Division of Cardiology, Department of Internal Medicine, Leonard M Miller School of Medicine, 1600 NW 10th Ave, Miami, FL 33156, USA.
Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30.
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.
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.
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.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00562016.
虽然冠状动脉旁路移植术通常是严重、复杂多血管或左主干疾病有症状患者的首选治疗方法，但一些患者存在使冠状动脉旁路移植术在临床不可行的临床特征。对于这些患者，可能可以进行经皮冠状动脉介入治疗联合血流动力学支持。目前，对于这种适应证，还没有对血流动力学支持设备进行系统的比较评估。
我们将 452 例有复杂 3 支血管疾病或无保护左主干冠状动脉疾病且左心室功能严重受损的有症状患者随机分配至主动脉内球囊泵（IABP）（n=226）或 Impella 2.5（n=226）支持组，在非紧急高危经皮冠状动脉介入治疗期间使用。主要终点是 30 天内主要不良事件的发生率。按照方案，还需要 90 天的随访。与 IABP 相比，Impella 2.5 提供了更好的血流动力学支持，从基线最大降低心输出量为 -0.04±0.24 W，而 IABP 为 -0.14±0.27 W（P=0.001）。两组之间主要终点（30 天主要不良事件）无统计学差异：Impella 2.5 组为 35.1%，IABP 组为 40.1%，意向治疗人群中 P=0.227，在符合方案人群中 P=0.092。90 天时，与 IABP 相比，接受 Impella 2.5 支持的患者主要不良事件发生率呈下降趋势：意向治疗人群中分别为 40.6%和 49.3%，P=0.066，在符合方案人群中分别为 40.0%和 51.0%，P=0.023。
接受 IABP 或 Impella 2.5 血流动力学支持的患者 30 天主要不良事件发生率无差异。然而，90 天时观察到 Impella 2.5 支持患者的结局改善趋势。
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