In cancer patients treated for venous thromboembolism (VTE), including deep-vein thrombosis (DVT) and pulmonary embolism (PE), analyzing mortality associated with recurrent VTE or major bleeding is needed to determine the optimal duration of anticoagulation.
This was a cohort study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) Registry database to compare rates of fatal recurrent PE and fatal bleeding in cancer patients receiving anticoagulation for VTE.
As of January 2013, 44,794 patients were enrolled in RIETE, of whom 7911 (18%) had active cancer. During the course of anticoagulant therapy (mean, 181 ± 210 days), 178 cancer patients (4.3%) developed recurrent PE (5.5 per 100 patient-years; 95% CI: 4.8–6.4), 194 (4.7%) had recurrent DVT (6.2 per 100 patient-years; 95% confidence interval [CI]: 5.3–7.1), and 367 (8.9%) bled (11.3 per 100 patient-years; 95% CI: 10.2–12.5). Of 4125 patients initially presenting with PE, 43 (1.0%) died of recurrent PE and 45 (1.1%) of bleeding; of 3786 patients with DVT, 19 (0.5%) died of PE, and 55 (1.3%) of bleeding. During the first 3 months of anticoagulation, there were 59 (1.4%) fatal PE recurrences and 77 (1.9%) fatal bleeds. Beyond the third month, there were 3 fatal PE recurrences and 23 fatal bleeds.
In RIETE cancer patients, the rate of fatal recurrent PE or fatal bleeding was much higher within the first 3 months of anticoagulation therapy.
From the Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Internal Medicine and Vascular Disease Unit and Groupe Francophone on Thrombosis and Cancer, Paris7 Diderot University, Sorbonne Paris Cité, Paris, France (DF); Department of Internal Medicine, Hospital Universitario Santa-Lucía, Cartagena, Murcia, Spain (JT-S); Department of Oncology, Clinique Sainte Catherine, Groupe Francophone on Thrombosis and Cancer, Avignon, France (PD); Department of Vascular Medicine, Hôpital de Rangueil, Toulouse, France (AB-R); Department of Internal Medicine, Hospital Ntra, Sra. de Sonsoles, Avila, Spain (EMR); Department of Internal Medicine, Hospital General Virgen de la Luz, Cuenca, Spain (JAN); Consorcio Hospitalario Provincial de Castellón, Castellón, Spain (MLP); Department of Internal Medicine, Tel Aviv Soursky Medical Center, Tel Aviv, Israel (DZ); Department of Angiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (LM); Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Internal Medicine and Vascular Disease Unit and Groupe Francophone on Thrombosis and Cancer, Paris, France (AH); and Servicio de Medicina Interna, Hospital Universitari Germans Trias i Pujol, Badalona, Universidad Católica de Murcia, Spain (MM).
Correspondence: Dominique Farge, Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, UH 04 Internal Medicine Unit: Autoimmune Diseases and Vascular Diseases and Groupe Francophone on Thrombosis and Cancer (www.thrombose-cancer.com), Paris 7 Diderot University, Sorbonne Paris Cité; 1 avenue Claude-Vellefaux, 75010 Paris, France (e-mail: email@example.com).
Abbreviations: CFR = case fatality rate, CI = confidence interval, CrCl = creatinine clearance, DVT = deep-vein thrombosis, IQR = interquartile range, IU = international units, LMWH = low-molecular-weight heparin, PE = pulmonary embolism, RIETE = Registro Informatizado de Enfermedad TromboEmbólica, SD = standard deviation, UFH = unfractionated heparin, VCF = vena cava filter, VKA = vitamin K antagonists, VTE = venous thromboembolism.
A full list of RIETE investigators is given in the Appendix.
Sanofi Spain supported the Registry with an unrestricted educational grant, and Bayer Pharma AG supported the part of RIETE Registry outside Spain, which accounts for 16.7% of the total patients included in the RIETE Registry.
The authors have no conflicts of interest to disclose.
This is an open access article distributed under the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
Received March 17, 2015
Received in revised form May 15, 2015
Accepted July 3, 2015