Extensive Revascularization with Impella Improves Outcomes at 90 Days

Danvers, MA & San Francisco, CA --Abiomed Inc., 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
                                   (n=145)    (n=133)   Difference
        -----------------------   -------    -------    ----------    -------
        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

SOURCE: Business Wire, Abiomed, Inc.