Table 2.

Primary and secondary outcomes of thromboprophylaxis with dabigatran, nadroparin or rivaroxaban after total knee arthroplasty

	Dabigatran (n=45)		Nadroparin (n=45)		Rivaroxaban (n=48)		P value
	n	%	n	%	n	%
Primary outcome
Major and clinically relevant non-major bleeding	15	33.3	11	24.4	13	27.1	0.67
Major bleedings	0	0	2	4.4	0	0	0.21
Fatal bleeding	0	0	0	0	0	0
Clinically overt bleeding, haemoglobin (Hb) decrease >20 g/L	0	0	0	0	0	0
Clinically overt bleeding, transfusion	0	0	1	2.2	0	0	0.65
Critical bleeding	0	0	1*	2.2	0	0	0.65
Bleeding warranting treatment cessation	0	0	1*	2.2	0	0	0.65
Bleeding located at surgical site	0	0	0	0	0	0
Clinically relevant non-major bleeding	15	33.3	10	22.2	13	27.1	0.51
Spontaneous skin haematoma >25 cm2	1	2.2	0	0	0	0	0.65
Wound haematoma >100 cm2	14	31.1	9	20.0	12	25.0	0.49
Spontaneous nose bleeding >5 min	0	0	1	2.2	0	0	0.65
Spontaneous rectal bleeding >1 spot	0	0	0	0	0	0
Macroscopic haematuria >24 hours	0	0	0	0	1	2.1	1.0
Other bleeding events (not major)	0	0	0	0	0	0
Last primary outcome (median days after surgery) (range)	7 (1–21)		7 (2–26)		6 (2–16)		0.32
Patients with primary outcome more than 14 days after surgery (%)	1	2.2	1	2.2	1	2.1	1.0
Secondary outcome
VTE	1*	2.2	0	0	0	0	0.65
Death due to VTE	1*		0		0
DVT	0		0		0
PE	1*		0		0
Hospital stay (median, days) (range)	3 (2–9)			3 (2–10)	4(2–28)		0.098
Readmission within 3 months, n (%)	2 (4.4)			4 (8.9)	3 (6.3)		0.77
Patients with adverse reactions, n (%)	9 (20)			2 (4.4)	5 (10.4)		0.072
Patient compliant, n (%)	27 of 44 (61.4)†			25 of 44 (56.8)†	25 (52.1)		0.66
Days of missed dosages (median, days) (range)	0 (0–7); n=42			0 (0–23); n=40	0 (0–4); n=40		0.73

*Identical patient.

†One missing value. Due to the explorative nature of this pilot study, all p values are explorative rather than confirmative and are not corrected for multiple testing.

DVT, deep venous thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.