Three Months versus One Year of Oral Anticoagulant Therapy for Idiopathic Deep Venous Thrombosis

作者：Giancarlo Agnelli, Paolo Prandoni, Maria Gabriella Santamaria, Paola Bagatella, Alfonso Iorio, Mario Bazzan, Marco Moia, Giuliana Guazzaloca, Adriano Bertoldi, Cristina Tomasi, Gianluigi Scannapieco, Alessandra Ascani, Sabina Villalta, Michela Frulla, Laura Mosena, Antonio Girolami, Antonella Vaccarino, Adriano Alatri, Gualtiero Palareti, Mario Marchesi, Giovanni Battista Ambrosio, Roberto Parisi, Silvia Maria da Silva Doria, Luigi Steidl, Fabio Ambrosini, Mauro Silingardi, Angelo Ghirarduzzi, Ido Iori, Walter Ageno · 发表于：New England Journal of Medicine · 年份：2001 · DOI：10.1056/nejm200107193450302 · 被引用次数：600 · 研究领域：Venous Thromboembolism Diagnosis and Management、Cerebral Venous Sinus Thrombosis、Diagnosis and Treatment of Venous Diseases

BACKGROUND: In patients with idiopathic deep venous thrombosis, continuing anticoagulant therapy beyond three months is associated with a reduced incidence of recurrent thrombosis during the period of therapy. Whether this benefit persists after anticoagulant therapy is discontinued is controversial. METHODS: Patients with a first episode of idiopathic proximal deep venous thrombosis who had completed three months of oral anticoagulant therapy (with warfarin, in 97 percent of the cases and acenocoumarol in 3 percent) were randomly assigned to the discontinuation of oral anticoagulants or to their continuation for nine additional months. The primary study outcome was recurrence of symptomatic, objectively confirmed venous thromboembolism during at least two years of follow-up. RESULTS: The primary intention-to-treat analysis showed that of 134 patients assigned to continued oral anticoagulant therapy, 21 had a recurrence of venous thromboembolism (15.7 percent; average follow-up, 37.8 months), as compared with 21 of 133 patients assigned to the discontinuation of oral anticoagulant therapy (15.8 percent; average follow-up, 37.2 months), resulting in a relative risk of 0.99 (95 percent confidence interval, 0.57 to 1.73). During the initial nine months after randomization (after all patients received three months of therapy), 1 patient had a recurrence while receiving oral anticoagulant therapy (0.7 percent), as compared with 11 of the patients assigned to the discontinuation of...