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Blood, 1 August 2008, Vol. 112, No. 3, pp. 511-515.
Prepublished online as a Blood First Edition Paper on May 27, 2008; DOI 10.1182/blood-2008-01-131656.


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CLINICAL TRIALS AND OBSERVATIONS

Residual vein thrombosis to establish duration of anticoagulation after a first episode of deep vein thrombosis: the Duration of Anticoagulation based on Compression UltraSonography (DACUS) study

Sergio Siragusa1, Alessandra Malato1, Raffaela Anastasio1, Valeria Cigna1, Glauco Milio2, Corrado Amato2, Mario Bellisi3, Maria Teresa Attanzio3, Oreste Cormaci4, Massimo Pellegrino5, Alberto Dolce1, Alessandra Casuccio6, Guido Bajardi3, and Guglielmo Mariani7

1 Cattedra ed Unità di Ematologia con trapianto, Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche, Università degli Studi di Palermo, Palermo; 2 Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche, Università degli Studi di Palermo, Palermo; 3 Dipartimento di Discipline Chirurgiche ed Anatomiche, Università degli Studi di Palermo, Palermo; 4 Unità di Chirurgia Vascolare, Ospedale Garibaldi di Catania, Catania; 5 Unità di Patologia Vascolare, Ospedale S. Antonio Abate di Trapani, Trapani; 6 Dipartimento di Neuroscienze Cliniche, Università degli Studi di Palermo, Palermo; and 7 Dipartimento di Medicina Interna e Sanità Pubblica, Università degli Studi de L'Aquila, L'Aquila, Italy

Residual vein thrombosis (RVT) indicates a prothrombotic state and is useful for evaluating the optimal duration of oral anticoagulant treatment (OAT). Patients with a first episode of deep vein thrombosis, treated with OAT for 3 months, were managed according to RVT findings. Those with RVT were randomized to either stop or continue anticoagulants for 9 additional months, whereas in those without RVT, OAT was stopped. Outcomes were recurrent venous thromboembolism and/or major bleeding. Residual thrombosis was detected in 180 (69.8%) of 258 patients; recurrent events occurred in 27.2% of those who discontinued (25/92; 15.2% person-years) and 19.3% of those who continued OAT (17/88; 10.1% person-years). The relative adjusted hazard ratio (HR) was 1.58 (95% confidence interval [CI], 0.85-2.93; P = .145). Of the 78 (30.2%) patients without RVT, only 1 (1.3%; 0.63% person-years) had a recurrence. The adjusted HR of patients with RVT versus those without was 24.9 (95% CI, 3.4-183.6; P = .002). One major bleeding event (1.1%; 0.53% person-years) occurred in patients who stopped and 2 occurred (2.3%; 1.1% person-years) in those who continued OAT. Absence of RVT identifies a group of patients at very low risk for recurrent thrombosis who can safely stop OAT. This trial was registered at http://www.ClinicalTrials.gov as no. NCT00438230 [ClinicalTrials.gov] .


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