Abstract / Description: 

Introduction: Atrial fibrillation is a major cause of morbidity and mortality in the United States. Ensuring racial/ethnic diversity in clinical trial participation is vital for generalizability of atrial fibrillation therapies and practice guidelines.

Methods: We identified clinical trials cited in the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for Atrial Fibrillation. We examined published manuscripts and supplementary data for participant racial/ethnic data. We classified studies by reported proportion of non-Hispanic white (NHW), African-American, Hispanic, and/or Asian participants. For each race/ethnicity, we pooled trial data to determine overall percentage of participation. We also classified studies by whether they reported geographic areas (North America, Europe, Latin America, and Asia-Pacific).

Results: We identified 28 trials published between 1996 and 2019. Only 10 studies (36%) explicitly reported participant level racial/ethnic data. An additional 7 trials reported geographic areas. All 10 studies reporting participant data were published between 2010 and 2019. Among these, 88.6% of participants were identified as NHW. Only 6 studies reported African-American participants (pooled proportion 2%), 5 reported Hispanic participants (pooled proportion 5.8%), and 5 reported Asian participants (pooled proportion 10.6%). African Americans and Hispanics were under-represented in clinical trials compared to the US population per 2018 census data (Figure).

Conclusions: Participant level racial/ethnic data are under-reported in guideline-informing atrial fibrillation clinical trials. In trials reporting participant level data, African-American and Hispanic populations are under-represented. These factors may limit generalizability of trial results and practice guidelines across diverse groups. Future trials should focus on improving reporting and participation of racial/ethnic minorities.

eCardio Hub Collection
Ashish Sarraju, David J Maron, Fatima Rodriguez