Apr 03 2011
DANVERS, Mass. — Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the final results from the PROTECT II study, presented by William O’Neill, M.D., Dean of University of Miami and Principal Investigator of PROTECT II, at the American College of Cardiology’s (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans. The results included data from the entire study population and demonstrated a significant positive overall outcome for per-protocol patients treated with Impella® 2.5 at 90 days (p=0.029).
The PROTECT II study was a prospective, multicenter, randomized trial, designed to measure a composite of major adverse events at 30 days, with 90 day follow-up in high-risk percutaneous coronary intervention (PCI) patients requiring hemodynamic support, comparing the Impella 2.5 to the intra-aortic balloon pump (IABP).
Summary and Conclusion of PROTECT II (Per-Protocol):
1. Positive overall outcome for the Impella arm over the IABP arm in the entire study cohort at 90 days, resulting in a 21% reduction in major adverse events over the IABP (p=0.029);
2. In the pre-specified high-risk PCI without atherectomy subgroup (88% of study), Impella provided a significant benefit over the IABP at 30 days (p=0.009) and at 90 days (p=0.003) with a 29% reduction of major adverse events;
3. In the pre-specified atherectomy group (12% of study), there was no overall statistical difference (p=0.316) in major adverse events at 90 days. In this subgroup, the Impella arm demonstrated a significant increase in peri-procedural CK-MB release (p=0.030) and decreased repeat revascularization at 90 days (p=0.006);
4. Impella significantly reduced out-of-hospital major adverse events overall by 56% (p=0.002) over the IABP arm. Per the study conducted by an independent economic health organization (n=227), the Impella reduction of major adverse events translated into overall lower hospital charges per patient, ranging from $12,000 (all patients) to $17,000 (survivors only) at 90 days¹. More economic analysis data will be presented in future healthcare forums highlighting reduced repeat revascularization, lower charges per readmission and reduced critical care length of stay;
5. The PROTECT II study was prematurely halted in December 2010 per the recommendation of the Data Safety Monitoring Board based on the 50% interim enrollment data with the assumption that it would not meet its primary endpoint at 30 days. The treatment effect of Impella over IABP improved during the course of the trial, suggesting a learning curve. The superior hemodynamic support of Impella appears to have led to significant procedural differences between the two arms. The original study was powered at 80% with the intended final population of 654 patients. The interim report included the 50% mark and final analysis included an additional 19% of patients. The pre-specified “roll-in subject” analysis demonstrated that, without the first patient in both arms, Impella was significantly better at 90 days (n=307; p=0.027).
“The PROTECT II study is a major advance that will help guide how interventional cardiologists treat the high-risk PCI patient population. At 90 days, there is a very significant advantage to the Impella-treated patients,” said Dr. O’Neill. “As evidenced by this data, this superior level of hemodynamic support in the cath lab allowed for a more complete procedure, leading to a reduction in out-of-hospital major adverse events.”
“Impella’s adoption will be enhanced by these data which demonstrate the clinical and cost-effective advantages of the Impella platform. Abiomed’s goal is to change the standard of care for PCI for all prophylactic and emergency patients requiring hemodynamic support. Abiomed is grateful to all the dedicated healthcare professionals involved in this groundbreaking study,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.
The PROTECT II is a landmark study because it is a first in many categories such as: the complexity and advanced disease of the patient population receiving PCI requiring hemodynamic support (approximately 60% were turned down for surgery), number of endpoints measured prospectively at 30 and 90 days post hemodynamic supported PCI, first analysis of use of atherectomy in low ejection fraction (EF) PCI patients and the first FDA Premarket Approval (PMA) study measuring IABP major adverse events.
For purposes of this press release, we are reporting a per-protocol (PP) population, and noting the intent to treat (ITT) population. The PP population includes patients that received treatment and met all the pre-specified inclusion and exclusion criteria of the PROTECT II study. The PP population was pre-specified and patients were identified prospectively prior to the statistical analysis. The Impella product is a protocol-driven technology and utilized for patients that meet the criteria of requiring hemodynamic support. For purposes of the ACC presentation and future publications, both groups will be reported.
These data reported have been collected, monitored and analyzed by a third party academic research organization. The major adverse events (MAE) were assessed at 30 and 90 days.