Five-year clinical trial data in Late Breaking Clinical Trial Presentation at the American Heart Association’s Scientific Sessions

Every year, approximately 8 million Americans are susceptible to dangerous, often fatal blood clots when they are admitted to the hospital for a medical illness such as stroke or an infection like COVID-19. During the Late Breaking Clinical Trial Presentation at the American Heart Association’s Scientific Sessions 2022 in Chicago, Illinois, the Feinstein Institutes for Medical Research’s Alex C. Spyropoulos, MD, shared data from a large clinical trial showing the effectiveness of a new digital tool that assesses and decreases the risks of these blood clots – both during hospitalization and post-discharge period – as well as provide life-saving preventative therapy.

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Dr. Alex Spyropoulos’ research shows a better way to conduct patient care for those who are suffering from blood clots. (Credit: Feinstein Institutes)

Dr. Spyropoulos is a world-renowned expert in blood clots who shared critical COVID-19 research during the height of the pandemic. In addition, he is a member of the Executive Committee of the nationwide PREVENT-HD clinical trial looking to assess the benefits of anticoagulation in high-risk COVID-19 outpatients; the primary results of which will also be presented as a Late Breaking Clinical Trial in the same session at AHA.

Details about the novel universal digital platform presented during the Late Breaking Clinical Trial Presentation noted it was created by the informatics group at the Feinstein Institutes’ Institute for Health System Sciences with clinical decision support called Evidence-Point that incorporated a validated thrombosis risk score called IMPROVE-DD VTE. The platform uses electronic health records (EHR) that provide clinicians with important data to assess a patient’s risk of venous thromboembolism (VTE) – when a blood clot forms in a vein – both in hospital and in the immediate post-discharge period. This would allow doctors to prescribe much-needed appropriate thromboprophylaxis, or clot preventative medicine, to help those patients avoid thrombosis – both VTE and arterial thromboembolism (ATE) – that include strokes, MIs and systemic clots.

“Either in the hospital or in the immediate post-discharge period, armed with the right clinical decision tool, physicians can properly prevent dangerous blood clots in hospitalized medically ill patients,” said Dr. Spyropoulos, professor in the Institute of Health System Science at the Feinstein Institutes. “This new digital platform is not only able to identify at-risk and high-risk medical patients to increase rates of appropriate thromboprophylaxis, but for the first time shows that use of this tool actually decreases hard outcomes, namely thrombotic events. The results of our trial using this innovative technology has implications not only for our large health system, but globally as well in a very large at-risk hospitalized population.”

The trial showed that with this tool, there was an approximate 50 percent increase in the use of appropriate thromboprophylaxis for moderate-risk medical patients, and an approximately two-fold increase for high-risk patients using extended prophylaxis at hospital discharge. Because of the increase in thromboprophylaxis, VTE was significantly reduced by 20 percent and arterial thromboembolism was significantly reduced by 65 percent in the intervention hospital group that utilized the tool, compared to the control hospital group with usual medical care. There was also no increase in major bleeding, a potential side effect of thromboprophylaxis, because doctors were able to properly dose patients.

"Early recognition and diagnosis can prevent serious and even fatal complications of blot clots,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “Dr. Spyropoulos and colleagues discovered how to harness digital technology to guide decision making and identify those patients who benefit most from early intervention.”

Currently, most health providers do not use a standard system that predicts hospitalized patients with high, moderate or low risks of blood clots and various methods have failed to show a reduction of VTE. Using the IMPROVE-DD VTE score, doctors can prescribe the appropriate thromboprophylaxis for patients at moderate and high risk of blood clots. This new digital tool integrates clinical decision support (CDS) using technology that can be adapted into any EHR, which has never been done before. The tool produces a score that identified a patient at moderate or high VTE risk and displays an appropriate prophylaxis regimen, which is then recorded in the EHR.

Results of IMPROVE-DD VTE CDS are pending peer review and are expected to publish in AHA’s journal Circulation after the conference.

About the Feinstein Institutes

The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.

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