Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: findings from the RIETE registry

J A Nieto, R Solano, M D Ruiz-Ribó, N Ruiz-Gimenez, P Prandoni, C Kearon, M Monreal, Riete Investigators, J I Arcelus, R Barba, A Blanco, M Barrón, T Bueso, I Casado, E Cisneros, R del Campo, F del Molino, J del Toro, C Delgado, M Durán, C Falgá, C Fernández-Capitán, F Gabriel, P Gallego, F García-Bragado, S Gomez-Zorilla, S Guijarro, M Guil, M Gutiérrez J, M R Gutiérrez Tous, L Hernández, D Hernández-Huerta, P Jiménez, S Jordán, R Lecumberri, J L Lobo, L López, A Lorenzo, M Llado, A Maestre, P J Marchena, J J Martín-Villasclaras, M Monreal, M D Nauffal, J A Nieto, M J Núñez, J L Ogea, M Oribe, J M Pedrajas, R Rabuñal, A Riera-Mestre, P Román, V Rosa, A Ruíz-Gamietea, N Ruíz-Giménez, J C Sahuquillo, J F Sánchez Muñoz-Torrero, R Sánchez, S Soler, C Soler, G Tiberio, R Tirado, J A Todolí, C Tolosa, J Trujillo, M Valdés, V Valdés, R Valle, M Vahi, J Vela, J Villalta, H Boccalon, D Farge-Bancel, P Le Corvoisier, K Rivron-Guillot, B Brenner, G Barillari, A Barillari, M Ciammaichella, F Dalla Valle, P Di Micco, R Duce, A Ferrari, S Pasca, R Poggio, P Prandoni, R Quintavalla, L Rota, A Schenone, E Tiraferri, A Visonà, J A Nieto, R Solano, M D Ruiz-Ribó, N Ruiz-Gimenez, P Prandoni, C Kearon, M Monreal, Riete Investigators, J I Arcelus, R Barba, A Blanco, M Barrón, T Bueso, I Casado, E Cisneros, R del Campo, F del Molino, J del Toro, C Delgado, M Durán, C Falgá, C Fernández-Capitán, F Gabriel, P Gallego, F García-Bragado, S Gomez-Zorilla, S Guijarro, M Guil, M Gutiérrez J, M R Gutiérrez Tous, L Hernández, D Hernández-Huerta, P Jiménez, S Jordán, R Lecumberri, J L Lobo, L López, A Lorenzo, M Llado, A Maestre, P J Marchena, J J Martín-Villasclaras, M Monreal, M D Nauffal, J A Nieto, M J Núñez, J L Ogea, M Oribe, J M Pedrajas, R Rabuñal, A Riera-Mestre, P Román, V Rosa, A Ruíz-Gamietea, N Ruíz-Giménez, J C Sahuquillo, J F Sánchez Muñoz-Torrero, R Sánchez, S Soler, C Soler, G Tiberio, R Tirado, J A Todolí, C Tolosa, J Trujillo, M Valdés, V Valdés, R Valle, M Vahi, J Vela, J Villalta, H Boccalon, D Farge-Bancel, P Le Corvoisier, K Rivron-Guillot, B Brenner, G Barillari, A Barillari, M Ciammaichella, F Dalla Valle, P Di Micco, R Duce, A Ferrari, S Pasca, R Poggio, P Prandoni, R Quintavalla, L Rota, A Schenone, E Tiraferri, A Visonà

Abstract

Background: Fatal bleeding is a serious consequence of anticoagulant therapy, but factors associated with fatal bleeding during the first 3 months of treatment of venous thromboembolism (VTE) are uncertain.

Methods: Using data from RIETE, an ongoing registry of consecutive patients with acute VTE, we assessed risk factors for fatal bleeding among all patients. We then used this information to derive a clinical model that would stratify a patient's risk of fatal bleeding during the first 3 months of treatment.

Results: Of 24 395 patients, 546 (2.24%) had a major bleed and 135 (0.55%) had a fatal bleed. The gastrointestinal tract was the most common site (40% of fatal bleeds), followed by intracranial bleeding (25%). Fatal bleeding was independently associated with the following factors at the time of VTE diagnosis: age >75 years (OR, 2.16), metastatic cancer (OR, 3.80), immobility > or = 4 days (OR, 1.99), a major bleed within the past 30 days (OR, 2.64), an abnormal prothrombin time (OR, 2.09), a platelet count < 100 x 10(9) L(-1) (OR, 2.23), creatinine clearance < 30 mL min(-1) (OR, 2.27), anemia (OR, 1.54), and distal deep vein thrombosis (OR, 0.39). INR at the time of bleeding is not known. A clinical prediction rule for risk of fatal bleeding that included nine baseline factors was derived. Fatal bleeding occurred in 0.16% (95% CI, 0.11-0.23) of the low-risk, 1.06% (95% CI, 0.85-1.30) of the moderate-risk, and 4.24% (95% CI, 2.76-6.27) of the high-risk category.

Conclusions: Patient characteristics and laboratory variables can identify patients at high risk for fatal bleeding during treatment of VTE.

References

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Source: PubMed

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