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Previous Volume 345:165-169 July 19, 2001 Number 3 Next

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ABSTRACT

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 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 oral anticoagulant therapy (8.3 percent, P=0.003). The incidence of recurrence after the discontinuation of treatment was 5.1 percent per patient-year in patients in whom oral anticoagulant therapy was discontinued after 3 months and 5.0 percent per patient-year in patients who received an additional 9 months of oral anticoagulant therapy. None of the recurrences were fatal. Four patients had nonfatal major bleeding during the extended period of anticoagulant therapy (3.0 percent).

Conclusions In patients with idiopathic deep venous thrombosis, the clinical benefit associated with extending the duration of anticoagulant therapy to one year is not maintained after the therapy is discontinued.

Source Information

From the Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Perugia (G.A., M.G.S., A.I.); the Istituto di Clinica Medica II, Università di Padova, Padua (P.P., P.B.); the Istituto di Ematologia, Università di Torino, Turin (M.B.); the Centro Emofilia e Trombosi, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale Maggiore, Milan (M.M.); the Divisione di Angiologia, Policlinico S. Orsola-Malpighi, Bologna (G.G.); the Divisione di Chirurgia Vascolare, Ospedale S. Chiara, Trento (A.B.); the Divisione di Medicina, Ospedale Civile, Bolzano (C.T.); the Divisione Medica I, Ospedale S. Giovanni e Paolo, Venice (G.S.), and the Dipartimento di Medicina Interna e Terapia Medica, Università di Varese, Varese (W.A.) — all in Italy.



Other authors were Alessandra Ascani, M.D. (Università di Perugia, Perugia); Sabina Villalta, M.D., Michela Frulla, M.D., Laura Mosena, M.D., Antonio Girolami, M.D. (Università di Padova, Padua); Antonella Vaccarino, M.D. (Università di Torino, Turin); Adriano Alatri, M.D. (Università di Milano, Milan); Gualtiero Palareti, M.D. (Policlinico S. Orsola-Malpighi, Bologna); Mario Marchesi, M.D. (Ospedale Civile, Bolzano); Giovanni Battista Ambrosio, M.D., Roberto Parisi, M.D., Silvia Doria, M.D. (Ospedale S. Giovanni e Paolo, Venice); Luigi Steidl, M.D., Fabio Ambrosini, M.D. (Università di Varese, Varese); Mauro Silingardi, M.D., Angelo Ghirarduzzi, M.D., and Ido Iori, M.D. (Arcispedale S. Maria Nuova, Reggio Emilia).

Address reprint requests to Professor Agnelli at the Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Via Enrico dal Pozzo, 06123 Perugia, Italy, or at agnellig{at}unipg.it.

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