Review Article

Female Sex as a Thromboembolic Risk Factor in the Era of Nonvitamin K Antagonist Oral Anticoagulants

Table 2

Sex-based analysis of rate of stroke/SE and major bleeding studies.

Authors, yearSample ()Type of the studyMean CHA2DS2-VASc scoreRate of strokes/SE and major bleeding in female vs male patientsAnticoagulant therapy

Poli et al., (2013) [9]Total patients
3,015 (aged > 80 years):
Men 1,361,
Women 1,654
Observational studyFemales showed a higher risk score for all the classes of risk when CHA2DS2VASc was appliedStroke:
Men
nr. 45 (1.3 per 100 person year)
Women
nr. 67 (1.6 per 100 person year)
RR 1.2 (95% CI 0.8-1.8)
Major bleeding:
Men
nr. 75 (2.2 per 100 person year)
Women
nr. 97 (1.4 per 100 person year)
RR 1.6 (95% CI 1.1-2.3)
VKA treatment

Avgil Tsadok et al., (2015) [33]Total patients:
15,918
Men 8,346
Women 7,572
Observational studyMen
2.6
Women
3.9
Stroke:
Men
HR (95% CI) 0.98 (0.78-1.23)
Women
HR (95% CI) 0.79 (0.56- 1.04)
Major bleeding:
Men
HR (95% CI) 0.73 (0.64-0.84)
Women
HR (95% CI) 0.85 (0.71-1.01)
Dabigatran

Vinereanu et al., (2015) [34]Total patients:
9,120
Men 5886
Women 3234
Randomized controlled trialMen 3 (median)
Women 4 (median)
Stroke/SE:
Men
HR (95% CI) 0.84 (0.66-1.05)
Women
HR (95% CI) 0.73 (0.54- 0.97)
Major bleeding:
Men
HR (95% CI) 0.76 (0.64- 0.90)
Women
HR (95% CI) 0.56 (0.44- 0.72)
Apixaban vs warfarin

Camm et al.,
(2017) [15]
Total patients:
28, 624
Men 15 915,
Women 12,709
Prospective studyMen

Women
Stroke/SE:
Men
1.17 (CI 1.01-1.37)
Women
1.62 (CI 1.41-1.87)
Major bleeding:
Men
0.79 (CI 1.01 - 0.95)
Women
0.93 (CI 0.78 - 1.1.3)
Men: 33.8% VKA, 12.2% VKA+AP, 13.1% NOAC, 3.8% NOAC+AP, 24.9% AP, 12.2% none.
Women: 37.1% VKA, 9.7% VKA+ AP, 13.9% NOAC, 3.2% NOAC+AP, 23.9% AP, 12.3% none

Law et al., (2018) [31]Total patients:
15,292
Men 7,952
Women 7,340
Cohort studyMen 2.96 (SD 1.68)
Women 4.34 (SD 1.79)
Stroke:
Men
HR (95% CI) 0.85 (0.65-1.12)
Women
HR (95% CI) 0.81 (0.63- 1.03)
Major bleeding:
Men
HR (95% CI) 1.13 (0.73- 1.4)
Women
HR (95% CI) 0.89 (0.63- 1.27)
Warfarin vs DOAC

AP: Antiplatelet; CI: Confidence interval; DOAC: Direct oral anticoagulant; HR: Hazard ratio; NOAC: Nonvitamin K antagonist oral anticoagulants; RR: Risk ratio; SE: Systemic embolism; VKA: Vitamin K antagonists.