Study Shows High-Risk PCI with Impella Improved 90-day Event-Free Survival Compared to IABP
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.
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.
- 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
- 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.
High-risk PCI with the Impella 2.5 “resulted in improved event-free survival” 90 days after the PCI procedure compared to IABP.
- Read the original paper by Dangas et al. 2014.
- Read the original PROTECT II paper by O’Neill et al. 2012.
- Read article on quality of care and health costs with Impella by Gregory et al. 2013.
- Learn more about Protected PCI.
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/