The Clinical Course of Venous Thromboembolism May Differ According to Cancer Site

Mahé, Isabelle; Chidiac, Jean; Peris, Marisa; Ductor, Cristina Pérez; Aibar, M.A.; Arcelus, J.I.; Ballaz, Aitor; Barba, Raquel; Barrón, M.; Barrón‐Andrés, B.; Bascuñana, J.; Blanco-Molina, Ángeles; Bueso, Tulio; Casado, I.; Culla, Alex; Miguel, Javier de; Toro, J. del; Díaz-Peromingo, J.A.; Falgá, C.; Fernández‐Capitán, Carmen; Font, Carme; Font, Llorenç; Gallego, P.; García‐Bragado, F.; García-Brotons, P.; Gómez, Vicente; González, J.; Grau, E; Grimón, A.; Guirado, L.; Gutiérrez, J.; Hernández, Giselle Riquelme; Hernández‐Blasco, Luis; Isern, Virginia; Jara‐Palomares, Luis; Jaras, M.J.; Jiménez, David; Lacruz, Beatriz; Lecumberri, Ramón; Lobo, José Luís; López-Jiménez, Luciano; López‐Reyes, Raquel; López-Sáez, J.B.; Lorente, Manuel; Lorenzo, Alicia; Madridano, Olga; Marchena, PJ; Martín‐Antorán, J.M.; Martín-Martos, F.; Monréal, Manuel; Morales, MV; Nauffal, Dolores; Nieto, J.A.; Nieto, Santiago; Núñez, Marta; Otalora, S.; Otero, Remedios; Pagán, B.; Pedrajas, José María; Pérez, C.; Pérez, Gustavo; Peris, M.L.; Porras, José Antonio; Ramírez, Leidy Natalia Idarraga; Reig, Òscar; Riéra, Antoni; Rivas, Agustina; Rodríguez‐Dávila, M.A.; Rosa, Vladimir; Ruiz-Artacho, Pedro; Ruíz-Giménez, Nuria; Ruíz-Martinez, Carlos; Sampériz, A.; Sala, Carlos; Sanz, O.; Soler, Silvia; Sopeña, B.; Suárez, Ignacio Donate; Suriñach, JM; Tiberio, G; Tolosa, Carles; Trujillo‐Santos, Javier; Uresandi, Fernando; Valle, Reina; Vela, J.; Villalta, J; Malfante, Pablo; Verhamme, Peter; Wells, Philip S.; Hirmerová, Jana; Malý, Radován; Tomko, T.; Salgado, E.; Bertoletti, Laurent; Bura-Rivière, A.; Farge‐Bancel, Dominique; Hij, A.; Mahé, I.; Merah, Adel; Papadakis, Manolis; Braester, Andrei; Brenner, Benjamin; Tzoran, Inna; Apollonio, A.; Barillari, Giovanni; Candeloro, Giampiero; Ciammaichella, Maurizio; Micco, P. Di; Ferrazzi, Paola; Grandone, E.; Lessiani, Gianfranco; Lodigiani, Corrado; Mastroiacovo, Daniela; Pace, F.; Pinelli, Massimiliano; Prandoni, Paolo; Rota, L.; Tiraferri, Eros; Tufano, Antonella; Visonà, Adriana; Belovs, A.; Skride, Andris; Cardoso-Moreira, Margarida; Ribeiro, José Luís Pais; Sousa, Marta; Bosevski, Marijan; Zdraveska, Marija; Alatri, Adriano; Bounameaux, Henri; Calanca, Luca; Mazzolai, Lucia; Serrano, Juan Carlos; Décousus, Hervé; Reis, Abílio

doi:10.1016/j.amjmed.2016.10.017

Cited by 83 publications

(57 citation statements)

References 28 publications

(34 reference statements)

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“…The clinical course of VTE and response to anticoagulant therapy in terms of balance between fatal VTE and fatal bleeding may differ according to cancer site, which is an interesting area for further research. 35 Finally, our metaanalysis is based on data from selected populations from clinical trials, 36 but causes of death are consistent with those reported in unselected populations in standard practice. 30…”

Section: Discussionsupporting

confidence: 52%

Causes of Death in Patients with Venous Thromboembolism Anticoagulated with Direct Oral Anticoagulants: A Systematic Review and Meta-Analysis

Gómez-Outes

Terleira-Fernández

Suárez-Gea

et al. 2018

Semin Thromb Hemost

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Death is more frequent than nonfatal recurrent venous thromboembolism (VTE) and major bleeding after acute VTE. The analysis of the causes of death is fundamental to explore new strategies to reduce mortality rates in these patients. The authors performed a meta-analysis to analyze mortality and independently adjudicated causes of death in anticoagulated patients due to VTE, and to evaluate potential differences between different anticoagulant schemes. They searched MEDLINE and CENTRAL, from January 1, 2000, to January 31, 2017, and performed additional searches in Web sites of regulatory agencies, clinical trial registers, and conference proceedings. Two investigators independently selected studies and extracted the data. Study quality was assessed with the Cochrane Collaboration's tool for assessing the risk of bias in randomized studies. Seven prospective randomized trials in 29,844 patients (22,025 patient-year follow-up) were included, comparing dabigatran, rivaroxaban, apixaban, and edoxaban with the standard anticoagulant treatment of VTE. A total of 718 patients died during the follow-up (3.4% per year; 95% confidence interval [CI]: 2.3-4.8). The most frequent causes of death were cancer (42%), followed by VTE (20%), infections (13%), hemorrhage (6%), heart disease (4%), and stroke (2%). There were no differences in the overall survival and causes of death according to the anticoagulant type. Concomitant active cancer during the study was significantly associated with death (odds ratio: 15.2; 95% CI: 9.2-25.1). Cancer is the leading cause of death in contemporary VTE trials. Interventions beyond anticoagulation, particularly in patients with active cancer, are needed.

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Section: Discussionsupporting

confidence: 52%

Causes of Death in Patients with Venous Thromboembolism Anticoagulated with Direct Oral Anticoagulants: A Systematic Review and Meta-Analysis

Gómez-Outes

Terleira-Fernández

Suárez-Gea

et al. 2018

Semin Thromb Hemost

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“…Real‐world observational data have suggested higher rates of VTE as well as major bleeding in unselected patients including those with more comorbid conditions less likely to enter clinical trials . Furthermore, cancer site may widely influence both the risk of VTE and bleeding on anticoagulant . These important questions cannot be addressed by meta‐analyses of RCTs and highlight the importance of longitudinal observational thromboprophylaxis studies that included unselected patients with various malignancy types.…”

Section: Discussionmentioning

confidence: 99%

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Kuderer

García

et al. 2019

Journal of Thrombosis and Haemostasis

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Background It is unclear if direct oral anticoagulant (DOAC) is efficacious and safe for prophylaxis of venous thromboembolism (VTE) in ambulatory patients with cancer. Methods We performed a systematic review using EMBASE, MEDLINE, and CENTRAL. Inclusion criteria included adult ambulatory patients with cancer, prophylactic use of DOAC, and randomized controlled trials. Exclusion criteria included pediatric patients, inpatient or postoperative setting, therapeutic indication of DOAC, or non‐phase III randomized controlled trial. Two authors screened/reviewed articles and abstracted the data. Meta‐analysis was performed using random‐effects model. Efficacy outcome included overall and symptomatic VTE incidence during the first 6 months. Safety outcomes included major bleeding and clinically relevant non‐major bleeding (CRNMB) incidence during the on‐treatment period. Subgroup analysis was performed for intermediate‐ and high‐risk Khorana score. Results A total of 202 records were identified and 28 full‐text articles were assessed. Two studies with 1415 participants were included for meta‐analysis. For DOAC vs placebo, the relative risks for overall and symptomatic VTE incidence by 6 months were 0.56 (0.35‐0.89) and 0.58 (0.29‐1.13), respectively. The relative risks for major bleeding and CRNMB while on‐treatment were 1.96 (0.80‐4.82) and 1.28 (0.74‐2.20), respectively. Patients with high‐risk Khorana score (3+) derived the largest absolute risk reduction of VTE. Conclusions Low‐dose DOAC reduces the rate of overall VTE in higher risk cancer patients starting systemic chemotherapy. It may reduce the rate of symptomatic VTE but increase the likelihood of bleeding.

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“…Of note, all these studies have examined the rates of recurrent VTE and bleeding in pooled patient populations with different types of cancer. Since significant differences in the clinical course of VTE have been observed according to the site of cancer [31,32], this approach may have failed to capture these differences.…”

Section: Risk Of Recurrent Vte and Bleeding In Patients With An "Actimentioning

confidence: 99%

Are Patients with Active Cancer and Those with History of Cancer Carrying the Same Risks of Recurrent VTE and Bleeding While on Anticoagulants?

Frère

Crichi

Lejeune

et al. 2020

Cancers

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Direct oral anticoagulants (DOAC) are now recommended for the treatment of cancer-associated thrombosis (CAT) based on the results of dedicated trials demonstrating that DOAC are non-inferior to low molecular weight heparins in preventing recurrent venous thromboembolism (VTE) in this population. The definition of "cancer patient" differs substantially among studies. Whether patients with active cancer and those with a history of cancer (HOC) carry the same risks of recurrent VTE and bleeding remains unclear. Few studies reported data on the efficacy and safety of anticoagulants according to active cancer or HOC categories. While in subgroup analyses of EINSTEIN and HOKUSAI the rates of recurrent VTE and bleeding did not differ between these categories, results from a subgroup analysis of AMPLIFY, from HOKUSAI-Cancer, and from the COMMAND cohort suggest that HOC patients might have a lower bleeding risk than active cancer patients. Whether the inclusion of HOC patients in CAT studies might introduce some bias by decreasing the rates of both recurrent VTE and bleeding remains an unanswered issue since no dedicated prospective study addressed this question. A strict definition of active cancer should be used in further trials.

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The Clinical Course of Venous Thromboembolism May Differ According to Cancer Site

Abstract: Significant differences in the clinical profile of venous thromboembolic-related outcomes were observed according to the site of cancer. These findings suggest the development of cancer-specific anticoagulant strategies as an area for further research.

Cited by 83 publications

References 28 publications

Causes of Death in Patients with Venous Thromboembolism Anticoagulated with Direct Oral Anticoagulants: A Systematic Review and Meta-Analysis

Causes of Death in Patients with Venous Thromboembolism Anticoagulated with Direct Oral Anticoagulants: A Systematic Review and Meta-Analysis

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Are Patients with Active Cancer and Those with History of Cancer Carrying the Same Risks of Recurrent VTE and Bleeding While on Anticoagulants?

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