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Extended Oral Anticoagulant Therapy after a First Episode of Pulmonary Embolism

Giancarlo Agnelli, MD; Paolo Prandoni, MD, PhD; Cecilia Becattini, MD; Mauro Silingardi, MD; Maria Rita Taliani, MD; Maddalena Miccio, MD; Davide Imberti, MD; Renzo Poggio, MD; Walter Ageno, MD; Enrico Pogliani, MD; Fernando Porro, MD; Pietro Zonzin, MD, Warfarin Optimal Duration Italian Trial Investigators*
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From Università di Perugia, Perugia; Istituto di Clinica Medica II, Università di Padova, Padua; Arcispedale S. Maria Nuova, Reggio Emilia; Ospedale Maggiore, Trieste; Centro Trombosi, Ospedale Galliera, Genoa; Ospedale di Piacenza, Piacenza; Università di Milano-Bicocca, Ospedale San Gerardo, Monza; Università d'nsubria, Varese; Ospedale Maggiore di Milano IRCCS, Milan; and Ospedale S. Maria della Misericordia, Rovigo, Italy.


Presented in part at the 21st Congress of the International Society of Thrombosis and Haemostasis, Paris, France, 10 July 2001.

Acknowledgment: The authors thank Eva Tikotin for her editorial assistance, the nursing and laboratory staff of the participating centers for their enthusiastic cooperation, and the patients included in the study for their trust and support.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Giancarlo Agnelli, MD, Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Via Enrico Dal Pozzo, 06123 Perugia, Italy; e-mail, agnellig@unipg.it.

Current Author Addresses: Drs. Agnelli, Becattini, and Taliani: Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Via Enrico Dal Pozzo, 06123 Perugia, Italy.

Dr. Prandoni: Istituto di Clinica Medica II, Università di Padova, Via Ospedale Civile 105, 35100 Padua, Italy.

Dr. Silingardi: Divisione di Medicina Interna I, Arcispedale S. Maria Nuova, Viale Umberto I 50, 42100 Reggio Emilia, Italy.

Dr. Miccio: Medicina d'Urgenza, Ospedale Maggiore, Piazza Ospedale 2, 34100 Trieste, Italy.

Dr. Imberti: III Unità Operativa di Medicina Interna, Ospedale di Piacenza, Via Taverna 49, 29100 Piacenza, Italy.

Dr. Poggio: II Divisione Medicina Generale-Centro Trombosi, Ospedale Galliera, Via Volta 4, 16128 Genoa, Italy.

Dr. Ageno: Dipartimento di Medicina Interna e Terapia Medica, Università d'nsubria, Viale Borri 57, 21100 Varese, Italy.

Dr. Pogliani: Divisione di Ematologia, Dipartimento di Medicina Interna, Università di Milano-Bicocca, Ospedale San Gerardo, Via Donizetti 106, Monza, Italy.

Dr. Porro: Medicina d'Urgenza, Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20100 Milan, Italy.

Dr. Zonzin: Divisione di Cardiologia, Ospedale S. Maria della Misericordia, Via tre Martiri 140, 45100 Rovigo, Italy.

Author Contributions: Conception and design: P. Prandoni, C. Becattini, M.R. Taliani.

Analysis and interpretation of the data: G. Agnelli, C. Becattini.

Drafting of the article: G. Agnelli, P. Prandoni, C. Becattini, M. Silingardi, M.R. Taliani, M. Miccio, D. Imberti, R. Poggio, W. Ageno, E. Pogliani, F. Porro, P. Zonzin.

Final approval of the article: G. Agnelli, P. Prandoni, C. Becattini, M. Silingardi, M.R. Taliani, M. Miccio, D. Imberti, R. Poggio, W. Ageno, E. Pogliani, F. Porro, P. Zonzin.

Provision of study materials or patients: P. Prandoni, M. Silingardi, M.R. Taliani, M. Miccio, D. Imberti, R. Poggio, W. Ageno, E. Pogliani, F. Porro, P. Zonzin.


Ann Intern Med. 2003;139(1):19-25. doi:10.7326/0003-4819-139-1-200307010-00008
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We found that patients with a first episode of pulmonary embolism who received extended anticoagulation were protected from a recurrence of venous thromboembolism while they were receiving treatment. However, the clinical benefit during the additional months of anticoagulation was not maintained after treatment was discontinued. The CIs of the relative risk for recurrent venous thromboembolism do not rule out substantive differences between the two treatment groups. However, our results in patients with pulmonary embolism are consistent with those previously observed in patients with deep venous thrombosis, a disease whose pathophysiology is similar to that of pulmonary embolism (2). The similarity in the results between the two studies, concerning both the incidence of the events and their time patterns, bolsters the conclusion that in patients with venous thromboembolism, prolonging anticoagulant therapy beyond 3 months simply delays recurrence until anticoagulant therapy is stopped.

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Figures

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Figure 1.
Flow chart for inclusion of patients in the study.

PE = pulmonary embolism.

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Figure 2.
Cumulative hazard of recurrence of venous thromboembolism in patients assigned to discontinue anticoagulation or to continue anticoagulation.

The rows parallel to the time axis report the number of patients at risk in the two treatment groups.

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Grahic Jump Location
Figure 3.
Cumulative hazard of recurrence of venous thromboembolism in patients with idiopathic pulmonary embolism and in patients with pulmonary embolism (PE) associated with transient risk factors according to treatment duration.

The rows parallel to the time axis report the number of patients at risk in each treatment group.

Grahic Jump Location

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Summary for Patients

How Long Should Blood Thinners Be Given to Patients Who Have Had a Pulmonary Embolism?

The summary below is from the full report titled “Extended Oral Anticoagulant Therapy after a First Episode of Pulmonary Embolism.” It is in the 1 July 2003 issue of Annals of Internal Medicine (volume 139, pages 19-25). The authors are G. Agnelli, P. Prandoni, C. Becattini, M. Silingardi, M.R. Taliani, M. Miccio, D. Imberti, R. Poggio, W. Ageno, E. Pogliani, F. Porro, and P. Zonzin, for the Warfarin Optimal Duration Italian Trial Investigators.

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