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443 Thromboembolic Outcomes of Hospitalized COVID-19 Patients in the 90-Day Post-Discharge Period: Early Data from the Northwell CORE-19 Registry

Program: Oral and Poster Abstracts
Type: Oral
Session: 331. Pathophysiology of Thrombosis I
Hematology Disease Topics & Pathways:
Coronaviruses, SARS-CoV-2/COVID-19, viral, Adult, Diseases, Infectious Diseases, Study Population, Clinically relevant
Sunday, December 6, 2020: 2:15 PM

Dimitrios Giannis, MD, MSc1*, Steven L. Allen, MD2,3, Anne Davidson, MD4,5*, Galina S. Marder, MD5*, Sarah Flint, MD1,6*, David Garrett, MD1,6*, Richa Thakur, MD1,6*, Matthew Snyder, DO1,6*, Cristina Ghiuzeli, MD3, Thomas G. McGinn, MD, MPH1,6, Karina W. Davidson, PhD, MASc1,6*, Michael Qiu, MD, PhD1*, Matthew Barish, MD7* and Alex C. Spyropoulos, MD1,8*

1Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY
2Monter Cancer Center, Northwell Health, Lake Success, NY
3Division of Hematology, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY
4Institute of Molecular Medicine, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY
5Division of Rheumatology, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
6Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY
7Department of Radiology, Northwell Health, Manhasset, NY
8Anticoagulation and Clinical Thrombosis Services, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department of Medicine, New York, NY

Introduction

Thromboembolic outcomes have emerged as an important issue in sick hospitalized patients with COVID-19. Multiple pathogenetic mechanisms for thrombosis have been implicated, including endothelial dysfunction, increased von Willebrand factor (vWF), interleukin-6 release, and activation of/interaction between macrophages, monocytes, endothelial cells, platelets and lymphocytes. The actual rate of arterial and venous thromboembolic events (ATE and VTE) in hospitalized patients with COVID-19, especially in the immediate post-hospital discharge period, has not been fully elucidated, with most of the data derived from retrospective studies with small sample sizes.

Methods

Against this background, we have designed and implemented an ongoing prospective registry (CORE-19) consisting of 11,249 consecutive hospitalized patients with COVID-19 from March 1st 2020 through May 31st 2020 using data derived from the Northwell Health System and the COVID-19 Research Consortium to study through 90-days post-discharge the rate of VTE and ATE, major bleeding, all-cause mortality, and other complications. We are capturing data of interest including demographic characteristics, co-morbidities, relevant medications, hospital setting, in-hospital treatment, thromboprophylaxis usage, key laboratory parameters, and 90-day thromboembolic and other key outcomes. A unified data repository (datamart) of hospitalized COVID-19 patients across multiple datasets from electronic health records, health informatics exchange, a dedicated radiology database, and a standardized data collection tool in REDCap, that includes telephonic calls up to 90 days post-discharge, is being implemented. A common data model (CDM) is utilized to ensure semantic interoperability between data originating from disparate sources. Northwell Health protocols stipulate the use of post-discharge low-molecular weight heparin, direct oral anticoagulants, or baby aspirin in hospitalized COVID-19 patients with high thrombotic risk features.

Results

Our cohort as of August 7, 2020 consists of complete follow up in 4,100 patients with a mean age of 61.0 years (SD: 17.0) with 54.7% males (Table 1). Preliminary data show an all-cause mortality rate of 4.29%, an overall thromboembolic rate of 3.51% (2.41% VTE and 1.10% ATE), a major bleeding rate of 1.61%, and a rehospitalization rate of 12.85%. Of patients with either DVT or PE post-discharge, 13.43% (9/67) died. The full dataset, including risk factors, comorbidities, key in-hospital and post-discharge medications including anticoagulant and antiplatelet agents, will be available at the time of presentation to the ASH congress.

Conclusion

Our ongoing registry is a large prospective study evaluating the rate of overall thromboembolic complications and all-cause mortality in hospitalized COVID-19 patients through 90 days post discharge. Current rates of thromboembolic events signify the importance of post-discharge surveillance and, potentially, post-discharge extended thromboprophylaxis, in this acutely ill medical population.

Disclosures: Allen: Bristol Myers Squibb: Current equity holder in publicly-traded company. Spyropoulos: Janssen, Boehringer Ingelheim, Bayer, BMS, Portola, ATLAS Group: Consultancy; Janssen, Boehringer Ingelheim: Research Funding.

*signifies non-member of ASH