Philippe Girard1,2, Silvy Laporte2,3,4, Céline Chapelle4, Nicolas Falvo2,5, Lionel Falchero6, Nicolas Cloarec7, Isabelle Monnet8, Alexis Burnod9, Pascale Tomasini10, Carine Boulon11, Philippe Debourdeau12, Bettina Boutruche13, Florian Scotté14, Anne Lamblin15, Guy Meyer2,16,17. 1. Institut Mutualiste Montsouris, Paris, France. 2. F-CRIN INNOVTE network, Saint-Etienne, France. 3. SAINBIOSE INSERM U1059, Université Jean Monnet, Saint-Etienne, France. 4. Unité de Recherche Clinique Innovation et Pharmacologie, CHU Saint-Etienne, Saint-Etienne, France. 5. CHU de Dijon, Hôpital du Bocage, Dijon, France. 6. Hôpital Nord-Ouest Villefranche, Villefranche sur Saône, France. 7. CH Henri Duffaut, Avignon, France. 8. CH Intercommunal de Créteil, Créteil, France. 9. Institut Curie, Paris, France. 10. CHU de Marseille, Hôpital Nord, Marseille, France. 11. CHU Bordeaux - Hôpital saint André, Bordeaux, France. 12. Institut Sainte Catherine, Avignon, France. 13. CLCC Eugène Marquis, Rennes, France. 14. Gustave Roussy, Villejuif, France. 15. LEO Pharma, Montigny le Bretonneux, France. 16. Hôpital Européen Georges Pompidou, APHP, Paris, France. 17. INSERM CIC1418, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Abstract
INTRODUCTION: Recurrent venous thromboembolism (VTE) despite curative anticoagulation is frequent in patients with cancer. Identifying patients with a high risk of recurrence could have therapeutic implications. A prospective study was designed to validate the Ottawa risk score of recurrent VTE in cancer patients. METHODS: In a prospective multicenter observational cohort, adult cancer patients with a recent diagnosis of symptomatic or incidental lower limb deep vein thrombosis or pulmonary embolism (PE) were treated with tinzaparin for 6 months. The primary endpoint was the recurrence of symptomatic or asymptomatic VTE within the first 6 months of treatment. All clinical events were centrally reviewed and adjudicated. Time-to-event outcomes were estimated by the Kalbfleisch and Prentice method to take into account the competing risk of death. A C-statistic value of > 0.70 was needed to validate the Ottawa score. RESULTS: A total of 409 patients were included and analyzed on an intention-to-treat basis. Median age was 68 years, 60.4% of patients had PE, and VTE was symptomatic in 271 patients (66.3%). The main primary sites were lung (31.3%), lower digestive tract (14.4%), and breast (13.9%) cancers. The Ottawa score was high (≥ 1) in 58% of patients. The 6-month cumulative incidence of recurrent VTE was 7.3% (95% confidence interval [CI]: 4.9-11.1) overall, and 5.0% (95% CI: 2.3-10.8) versus 9.1% (95%CI: 6.1-13.6) in the Ottawa low versus high risk groups, respectively. The C-statistic value was 0.60 (95% CI: 0.55-0.65). CONCLUSION: In this prospective cohort of patients with cancer receiving tinzaparin for VTE, the Ottawa score failed to accurately predict recurrent VTE. Thieme. All rights reserved.
INTRODUCTION: Recurrent venous thromboembolism (VTE) despite curative anticoagulation is frequent in patients with cancer. Identifying patients with a high risk of recurrence could have therapeutic implications. A prospective study was designed to validate the Ottawa risk score of recurrent VTE in cancer patients. METHODS: In a prospective multicenter observational cohort, adult cancer patients with a recent diagnosis of symptomatic or incidental lower limb deep vein thrombosis or pulmonary embolism (PE) were treated with tinzaparin for 6 months. The primary endpoint was the recurrence of symptomatic or asymptomatic VTE within the first 6 months of treatment. All clinical events were centrally reviewed and adjudicated. Time-to-event outcomes were estimated by the Kalbfleisch and Prentice method to take into account the competing risk of death. A C-statistic value of > 0.70 was needed to validate the Ottawa score. RESULTS: A total of 409 patients were included and analyzed on an intention-to-treat basis. Median age was 68 years, 60.4% of patients had PE, and VTE was symptomatic in 271 patients (66.3%). The main primary sites were lung (31.3%), lower digestive tract (14.4%), and breast (13.9%) cancers. The Ottawa score was high (≥ 1) in 58% of patients. The 6-month cumulative incidence of recurrent VTE was 7.3% (95% confidence interval [CI]: 4.9-11.1) overall, and 5.0% (95% CI: 2.3-10.8) versus 9.1% (95%CI: 6.1-13.6) in the Ottawa low versus high risk groups, respectively. The C-statistic value was 0.60 (95% CI: 0.55-0.65). CONCLUSION: In this prospective cohort of patients with cancer receiving tinzaparin for VTE, the Ottawa score failed to accurately predict recurrent VTE. Thieme. All rights reserved.