RECORD 3 trial

active bleeding or a high risk of bleeding that contraindicated the use of low-molecular-weight heparin; any contraindication to the use of enoxaparin; or necessitating adjustment of its dose;conditions preventing bilateral venography, clinically significant liver disease, concomitant use of protease inhibitors of the human immunodeficiency virus or fibrinolytic agents; planned intermittent pneumatic compression; requirement of ongoing anticoagulant therapy; pregnancy or breast-feeding

Baseline characteristics

Age (mean), years	67.6y
Total hip replacement	0%
Total knee replacement	100%
Weight, kg,	80.65
Female	68.23
general anesthesia	33.9%

Method and design

Randomized effectives	1254 / 1277 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	13-17 days
Number of centre	147 centers
Geographic area	19 countries worldwide
Hypothesis	Superiority
Primary endpoint	DVT, PE all cause mortality

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

0 / 1201
6 / 1217
classic 0,04 [0,00;2,21]

non-fatal pulmonary embolism

0 / 824
2 / 878
classic 0,12 [0,00;7,37]

proximal DVT

9 / 824
20 / 878
0,48 [0,22;1,05]

Major bleeding

7 / 1254
6 / 1277
classic 1,19 [0,40;3,53]

Symptomatic venous thromboembolism (DVT, PE)

8 / 1201
24 / 1217
0,34 [0,15;0,75]

total VTE and all-cause mortality

79 / 824
166 / 878
0,51 [0,39;0,65]

distal DVT

70 / 824
140 / 878
0,53 [0,41;0,70]

major VTE (fatal and non fatal DVT,PE)

9 / 908
24 / 925
0,38 [0,18;0,82]

Deep vein thrombosis

79 / 824
160 / 878
0,53 [0,41;0,68] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
All cause death	0 / 1201 (0,0%)	6 / 1217 (0,5%)	0,08	[0,00;1,51]
non-fatal pulmonary embolism	0 / 824 (0,1%)	2 / 878 (0,2%)	0,27	[0,01;5,90]
proximal DVT	9 / 824 (1,1%)	20 / 878 (2,3%)	0,48	[0,22;1,05]
Major bleeding	7 / 1254 (0,6%)	6 / 1277 (0,5%)	1,19	[0,40;3,53]
Symptomatic venous thromboembolism (DVT, PE)	8 / 1201 (0,7%)	24 / 1217 (2,0%)	0,34	[0,15;0,75]
total VTE and all-cause mortality	79 / 824 (9,6%)	166 / 878 (18,9%)	0,51	[0,39;0,65]
distal DVT	70 / 824 (8,5%)	140 / 878 (15,9%)	0,53	[0,41;0,70]
major VTE (fatal and non fatal DVT,PE)	9 / 908 (1,0%)	24 / 925 (2,6%)	0,38	[0,18;0,82]
Deep vein thrombosis	79 / 824 (9,6%)	160 / 878 (18,2%)	0,53	[0,41;0,68]		7771
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 7771: Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AGRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty.N Engl J Med 2008 Jun 26;358:2776-86

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
proximal DVT	1,09%	2,28%	-11,9‰
Major bleeding	5,58‰	4,70‰	0,9‰
Symptomatic venous thromboembolism (DVT, PE)	6,66‰	1,97%	-13,1‰
total VTE and all-cause mortality	9,59%	18,91%	-93,2‰
distal DVT	8,50%	15,95%	-74,5‰
major VTE (fatal and non fatal DVT,PE)	9,91‰	2,59%	-16,0‰
Deep vein thrombosis	9,59%	18,22%	-86,4‰

Meta-analysis of all similar trials:

anticoagulant in DVT prophylaxis for orthopedic surgery

antithrombotics in DVT prophylaxis for orthopedic surgery

antithrombotics in DVT prophylaxis for elective major knee surgery

direct factor Xa inhibitors in DVT prophylaxis for all type of patients

new anticoagulants in DVT prophylaxis for all type of patients

new anticoagulants in DVT prophylaxis for elective major knee surgery

Reference(s)

Trials register #	NCT00361894
Study web site link	,

Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty.. N Engl J Med 2008 Jun 26;358:2776-86
Pubmed | Hubmed | Fulltext

RECORD 3 study, 2008

Treatments

Patients

Method and design

Results

Reference(s)