NOTE Registry

NOTE Registry: Safety and Efficacy of NOACS in Congenital Heart Disease

Introduction

Non-vitamin K oral antagonists (NOACs) have two advantages compared with vitamin-K antagonists; no need for regular laboratory monitoring and decreased chance of brain hemorrhage, one of the most serious complications of anticoagulants. In patients without congenital heart disease, studies have shown that NOACs are just as effective and safe as vitamin-K antagonists. However, these studies excluded patients with congenital heart disease.

Aims
The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for thromboembolic prevention in adult patients with congenital heart disease over a minimum period of two years. The primary objective of the registry is to evaluate the two-year incidence of thromboembolic and bleeding events in adult congenital heart disease patients using NOACs for thromboembolic prevention. The secondary objectives of the registry are to evaluate adherence to NOAC therapy and the quality of life when using NOACs, and to identify congenital heart disease-specific risk factors for developing thromboembolism. 

Progress
As of May 2019, 40 countries are taking part in this registry, which was launched in April 2014. We have enrolled 615 patients so far and are still enrolling! To date, five publications have been published in an international peer-reviewed journals. Please click here for the study newsletter that includes a map of participating sites! NOTE registry newsletter

Organization
If you wish to know more about this registry or to participate please contact professor Barbara Mulder (Netherlands) or study coordinator, Tara Hankel (Netherlands), at note@amc.uva.nl.