Two Weeks of Low Molecular Weight Heparin for Isolated Symptomatic Distal Vein Thrombosis (TWISTER study).
Anticoagulants
Calf vein thrombosis
Distal deep vein thrombosis
Pulmonary embolism
Venous thromboembolism
Journal
Thrombosis research
ISSN: 1879-2472
Titre abrégé: Thromb Res
Pays: United States
ID NLM: 0326377
Informations de publication
Date de publication:
11 Sep 2021
11 Sep 2021
Historique:
received:
02
05
2021
revised:
06
08
2021
accepted:
07
09
2021
pubmed:
17
9
2021
medline:
17
9
2021
entrez:
16
9
2021
Statut:
aheadofprint
Résumé
Treatment of low-risk patients with isolated symptomatic distal deep vein thrombi (IDDVT) is uncertain. assess whether two weeks of therapeutic anticoagulation is efficacious/safe for IDDVT. symptomatic three-month venous thromboembolism (VTE) incidence in the two-week anticoagulation group. Secondary outcomes included post-thrombotic syndrome (PTS) and bleeding. Prospective multicentre cohort study. Consecutive low-risk IDDVT patients enrolled within 72 h of diagnosis and treated with therapeutic dose enoxaparin or rivaroxaban. At two weeks, patients had repeat complete whole leg compression ultrasound (CUS)/clinical review. If resolution of leg symptoms AND no radiological evidence of thrombus extension, anticoagulation was stopped. If ongoing symptoms and/or radiographic extension within distal veins, anticoagulation was continued for four more weeks. Patients with extension into the popliteal vein on two-week ultrasound were treated off-study. Patients were reviewed at three and six months. 241 eligible patients received ≥2 weeks anticoagulation. 167/241 (69%) were assigned to the 2-week anticoagulation group; 71/241 (30%) to the six-week anticoagulation group; 3/241 patients (1%) had extension into the popliteal vein on two-week CUS. Two patients in the two-week anticoagulation group had symptomatic IDDVT recurrence in ≤3 months; VTE recurrence 2/156; 1.3%(95% CI 0.05-4.85%). 69% of patients had complete resolution of symptoms within two weeks. Six-month PTS rates were 8/184, 4.4%(95% CI 2.1-8.5%). No major bleeding was reported. Our findings suggest it's safe/efficacious to stop therapeutic anticoagulation at two weeks in low-risk IDDVT patients with resolution of symptoms/no extension on ultrasound. This could replace 6-12 weeks of anticoagulation for ambulatory, low-risk IDDVT patients. ClinicalTrials.govNCT01252420.
Sections du résumé
BACKGROUND
BACKGROUND
Treatment of low-risk patients with isolated symptomatic distal deep vein thrombi (IDDVT) is uncertain.
OBJECTIVE
OBJECTIVE
assess whether two weeks of therapeutic anticoagulation is efficacious/safe for IDDVT.
PRIMARY OUTCOME
METHODS
symptomatic three-month venous thromboembolism (VTE) incidence in the two-week anticoagulation group. Secondary outcomes included post-thrombotic syndrome (PTS) and bleeding.
METHODS
METHODS
Prospective multicentre cohort study. Consecutive low-risk IDDVT patients enrolled within 72 h of diagnosis and treated with therapeutic dose enoxaparin or rivaroxaban. At two weeks, patients had repeat complete whole leg compression ultrasound (CUS)/clinical review. If resolution of leg symptoms AND no radiological evidence of thrombus extension, anticoagulation was stopped. If ongoing symptoms and/or radiographic extension within distal veins, anticoagulation was continued for four more weeks. Patients with extension into the popliteal vein on two-week ultrasound were treated off-study. Patients were reviewed at three and six months.
FINDINGS/INTERPRETATION
UNASSIGNED
241 eligible patients received ≥2 weeks anticoagulation. 167/241 (69%) were assigned to the 2-week anticoagulation group; 71/241 (30%) to the six-week anticoagulation group; 3/241 patients (1%) had extension into the popliteal vein on two-week CUS. Two patients in the two-week anticoagulation group had symptomatic IDDVT recurrence in ≤3 months; VTE recurrence 2/156; 1.3%(95% CI 0.05-4.85%). 69% of patients had complete resolution of symptoms within two weeks. Six-month PTS rates were 8/184, 4.4%(95% CI 2.1-8.5%). No major bleeding was reported. Our findings suggest it's safe/efficacious to stop therapeutic anticoagulation at two weeks in low-risk IDDVT patients with resolution of symptoms/no extension on ultrasound. This could replace 6-12 weeks of anticoagulation for ambulatory, low-risk IDDVT patients.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.govNCT01252420.
Identifiants
pubmed: 34530387
pii: S0049-3848(21)00457-6
doi: 10.1016/j.thromres.2021.09.004
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01252420']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
33-39Informations de copyright
Copyright © 2021 Elsevier Ltd. All rights reserved.