Study Shows High-Risk PCI with Impella Improved 90-day Event-Free Survival Compared to IABP

ProtectedPCI
December 29, 2015

Clinical Outcomes of Impella Heart Pump vs Intra Aortic BalloonArticle

Dangas GD, Kini AS, Sharma SK, Henriques JPS, Claessen BE, Dixon SR, Massaro JM, Palacios I, Popma JJ, Ohman EM, Stone GW, O’Neill WW. 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). Am J Cardiol 2014;113:222-228.

Objective

To compare clinical outcomes resulting from the use of the Impella 2.5 heart pump to those of the intra aortic balloon pump (IABP) during high-risk PCI.

Study Design

  • Data from the PROTECT II study were reanalyzed retrospectively using the following clinically relevant definition of myocardial infarction: “the advent of new Q-waves or a creatine kinase-MB elevation >8X normal.”
  • The PROTECT II study was a prospective, multi-center, randomized controled trial of the IMPELLA RECOVER LP 2.5 system versus IABP in patients undergoing non emergent high- risk PCI.
  • Eligible high-risk PCI patients were randomized to one of the following groups: Impella 2.5 or IABP.
  • Patient follow-up was compared 30 and 90 days post-procedure.
  • Clinical outcomes assessed:
    • Major adverse events (MAE)
    • Major adverse cardiac and cerebrovascular events (MACCE)
    • Any repeat revascularizaions

Key Points

  • The numbers of patients in each group who met the eligibility criteria:
    • Impella 2.5 group: 216
    • IABP group: 211
  • The baseline clinical characteristics of the two groups at baseline were similar with the following exceptions:
    • Impella 2.5 group had higher rates of congestive heart failure, smokers, previous aortocoronary bypass surgery, and a trend of fewer patients with chronic kidney failure.
  • Mean left ventricular ejection fraction of the total patient population was 24%.
  • When retrospectively considering the updated definition of myocardial infarction, 30 days after high-risk PCI, the Impella 2.5 group had (p=0.04) fewer MAE, stroke/transient ischemic attack and repeat revascularizations compared to the IABP group.
  • When retrospectively considering the updated definition of myocardial infarction, 90 days after high-risk PCI, the Impella 2.5 group had significantly (p< or equal to 0.04) fewer MAE, MACEE, myocardial infarction and repeat revascularizations compared to the IABP group.

Conclusion

High-risk PCI with the Impella 2.5 “resulted in improved event-free survival” 90 days after the PCI procedure compared to IABP.

Next Steps:

  1. Read the original paper by Dangas et al. 2014.
  2. Read the original PROTECT II paper by O’Neill et al. 2012.
  3. Read article on quality of care and health costs with Impella by Gregory et al. 2013.
  4. Learn more about Protected PCI.

 


About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.