Walter Ageno1, Nicoletta Riva1, Sam Schulman2, Jan Beyer-Westendorf3, Soo Mee Bang4, Marco Senzolo5, Elvira Grandone6, Samantha Pasca7, Matteo Nicola Dario Di Minno8, Rita Duce9, Alessandra Malato10, Rita Santoro11, Daniela Poli12, Peter Verhamme13, Ida Martinelli14, Pieter Kamphuisen15, Doyeun Oh16, Elbio D'Amico17, Cecilia Becattini18, Valerio De Stefano19, Gianpaolo Vidili20, Antonella Vaccarino21, Barbara Nardo22, Marcello Di Nisio23, Francesco Dentali1. 1. Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy. 2. Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 3. Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital "Carl Gustav Carus," Dresden, Germany. 4. Department of Internal Medicine, Seoul National University, Seoul, South Korea. 5. Multivisceral Transplant Unit, Gastroenterology, University Hospital of Padova, Padova, Italy. 6. Istituto di Ricovero e Cura a Carattere Scientifico, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 7. Center for Hemorrhagic and Thrombotic Diseases, University Hospital, Udine, Italy. 8. Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy9Unit of Cell and Molecular Biology in Cardiovascular Diseases, Centro Cardiologico Monzino, Milan, Italy. 9. Thrombosis Center, Galliera Hospital, Genoa, Italy. 10. Department of Hematology, Policlinico Universitario di Palermo, Palermo, Italy. 11. Haemophilia Center, Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy. 12. Thrombosis Center, Careggi Hospital, Florence, Italy. 13. Vascular Medicine and Haemostasis, University of Leuven, Leuven, Belgium. 14. A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy. 15. Department of Vascular Medicine, University of Groningen, Groningen, the Netherlands. 16. Department of Internal Medicine, Pochon CHA University, Seoul, Korea. 17. Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 18. Department of Internal and Vascular Medicine, University of Perugia, Ospedale S. Maria della Misericordia, Perugia, Italy. 19. Institute of Hematology, Catholic University, Rome, Italy. 20. Department of Clinical Medicine, University Hospital of Sassari, Sassari, Italy. 21. Unità Operativa Semplice Dipartimentale di Ematologia e Malattie Trombotiche, Ospedale San Giovanni Bosco, Torino, Italy. 22. Department of Medicine I, Busto Arsizio Hospital, Busto Arsizio, Italy. 23. Department of Medical, Oral, and Biotechnological Sciences, University G. D'Annunzio, Chieti, Italy.
Abstract
IMPORTANCE: Little information is available on the long-term clinical outcome of patients with splanchnic vein thrombosis (SVT). OBJECTIVE: To assess the incidence rates of bleeding, thrombotic events, and mortality in a large international cohort of patients with SVT. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study was conducted beginning May 2, 2008, and completed January 30, 2014, at hospital-based centers specialized in the management of thromboembolic disorders; a 2-year follow-up period was completed January 30, 2014, and data analysis was conducted from July 1, 2014, to February 28, 2015. Participants included 604 consecutive patients with objectively diagnosed SVT; there were no exclusion critieria. Information was gathered on baseline characteristics, risk factors, and antithrombotic treatment. Clinical outcomes during the follow-up period were documented and reviewed by a central adjudication committee. MAIN OUTCOMES AND MEASURES: Major bleeding, defined according to the International Society on Thrombosis and Hemostasis; bleeding requiring hospitalization; thrombotic events, including venous and arterial thrombosis; and all-cause mortality. RESULTS: Of the 604 patients (median age, 54 years; 62.6% males), 21 (3.5%) did not complete follow-up. The most common risk factors for SVT were liver cirrhosis (167 of 600 patients [27.8%]) and solid cancer (136 of 600 [22.7%]); the most common sites of thrombosis were the portal vein (465 of 604 [77.0%]) and the mesenteric veins (266 of 604 [44.0%]). Anticoagulation was administered to 465 patients in the entire cohort (77.0%) with a mean duration of 13.9 months; 175 of the anticoagulant group (37.6%) received parenteral treatment only, and 290 patients (62.4%) were receiving vitamin K antagonists. The incidence rates (reported with 95% CIs) were 3.8 per 100 patient-years (2.7-5.2) for major bleeding, 7.3 per 100 patient-years (5.8-9.3) for thrombotic events, and 10.3 per 100 patient-years (8.5-12.5) for all-cause mortality. During anticoagulant treatment, these rates were 3.9 per 100 patient-years (2.6-6.0) for major bleeding and 5.6 per 100 patient-years (3.9-8.0) for thrombotic events. After treatment discontinuation, rates were 1.0 per 100 patient-years (0.3-4.2) and 10.5 per 100 patient-years (6.8-16.3), respectively. The highest rates of major bleeding and thrombotic events during the whole study period were observed in patients with cirrhosis (10.0 per 100 patient-years [6.6-15.1] and 11.3 per 100 patient-years [7.7-16.8], respectively); the lowest rates were in patients with SVT secondary to transient risk factors (0.5 per 100 patient-years [0.1-3.7] and 3.2 per 100 patient-years [1.4-7.0], respectively). CONCLUSIONS AND RELEVANCE: Most patients with SVT have a substantial long-term risk of thrombotic events. In patients with cirrhosis, this risk must be balanced against a similarly high risk of major bleeding. Anticoagulant treatment appears to be safe and effective in most patients with SVT.
IMPORTANCE: Little information is available on the long-term clinical outcome of patients with splanchnic vein thrombosis (SVT). OBJECTIVE: To assess the incidence rates of bleeding, thrombotic events, and mortality in a large international cohort of patients with SVT. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study was conducted beginning May 2, 2008, and completed January 30, 2014, at hospital-based centers specialized in the management of thromboembolic disorders; a 2-year follow-up period was completed January 30, 2014, and data analysis was conducted from July 1, 2014, to February 28, 2015. Participants included 604 consecutive patients with objectively diagnosed SVT; there were no exclusion critieria. Information was gathered on baseline characteristics, risk factors, and antithrombotic treatment. Clinical outcomes during the follow-up period were documented and reviewed by a central adjudication committee. MAIN OUTCOMES AND MEASURES: Major bleeding, defined according to the International Society on Thrombosis and Hemostasis; bleeding requiring hospitalization; thrombotic events, including venous and arterial thrombosis; and all-cause mortality. RESULTS: Of the 604 patients (median age, 54 years; 62.6% males), 21 (3.5%) did not complete follow-up. The most common risk factors for SVT were liver cirrhosis (167 of 600 patients [27.8%]) and solid cancer (136 of 600 [22.7%]); the most common sites of thrombosis were the portal vein (465 of 604 [77.0%]) and the mesenteric veins (266 of 604 [44.0%]). Anticoagulation was administered to 465 patients in the entire cohort (77.0%) with a mean duration of 13.9 months; 175 of the anticoagulant group (37.6%) received parenteral treatment only, and 290 patients (62.4%) were receiving vitamin K antagonists. The incidence rates (reported with 95% CIs) were 3.8 per 100 patient-years (2.7-5.2) for major bleeding, 7.3 per 100 patient-years (5.8-9.3) for thrombotic events, and 10.3 per 100 patient-years (8.5-12.5) for all-cause mortality. During anticoagulant treatment, these rates were 3.9 per 100 patient-years (2.6-6.0) for major bleeding and 5.6 per 100 patient-years (3.9-8.0) for thrombotic events. After treatment discontinuation, rates were 1.0 per 100 patient-years (0.3-4.2) and 10.5 per 100 patient-years (6.8-16.3), respectively. The highest rates of major bleeding and thrombotic events during the whole study period were observed in patients with cirrhosis (10.0 per 100 patient-years [6.6-15.1] and 11.3 per 100 patient-years [7.7-16.8], respectively); the lowest rates were in patients with SVT secondary to transient risk factors (0.5 per 100 patient-years [0.1-3.7] and 3.2 per 100 patient-years [1.4-7.0], respectively). CONCLUSIONS AND RELEVANCE: Most patients with SVT have a substantial long-term risk of thrombotic events. In patients with cirrhosis, this risk must be balanced against a similarly high risk of major bleeding. Anticoagulant treatment appears to be safe and effective in most patients with SVT.
Authors: Eva N Hamulyák; Joost G Daams; Frank W G Leebeek; Bart J Biemond; Peter A W Te Boekhorst; Saskia Middeldorp; Mandy N Lauw Journal: Blood Adv Date: 2021-01-12