Abiomed (NASDAQ: ABMD) announces the results of PROTECT III, the
ongoing, prospective, single-arm FDA post-approval study for the
PMA approval of Impella 2.5 and Impella CP in high-risk PCI.
PROTECT III follows the PROTECT II Randomized Controlled Trial
(RCT).
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PROTECT III Presented at TCT 2019 –
Clinical Data Demonstrates Protected PCI with Impella is Associated
with Improved Outcomes (Graphic: Business Wire)
PROTECT III demonstrates a reduction in the primary endpoint of
death, stroke, myocardial infarction and repeat procedures at 90
days with Impella-supported Protected PCI, compared to PROTECT II.
Death, stroke, myocardial infarction and repeat procedures are
known collectively as major adverse cardiac and cerebrovascular
events (MACCE).
The findings of this interim analysis on 898 patients were
announced today at the 31st Transcatheter Cardiovascular
Therapeutics (TCT) conference by a member of the study’s steering
committee, Jeffrey J. Popma, MD, the director of interventional
cardiology clinical services at Beth Israel Deaconess Medical
Center, and professor of medicine at Harvard Medical School.
The PROTECT series of FDA clinical studies, which includes
PROTECT I, the PROTECT II RCT and PROTECT III, is the largest-ever
FDA study of hemodynamically supported high-risk PCI patients. The
series has enrolled 1,366 patients as of July and includes the only
FDA randomized controlled trial ever conducted for hemodynamically
supported high-risk PCI.
Protect III Findings Announced
Patients in PROTECT III are statistically older (71 years),
include more women (26%) and non-Caucasians (33%), received longer
support and had more complex procedures with more vessels treated
than patients in PROTECT II. Yet the 90-day MACCE rate in PROTECT
III is lower than the intra-aortic balloon pump (IABP) control arm
from PROTECT II. The composite MACCE rate in the IABP arm was 31%,
compared to the Impella 2.5 and Impella CP arm at 16.8%
(p<0.0001).
“Based on the learnings from the PROTECT studies, decisions to
provide hemodynamic support during PCI should be made in the
context of providing complete revascularization and patient
outcomes should include in-hospital and out-of-hospital
improvements,” said Dr. Popma. “Prior studies have demonstrated it
is important to achieve complete revascularization because it can
result in a 30-50% reduction in MACCE, compared to incomplete
revascularization.”
Summary of Acute Kidney Injury (AKI) Data
High-risk PCI patients face elevated risk of AKI due to high
levels of contrast and long procedures. Additionally, chronic
kidney disease is a common co-morbidity. According to a NCDR Cath
PCI Registry Study of 985,737 patients, in-hospital mortality for
patients with AKI is 10% and escalates to 34% if dialysis is
required.
In PROTECT III, a sub-study (N=106) of patients were evaluated
for acute kidney injury (AKI) rate and compared to a propensity
matched control group (N=106). The results will be presented during
the TCT Scientific Sessions. Multiple studies with Impella have
measured the AKI rate based on predicted AKI risk factors,
including contrast volume. These include:
- Circulation, 2012 -The PROTECT II RCT found Impella patients
had statistically higher contrast volume than the IABP arm (267 ml
vs. 241 ml, p=0.04), but a numerically lower rate of acute renal
dysfunction at 30 days and 90 days (p=0.792 and p=0.776,
respectively), showing a decoupling of contrast volume from renal
dysfunction
- Circulation Research, 2017 - Flaherty, et al., identified a
six-fold reduction in AKI requiring dialysis when Impella support
was used, compared to without Impella support (p=0.031).
- Catherization and Cardiovascular Interventions, 2019 – Flaherty
et al., found, compared to a predicted rate of 22% (using the
Mehran risk score), only 5% of Impella-supported patients developed
AKI (exclusively stage 1) at 48 hours, representing a 77.6% lower
AKI risk (p<0.0001).
The PROTECT Series
The PROTECT III Study includes 898 patients enrolled at 45 sites
in the United States between March 2017 and July 2019. The PROTECT
Series now includes 1,366 patients and Impella is the most studied
mechanical circulatory support device in the history of the
FDA.
“The totality of clinical data in favor of Impella supported
high-risk PCI allows interventional cardiologists to be confident
they are using the optimal treatment and technologies to help
achieve complete revascularization in a single setting, improve
procedural hemodynamic stability and improve patient quality of
life,” said William O’Neill, MD, medical director of the Center for
Structural Heart Disease at Henry Ford Hospital.
Abiomed initiated the PROTECT series of studies in 2006 with
PROTECT I and conducted the PROTECT II RCT from 2007 to 2010. In
2009, Abiomed created the Impella Quality (IQ) Database that has
now collected real world clinical data on more than 100,000
patients.
The FDA granted Impella its highest level of safety and efficacy
approval, a post-market approval (PMA) for a first-of-its-kind
indication for high-risk PCI, based on the results of PROTECT I
(N=20), the PROTECT II RCT (N=448) and registry data. Impella is
included in eight clinical guidelines and more than 550
peer-reviewed publications.
A video of Dr. Popma commenting on the results of PROTECT III
and slides from Dr. Popma’s presentation at TCT are available
online at www.ProtectIIIStudy.com. Dr. Popma’s presentation from
TCT will be posted at www.ProtectIIIStudy.com within the next 24
hours.
The study is sponsored by Abiomed as part of its commitment to
improving clinical outcomes.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA
approved to treat certain advanced heart failure patients
undergoing elective and urgent percutaneous coronary interventions
(PCI) such as stenting or balloon angioplasty, to re-open blocked
coronary arteries. The Impella 2.5, Impella CP, Impella CP with
SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5™ with
Smart Assist® are U.S. FDA approved heart pumps used to treat heart
attack or cardiomyopathy patients in cardiogenic shock, and have
the unique ability to enable native heart recovery, allowing
patients to return home with their own heart. The Impella RP® is
U.S. FDA approved to treat right heart failure or decompensation
following left ventricular assist device implantation, myocardial
infarction, heart transplant, or open-heart surgery. Impella is the
most studied mechanical circulatory support device in the history
of the FDA with real world clinical data on more than 100,000
patients and more than 550 peer-reviewed publications.
In Europe, the Impella 2.5, Impella CP and Impella CP with
SmartAssist are CE marked for treatment of high-risk PCI and AMI
cardiogenic shock patients for up to 5 days. Impella 5.0 and
Impella LD are CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 10 days. The Impella 5.5™
with Smart Assist® is CE marked to treat heart attack or
cardiomyopathy patients in cardiogenic shock for up to 30 days. The
Impella RP is CE marked to treat right heart failure or
decompensation following left ventricular assist device
implantation, myocardial infarction, heart transplant, open-heart
surgery, or refractory ventricular arrhythmia.
To learn more about the Impella platform of heart pumps,
including their approved indications and important safety and risk
information associated with the use of the devices, please visit
www.impella.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading
provider of medical devices that provide circulatory support. Our
products are designed to enable the heart to rest by improving
blood flow and/or performing the pumping of the heart. For
additional information, please visit www.abiomed.com.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella
CP, Impella RP, and Impella Connect are registered trademarks of
Abiomed, Inc., and are registered in the U.S. and certain foreign
countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and
SmartAssist are pending trademarks of Abiomed, Inc.
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 and expected regulatory approvals. 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, including the potential
for future losses, complex manufacturing, high quality
requirements, dependence on limited sources of supply, competition,
technological change, government regulation, litigation matters,
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 most recently
filed Annual Report on Form 10-K and Quarterly Report on 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190926005305/en/
Tom Langford Director, Communications and Public Relations
978-882-8408 tlangford@abiomed.com
Ingrid Goldberg Ward Director, Investor Relations 978-646-1590
igoldberg@abiomed.com
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