Abiomed has completed the PROTECT II study of Impella, its minimally invasive catheter-based cardiac assist device, based on the futility determination at the planned interim analysis of the primary end-point.
The PROTECT II study is a prospective, multi-center, randomized controlled study of the Impella 2.5 versus the intra-aortic balloon (IAB) in patients undergoing non emergent high risk percutaneous coronary intervention (PCI) requiring hemodynamic support.
The study was designed to compare Impella with intra-aortic balloon (IAB), and it enrolled 305 high risk percutaneous coronary intervention (PCI) patients.
The patients were randomised to receive hemodynamic support during the procedure with the Impella versus intra-aortic balloon (IAB).
Abiomed said the major adverse events at 30 days in both the study arms were measured.
The study results revealed that Impella significantly reduced out of hospital major adverse events by 52% compared to IAB for the duration of 90-day monitoring.
In addition, Impella also significantly reduced repeat revascularisation when using atherectomy.
However, the data revealed confounding variables in the treatment between the two arms with the most significant differences associated with the use of rotational atherectomy in the study.
Following the recommendations of the Data Safety Monitoring Board, the company has decided to complete the study.
Abiomed chairman, president and CEO Michael Minogue said with PROTECT II interim results, they now have both the clinical and cost effectiveness data to pave the way to change the standard of care for PCI requiring prophylactic hemodynamic support.