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 |
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Events |
|
|
IABP (n=145) |
|
|
|
Impella (n=133) |
|
|
|
Relative Difference |
|
|
|
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. ONeill, 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.