REDUCE LAP-HF II Analyses Show 50% of Study Patients Demonstrated Significant Clinical Benefit from the Corvia (R) Atrial Shunt
PR95294
TEWKSBURY, Mass., April 1, 2022 /PRNewswire=KYODO JBN/ --
Landmark trial advances understanding of which HFpEF patients may benefit from
atrial shunt therapy
Corvia Medical, Inc, a company dedicated to transforming the treatment of heart
failure (HF), announced publication of analyses from its global, phase III
REDUCE LAP-HF II randomized trial of heart failure patients with preserved
(HFpEF) or mildly reduced (HFmrEF) ejection fraction. In a large responder
population, representing 50% of study patients, treatment with the Corvia (R)
Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater
improvement in quality of life compared to sham control. Additionally, these
data offer essential new insights into the role of exercise in accurately
predicting patients who may or may not benefit from this novel therapy. The
analyses were published online in Circulation1 (
)
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"We are extremely encouraged by these analyses from the REDUCE LAP-HF II trial.
Not only have we identified a large responder group comprising two-thirds of
people with HFpEF, or approximately 2 million people in the US alone, but we
have also learned how to identify potential patients who are most likely to
derive significant benefit," said Sanjiv Shah, MD, Professor of Medicine,
Director of Research for the Bluhm Cardiovascular Institute, Director of the
HFpEF Program at Northwestern University Feinberg School of Medicine and
co-principal investigator of the REDUCE LAP-HF II trial.
More than 26 million people worldwide have HF,2 and over half those have
HFpEF,3 which has been described as the largest unmet clinical need in
cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated
left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF
patients. The shunt is placed via catheter between the left and right atria,
forming a passage that allows blood to flow from the high pressure left atrium
to the lower pressure right atrium, with the aim of reducing HF symptoms and
events and improving quality of life.
Barry Borlaug, MD, Professor of Medicine, Director of Circulatory Failure
Research at Mayo Clinic and lead author of the publication commented, "Exercise
hemodynamic evaluation appears to be a key factor in predicting which patients
will do well with atrial shunt therapy. Patients whose pulmonary blood vessels,
or vessels in the lungs, can accommodate an increase in blood flow during
exercise appear to derive significant benefit from the shunt, compared to those
whose blood vessels can't accommodate the additional flow. While I have long
been an advocate for hemodynamic testing in heart failure, the data from this
study reinforces the importance of exercise phenotyping and will change how we
evaluate heart failure patients and personalize their care."
The REDUCE LAP-HF II trial randomized 626 patients at 89 centers across the US,
Canada, Europe, Australia, and Japan. A systematic, independent, statistical
analysis identified exercise pulmonary vascular resistance (PVR), a measure
indicating the degree of pulmonary vascular disease, and the presence of a
pacemaker as the most significant variables affecting how patients responded to
atrial shunting. The results showed that patients without a pacemaker and with
normal exercise PVR comprised 50% of the total study population and derived
significant clinical benefit:
- 45% reduction in HF events compared to sham control (12 vs. 22 events
per 100 patient-years, p=0.007)
- 55% greater improvement (+5.5 points) in health status as measured
by Kansas City Cardiomyopathy Questionnaire (KCCQ), with 40%
more shunt patients reporting a very large improvement
(Greater than 20 points)in quality of life
- 50% greater improvement in New York Heart Association (NYHA) HF class,
indicating fewer HF symptoms
"HFpEF has a complex pathophysiology and remains a significant therapeutic
challenge. While novel drugs are now available, limitations remain, and
additional therapies are required to treat this heterogenous population,"
commented Prof. David Kaye, MD, PhD, Director of the Department of Cardiology
at The Alfred Hospital, Head of Heart Failure Research at the Baker Institute
in Melbourne, Australia, and an investigator in the study." We now know the
importance of exercise hemodynamic phenotyping prior to determining a
therapeutic strategy for HFpEF patients and these learnings should be applied
today in both the commercial and clinical trial settings. Assuming additional
studies confirm the responder population findings, this therapy has enormous
potential to improve the lives of millions of heart failure patients."
REDUCE LAP-HF II represents the largest randomized controlled trial of
device-based therapy for HFpEF patients and is the only study of an implantable
therapeutic device to show clinical benefit in this population. "The Corvia
Atrial Shunt is the most rigorously studied atrial shunt therapy. Exercise
hemodynamic evaluation has been a key component of all our studies and its
importance in identifying suitable patients for atrial shunting has now been
confirmed," commented Jan Komtebedde, Senior Vice President and Chief Medical
Officer at Corvia Medical. "We are working with advisors and regulators to
design a confirmatory study that builds on the extensive data and progressive
learnings from REDUCE LAP-HF II and we look forward to bringing this
breakthrough therapy to the US and international markets to help this
underserved population."
About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through
novel transcatheter cardiovascular devices. Founded in 2009 and headquartered
in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for
heart failure treatment, enabling patients to reclaim their lives. The Corvia
Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019.
Privately held, the company is backed by Third Rock Ventures, General Catalyst
Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed
strategic investor. Visit https://corviamedical.com/.
MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
https://corviamedical.com/newsroom/
1. Borlaug BA et al. Latent Pulmonary Vascular Disease May Alter the
Response to Therapeutic Atrial Shunt Device in Heart Failure.
Circulation. 2022;10.1161.
2. Savarese G, Lund LH. Global Public Health Burden of Heart Failure.
Card Fail Rev. 2017;3(1):7-11.
3. Owan TE et al. Trends in prevalence and outcome of heart failure
with preserved ejection fraction. N Engl J Med. 2006;355:251-259.
SOURCE CORVIA MEDICAL, INC
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