RE-MOBILIZE (150mg) trial

known inherited or acquired clinically significant bleeding disorder; major surgery, trauma, uncontrolled hypertension, or myocardial infarction within the last 3 months; history of acute intracranial disease or hemorrhagic stroke; gastrointestinal or urogenital bleeding or ulcer disease within the last 6 months; severe liver disease; aspartate or alanine aminotransferase (AST, ALT) levels higher than 2x the upper limit of the normal range (ULN) within the last month; severe renal insufficiency (creatinine clearance <30 mL/min); need for concomitant longacting nonsteroidal anti-inflammatory drug therapy or treatment with an anticoagulant during study drug treatment; active malignant disease; platelet count less than 100 � 10^9/L,

Remarks

Baseline characteristics

Age (mean), years	66y
Total hip replacement	0%
Total knee replacement	100%
Weight, kg,	88kg
Female	57%
general anesthesia	53%
BMI (kg/m�)	NA
History of venous thromboembolism (%)	NA
Use of cement	NA
Estimated creatinine clearance >60 ml/min	NA (mean clearance 82.9 ml/min)
Previous orthopedic surgery (%)	NA
Duration of surgery (min)	91 min

Method and design

Randomized effectives	877 / 876 (studied vs. control)
Blinding	double blind
Follow-up duration	12-15 days, median 14d
Number of centre	97
Geographic area	US, Canada, Mexico, UK
Hypothesis	Non inferiority
Primary endpoint	total VTE and all-cause mortality
Remarks

Remarks / Comments

Results

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

All cause death

1 / 877
0 / 876
classic 4,99 [0,07;365,56]

major or clinically relevant non-major bleeding

27 / 871
33 / 868
0,82 [0,49;1,34]

non-fatal pulmonary embolism

0 / 649
5 / 643
classic 0,05 [0,00;2,60]

major VTE (fatal and non fatal DVT,PE)

20 / 656
15 / 668
classic 1,36 [0,70;2,63]

total VTE and all-cause mortality

219 / 649
163 / 643
1,33 [1,12;1,58]

distal DVT

198 / 649
148 / 643
1,33 [1,10;1,59]

Major bleeding

5 / 871
12 / 868
0,42 [0,15;1,17] 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
major or clinically relevant non-major bleeding	27 / 871 (3,1%)	33 / 868 (3,8%)	0,82	[0,49;1,34]		12103
All cause death	1 / 877 (0,1%)	0 / 876 (0,1%)	2,00	[0,07;59,47]		12103
non-fatal pulmonary embolism	0 / 649 (0,1%)	5 / 643 (0,8%)	0,10	[0,01;1,81]		12103
Major bleeding	5 / 871 (0,6%)	12 / 868 (1,4%)	0,42	[0,15;1,17]		12103
total VTE and all-cause mortality	219 / 649 (33,7%)	163 / 643 (25,3%)	1,33	[1,12;1,58]		12103
distal DVT	198 / 649 (30,5%)	148 / 643 (23,0%)	1,33	[1,10;1,59]		12103
major VTE (fatal and non fatal DVT,PE)	20 / 656 (3,0%)	15 / 668 (2,2%)	1,36	[0,70;2,63]		12103
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 12103: Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, Lieberman JR, Muntz JE, Raskob GE, Clements ML, Hantel S, Schnee JM, Caprini JAOral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.J Arthroplasty 2009;24:1-9

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
major or clinically relevant non-major bleeding	3,10%	3,80%	-7,0‰
Major bleeding	5,74‰	1,38%	-8,1‰
total VTE and all-cause mortality	33,74%	25,35%	8,4%
distal DVT	30,51%	23,02%	7,5%
major VTE (fatal and non fatal DVT,PE)	3,05%	2,25%	8,0‰

Meta-analysis of all similar trials:

anticoagulant in DVT prophylaxis for orthopedic surgery

antithrombotics in DVT prophylaxis for elective major knee surgery

antithrombotics in DVT prophylaxis for orthopedic surgery

direct antithrombins in DVT prophylaxis for all type of patients

new anticoagulants in DVT prophylaxis for elective major knee surgery

new anticoagulants in DVT prophylaxis for orthopaedic surgery

new anticoagulants in DVT prophylaxis for all type of patients

Reference(s)

Trials register #

Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, Lieberman JR, Muntz JE, Raskob GE, Clements ML, Hantel S, Schnee JM, Caprini JA. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.. J Arthroplasty 2009;24:1-9 - 10.1016/j.arth.2008.01.132
Pubmed | Hubmed | Fulltext

RE-MOBILIZE (150mg) study, 2008

Treatments

Patients

Method and design

Remarks / Comments

Results

Reference(s)