ESC Congress FA eBook 2016 - 14


CLINICAL TRIAL HIGHLIGHTS

Figure 1. Major or Clinically Relevant Non-Major Bleeding
NOAC
Major or CRNM
Warfarin
Dabigatran
Rivaroxaban
Apixaban
Major
Warfarin
Dabigatran
Rivaroxaban
Apixaban
CRNM
Warfarin
Dabigatran
Rivaroxaban
Apixaban

IR*

HR (95%CI)

P

11.44
6.74
11.43
8.58

1 (ref.)
0.74 (066, 084)
1.05 (094, 1.17)
0.70 (0.61, 0.80)

< .001
.004
< .001

2.42
1.29
2.07
1.51

1 (ref.)
0.67 (0.52, 0.88)
0.86 (0.68, 1.10)
0.56 (0.40, 0.76)

.004
.231
.001

8.85
5.38
9.20
7.00

1 (ref.)
0.76 (0.66, 0.87)
1.10 (0.97, 1.24)
0.74 (0.64, 0.87)

< .001
.133
< .001
0.40

0.60

*Bleed cases per 100 patients a year

0.80

1.0

1.3

Favors NOAC

Favors Warfarin

HR adjusted for age, gender, previous bleeding, previous NOAC use, co-morbidities and concomitant medications at basline

NOAC, non-vitamin K antagonist oral anticoagulant; CRNM, clinically relevant non-major bleeding.
Reproduced with permission from S Halvorsen, MD, PhD.

Figure 2. Gastrointestinal, Intracranial, and Other Bleeding
NOAC
GI
Warfarin
Dabigatran
Rivaroxaban
Apixaban
ICH
Warfarin
Dabigatran
Rivaroxaban
Apixaban
Other
Warfarin
Dabigatran
Rivaroxaban
Apixaban

IR*

HR (95%CI)

P

2.67
2.43
3.33
2.16

1 (ref.)
1.26 (1.01, 1.57)
1.37 (1.12, 1.69)
0.77 (0.59, 1.02)

.037
.003
.068

1.20
0.45
1.19
0.80

1 (ref.)
0.46 (0.30, 0.70)
0.93 (0.67, 1.29)
0.56 (0.36, 0.86)

< .001
.656
.009

7.33
3.75
6.60
5.51

1 (ref.)
0.63 (0.54, 0.74)
0.95 (0.83, 1.10)
0.71 (0.60, 0.85)

< .001
.505
< .001
0.40

*Bleed cases per 100 patients a year

0.60

1.0

Favors NOAC

1.8

Favors Warfarin

HR adjusted for age, gender, previous bleeding, previous NOAC use, co-morbidities and concomitant medications at basline

GI, gastrointestinal; ICH, intracranial hemorrhage; NOAC, non-vitamin K antagonist oral anticoagulant; CRNM, clinically relevant non-major bleeding.
Reproduced with permission from S Halvorsen, MD, PhD.

Finally, drug exposure at the level of pharmacy dispensation rather than patient intake was studied.
This analysis showed that both apixaban and dabigatran were associated with a lower risk of major or
CRNM bleeding compared with warfarin. More studies
are needed to evaluate the optimal benefit to risk balance between thromboembolic prevention and bleeding
complications in patients with non-valvular AF receiving
NOACs.

14

October 2016

Outcomes of Radiofrequency
Catheter Ablation for Atrial
Fibrillation in Elderly Patients
Written by Phil Vinall

Yong-Soo Baek, MD, Yonsei University College of
Medicine, Seoul, Republic of South Korea, presented the
outcomes of elderly patients (aged ≥ 75 years) with atrial
fibrillation (AF) treated with radiofrequency catheter

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