Author + information
- Tze-Fan Chao,
- Shih-Ann Chen,
- Christian Ruff,
- Rose Hamershock,
- Elliott Antman,
- Eugene Braunwald and
- Robert Giugliano
Background: Prior studies suggest that stroke and bleeding in Asians with atrial fibrillation (AF) may be higher than in non-Asians. However, detailed adjusted analyses and comparisons of PK/PD data have not been performed.
Methods: Drug concentration (PK) and anti-FXa activity (PD) at trough (day 29), and the adjusted risks of clinical outcomes in pts of Asian (n=2909) vs non-Asians (n=18,195) in the ENGAGE AF-TIMI 48 trial were compared. We also evaluated effect modification of race on clinical outcomes of higher-dose edoxaban regimen (HDER) vs warfarin.
Results: With warfarin, the adjusted risk of ischemic stroke was similar (HR 1.12, p=0.55), but ICH higher (HR 1.71, p=0.03) in Asians (Figure). With HDER, the risks of most outcomes were similar by race, except mortality was lower in Asians (HR 0.78, p=0.04). Net clinical outcomes comparing HDER vs warfarin were even more favorable in Asians vs non-Asians (P-int=0.03-0.06). The better outcomes in Asians treated with HDER may be related to lower drug concentration (38.3 versus 46.0 ng/mL, P<0.05) in Asians vs non-Asians. Anti-FXa activity showed a similar pattern.
Conclusions: Asian AF patients treated with warfarin had higher ICH rates than non-Asians. With HDER, Asians had a significantly lower risk of mortality and a trend toward more favorable net clinical outcomes as compared to non-Asians.
Poster Hall, Hall C
Friday, March 17, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Atrial Fibrillation and VT: Unique Populations and Solutions
Abstract Category: 8. Arrhythmias and Clinical EP: Supraventricular/Ventricular Arrhythmias
Presentation Number: 1151-099
- 2017 American College of Cardiology Foundation