Additional data on blood thinner efficacy for COVID-19 and insight on
best possible regimens

Date:
August 26, 2020
Source:
The Mount Sinai Hospital / Mount Sinai School of Medicine
Summary:
Early in the COVID-19 pandemic, researchers found that
anticoagulation therapy was associated with improved survival among
hospitalized COVID-19 patients. But many questions remained --
about the size of the potential benefit, and about what dosage of
this therapy might be more effective.

New research suggests some possible answers.



FULL STORY ========================================================================== Early in the COVID-19 pandemic, Mount Sinai researchers were among the
first to show that anticoagulation therapy was associated with improved survival among hospitalized COVID-19 patients. But many questions
remained -- about the size of the potential benefit, and about what
dosage of this therapy might be more effective. Now, the research team
has suggested some possible answers, in a paper published in the August
26 online issue of the Journal of the American College of Cardiology.


==========================================================================
In this observational study, the researchers found all regimens of anticoagulants -- drugs that prevent blood clotting -- were far superior
to no anticoagulants in COVID-19 patients. More specifically, patients
on both a "therapeutic" or full dose, and those on a "prophylactic"
or lower dose, showed about a 50 percent higher chance of survival,
and roughly a 30 percent lower chance of intubation, than those not on anticoagulants. The researchers looked at six different anticoagulant
regimens, including both oral and intravenous dosing, within both
therapeutic and prophylactic groups. They observed that therapeutic and prophylactic subcutaneous low-molecular weight heparin, and therapeutic
oral apixaban may lead to better results.

"This work from the Mount Sinai COVID Informatics Center provides
additional insight on the role of anticoagulation in the management
of patients admitted to the hospital with COVID-19. Although this
is an observational study, it helped in the design of a large-scale international clinical trial that we are coordinating. The randomized
trial focuses on those three antithrombotic regimens -- therapeutic and prophylactic subcutaneous low-molecular weight heparin, and therapeutic
oral apixaban," says senior corresponding author Valentin Fuster, MD,
PhD, Director of Mount Sinai Heart and Physician-in-Chief of The Mount
Sinai Hospital.

This study is an extension of Mount Sinai research that showed that
treatment with anticoagulants was associated with improved outcomes
both in and out of the intensive care unit among hospitalized COVID-19 patients. The work was prompted by the discovery that many patients hospitalized with COVID-19 developed high levels of life-threatening
blood clots.

The team of investigators evaluated electronic medical records of 4,389 confirmed COVID-19-positive patients admitted to five hospitals in the
Mount Sinai Health System in New York City (The Mount Sinai Hospital,
Mount Sinai West, Mount Sinai Morningside, Mount Sinai Queens, and Mount
Sinai Brooklyn) between March 1 and April 30, 2020. They specifically
looked at survival and death rates for patients placed on therapeutic and prophylactic doses of blood thinners (oral antithrombotics, subcutaneous heparin, and intravenous heparin) versus those not placed on blood
thinners. The researchers used a hazard score to estimate risk of death,
which took relevant risk factors into account before evaluating the effectiveness of anticoagulation, including age, ethnicity, pre- existing conditions, and whether the patient was already on blood thinners. The researchers also took into account and corrected for disease severity, including low oxygen saturation levels and intubation.

Of the patients analyzed, 900 (20.5 percent) received a full-treatment
dose of anticoagulants. Another 1,959 patients (44.6 percent) received a
lower, prophylactic dose of anticoagulants, and 1,530 (34.5 percent) were
not given blood thinners. There was a strong association between blood
thinners and reduced likelihood of in-hospital deaths: both therapeutic
and prophylactic doses of anticoagulants reduced mortality by roughly
50 percent compared to patients on no blood thinners.

Overall, 467 (10.6 percent) of the patients required intubation and
mechanical ventilation during their hospitalization. Those on therapeutic
blood thinners had 31 percent fewer intubations than those not on blood thinners, while those on prophylactic blood thinners had 28 percent fewer.

Bleeding rates -- a known complication of blood thinners -- were
surprisingly low overall among all patients (three percent or less), but slightly higher in the therapeutic group compared to the prophylactic and no-blood-thinner groups, the researchers said. Their findings suggest
that clinicians should evaluate patients on an individual basis given
the benefit-risk tradeoff.

Separately, the researchers looked at autopsy results of 26 COVID-19
patients and found that 11 of them (42 percent) had blood clots --
pulmonary, brain, and/or heart -- that were never suspected in the
clinical setting. These findings suggest that treating patients with anticoagulants may be associated with improved survival.

"This report is much more in-depth than our previous brief report
and includes many more patients, longer follow-up, and rigorous
methodology. Clearly, anticoagulation is associated with improved outcomes
and bleeding rates appear to be low," says corresponding author Anu
Lala, MD, Assistant Professor of Medicine (Cardiology) and Director
of Heart Failure Research at the Icahn School of Medicine at Mount
Sinai. "As a clinician who has treated COVID-19 patients on the front
lines, I recognize the importance of having answers as to what the best treatment for these patients entails, and these results will inform the
design of clinical trials to ultimately give concrete information."
"These observational analyses were done with the highest level of
statistical rigor and provide exciting insights into the association
of anticoagulation with critical in-hospital outcomes of mortality
and intubation," says first author Girish Nadkarni, MD, Co-Founder and Co-Director of the Mount Sinai COVID Informatics Center and Clinical
Director of the Hasso Plattner Institute for Digital Health at Mount
Sinai. "We are excited that results from this observational study in one
of the largest and most diverse hospitalized populations have led to an
ongoing trial of type, duration, and doses of anticoagulation. Ultimately
we hope this work will lead to improved outcomes and treatment for
COVID-19 patients." "This work highlights the need to better understand
the disease from a diagnostic and therapeutic point of view and the
importance of conducting properly designed diagnostic and interventional studies," explains co-author Zahi Fayad, PhD, Co-Founder of the Mount
Sinai COVID Informatics Center and Director of Mount Sinai's BioMedical Engineering and Imaging Institute.


========================================================================== Story Source: Materials provided by The_Mount_Sinai_Hospital_/_Mount_Sinai_School_of Medicine. Note: Content
may be edited for style and length.


==========================================================================


Link to news story: https://www.sciencedaily.com/releases/2020/08/200826141400.htm

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