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1. A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Author

Gabrielle Sarlon-Bartoli, Juan Criado, Saskia Middeldorp, José Antonio Nieto, María del Carmen Díaz-Pedroche, Farès Moustafa, Nuria Ruiz-Giménez, Benjamin Brenner, Manuel Monreal, Pierpaolo DI Micco, Paolo Prandoni, Dominique Farge-Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Joseph A. Caprini, Hanh My Bui, M.D. Adarraga, P. Agudo, C. Amado, J.I. Arcelus, A. Ballaz, J. Bascuñana, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, F. Beddar Chaib, E. Botella, I. Cañas, R. Carrero-Arribas, I. Casado, P. Cerdá, L. Chasco, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, A.M. Díaz-Brasero, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, I.M. Domínguez, A. Dubois-Silva, J.C. Escribano, F. Espósito, A.I. Farfán-Sedano, C. Falgá, C. Fernández-Capitán, B. Fernández-Jiménez, J. Fernández-Muixi, J.L. Fernández-Reyes, C. Font, I. Francisco, F. Galeano-Valle, M.A. García, F. García-Bragado, M. García de Herreros, O. Gavín-Blanco, A. Gil-Díaz, C. Gómez-Cuervo, A.M. Gómez-Mosquera, M. Gonzalez-Moreno, E. Grau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, I. Jou, M.D. Joya, B. Lacruz, S. Lainez-Justo, Latorre A, Lima J, Lobo Jl, M. López-De la Fuente, L. López-Jiménez, M. López-Meseguer, P. López-Miguel, J.J. López-Núñez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, O. Madridano, A. Maestre, P.J. Marchena, J.M. Martín-Guerra, F. Martín-Martos, M. Mellado, E. Mena, J. Moisés, M.I. Mercado, M. Monreal, A. Muñoz-Blanco, G. Muñoz-Gamito, M.V. Morales, J.A. Nieto, E. Noguera-Gras, M.J. Núñez-Fernández, M. Olid-Velilla, J. Osorio, S. Otalora, R. Otero, D. Paredes-Ruiz, P. Parra, V. Parra, J.M. Pedrajas, M. Pérez-López, M.L. Peris, M.L. Pesce, J.A. Porras, J. Poyo-Molina, R. Puchades, A. Riera-Mestre, F. Rivera-Civico, A. Rivera-Gallego, M. Roca, V. Rosa, A. Rodríguez-Cobo, C. Rodríguez-Matute, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, G. Salgueiro, T. Sancho, V. Sendín, P. Sigüenza, S. Soler, B. Suárez-Rodríguez, J.M. Suriñach, G. Tiberio, M.I. Torres, A. Torres-Sánchez, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, R. Valle, J.F. Varona, L. Vela, J.R. Vela, A. Villalobos, P. Villares, C. Ay, S. Nopp, I. Pabinger, M.M. Engelen, C. Martens, P. Verhamme, H.H.B. Yoo, J.D. Arguello, A.C. Montenegro, J. Roa, J. Hirmerova, R. Malý, S. Accassat, L. Bertoletti, A. Bura-Riviere, J. Catella, R. Chopard, F. Couturaud, O. Espitia, S. El Harake, R. Le Mao, I. Mahé, F. Moustafa, L. Plaisance, G. Sarlon-Bartoli, P. Suchon, E. Versini, S. Schellong, A. Braester, B. Brenner, G. Kenet, I. Tzoran, P. Sadeghipour, M. Basaglia, F. Bilora, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, A. De Angelis, F. Dentali, P. Di Micco, E. Imbalzano, S. Merla, R. Pesavento, P. Prandoni, C. Siniscalchi, A. Tufano, A. Visonà, N. Vo Hong, B. Zalunardo, D. Kigitovica, E. Rusa, A. Skride, S. Fonseca, M. Manuel, J. Meireles, M. Bosevski, A. Eftimova, M. Zdraveska, H. Bounameaux, L. Mazzolai, A. Aujayeb, J.A. Caprini, I. Weinberg, and H.M. Bui

Subjects
Anticoagulants, Venous thromboembolism, Uterine bleeding, Prognostic score, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged 70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

Published
2023
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2. Symptomatic subsegmental versus more central pulmonary embolism: Clinical outcomes during anticoagulation

Author

Carmen Fernández‐Capitán, Ana Rodriguez Cobo, David Jiménez, Olga Madridano, Maurizio Ciammaichella, Esther Usandizaga, Remedios Otero, Pierpaolo Di Micco, Farès Moustafa, Manuel Monreal, M.D. Adarraga, M.A. Aibar, M. Alfonsa, J.I. Arcelus, P. Azcarate‐Agüero, A. Ballaz, P. Baños, R. Barba, M. Barrón, B. Barrón‐Andrés, J. Bascuñana, A. Blanco‐Molina, A.M. Camón, L. Chasco, A.J. Cruz, R. del Pozo, J. de Miguel, J. del Toro, M.C. Díaz‐Pedroche, J.A. Díaz‐Peromingo, J.C. Escribano, C. Falgá, C. Fernández‐Aracil, M.A. Fidalgo, C. Font, L. Font, M.A. García, F. García‐Bragado, M. García‐Morillo, A. García‐Raso, A.I. García‐Sánchez, O. Gavín, I. Gaya, C. Gómez, V. Gómez, J. González, E. Grau, R. Guijarro, J. Gutiérrez, G. Hernández‐Comes, L. Hernández‐Blasco, E. Hernando, L. Jara‐Palomares, M.J. Jaras, D. Jiménez, M.D. Joya, J. Lima, P. Llamas, J.L. Lobo, R. López‐Reyes, J.B. López‐Sáez, M.A. Lorente, A. Lorenzo, M. Lumbierres, A. Maestre, P.J. Marchena, F. Martín‐Martos, M. Martín‐Romero, M.V. Morales, J.A. Nieto, S. Nieto, A. Núñez, M.J. Núñez, M. Odriozola, M.C. Olivares, S. Otalora, J.M. Pedrajas, G. Pellejero, C. Pérez‐Ductor, M.L. Peris, I. Pons, J.A. Porras, L. Ramírez, O. Reig, A. Riera‐Mestre, D. Riesco, A. Rivas, M.A. Rodríguez‐Dávila, V. Rosa, P. Ruiz‐Artacho, J.C. Sahuquillo, M.C. Sala‐Sainz, A. Sampériz, R. Sánchez‐Martínez, S. Soler, B. Sopeña, J.M. Suriñach, C. Tolosa, M.I. Torres, J. Troya, J. Trujillo‐Santos, F. Uresandi, B. Valero, R. Valle, J. Vela, L. Vela, G. Vidal, A. Villalobos, T. Vanassche, C. Vandenbriele, P. Verhamme, H.H.B. Yoo, P. Wells, J. Hirmerova, R. Malý, E. Salgado, L. Bertoletti, A. Bura‐Riviere, N. Falvo, D. Farge‐Bancel, A. Hij, I. Mahé, I. Quere, A. Braester, B. Brenner, M. Ellis, I. Tzoran, G. Antonucci, G. Barillari, F. Bilora, C. Bortoluzzi, E. Bucherini, A. Camerota, C. Cattabiani, F. Dentali, R. Duce, M. Giorgi‐Pierfranceschi, E. Grandone, E. Imbalzano, G. Lessiani, R. Maida, D. Mastroiacovo, F. Pace, R. Pesavento, M. Pesavento, R. Poggio, P. Prandoni, R. Quintavalla, A. Rocci, C. Siniscalchi, E. Tiraferri, D. Tonello, A. Visonà, B. Zalunardo, V. Gibietis, A. Skride, B. Vitola, A. Alatri, H. Bounameaux, L. Calanca, and L. Mazzolai

Subjects
Subsegmental, medicine.medical_specialty, anticoagulant, deep vein thrombosis, outcomes, pulmonary embolism, subsegmental, medicine.drug_class, Deep vein, Outcomes, Deep vein thrombosis, Internal medicine, medicine, First episode, lcsh:RC633-647.5, business.industry, Pulmonary embolism, Hazard ratio, Anticoagulant, Anticoagulants, lcsh:Diseases of the blood and blood-forming organs, Hematology, Heparin, Original Articles ‐ Thrombosis, medicine.disease, Thrombosis, Confidence interval, medicine.anatomical_structure, Cardiology, Original Article, business, medicine.drug
Abstract

The RIETE Investigators., [Background] The optimal therapy of patients with acute subsegmental pulmonary embolism (PE) is controversial., [Methods] We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to compare the rate of symptomatic PE recurrences during anticoagulation in patients with subsegmental, segmental, or more central PEs. [Results] Among 15 963 patients with a first episode of symptomatic PE, 834 (5.2%) had subsegmental PE, 3797 (24%) segmental, and 11 332 (71%) more central PE. Most patients in all subgroups received initial therapy with low‐molecular‐weight heparin, and then most switched to vitamin K antagonists. Median duration of therapy was 179, 185, and 204 days, respectively. During anticoagulation, 183 patients developed PE recurrences, 131 developed deep vein thrombosis (DVT), 543 bled, and 1718 died (fatal PE, 135). The rate of PE recurrences was twofold higher in patients with subsegmental PE than in those with segmental (hazard ratio [HR], 2.13; 95% confidence interval [CI], 1.16‐3.85) or more central PE (HR, 1.89; 95% CI, 1.12‐3.13). On multivariable analysis, patients with subsegmental PE had a higher risk for PE recurrences than those with central PE (adjusted HR, 1.75; 95% CI, 1.02‐3.03). After stratifying patients with subsegmental PE according to ultrasound imaging in the lower limbs, the rate of PE recurrences was similar in patients with DVT, in patients without DVT, and in those with no ultrasound imaging. [Conclusions] Our study reveals that the risk for PE recurrences in patients with segmental PE is not lower than in those with more central PE, thus suggesting that the risk of PE recurrences is not influenced by the anatomic location of PE.

Published
2021
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3. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Author

Deisy Barrios, Jeremy Chavant, David Jiménez, Laurent Bertoletti, Vladimir Rosa-Salazar, Alfonso Muriel, Alain Viallon, Carmen Fernández-Capitán, Roger D. Yusen, Manuel Monreal, Hervè Decousus, Paolo Prandoni, Benjamin Brenner, Raquel Barba, Pierpaolo Di Micco, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Philip Wells, Peter Verhamme, M.D. Adarraga, M.A. Aibar, M. Alfonso, J.I. Arcelus, P.M. Azcarate-Agüero, A. Ballaz, R. Barba, M. Barrón, B. Barrón-Andrés, J. Bascuñana, A. Blanco-Molina, G. Cañada, I. Cañas, I. Casado, N. Chic, R. del Pozo, J. del Toro, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, C. Falgá, C. Fernández-Aracil, C. Fernández-Capitán, M.A. Fidalgo, C. Font, L. Font, P. Gallego, M.A. García, F. García-Bragado, P. García-Brotons, O. Gavín, C. Gómez, V. Gómez, J. González, E. Grau, A. Grimón, L. Guirado, J. Gutiérrez, G. Hernández-Comes, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, J. Jiménez, M.D. Joya, P. Llamas, J.L. Lobo, P. López, L. López-Jiménez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, J.M. Luque, P.J. Marchena, C. Martínez, F. Martín-Martos, M. Monreal, J.A. Nieto, S. Nieto, A. Núñez, M.J. Núñez, S. Otalora, R. Otero, J.M. Pedrajas, G. Pérez, C. Pérez-Ductor, M.L. Peris, I. Pons, J.A. Porras, O. Reig, A. Riera-Mestre, D. Riesco, A. Rivas, M. Rodríguez, M.A. Rodríguez-Dávila, V. Rosa, J.C. Sahuquillo, M.C. Sala-Sainz, A. Sampériz, R. Sánchez-Martínez, O. Sanz, S. Soler, B. Sopeña, J.M. Suriñach, C. Tolosa, M.I. Torres, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, B. Valero, R. Valle, J. Vela, G. Vidal, C. Vilar, B. Xifre, T. Vanassche, P. Verhamme, H.H.B. Yoo, P. Wells, J. Hirmerova, R. Malý, E. Salgado, L. Bertoletti, A. Bura-Riviere, D. Farge-Bancel, A. Hij, I. Mahé, A. Merah, F. Moustafa, A. Braester, B. Brenner, I. Tzoran, G. Antonucci, G. Barillari, F. Bilora, A. Bonanome, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, P. De Ciantis, F. Dentali, P. Di Micco, R. Duce, M. Giorgi-Pierfranceschi, E. Grandone, E. Imbalzano, G. Lessiani, R. Maida, D. Mastroiacovo, F. Pace, R. Parisi, R. Pesavento, M. Pinelli, R. Poggio, P. Prandoni, R. Quintavalla, A. Rocci, E. Tiraferri, D. Tonello, A. Tufano, U. Venturelli, A. Visonà, V. Gibietis, A. Skride, B. Vitola, M. Bosevski, M. Zdraveska, H. Bounameaux, and L. Mazzolai

Subjects
Male, medicine.medical_specialty, Heart Diseases, medicine.medical_treatment, Hemorrhage, 030204 cardiovascular system & hematology, Lower risk, 03 medical and health sciences, Anticoagulation, 0302 clinical medicine, Reperfusion therapy, Recurrence, Internal medicine, Cause of Death, medicine, Humans, Thrombolytic Therapy, 030212 general & internal medicine, Propensity Score, Cause of death, Right heart thrombi, Aged, business.industry, Pulmonary embolism, Anticoagulants, Thrombosis, General Medicine, Thrombolysis, Middle Aged, medicine.disease, Confidence interval, Treatment, Treatment Outcome, Propensity score matching, Cardiology, Female, business, Pulmonary Embolism
Abstract

Background Evidence-based recommendations do not adequately address the treatment of right heart thrombi in patients who present with acute symptomatic pulmonary embolism. Methods This study included patients who had acute pulmonary embolism associated with right heart thrombi and participated in the Registro Informatizado de la Enfermedad TromboEmbolica registry. We assessed the effectiveness of anticoagulation versus reperfusion treatment for the outcomes of all-cause mortality, pulmonary embolism–related mortality, recurrent venous thromboembolism, and major bleeding rates through 30 days after initiation of pulmonary embolism treatment. We used propensity score matching to adjust for the likelihood of receiving reperfusion treatment. Results Of 325 patients with pulmonary embolism and right heart thrombi, 255 (78%; 95% confidence interval, 74-83) received anticoagulation and 70 (22%; 95% confidence interval, 17-26) also received reperfusion treatment. Propensity score–matched pairs analyses did not detect a statistically lower risk of all-cause death (6.2% vs 14%, P = .15) or pulmonary embolism–related mortality (4.7% vs 7.8%; P = .47) for reperfusion compared with anticoagulation. Of the patients who received reperfusion treatment, 6.2% had a recurrence during the study follow-up period, compared with 0% of those who received anticoagulation ( P = .049). The incidence of major bleeding events was not statistically different between the 2 treatment groups (3.1% vs 3.1%; P = 1.00). Conclusions In patients with pulmonary embolism and right heart thrombi, no significant difference was found between reperfusion therapy and anticoagulant therapy for mortality and bleeding. The risk of recurrences was significantly higher for reperfusion therapy compared with anticoagulation. Right heart thrombi may not warrant riskier interventions than standard anticoagulation.

Published
2017

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