Table 3.

Efficacy and Safety Outcomes

Event	Dabigatran, n = 122, No. (%)	Warfarin, n = 122, No. (%)	Dabigatran vs Warfarin, Adjusted HR (95% CI)	P Value
Efficacy outcomes
Stroke	2 (1.64)	4 (3.28)	0.53 (0.10‐2.96)	0.469
Hemorrhagic	2 (1.64)	1 (0.82)	1.50 (0.01‐227.74)	0.875
Ischemic	0 (0.00)	3 (2.46)	—	—
Transient ischemic attack	2 (1.64)	2 (1.64)	1.06 (0.15‐7.60)	0.958
Myocardial infarction	0 (0.00)	1 (0.82)	—	—
Unstable angina	1 (0.82)	2 (1.64)	0.50 (0.04‐5.71)	0.579
Death from stroke	1 (0.82)	2 (1.64)	0.65 (0.06‐7.55)	0.734
Death from any cause	3 (2.46)	4 (3.28)	0.99 (0.22‐4.48)	0.986
Cardiac events	5 (4.10)	8 (6.56)	0.69 (0.22‐2.12)	0.516
Safety outcomes
Intracranial bleeding	2 (1.64)	2 (1.64)	1.94 (0.01‐402.82)	0.808
Gastrointestinal bleeding	8 (6.56)	15 (12.3)	0.57 (0.24‐1.35)	0.199
Subconjunctival hemorrhage	4 (3.28)	5 (4.10)	0.81 (0.22‐3.03)	0.754
Gum	2 (1.64)	3 (2.46)	0.62 (0.11‐4.02)	0.654
Hemoptysis	1 (0.82)	3 (2.46)	0.32 (0.03‐3.15)	0.330
Hematuria	4 (3.28)	5 (4.10)	0.97 (0.26‐3.65)	0.968
Nose	1 (0.82)	4 (3.28)	0.25 (0.03‐2.22)	0.212
Bruising	7 (5.74)	9 (7.38)	0.66 (0.23‐1.65)	0.428
Hematoma	2 (1.64)	0 (0.00)	—	—
Others	1 (0.82)	1 (0.82)	—	—
Major bleedinga	2 (1.64)	3 (2.46)	0.72 (0.19‐4.37)	0.719
Minor bleeding	26 (21.31)	37 (30.33)	0.71 (0.43‐1.18)	0.188
All bleedingb	28 (22.95)	38 (31.15)	0.76 (0.45‐1.25)	0.281

Abbreviations: CI, confidence interval; HR, hazard ratio.

^aMajor bleeding was defined according to the guideline by International Society on Thrombosis and Haemostasis.20

^bFor those who encountered both major and minor bleeding, each of them were only counted once in all bleeding events. Thus, the sum of major bleeding and minor bleeding events did not necessarily equal that of all bleeding.