ABBOTT PARK, Ill., Aug. 27, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced results of
the landmark GUIDE-HF clinical trial, a 1,000 patient randomized
study designed to assess the benefits of the CardioMEMS™ HF System
in people living with NYHA Class II, III and IV heart failure. Data
adjusted for the impact of COVID-19 show a strong reduction in a
composite endpoint of heart failure hospitalizations, emergency
visits and death in a broad range of patients, suggesting new
benefits from the CardioMEMS device.
CardioMEMS is currently approved for use in NYHA Class III
patients with a prior heart failure hospitalization within the last
year. The GUIDE-HF study examined an expanded patient population,
including patients with NYHA Class II and Class IV heart failure,
to evaluate the device in patients in earlier or later-stage
disease progression.
GUIDE-HF is one of many large trials conducted amid the COVID-19
pandemic, when healthcare systems experienced significant
disruption. Heart failure patients are at a heightened risk of
COVID-19 and – as a result – experienced changes to their care
management and hospitalization during the pandemic. An analysis of
the full one-year data set, of which 28% of the follow-up data was
collected during COVID-19, showed CardioMEMS-guided patients had a
lower composite endpoint rate of total heart failure events and
death compared to the study's control group, which was not
statistically significant. In an analysis of data adjusted for the
impact of COVID-19 (captured prior to March
13, 2020 – the date the U.S. national emergency was
declared), CardioMEMS demonstrated a significant 19% reduction in
the study's composite endpoint and a 28% reduction in heart failure
hospitalizations.
The results of GUIDE-HF were presented at the ESC Congress 2021
(organized by the European Society of Cardiology) and
simultaneously published in The Lancet. Based on the
strength of the GUIDE-HF data, Abbott has filed a Premarket
Approval (PMA) supplement with the U.S. Food and Drug
Administration (FDA) for consideration of an expanded indication
for the CardioMEMS device.
The CardioMEMS HF System includes a small sensor the size of a
paperclip that, once placed in the pulmonary artery during a
minimally invasive procedure, monitors for pressure changes that
indicate worsening heart failure even before patients feel
symptoms. The CardioMEMS sensor connects to a system that remotely
provides daily pressure readings to a patient's clinical team,
allowing physicians to make therapy changes to combat worsening
heart failure.
"The two most important strategies in treating heart failure are
helping doctors stay ahead of the condition as it progresses and
keeping people stable and out of the hospital and emergency room.
The GUIDE-HF trial shows that Abbott's CardioMEMS device has a role
in both," said Philip B. Adamson,
M.D., chief medical officer of Abbott's heart failure business.
"This tiny cardiac sensor, coupled with the increased improvements
in informed telemedicine, can have a tremendous impact on helping
people at all stages of heart failure live their healthiest
lives."
GUIDE-HF Data Overview
Though not designed to assess
the benefits of CardioMEMS in specific patient sub-groups, when
adjusted for the impact of COVID-19, the GUIDE-HF study suggests
potential benefits of the device in new groups of patients,
including:
- Patients in earlier stages of heart disease.
GUIDE-HF data suggests better outcomes in Class II patients when
their therapy is guided by pulmonary pressure monitoring, with a
34% reduction in heart failure hospitalizations, emergency visits
and death.
- Specific patient groups. GUIDE-HF also demonstrated a
relative risk reduction for both women (33%) and African American
patients (41%), two patient segments disproportionately impacted by
effects of heart failure.
- Patients at risk of potential hospitalization. GUIDE-HF
showed a 25% reduction in hospitalization or emergency department
visits in patients without a prior heart failure hospitalization
but who undergo blood tests that show elevated levels of a
biomarker known as B-type Natriuretic Peptide (BNP), which
indicates worsening heart failure.
"Clinicians have seen firsthand the importance of CardioMEMS in
helping them proactively manage heart failure to keep patients out
of the hospital, and the GUIDE-HF trial showed the device provides
benefits for more patients than ever before," said JoAnn Lindenfeld, M.D., primary investigator for
the GUIDE-HF trial and director of advanced heart failure
at Vanderbilt University Medical Center
in Nashville, Tenn. "Even with the disruptions that we saw as
a result of the COVID-19 pandemic, this trial was still able to
show significant reductions in heart failure hospitalizations and
reduced emergency visits with pulmonary pressure sensor
monitoring."
About the GUIDE-HF Study
Prior clinical and real-world
evidence, including the landmark CHAMPION study, has shown
substantial benefits of CardioMEMS, including reduced heart failure
hospitalization, positive economic impact and reduction in
pulmonary artery pressures – which physicians use to assess their
patients' heart failure. GUIDE-HF built upon these prior studies by
expanding the patient population (Class II – IV and patients with
elevated BNP or NT-proBNP levels), while also broadening the
primary endpoint to include hospitalization, visits to emergency
departments or outpatient urgent care centers and death.
The GUIDE-HF study included a randomized arm of 1,000 patients
and a single arm of up to an additional 2,600 patients that is
currently enrolling for a total of 3,600 patients across 118
centers in North America. All
patients received a CardioMEMS device, but therapy for patients in
the control arm was not guided by the device.
About the GUIDE-HF Study's COVID-19 Sensitivity
Analysis
The COVID-19 pandemic had a significant impact on
clinical trials, research procedures, patient behavior and
hospitalizations. To reflect the point in time where patient
behaviors and research procedures may have changed or potentially
impacted the GUIDE-HF trial, Abbott received FDA approval in
August 2020 to proactively add a
COVID-19 sensitivity analysis to the study's statistical analysis
plan. The analysis is designed to assess all data captured prior to
March 13, 2020, when 1,000 patients
had been enrolled, implanted and randomized, and 72% of the study's
patient follow-up had been completed.
About CardioMEMS
CardioMEMS is currently only approved
for NYHA Class III patients with a prior heart failure
hospitalization within the last year. CardioMEMS is currently under
investigation to treat patients outside of the existing approved
indication in the U.S.
For U.S. important safety information for the CardioMEMS HF
System, visit :
https://www.cardiovascular.abbott/us/en/patients/treatments-therapies/pulmonary-artery-pressure-monitoring-for-heart-failure/important-safety-information.html
About Abbott:
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
109,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
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@AbbottNews.
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SOURCE Abbott