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. 2020 Apr 9;2020(4):CD013422. doi: 10.1002/14651858.CD013422.pub2

Pinede 2001.

Methods Open‐label, randomised, controlled trial
Participants Number: 197 participants
105 received 6 weeks of anticoagulation treatment and 92 received 12 weeks of anticoagulation treatment
Age, % > 60 years age: 38.5%, 6‐week treatment group; 27.0%, 12‐week treatment group
Gender: not specified for distal thrombosis
Interventions VKAs for 6 weeks vs 12 weeks.
All participants received fluindione, a VKA with a long half‐life. During the acute phase, physicians were free to use either intravenous or subcutaneous UFH or 1 or 2 daily injections of LMWH. The recommended duration of heparin therapy was ≥ 5 days and until an anticoagulation value within the INR target range of 2.0–3.0.
Graduated compression stockings were systematically recommended for all participants with DVT.
Outcomes Recurrent VTE and haemorrhage
Notes Exclusion criteria: pregnancy, breastfeeding, previous VTE, vena cava filter implantation, surgical thrombectomy, free‐floating thrombus in the inferior vena cava lumen, evolutive cancer or malignant haematological disease, known biological thrombophilia, severe PE (defined by an amputation of > 50% of vascularisation), PE treated by thrombolysis (considered a marker of severe PE), myocardiopathy or other diseases justifying prolonged anticoagulation therapy, and liver insufficiency.
The data came from a larger study which included people with proximal and distal DVT.
Funding/support; quote: "The DOTAVK study was financially supported by the French Ministry of Health (HCL‐PHRC n°93‐95.010), Hospices Civils de Lyon, Conseil Régional Rhône‐Alpes, and the Association pour la recherche et l’évaluation thérapeutique (APRET)."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated allocation schedule in blocks of 4.
Allocation concealment (selection bias) Low risk Random allocation via centralised computer.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding of outcome assessment but the review authors judged that the outcome measurement was unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data.
Selective reporting (reporting bias) Low risk Published report included all expected outcomes.
Other bias Low risk Study appeared free of other sources of bias.