# Optimizing stroke prevention for older adults with atrial fibrillation: Towards rigorous evaluation and judicious application of a new device

> **NIH NIH R01** · MAYO CLINIC ROCHESTER · 2021 · $493,168

## Abstract

PROJECT SUMMARY/ABSTRACT
Atrial fibrillation (AF) affects about 10% of older adults and accounts for a growing proportion of strokes.
Lifelong oral anticoagulation, with warfarin or a non-vitamin K antagonist oral anticoagulant (NOAC), is
recommended for stroke prevention in most AF patients. However, the drugs increase the risk of bleeding and
the adherence to the lifelong drug therapy is poor, leaving many patients under-treated. The recently-approved
Watchman device offers an attractive alternative to lifelong drug therapy for AF stroke prevention.
However, the device has been studied in only two clinical trials, both of which compared it to warfarin. Little is
known about how Watchman compares with the current mainstay therapy, NOACs, or how Watchman
compares with no treatment in patients who have difficulties taking anticoagulation drugs. Furthermore, for
preventive treatment with a high upfront cost and some procedural risks, a personalized approach is needed to
target Watchman to patients who are most likely to benefit and avoid it in those who have little to gain.
Therefore, the overall objective of this project is to address these evidence gaps and develop new prediction
tools to optimize the use of Watchman for AF stroke prevention. In Aim 1, we will conduct comparative
effectiveness studies using a large national administrative database (OptumLabs) that contains insurance
claims for over two million patients with AF of all ages and races from all 50 states with linked EHRs in a
subset. The findings will provide timely evidence to address the key unanswered questions highlighted in
current practice guidelines and will facilitate the design, analysis, and interpretation of future clinical trials. In
Aim 2, we will develop and validate machine-learning models to predict how Watchman compares with
non-invasive therapies. We will develop the models using the OptumLabs data, and validate the models in
two RCTs and two large health systems’ EHRs, thereby validating models in both clinical trial and routine
practice settings. The new prediction models will provide personalized estimates for the benefits and harms,
and thus, engage patients in making informed choices consistent with their preferences and ease clinicians’
cognitive burden. In Aim 3, we will assess how the Watchman decisions made in contemporary practice
agree with those suggested by the new prediction models. We will use machine-learning methods to
identify patient and provider characteristics associated with incongruent decisions. Such findings will highlight
patient and provider groups who may particularly benefit from the decision support, thereby informing future
implementation and translation efforts. We have assembled a team with complementary clinical and research
expertise, a solid record of successful collaboration, and extensive experience in outcomes research and
prediction modeling. We also have developed a web-based decision aid that is ready to translate the
predic...

## Key facts

- **NIH application ID:** 10074511
- **Project number:** 5R01AG062436-02
- **Recipient organization:** MAYO CLINIC ROCHESTER
- **Principal Investigator:** Peter A Noseworthy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $493,168
- **Award type:** 5
- **Project period:** 2020-01-01 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10074511

## Citation

> US National Institutes of Health, RePORTER application 10074511, Optimizing stroke prevention for older adults with atrial fibrillation: Towards rigorous evaluation and judicious application of a new device (5R01AG062436-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10074511. Licensed CC0.

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