ESC Congress FA eBook 2016 - 13

ESC CONGRESS 2016

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IN REVIEW

FOCUS ON ARRHYTHMIAS

and false positives using the GARFIELD risk score were
0.63 for ischemic stroke/SE, 0.67 for hemorrhagic stroke/
major bleed, and 0.78 for all-cause mortality.
In comparison, the C statistics CHA2DS2-VASc in the
same data set were 0.63 for ischemic stroke/SE, 0.61 for
hemorrhagic stroke/major bleed, and 0.66 for all-cause
mortality. The difference in performance as measured
by the C statistic was even more in the low-risk patients
(CHA2DS2-VASc 0 or 1 for men and 1 or 2 for women); at
0.62 versus 0.56 for ischemic stroke/SE, 0.72 versus 0.57
for hemorrhagic stroke/major bleed and 0.72 versus 0.56
for all-cause mortality (GARFIELD vs CHA2DS2-VASc
respectively; Table 1).
Table 1. Comparison of GARFIELD Score With CHA2DS2-VASc
in All and Low-Risk Patients
Event

C Statistic
GARFIELD
Score

CHA2DS2-VASc

All-cause mortality

0.78

0.66

Ischemic stroke/systemic embolism

0.63

Hemorrhagic stroke/major bleed

0.67

0.61

All-cause mortality

0.72

0.56

Ischemic stroke/systemic embolism

0.62

0.56

Hemorrhagic stroke/major bleed

0.72

0.57

All Patients

Low Risk Patients*

*CHA 2DS2-VASc 0 or 1 for men and 1 or 2 for women

Validation of the GARFIELD score in ORBIT-I showed
similar C statistics for outcomes. These results demonstrated that the performance of the GARFIELD score was
superior to CHA2DS2-VASc for predicting ischemic stroke
in all patients and in those with a low risk of stroke. This
integrated risk tool has the potential for incorporation into
routine electronic systems. A simplified GARFIELD score,
validated using data from ORBIT-AF, is being developed
for web-based and mobile device applications.

Reduced Major and CRNM Bleeding
With Apixaban and Dabigatran Versus
Warfarin in BEYOND NORWAY
Written by Toni Rizzo

Data from clinical practice on bleeding rates in atrial
fibrillation (AF) patients treated with non-vitamin K
antagonist oral anticoagulants (NOACs) compared with

warfarin are limited. The aim of this study, presented by
Professor Sigrun Halvorsen, MD, PhD, Oslo University
Hospital Ulleval, Ulleval, Norway, was to evaluate bleeding risk in routine clinical practice in patients with AF
prescribed dabigatran, rivaroxaban, or apixaban compared with warfarin.
This cohort study in Norway used data from two
mandatory linked nationwide registries: the Norwegian
Patient Register of all hospital admissions and the
Norwegian Prescription Database of all dispensed prescription drugs. The study population included all
patients with non-valvular AF in Norway prescribed
NOACs for the first time from January 1, 2013 to June 30,
2015. Exclusion criteria included valvular AF, treatment
with NOACs ≤ 180 days before the index date, venous
thromboembolism ≤ 180 days before the index date, and
knee or hip replacement surgery ≤ 5 weeks before the
index date.
The study included data from 32675 patients. The primary endpoint was major or clinically relevant non-major
(CRNM) bleeding, using the modified ISTH definition.
The secondary endpoints were gastrointestinal bleeding,
intracranial bleeding, and bleeding from other sites. The
data were analyzed with Cox proportional hazard regression analysis adjusted for age, gender, previous bleeding,
previous NOAC use (> 180 days before study), comorbidities, and concomitant medications at baseline.
The median follow-up time was 173 days. The data
analysis showed that the risk of major or CRNM bleeding was significantly lower with dabigatran (HR, 0.74; 95%
CI, 0.66 to 0.84; P < .001) and apixaban (HR, 0.70; 95% CI,
0.61 to 0.80; P < .001) compared with warfarin but not with
rivaroxaban (HR, 1.05; 95% CI, 0.94 to 1.17; Figure 1).
Gastrointestinal bleeding was significantly more frequent
with dabigatran (HR, 1.26; 95% CI, 1.01 to 1.57; P = .037) and
rivaroxaban (HR, 1.37; 95% CI, 1.12 to 1.69; P = .003) compared with warfarin (Figure 2). The risk of intracranial bleeding was significantly lower with dabigatran (HR, 0.45; 95% CI,
0.30 to 0.70; P < .001) and apixaban (HR, 0.56; 95% CI, 0.36
to 0.86; P = .009) compared with warfarin. The risk of other
bleeding was significantly lower with dabigatran (HR, 0.63;
95% CI, 0.54 to 0.74; P < .001) and apixaban (HR, 0.71; 95%
CI, 0.60 to 0.85; P < .001) compared with warfarin.
Similar results were found in the subgroup of patients
aged ≥ 75 years (n = 16,034; 49%) and in those who
received a reduced dose of a NOAC.
Among this study's limitations were the lack of randomization and the existence of unmeasured residual
confounding. The benefit to risk balance of oral anticoagulation could not be evaluated because the risk of
stroke was not assessed. There was a risk of misclassification related to coding errors of hospital diagnoses.

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