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1. Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry

Author

Universitat Rovira i Virgili, Bikdeli B; Jiménez D; Demelo-Rodriguez P; Galeano-Valle F; Porras JA; Barba R; Ay C; Malý R; Braester A; Imbalzano E; Rosa V; Lecumberri R; Siniscalchi C; Fidalgo Á; Ortiz S; Monreal M, Universitat Rovira i Virgili, and Bikdeli B; Jiménez D; Demelo-Rodriguez P; Galeano-Valle F; Porras JA; Barba R; Ay C; Malý R; Braester A; Imbalzano E; Rosa V; Lecumberri R; Siniscalchi C; Fidalgo Á; Ortiz S; Monreal M

Abstract

Background: Venous thromboembolism (VTE)—including deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis (CVST)—may occur early after vaccination against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We sought to describe the site, clinical characteristics, and outcomes of VTE after vaccination against SARS-CoV-2. Methods: In a prospective study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) platform, patients with VTE 4–30 days after vaccination against SARS-CoV-2 (1 February 2021 through 30 April 2021) were included. VTE patients recruited from the same centers into RIETE in the same months in 2018–2019 were selected as the reference group. All-cause mortality and major bleeding were the main study outcomes. Results: As of 30 April 2020, 102 patients with post-vaccination VTEs had been identified (28 after adenovirus-based vaccination [ChAdOx1 nCov-19; AstraZeneca] and 74 after mRNA-based vaccination [mRNA-1273; Moderna, and BNT162b2; Pfizer]). Compared with 911 historical controls, patients with VTE after adenovirus-based vaccination more frequently had CVST (10.7% vs. 0.4%, p < 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, p < 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, p < 0.001), and had higher 14-day mortality (14.3% vs. 0.7%; odds ratio [OR]: 25.1; 95% confidence interval [CI]: 6.7–94.9) and major bleeding rates (10.3% vs. 1.0%, OR: 12.03, 95% CI: 3.07–47.13). The site of thrombosis, accompanying thrombocytopenia, and 14-day mortality rates were not significantly different for patients with VTE after mRNA-based vaccination, compared with historical controls. Conclusions: Compared with historical controls, VTE after adenovirus-based vaccination against SARS-CoV-2 is a

Published
2022

2. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Author

Medicina i Cirurgia, Universitat Rovira i Virgili, Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Medicina i Cirurgia, Universitat Rovira i Virgili, and Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R.

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 TromboEmbólica 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 anticoagulati

Published
2017

3. Outcome of Patients with Venous Thromboembolism and Factor V Leiden or Prothrombin 20210 Carrier Mutations During the Course of Anticoagulation

Author

Medicina i Cirurgia, Universitat Rovira i Virgili, Tzoran I., Papadakis M., Brenner B., Fidalgo Á., Rivas A., Wells P.S., Gavín O., Adarraga M.D., Moustafa F., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Aibar M.A., Alfonso M., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañada G., Cañas I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Falgá C., Fernández-Capitán C., Fidalgo M.A., Font C., Font L., Tzoran I., Papadakis M., Brenner B., Fidalgo Á., Rivas A., Wells P.S., Gavín O., Adarraga M.D., Moustafa F., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Aibar M.A., Alfonso M., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañada G., Cañas I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Falgá C., Fernández-Capitán C., Fidalgo M.A., Font C., Font L., Tzoran I., Papadakis M., Brenner B., Fidalgo Á., Rivas A., Wells P.S., Gavín O., Adarraga M.D., Moustafa F., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Medicina i Cirurgia, Universitat Rovira i Virgili, and Tzoran I., Papadakis M., Brenner B., Fidalgo Á., Rivas A., Wells P.S., Gavín O., Adarraga M.D., Moustafa F., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Aibar M.A., Alfonso M., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañada G., Cañas I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Falgá C., Fernández-Capitán C., Fidalgo M.A., Font C., Font L., Tzoran I., Papadakis M., Brenner B., Fidalgo Á., Rivas A., Wells P.S., Gavín O., Adarraga M.D., Moustafa F., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Aibar M.A., Alfonso M., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañada G., Cañas I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Falgá C., Fernández-Capitán C., Fidalgo M.A., Font C., Font L., Tzoran I., Papadakis M., Brenner B., Fidalgo Á., Rivas A., Wells P.S., Gavín O., Adarraga M.D., Moustafa F., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P.

Abstract

Background Individuals with factor V Leiden or prothrombin G20210A mutations are at a higher risk to develop venous thromboembolism. However, the influence of these polymorphisms on patient outcome during anticoagulant therapy has not been consistently explored. Methods We used the Registro Informatizado de Enfermedad TromboEmbólica database to compare rates of venous thromboembolism recurrence and bleeding events occurring during the anticoagulation course in factor V Leiden carriers, prothrombin mutation carriers, and noncarriers. Results Between March 2001 and December 2015, 10,139 patients underwent thrombophilia testing. Of these, 1384 were factor V Leiden carriers, 1115 were prothrombin mutation carriers, and 7640 were noncarriers. During the anticoagulation course, 160 patients developed recurrent deep vein thrombosis and 94 patients developed pulmonary embolism (16 died); 154 patients had major bleeding (10 died), and 291 patients had nonmajor bleeding. On multivariable analysis, factor V Leiden carriers had a similar rate of venous thromboembolism recurrence (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.82-1.64), half the rate of major bleeding (adjusted HR, 0.50; 95% CI, 0.25-0.99) and a nonsignificantly lower rate of nonmajor bleeding (adjusted HR, 0.66; 95% CI, 0.43-1.01) than noncarriers. Prothrombin mutation carriers and noncarriers had a comparable rate of venous thromboembolism recurrence (adjusted HR, 1.00; 95% CI, 0.68-1.48), major bleeding (adjusted HR, 0.75; 95% CI, 0.42-1.34), and nonmajor bleeding events (adjusted HR, 1.10; 95% CI, 0.77-1.57). Conclusions During the anticoagulation course, factor V Leiden carriers had a similar risk for venous thromboembolism recurrence and half the risk for major bleeding compared with noncarr

Published
2017

4. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Author

Universitat Rovira i Virgili, Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Universitat Rovira i Virgili, and Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Verhamme P., Adarraga M.D., Aibar M.A., Alfonso M., Arcelus J.I., Azcarate-Agüero P.M., Ballaz A., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Cañada G., Cañas I., Casado I., Chic N., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Barrios D., Chavant J., Jiménez D., Bertoletti L., Rosa-Salazar V., Muriel A., Viallon A., Fernández-Capitán C., Yusen R.D., Monreal M., Decousus H., Prandoni P., Brenner B., Barba R., Di Micco P., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R.

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 TromboEmbólica 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 anticoagulati

Published
2017

5. Development of a Risk Prediction Score for Occult Cancer in Patients With VTE

Author

Universitat Rovira i Virgili, Jara-Palomares L., Otero R., Jimenez D., Carrier M., Tzoran I., Brenner B., Margeli M., Praena-Fernandez J.M., Grandone E., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Papadakis M., Aibar M.A., Alfonso M., Asensio-Cruz M.I., Auguet T., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañas I., Ceausu A., Chic N., Culla A., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Duffort M., Jara-Palomares L., Otero R., Jimenez D., Carrier M., Tzoran I., Brenner B., Margeli M., Praena-Fernandez J.M., Grandone E., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Papadakis M., Aibar M.A., Alfonso M., Asensio-Cruz M.I., Auguet T., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañas I., Ceausu A., Chic N., Culla A., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Duffort M., Jara-Palomares L., Otero R., Jimenez D., Carrier M., Tzoran I., Brenner B., Margeli M., Praena-Fernandez J.M., Grandone E., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Universitat Rovira i Virgili, and Jara-Palomares L., Otero R., Jimenez D., Carrier M., Tzoran I., Brenner B., Margeli M., Praena-Fernandez J.M., Grandone E., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Papadakis M., Aibar M.A., Alfonso M., Asensio-Cruz M.I., Auguet T., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañas I., Ceausu A., Chic N., Culla A., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Duffort M., Jara-Palomares L., Otero R., Jimenez D., Carrier M., Tzoran I., Brenner B., Margeli M., Praena-Fernandez J.M., Grandone E., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R., Wells P., Papadakis M., Aibar M.A., Alfonso M., Asensio-Cruz M.I., Auguet T., Arcelus J.I., Barrón M., Barrón-Andrés B., Bascuñana J., Blanco-Molina A., Bueso T., Cañas I., Ceausu A., Chic N., Culla A., del Pozo R., del Toro J., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Duffort M., Jara-Palomares L., Otero R., Jimenez D., Carrier M., Tzoran I., Brenner B., Margeli M., Praena-Fernandez J.M., Grandone E., Monreal M., Decousus H., Prandoni P., Barba R., Di Micco P., Bertoletti L., Reis A., Bosevski M., Bounameaux H., Malý R.

Abstract

The benefits of a diagnostic workup for occult cancer in patients with VTE are controversial. Our aim was to provide and validate a risk score for occult cancer in patients with VTE.We designed a nested case-control study in a cohort of patients with VTE included in the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry from 2001 to 2014. Cases included cancer detected beyond the first 30 days and up to 24 months after VTE. Control subjects were defined as patients with VTE with no cancer in the same period.Of 5,863 eligible patients, 444 (7.6%; 95% CI, 6.8%-8.2%) were diagnosed with occult cancer. On multivariable analysis, variables selected were male sex, age > 70 years, chronic lung disease, anemia, elevated platelet count, prior VTE, and recent surgery. We built a risk score assigning points to each variable. Internal validity was confirmed using bootstrap analysis. The proportion of patients with cancer who scored ? 2 points was 5.8% (241 of 4,150) and that proportion in those who scored ? 3 points was 12% (203 of 1,713). We also identified scores divided by sex and age subgroups.This is the first risk score that has identified patients with VTE who are at increased risk for occult cancer. Our score needs to be externally validated.Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Published
2017

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