Coronary Artery Disease
Impact of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump on Prognostically Important Clinical Outcomes in Patients Undergoing High-Risk Percutaneous Coronary Intervention (from the PROTECT II Randomized Trial)

https://doi.org/10.1016/j.amjcard.2013.09.008Get rights and content

A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 [95% confidence interval 0.61 to 0.92], p = 0.007) and MACCE (odds ratio = 0.76 [95% confidence interval 0.61 to 0.96], p = 0.020) at 90 days postprocedure. In conclusion, hemodynamic support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further supported by multivariate analyses.

Section snippets

Methods

PROTECT II was a prospective multicenter randomized trial conducted in 112 sites in the United States, Canada, and Europe, and its methods have been previously reported in detail.4 In brief, patients who underwent high-risk PCI requiring circulatory support and were randomized to the Impella 2.5 device versus IABP. Inclusion criteria were a nonemergent PCI on an unprotected left main or last patent coronary vessel with a left ventricular ejection fraction ≤35% or PCI in patients with 3-vessel

Results

The baseline features and procedural outcomes of the ITT groups have been previously reported,4 and thus the PP data are shown here. Baseline characteristics in the per protocol population were similar between groups, apart from higher rates of congestive heart failure, current smokers, and previous aortocoronary bypass surgery and a trend toward a lower rate of chronic renal failure in the Impella arm (Table 1). The overall patient population was anatomically complex and very high risk, with

Discussion

The principal results of the present study are that in a high-risk population that underwent PCI, use of Impella compared with IABP resulted in significantly lower MAE and MACCE rates at 90 days by both multivariable analyses performed when using a more clinically relevant definition of pMI. These results are new since the primary article of the PROTECT II trial (4).

The PROTECT II trial was terminated when only 69% of the planned enrollment was achieved because of a Data and Safety Monitoring

Disclosures

Drs. George Dangas, Annapoorna S. Kini, Samin K. Sharma, Neal Kleiman, Simon Dixon, and William O'Neill have no conflict of interest to report for this study. Dr. Henriques reported that his institution has received research funding from Abiomed as an investigator site for other Impella trials. Dr. Henriques received modest speaker honoraria from Abiomed. Dr. Claessen reported that his institution has received research funding from Abiomed as investigator site for other Impella trials. Dr.

References (26)

  • W.W. O'Neill et al.

    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

    Circulation

    (2012)
  • K. Thygesen et al.

    Universal definition of myocardial infarction

    Circulation

    (2007)
  • D.E. Cutlip et al.

    Clinical end points in coronary stent trials: a case for standardized definitions

    Circulation

    (2007)
  • Cited by (105)

    • Feasibility and Safety of Impella-Assisted High-Risk PCI Before TAVR in Patients With Severe Aortic Stenosis

      2023, Journal of the Society for Cardiovascular Angiography and Interventions
    • Imaging for Temporary Mechanical Circulatory Support Devices

      2022, Journal of Cardiothoracic and Vascular Anesthesia
      Citation Excerpt :

      The Impella devices include: Impella 2.5 (percutaneous through the femoral artery, up to 2.5 L/min flow), Impella Cardiac Power (CP) (percutaneous through the femoral artery, up to 3.5 L/min flow), Impella 5.0 (surgical cutdown through the femoral artery or the axillary artery, up to 5 L/min flow), Impella 5.5 (surgical cutdown through the axillary artery or direct aortic, up to 5 L/min flow), and Impella LD (direct aortic placement).58,59 The Protect II trial demonstrated the safety, efficacy, and superiority of these devices as compared with intraaortic balloon pumps in high-risk percutaneous coronary interventions and postcardiac arrest shock.60,61 Imaging Considerations: The presence of (1) aortic pathology, such as aortic dissection or severe atherosclerotic disease, (2) AV abnormalities, such as severe aortic regurgitation or presence of mechanical AV prostheses, (3) LV clots and VSDs58,62-66 are contraindications to the placement of the device.

    View all citing articles on Scopus

    The PROTECT-II clinical study was funded by Abiomed (Danvers, Massachusetts).

    Clinical trial registration: http://clinicaltrials.gov/ct2/show/NCT00562016 (identifier NCT00562016).

    See page 227 for disclosure information.

    View full text