impella 2.5支持的患者结局改善的趋势。
Background-Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication.Methods and Results-We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of -0.04 +/- 0.24 W in comparison with -0.14 +/- 0.27 W for IABP (P=0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the per protocol population, respectively.Conclusions-The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5-supported patients at 90 days.