# Contemporary Venous Thromboembolism Treatment

> **NIH NIH R01** · UNIVERSITY OF MINNESOTA · 2020 · $428,815

## Abstract

Project Summary/Abstract
 Venous thromboembolism (VTE), which includes both deep vein thrombosis and pulmonary embolism,
annually affects between 350,000 and 600,000 Americans and results in more than 100,000 deaths. This
makes VTE the third leading cause of cardiovascular mortality, behind heart attack and stroke. Treatment of
VTE events is best evaluated from the perspective of 3 phases: acute (first 5-10 days), primary treatment (first
6 months post-event) and secondary prevention (≥6 months post-event). Traditionally VTE was treated acutely
in-hospital, and warfarin was used for primary treatment and secondary prevention. Recently there have been
two major advances in the treatment of VTE: 1) the outpatient treatment of VTE in the acute phase, and 2) the
approval in 2012 of direct oral anticoagulants (DOACs) for VTE primary treatment and secondary prevention.
 Randomized trials have demonstrated that outpatient VTE management and DOACs (i.e. dabigatran,
rivaroxaban, apixaban, edoxaban) are at least as effective as their traditional alternatives. However,
randomized trials are not always generalizable to the usual clinical setting, and are typically underpowered to
identify subgroups most at risk for adverse outcomes. Moreover, safety concerns have been raised for DOACs.
As such, additional research is needed to determine, relative to their traditional alternatives, the effectiveness
of these new treatment strategies, their risks, and to identify patient subgroups more likely to experience
benefit or harm. Comparative effectiveness research can address these questions in “real-world” settings.
 Using data from two large U.S. commercial claims databases, Optum and MarketScan, which include
more than 500,000 patients with VTE, we propose to evaluate risks and benefits associated with inpatient vs.
outpatient management in the acute phase, DOACs versus warfarin for the primary treatment of VTE, and
DOACs versus warfarin versus no anticoagulant therapy for VTE secondary prevention. Primary outcomes
include recurrent VTE, intracranial hemorrhage, and mortality. We will also identify patient subgroups, defined
by age, sex, race/ethnicity, comorbidities, use of other medications, and index VTE presentation (unprovoked,
provoked non-cancer, cancer-related) for which DOACs are particularly beneficial or hazardous. Additionally,
we will develop the first risk prediction models for VTE recurrence, intracranial hemorrhage and mortality which
incorporate DOACs. These predictive models will have a direct and immediate impact on clinical practice,
helping clinicians and patients make decisions about the most appropriate anticoagulant therapy. NHLBI has
listed anticoagulant therapies as a top priority for comparative effectiveness research.
 In sum, findings from this research would immediately impact clinical practice, reinforcing or leading to
reconsideration of the existing clinical guidelines for VTE management. Further, in harmony with the 2015
Precision...

## Key facts

- **NIH application ID:** 9839424
- **Project number:** 5R01HL131579-04
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** PAMELA L. Lutsey
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $428,815
- **Award type:** 5
- **Project period:** 2017-01-01 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9839424

## Citation

> US National Institutes of Health, RePORTER application 9839424, Contemporary Venous Thromboembolism Treatment (5R01HL131579-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9839424. Licensed CC0.

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