STRONG-HF study results demonstrate clear benefits for acute heart
failure patients
- STRONG-HF study primary
outcomes showed significant reduction of all cause death or acute
heart failure readmissions, at day 180, when the study strategy was
implemented
- Rapid, simultaneous
up-titration of therapies, and close follow-up, led to increased
patient quality of life.
- The Roche
Elecsys®
NT-proBNP biomarker is an
integral part of the treatment strategy, comprising rapid
up-titration and close follow up after an acute
heart failure admission
Basel, 9 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced publication of the Safety, Tolerability and
Efficacy of Rapid Optimization of Heart Failure (STRONG-HF) study
in patients hospitalised for acute heart failure. The study, which
includes utilisation of the Roche Elecsys NT-proBNP biomarker, was
terminated early for superior efficacy in the active arm of the
study versus the usual standard of care, as it was considered
unethical to continue with usual care.
Implementing thestudy’s strategy in routine clinical practice,
has the opportunity to significantly reduce all cause deaths or
heart failure readmissions and increase quality of life for more
heart failure patients, evaluated after six months, compared to
current patient management practices. The results have been shared
at the American Heart Association (AHA) Late-Breaking Scientific
Session and published simultaneously in the Lancet.1
"We are very excited about the positive outcome of this
Investigator Initiated Study, which Roche supported, as it has the
potential to bring about a paradigm shift in the management of
heart failure patients,” said Thomas Schinecker, CEO of Roche
Diagnostics. “It also emphasises how diagnostic solutions like
NT-proBNP, embedded in a therapeutic strategy, are an integral part
of improving patient care.”
Acute heart failure (AHF) is a major contributor to morbidity
and mortality of patients with heart failure.2 Patients admitted
for acute heart failure are at high risk of readmission and death,
especially in the first months after hospital discharge.3 A recent
analysis, from the USA, showed that only 1% of patients with heart
failure with a reduced ejection fraction are on the optimal dose of
guideline-directed medical therapy.4
The STRONG-HF study outlines that guideline-recommended
therapies for heart failure can be safely up-titrated at the end of
an acute heart failure admission, and after discharge, under strict
follow-up and assessment of signs and symptoms of congestive heart
failure, renal function, potassium and Roche Elecsys NT-proBNP.
Prior to this study, there has been little data on the therapeutic
approach for patients after an acute heart failure admission,
including which medications should be prescribed, at which doses,
and based on what follow-up the patients get. This has led
clinicians to be cautious to up-titrate too quickly when they are
unsure how this could affect their patients.
About STRONG-HFSTRONG-HF is a multinational
open-label randomised, prospective clinical trial designed to
assess the safety and efficacy of early and rapid up-titration of
optimisation of heart failure therapies, including
guideline-recommended, frequent NT-proBNP measurements and close
follow-up in patients admitted to a hospital for acute heart
failure.
AHF patients who were not treated with full doses of
guideline-directed medical therapies (GDMT) were randomized just
prior to discharge 1:1 to either usual care (UC) or high intensity
care (HIC) in which therapies were up-titrated to 100% of
recommended doses within two weeks, with four outpatient visits
over two months encompassing close monitoring of clinical signs and
laboratory parameters, including NT-proBNP.
The study enrolled 1,078 of the initially planned 1,800 patients
at the time of termination for superior efficacy, as it was
considered unethical to continue with usual care.
The primary endpoint showed an absolute risk reduction of 8.1 %
and a relative risk reduction of 34% in all-cause mortality or
heart failure (HF) readmission 6 months after enrollment in the
high-intensity care arm (ARR 8·1%, p=0·0021; NNT = 12; RR 0·66;
High Intensity Care (HIC) vs. Usual Care (UC). The risk of all
cause mortality or hospital readmission was 15.2 % lower in the
high intensity care arm using NT-proBNP to inform titration of oral
HF medications vs. 23.3% in the usual care arm without routine
NT-proBNP testing and frequent visits.
Quality of life was higher in patients in the HIC arm (EQ-5D
visual analog scale (VAS) 3·49 points higher in favor of HIC arm
(p<0·0001)).
The number of adverse events (AEs) was increased, most notably
those related to blood pressure decrease, hyperkalemia, renal
impairment, and bradycardia. (HIC 41.1%, UC 29.5%). However, the
increase in AEs did not translate into an increase in serious
adverse events, nor fatal adverse events, especially no increase in
cardiovascular AEs or SAEs. The increase in adverse events can also
be explained by the higher frequency of follow-up, which may have
created a bias towards more AE detection and reporting in the HIC
arm.
The study is an Investigator Initiated Study sponsored by the
Heart Initiative, Durham, North Carolina, USA and supported with a
research grant and diagnostic products by Roche Diagnostics.
About Elecsys
NT-proBNPTests for NT-proBNP, a
cardiac hormone that is released into the blood when the heart wall
is stretched, are developed by Roche. The Roche Elecsys NT-proBNP
is an objective biomarker for the aid in diagnosis in individuals
suspected of having congestive heart failure. The test is further
indicated for the risk stratification of patients with acute
coronary syndrome and congestive heart failure and as an aid in
assessment of increased risk of cardiovascular events and mortality
in patients at risk for heart failure who have stable coronary
artery disease.5 The Elecsys electrochemiluminescence immunoassay
“ECLIA'' is intended for use on cobas e immunoassay
analyzers.About Roche Founded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavor to pursue a long-term perspective in
all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.References[1] Mebazaa A et al. The Lancet
2022. https://doi.org/10.1016/S0140-6736(22)02076-1[2] Chioncel O
et al. Eur J Heart Fail 2017;19:1242–1254.[3]Gheorghiade M et al. J
Am Coll Cardiol. 2013;61(4):391–403.[4] Greene SJ, et al. J Am Coll
Cardiol (2018) 72, 351-366.[5] NT-proBNP method sheet
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