Table 2.

Efficacy and Safety Outcomes

Event (Efficacy Outcomes)	Dabigatran, n = 122	Warfarin, n = 122	Dabigatran vs Warfarin, Adjusted HR (95% CI)	P Value
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%)	3 (2.46%)	—	—
TIA	2(1.64%)	2(1.64%)	1.06 (0.15–7.60)	0.958
MI	0	1(0.82%)	—	—
Systemic embolism	0	0	—	—
Pulmonary embolism	0	0	—	—
UA	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
Event (safety outcomes)
Intracranial bleeding	2 (1.64%)	2 (1.64%)	1.94 (0.01–402.82)	0.808
GI bleeding	8 (6.56%)	15 (12.30%)	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	—	—
Others	1 (0.82%)	1 (0.85%)	—	—
Major bleeding	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 bleedinga	28 (22.95%)	38 (31.15%)	0.76 (0.45–1.25)	0.281

Abbreviations: CI, confidence interval; GI, gastrointestinal; HR, hazard ratio; MI, myocardial infarction; TIA, transient ischemic attack; UA, unstable angina.

^aFor 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.