DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the final analysis from the PROTECT II trial at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) meeting.
PROTECT II is the first study to examine this cohort of complex patients with high clinical risk, low ejection fraction, and high STS and SYNTAX scores. The final PROTECT II 90-day analysis released today at TCT reiterates the overall benefit of Impella hemodynamic support during high-risk percutaneous coronary intervention (PCI), demonstrating the following:
- 22% relative reduction in overall Major Adverse Events (MAE) (p=0.023);
- 52% relative reduction in repeat revascularization (p=0.024);
- 56% relative reduction in MAE post hospital discharge (p=0.002)
Overall, patients experienced quality of life benefits, demonstrated by a 22% increase in ejection fraction and a 58% reduction in New York Heart Association (NYHA) Class III or Class IV heart failure at 90 days. However, these benefits were accompanied by a significantly lower MAE in patients supported with Impella compared to those supported with the intra-aortic balloon pump (IABP).
The new analysis, presented today by Jeffrey Popma, M.D., director of the angiographic Core Laboratory at Beth Israel Deaconess and responsible for planned analysis of the angiographic results, unveiled a new angiographic Ischemia Zone Score (IZ). The new score was used to assess the amount of ischemia in the myocardium at risk before and after PCI. Prior to PCI, the average IZ in these patients (both arms) was 9 out of 11, demonstrating a significant amount of ischemic myocardium. After PCI, the change in IZ was used to determine the completeness of revascularization in each patient and correlate the amount of ischemia reduction to outcomes.
The new PROTECT II analysis concluded that more extensive revascularization with PCI is appropriate and leads to better outcomes at 90 days in patients with coronary artery disease (CAD) and reduced left ventricular function. Furthermore, the patients that underwent more extensive revascularization had significantly better outcomes at 90 days with Impella support compared to those supported with the IABP.
Specifically, for the patients receiving extensive revascularization, the 90-day results were the following.
|
90-Day Outcomes With Extensive Revascularization |
|||||||||||||||
| Events |
IABP |
Impella |
Relative |
p value | |||||||||||
| MAE | 49.0% | 32.3% | 34% | 0.005 | |||||||||||
| Death/Stroke/MI/Revasc. | 31.0% | 20.3% | 35% | 0.041 | |||||||||||
| MACCE | 28.3% | 15.0% | 47% | 0.008 | |||||||||||
The analysis concluded that:
- In patients with extensive CAD and reduced left ventricular function undergoing PCI, the goal should be to perform as much revascularization as possible in order to reduce 90-day event rates, including death, myocardial infarction (MI), and repeat revascularization
- Temporary left ventricular support with Impella substantially improves clinical outcomes in patients undergoing extensive revascularization
The full results can be viewed via a TCTMD webcast, which went live today at 7 a.m. PT/ 10 a.m. ET. The webcast includes an analysis of the new PROTECT II clinical and economic data announced this week at TCT. Webcast panelists include: Jeffrey J. Popma, M.D., Beth Israel Deaconess Medical Center; William W. O’Neill, M.D., University of Miami; John M. Lasala, M.D., Washington University School of Medicine; and Jeffrey W. Moses, Columbia University.
The webcast can be viewed here at www.tctmd.com/mm.aspx
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
FORWARD-LOOKING STATEMENTS
This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K and most recently filed Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.