ESC Congress FA eBook 2016 - 16


CLINICAL TRIAL HIGHLIGHTS

Table 1. Patient Characteristics by Dosing
Appropriate Dose
n = 5000 (87%)

Under-dosed
n = 541 (9.4%)

Over-dosed
n = 197 (3.4%)

P-value

70 (63, 77)

79 (72, 85)

80 (76, 84)

< .0001

40.1%

48.2%

67%

< .0001

Age (years)
Female
CHA2DS2-VASc Score

< .0001

0

3.6%

0.9%

1%

1

10.8%

2.6%

1.5%

≥2

85.6%

96.5%

97.5%

ORBIT bleeding score

< .0001

Low: 0-2

76%

52.9%

48.7%

Medium: 3

13%

21.9%

19.7%

11.1%

25.2%

31.6%

Prior stroke/TIA

11.5%

14.6%

15.8%

.02

Prior GI bleeding

3.7%

5.9%

4.1%

.04

26.1%

24.6%

24.4%

.7

93 ± 43

67 ± 28

47 ± 28

High: ≥4

Concomitant aspirin
2

CrCl (mL/min/1.73m ), mean (SD)
Physician specialty
Primary care

.0001
< .0001

4.8%

9.6%

11.7%

Cardiology

67.7%

72.6%

69.5%

Electrophysiology

27.4%

17.7%

18.8%

GI, gastrointestinal; TIA, transient ischemic attack; CrCl, creatinine clearance.

associated with a significant (HR, 1.26; 95% CI, 1.07 to
1.50; P = .0065) increase in the risk of cardiovascular hospitalization and over-dosing was associated with a significantly increased risk of all-cause mortality.
This study is limited in that it did not include data
on some concomitant medications (eg, antibiotics), the

off-label groups were relatively small, and the follow-up
(12 months) is relatively short. With these limitations
in mind, Dr Piccini concluded that although over- and
under-dosing of NOAC therapy was not frequent in community practice, when it occurred, and often for unclear
reasons, it was associated with worse clinical outcomes.

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Table of Contents for the Digital Edition of ESC Congress FA eBook 2016
