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3. Safety of vitamin K antagonist treatment for splanchnic vein thrombosis: a multicenter cohort study

Author

Riva, N., Ageno, W., Poli, D., Testa, S., Rupoli, S., Santoro, R., Lerede, T., Piana, A., Carpenedo, M., Nicolini, A., Ferrini, P.M., Tosetto, A., Paoletti, O., Rancan, E., Federici, I., Canafoglia, L., Maggioni, A., Falanga, A., Martini, G., Mangione, C., Contino, L., Bonfanti, C., Gresele, P., Pedrini, S., Morandini, R., Marigo, L., Nante, G., Sivera, P., Pasca, S., Malcangi, G., Ettorre, C.P., Cavallero, G.B., Falco, P., Ruocco, L., Paparo, C., Bucherini, E., Suriano, L., Crisantemo, R., Ria, L., Toma, A., Insana, A., Zanatta, N., Zammataro, N., Iannone, A.M., Oriana, V., Pezzo, M.P., Isu, G., and Molinatti, M.

Published
2015
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7. International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban Evaluation in Real life setting (RIVER)

Author

Beyer-Westendorf, J., Camm, A. J., Fox, K. A. A., Le Heuzey, J. -Y., Haas, S., Turpie, A. G. G., Virdone, S., Kakkar, A. K., Pieper, K. S., Kayani, G., Gersh, B. J., Hildebrandt, P., Dominguez, H., Comuth, W., Frost, L., Moller, D. S., Christensen, H., Bruun, L. M., Milhem, A., Gauthier, J., Mielot, C., Chanseaume, S., Chopra, S., Amlaiky, A., Tricot, O., Sierra, V., Dompnier, A., Zannad, N., Pinzani, A., Quatre, A., Mansourati, J., Fauchier, L., Badenco, N., Gandjbakhch, E., Chachoua, K. F., Malquarti, V., Pierron, F., Sacher, F., Taieb, J., Davy, J. M., Marijon, E., Lellouche, N., Leenhardt, A., Salem, A., Lesto, I., Muller, J. J., Garcia, R., Neau, J. P., Berneau, J. B., Schon, N., Gulba, D., Appel, K. F., Merke, J., Dshabrailov, J., Bauknecht, C., Scheuermann, O., Schroder, T., Jung, W., Kopf, A., Brachmann, J., Leschke, M., Taggeselle, J., Seige, M., Lassig, T., Appel, S., Schmiedl, M., Muller, K., Heinz, G. U., Axthelm, C., Eberhard, K., Hugl, B., Schwarz, T., Sechtem, U., Falanga, A., Rubino, V., Calo, L., Ageno, W., Massari, F., Imberti, D., Di Gennaro, L., Gaita, F., Margonato, A., Cannava, G., Capasso, F., Diemberger, I., Pelliccia, F., Cafolla, A., Bardari, S., Mattei, L., Ruocco, L., Boriani, G., Poli, D., Testa, S., Indolfi, C., Quintavalla, R., Mos, L., Ladyjanskaia, G., Aksoy, I., Van De Wetering, M., Theunissen, L., Den Hartog, F., Nijmeijer, R., Van De Wal, R., Reinders, S., Patterson, M., Melker, E. D., Troquay, R., Korecki, J., Szyszka, A., Diks, F., Sumis, J., Cygler, J., Miklaszewicz, B., Litwiejko-Pietrynczak, E., Napora, P., Drelich, G., Kawka-Urbanek, T., Wranicz, J. K., Mierzejewski, M., Drzewiecka, A., Wronska, D., Fares, I., Baska, J., Stania, K., Krzyzanowski, W., Miekus, P., Tyminski, M., Dronov, D., Zenin, S., Isaeva, E., Lopukhov, A., Yakusevich, V., Kuznetsov, D., Kameneva, T., Pokushalov, E., Karetnikova, V., Dik, I., Karpushina, I., Nikolin, D., Doletsky, A., Ardashev, A., Timofeeva, A., Miller, O., Lyamina, N., Shubik, Y., Boldueva, S., Blanco Coronado, J. L., Gonzalez Juanatey, C., Otero, E., Alonso, D., Torres Llergo, J., Gonzalez Lama, J., De Prada Tiffe, J. A. V., Garcia Seara, F. J., Gomez Doblas, J. J., Riancho, J. A., Clua-Espuny, J. L., Motero, J., Arrarte, V. I., Martin Raymondi, D., Isasti Aizpurua, G., Marin, F., Nieto, J. A., Fernandez Portales, J., Alvarez Garcia, P., Torstensson, I., Cederin, B., Kalm, T., Rosenqvist, U., Thulin, J., Hajimirsadeghi, A., Crisby, M., Manoj, A., Bakhai, A., Mistri, A., Krishnan, M., Kumar, S., Kirubakaran, S., Thomas, H., Camm, J., Ahmed, F., Ross, A. M., Barry, K., Stockwell, R., Broadley, A., Mamun, M., Chatterjee, K., Cooke, J., Mccready, J., Dutta, D., John, K., Pandya, P., Howlett, R., Vinson, P., Lim, Foley, P., Bruce, D., Dixit, A., Broughton, D., Taylor, J., Schilling, R., Leon, K., Saeed, K., Shaheen, S., Tawfik, M., Mortadda, A., Seleem, M., Aly, M. S. I., Kazamel, G., Elbadry, M., Kamal, S., Hassan, M., Mostafa, M., Medhat, M. E. S., Ekhlas, Ghaleb, R., Taha, M. O., Daoud, I., Al Din, H., Imam, A. M., El Hameed, M. A., Helmy, Al-Murayeh, M., Akhtar, N., Matto, B. M., Ghani, M. A., Amoudi, O. A., Morsy, M. M., Bashir, A. A. F., Al Hossni, Y. M., Al Ghamdi, B., Zia-Ul-Sabah, Mir, S., Dardir, D., Masswary, A., Al Shehri, A. R., Iqbal, J., Almansori, M. A. J., Venkitachalam, C. G., Kurian, J., Rao, J., Aisheh, A., Albawab, A. A., Subbaraman, B., Amanat, A., Esfehani, K. J., Lochan, R., Bin Brek, A., Mittal, B., Ghazi, Y., Krishna, M., Tabatabaei, S. B., Thoppil, P. S., Nasim, S., El Khider Nour, S., Barros, P., Almeida, A. P., Andrade, M., Garbelini, B., Silvestrini, T. L., Alves, A. R., De Lima, C. E. B., Kormann, A., De Lima, G. G., Halperin, C., Salvadori Junior, D., Freitas, A. F., Gemelli, J. R., Ornelas, C. E., Dantas, J. M. M., Aziz, J. L., Backes, L. M., Barroso, W. S., Paiva, M. S., De Figueiredo Neto, J. A., Dos Santos, F. R., De Lima Neto, J. A., Bergo, R., Salvador Junior, P. R., Lopez, A. G., Alva, J. C. P., Gamba, M. A. A., Padilla-Padilla, F. G., Ruiz, A. E. B., Berlingieri, J., Bakbak, A., Gupta, M., Saunders, K., Costa-Vitali, A., Beaudry, P. R., Bhargava, R., Khaykin, Y., Healey, J. S., Crystal, E., Nadeau, Dhillon, Begg, A., Anderson, C., Baveja, S., Cross, D., Catanchin, A., Brieger, D., Lim, K. T., Davidson, P., Tan, R., Bhindi, R., Hickey, J., Layland, J., Bloch, M., Itty, C., Singh, B., Carroll, P., Lee, A., Starmer, G., Lehman, R., Universidad de Cantabria, Beyer-Westendorf J., Camm A.J., Fox K.A.A., Le Heuzey J.-Y., Haas S., Turpie A.G.G., Virdone S., Kakkar A.K., RIVER Registry Investigators: [..], A. Falanga, V. Rubino, L. Calo, W. Ageno, F. Massari, D. Imberti, L. Di Gennaro, F. Gaita, A. Margonato, G. Cannava, F. Capasso, I. Diemberger, F. Pelliccia, A. Cafolla, S. Bardari, L. Mattei, L. Ruocco, G. Boriani, D. Poli, S. Testa, C. Indolfi, R. Quintavalla, L. Mo, .., Beyer-Westendorf, J, Camm, A, Fox, K, Le Heuzey, J, Haas, S, Turpie, A, Virdone, S, Kakkar, A, Pieper, K, Kayani, G, Gersh, B, Hildebrandt, P, Dominguez, H, Comuth, W, Frost, L, Moller, D, Christensen, H, Bruun, L, Milhem, A, Gauthier, J, Mielot, C, Chanseaume, S, Chopra, S, Amlaiky, A, Tricot, O, Sierra, V, Dompnier, A, Zannad, N, Pinzani, A, Quatre, A, Mansourati, J, Fauchier, L, Badenco, N, Gandjbakhch, E, Chachoua, K, Malquarti, V, Pierron, F, Sacher, F, Taieb, J, Davy, J, Marijon, E, Lellouche, N, Leenhardt, A, Salem, A, Lesto, I, Muller, J, Garcia, R, Neau, J, Berneau, J, Schon, N, Gulba, D, Appel, K, Merke, J, Dshabrailov, J, Bauknecht, C, Scheuermann, O, Schroder, T, Jung, W, Kopf, A, Brachmann, J, Leschke, M, Taggeselle, J, Seige, M, Lassig, T, Appel, S, Schmiedl, M, Muller, K, Heinz, G, Axthelm, C, Eberhard, K, Hugl, B, Schwarz, T, Sechtem, U, Falanga, A, Rubino, V, Calo, L, Ageno, W, Massari, F, Imberti, D, Di Gennaro, L, Gaita, F, Margonato, A, Cannava, G, Capasso, F, Diemberger, I, Pelliccia, F, Cafolla, A, Bardari, S, Mattei, L, Ruocco, L, Boriani, G, Poli, D, Testa, S, Indolfi, C, Quintavalla, R, Mos, L, Ladyjanskaia, G, Aksoy, I, Van De Wetering, M, Theunissen, L, Den Hartog, F, Nijmeijer, R, Van De Wal, R, Reinders, S, Patterson, M, Melker, E, Troquay, R, Korecki, J, Szyszka, A, Diks, F, Sumis, J, Cygler, J, Miklaszewicz, B, Litwiejko-Pietrynczak, E, Napora, P, Drelich, G, Kawka-Urbanek, T, Wranicz, J, Mierzejewski, M, Drzewiecka, A, Wronska, D, Fares, I, Baska, J, Stania, K, Krzyzanowski, W, Miekus, P, Tyminski, M, Dronov, D, Zenin, S, Isaeva, E, Lopukhov, A, Yakusevich, V, Kuznetsov, D, Kameneva, T, Pokushalov, E, Karetnikova, V, Dik, I, Karpushina, I, Nikolin, D, Doletsky, A, Ardashev, A, Timofeeva, A, Miller, O, Lyamina, N, Shubik, Y, Boldueva, S, Blanco Coronado, J, Gonzalez Juanatey, C, Otero, E, Alonso, D, Torres Llergo, J, Gonzalez Lama, J, De Prada Tiffe, J, Garcia Seara, F, Gomez Doblas, J, Riancho, J, Clua-Espuny, J, Motero, J, Arrarte, V, Martin Raymondi, D, Isasti Aizpurua, G, Marin, F, Nieto, J, Fernandez Portales, J, Alvarez Garcia, P, Torstensson, I, Cederin, B, Kalm, T, Rosenqvist, U, Thulin, J, Hajimirsadeghi, A, Crisby, M, Manoj, A, Bakhai, A, Mistri, A, Krishnan, M, Kumar, S, Kirubakaran, S, Thomas, H, Camm, J, Ahmed, F, Ross, A, Barry, K, Stockwell, R, Broadley, A, Mamun, M, Chatterjee, K, Cooke, J, Mccready, J, Dutta, D, John, K, Pandya, P, Howlett, R, Vinson, P, Lim, Foley, P, Bruce, D, Dixit, A, Broughton, D, Taylor, J, Schilling, R, Leon, K, Saeed, K, Shaheen, S, Tawfik, M, Mortadda, A, Seleem, M, Aly, M, Kazamel, G, Elbadry, M, Kamal, S, Hassan, M, Mostafa, M, Medhat, M, Ekhlas, Ghaleb, R, Taha, M, Daoud, I, Al Din, H, Imam, A, El Hameed, M, Helmy, Al-Murayeh, M, Akhtar, N, Matto, B, Ghani, M, Amoudi, O, Morsy, M, Bashir, A, Al Hossni, Y, Al Ghamdi, B, Zia-Ul-Sabah, Mir, S, Dardir, D, Masswary, A, Al Shehri, A, Iqbal, J, Almansori, M, Venkitachalam, C, Kurian, J, Rao, J, Aisheh, A, Albawab, A, Subbaraman, B, Amanat, A, Esfehani, K, Lochan, R, Bin Brek, A, Mittal, B, Ghazi, Y, Krishna, M, Tabatabaei, S, Thoppil, P, Nasim, S, El Khider Nour, S, Barros, P, Almeida, A, Andrade, M, Garbelini, B, Silvestrini, T, Alves, A, De Lima, C, Kormann, A, De Lima, G, Halperin, C, Salvadori Junior, D, Freitas, A, Gemelli, J, Ornelas, C, Dantas, J, Aziz, J, Backes, L, Barroso, W, Paiva, M, De Figueiredo Neto, J, Dos Santos, F, De Lima Neto, J, Bergo, R, Salvador Junior, P, Lopez, A, Alva, J, Gamba, M, Padilla-Padilla, F, Ruiz, A, Berlingieri, J, Bakbak, A, Gupta, M, Saunders, K, Costa-Vitali, A, Beaudry, P, Bhargava, R, Khaykin, Y, Healey, J, Crystal, E, Nadeau, D, Begg, A, Anderson, C, Baveja, S, Cross, D, Catanchin, A, Brieger, D, Lim, K, Davidson, P, Tan, R, Bhindi, R, Hickey, J, Layland, J, Bloch, M, Itty, C, Singh, B, Carroll, P, Lee, A, Starmer, G, Lehman, R, Beyer-Westendorf, J., Camm, A. J., Fox, K. A. A., Le Heuzey, J. -Y., Haas, S., Turpie, A. G. G., Virdone, S., Kakkar, A. K., Pieper, K. S., Kayani, G., Gersh, B. J., Hildebrandt, P., Dominguez, H., Comuth, W., Frost, L., Moller, D. S., Christensen, H., Bruun, L. M., Milhem, A., Gauthier, J., Mielot, C., Chanseaume, S., Chopra, S., Amlaiky, A., Tricot, O., Sierra, V., Dompnier, A., Zannad, N., Pinzani, A., Quatre, A., Mansourati, J., Fauchier, L., Badenco, N., Gandjbakhch, E., Chachoua, K. F., Malquarti, V., Pierron, F., Sacher, F., Taieb, J., Davy, J. M., Marijon, E., Lellouche, N., Leenhardt, A., Salem, A., Lesto, I., Muller, J. J., Garcia, R., Neau, J. P., Berneau, J. B., Schon, N., Gulba, D., Appel, K. F., Merke, J., Dshabrailov, J., Bauknecht, C., Scheuermann, O., Schroder, T., Jung, W., Kopf, A., Brachmann, J., Leschke, M., Taggeselle, J., Seige, M., Lassig, T., Appel, S., Schmiedl, M., Muller, K., Heinz, G. U., Axthelm, C., Eberhard, K., Hugl, B., Schwarz, T., Sechtem, U., Falanga, A., Rubino, V., Calo, L., Ageno, W., Massari, F., Imberti, D., Di Gennaro, L., Gaita, F., Margonato, A., Cannava, G., Capasso, F., Diemberger, I., Pelliccia, F., Cafolla, A., Bardari, S., Mattei, L., Ruocco, L., Boriani, G., Poli, D., Testa, S., Indolfi, C., Quintavalla, R., Mos, L., Ladyjanskaia, G., Aksoy, I., Van De Wetering, M., Theunissen, L., Den Hartog, F., Nijmeijer, R., Van De Wal, R., Reinders, S., Patterson, M., Melker, E. D., Troquay, R., Korecki, J., Szyszka, A., Diks, F., Sumis, J., Cygler, J., Miklaszewicz, B., Litwiejko-Pietrynczak, E., Napora, P., Drelich, G., Kawka-Urbanek, T., Wranicz, J. K., Mierzejewski, M., Drzewiecka, A., Wronska, D., Fares, I., Baska, J., Stania, K., Krzyzanowski, W., Miekus, P., Tyminski, M., Dronov, D., Zenin, S., Isaeva, E., Lopukhov, A., Yakusevich, V., Kuznetsov, D., Kameneva, T., Pokushalov, E., Karetnikova, V., Dik, I., Karpushina, I., Nikolin, D., Doletsky, A., Ardashev, A., Timofeeva, A., Miller, O., Lyamina, N., Shubik, Y., Boldueva, S., Blanco Coronado, J. L., Gonzalez Juanatey, C., Otero, E., Alonso, D., Torres Llergo, J., Gonzalez Lama, J., De Prada Tiffe, J. A. V., Garcia Seara, F. J., Gomez Doblas, J. J., Riancho, J. A., Clua-Espuny, J. L., Motero, J., Arrarte, V. I., Martin Raymondi, D., Isasti Aizpurua, G., Marin, F., Nieto, J. A., Fernandez Portales, J., Alvarez Garcia, P., Torstensson, I., Cederin, B., Kalm, T., Rosenqvist, U., Thulin, J., Hajimirsadeghi, A., Crisby, M., Manoj, A., Bakhai, A., Mistri, A., Krishnan, M., Kumar, S., Kirubakaran, S., Thomas, H., Camm, J., Ahmed, F., Ross, A. M., Barry, K., Stockwell, R., Broadley, A., Mamun, M., Chatterjee, K., Cooke, J., Mccready, J., Dutta, D., John, K., Pandya, P., Howlett, R., Vinson, P., Foley, P., Bruce, D., Dixit, A., Broughton, D., Taylor, J., Schilling, R., Leon, K., Saeed, K., Shaheen, S., Tawfik, M., Mortadda, A., Seleem, M., Aly, M. S. I., Kazamel, G., Elbadry, M., Kamal, S., Hassan, M., Mostafa, M., Medhat, M. E. S., Ghaleb, R., Taha, M. O., Daoud, I., Al Din, H., Imam, A. M., El Hameed, M. A., Al-Murayeh, M., Akhtar, N., Matto, B. M., Ghani, M. A., Amoudi, O. A., Morsy, M. M., Bashir, A. A. F., Al Hossni, Y. M., Al Ghamdi, B., Mir, S., Dardir, D., Masswary, A., Al Shehri, A. R., Iqbal, J., Almansori, M. A. J., Venkitachalam, C. G., Kurian, J., Rao, J., Aisheh, A., Albawab, A. A., Subbaraman, B., Amanat, A., Esfehani, K. J., Lochan, R., Bin Brek, A., Mittal, B., Ghazi, Y., Krishna, M., Tabatabaei, S. B., Thoppil, P. S., Nasim, S., El Khider Nour, S., Barros, P., Almeida, A. P., Andrade, M., Garbelini, B., Silvestrini, T. L., Alves, A. R., De Lima, C. E. B., Kormann, A., De Lima, G. G., Halperin, C., Salvadori Junior, D., Freitas, A. F., Gemelli, J. R., Ornelas, C. E., Dantas, J. M. M., Aziz, J. L., Backes, L. M., Barroso, W. S., Paiva, M. S., De Figueiredo Neto, J. A., Dos Santos, F. R., De Lima Neto, J. A., Bergo, R., Salvador Junior, P. R., Lopez, A. G., Alva, J. C. P., Gamba, M. A. A., Padilla-Padilla, F. G., Ruiz, A. E. B., Berlingieri, J., Bakbak, A., Gupta, M., Saunders, K., Costa-Vitali, A., Beaudry, P. R., Bhargava, R., Khaykin, Y., Healey, J. S., Crystal, E., Nadeau, Dhillon, Begg, A., Anderson, C., Baveja, S., Cross, D., Catanchin, A., Brieger, D., Lim, K. T., Davidson, P., Tan, R., Bhindi, R., Hickey, J., Layland, J., Bloch, M., Itty, C., Singh, B., Carroll, P., Lee, A., Starmer, G., and Lehman, R.

Subjects
medicine.medical_specialty, Registry, medicine.drug_class, Population, Thromboembolic stroke, Outcomes, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Antithrombotic, Rivaroxaban, Anticoagulant, Atrial fibrillation, medicine, 030212 general & internal medicine, Risk factor, education, Stroke, Outcome, education.field_of_study, business.industry, lcsh:RC633-647.5, Research, Hematology, lcsh:Diseases of the blood and blood-forming organs, medicine.disease, ddc, Clinical trial, Emergency medicine, business, medicine.drug
Abstract

Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions: The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world. Funding: This work is supported by an unrestricted research grant from Bayer AG (Berlin, Germany) to the Thrombosis Research Institute (London, UK), which sponsors the RIVER registry. The funding source had no involvement in the data collection, data analysis or data interpretation.

Published
2019

8. Vitamin K antagonist therapy: changes in the treated populations and in management results in Italian anticoagulation clinics compared with those recorded 20 years ago

Author

Palareti G, Antonucci E, Migliaccio L, Erba N, Marongiu F, Pengo V, Poli D, Testa S, Tosetto A, Tripodi A, Moia M, Paoletti O, Guazzaloca G, Marcucci R, Falanga A, Lerede T, Piana A, Cibecchini F, Martini G, Ruocco L, Pedrini S, Masciocco L, Saracino P, Benvenuto A, Vasselli C, Bucherini E, Toma A, Barbera P, Insana A, Paparo C, Rupoli S, Malcangi G, Sangiorgio R, Zighetti ML, Mangione C, Agostinelli E, Ageno W, Oriana V, Liberato NL, Casasco P, Palareti, G, Antonucci, E, Migliaccio, L, Erba, N, Marongiu, F, Pengo, V, Poli, D, Testa, S, Tosetto, A, Tripodi, A, Moia, M, Paoletti, O, Guazzaloca, G, Marcucci, R, Falanga, A, Lerede, T, Piana, A, Cibecchini, F, Martini, G, Ruocco, L, Pedrini, S, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Bucherini, E, Toma, A, Barbera, P, Insana, A, Paparo, C, Rupoli, S, Malcangi, G, Sangiorgio, R, Zighetti, M, Mangione, C, Agostinelli, E, Ageno, W, Oriana, V, Liberato, N, and Casasco, P

Subjects
Male, Vitamin K, Atrial fibrillation, Bleeding, Thrombotic, Venous thromboembolism, Warfarin, Administration, Oral, 030204 cardiovascular system & hematology, Ambulatory Care Facilities, 0302 clinical medicine, Risk Factors, Registries, 030212 general & internal medicine, Aged, 80 and over, education.field_of_study, Incidence, Incidence (epidemiology), Middle Aged, Vitamin K antagonist, Italy, Heart Valve Prosthesis, Emergency Medicine, Female, Major bleeding, medicine.drug, medicine.medical_specialty, medicine.drug_class, Population, Hemorrhage, History, 21st Century, 03 medical and health sciences, Population Groups, Fibrinolytic Agents, Thromboembolism, Internal medicine, Internal Medicine, medicine, Humans, education, Aged, Chi-Square Distribution, business.industry, Acenocoumarol, Anticoagulants, History, 20th Century, medicine.disease, Im - Original, Surgery, Observational study, business
Abstract

Vitamin K antagonists (VKA) are the most widely used anticoagulants in the world. An appropriate management of treated patients is crucial for their efficacy and safety. The prospective, observational, multicenter, inception-cohort FCSA-START Register, a branch of START Register (NCT02219984) included VKA-treated patients managed by centers of Italian Federation of anticoagulation clinics (AC). Baseline patient characteristics and data during treatment were analyzed and compared with those of ISCOAT study, performed by the Federation and published in 1996/7. 5707 naïve patients [53% males, mean age 73.0 years (28.1% >80 years)], 61.6% treated for atrial fibrillation (AF), and 28.0% for venous thromboembolism were included. During the 8906 patient-years (pt-yrs) of observation, 123 patients had major bleeding (MB) (1.38% pt-yrs; fatal: 0.11% pt-yrs), while non-major clinically relevant bleeds were 144 (1.62% pt-yrs). Bleeding was more frequent in elderly (≥70 years; p = 0.04), and during initial 3-month therapy (p = 0.02). Bleeding rate was 2.5% pt-yrs for temporally related INR results

Published
2017
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10. International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban Evaluation in Real life setting (RIVER)

Author

Beyer-Westendorf, J, Camm, A, Fox, K, Le Heuzey, J, Haas, S, Turpie, A, Virdone, S, Kakkar, A, Pieper, K, Kayani, G, Gersh, B, Hildebrandt, P, Dominguez, H, Comuth, W, Frost, L, Moller, D, Christensen, H, Bruun, L, Milhem, A, Gauthier, J, Mielot, C, Chanseaume, S, Chopra, S, Amlaiky, A, Tricot, O, Sierra, V, Dompnier, A, Zannad, N, Pinzani, A, Quatre, A, Mansourati, J, Fauchier, L, Badenco, N, Gandjbakhch, E, Chachoua, K, Malquarti, V, Pierron, F, Sacher, F, Taieb, J, Davy, J, Marijon, E, Lellouche, N, Leenhardt, A, Salem, A, Lesto, I, Muller, J, Garcia, R, Neau, J, Berneau, J, Schon, N, Gulba, D, Appel, K, Merke, J, Dshabrailov, J, Bauknecht, C, Scheuermann, O, Schroder, T, Jung, W, Kopf, A, Brachmann, J, Leschke, M, Taggeselle, J, Seige, M, Lassig, T, Appel, S, Schmiedl, M, Muller, K, Heinz, G, Axthelm, C, Eberhard, K, Hugl, B, Schwarz, T, Sechtem, U, Falanga, A, Rubino, V, Calo, L, Ageno, W, Massari, F, Imberti, D, Di Gennaro, L, Gaita, F, Margonato, A, Cannava, G, Capasso, F, Diemberger, I, Pelliccia, F, Cafolla, A, Bardari, S, Mattei, L, Ruocco, L, Boriani, G, Poli, D, Testa, S, Indolfi, C, Quintavalla, R, Mos, L, Ladyjanskaia, G, Aksoy, I, Van De Wetering, M, Theunissen, L, Den Hartog, F, Nijmeijer, R, Van De Wal, R, Reinders, S, Patterson, M, Melker, E, Troquay, R, Korecki, J, Szyszka, A, Diks, F, Sumis, J, Cygler, J, Miklaszewicz, B, Litwiejko-Pietrynczak, E, Napora, P, Drelich, G, Kawka-Urbanek, T, Wranicz, J, Mierzejewski, M, Drzewiecka, A, Wronska, D, Fares, I, Baska, J, Stania, K, Krzyzanowski, W, Miekus, P, Tyminski, M, Dronov, D, Zenin, S, Isaeva, E, Lopukhov, A, Yakusevich, V, Kuznetsov, D, Kameneva, T, Pokushalov, E, Karetnikova, V, Dik, I, Karpushina, I, Nikolin, D, Doletsky, A, Ardashev, A, Timofeeva, A, Miller, O, Lyamina, N, Shubik, Y, Boldueva, S, Blanco Coronado, J, Gonzalez Juanatey, C, Otero, E, Alonso, D, Torres Llergo, J, Gonzalez Lama, J, De Prada Tiffe, J, Garcia Seara, F, Gomez Doblas, J, Riancho, J, Clua-Espuny, J, Motero, J, Arrarte, V, Martin Raymondi, D, Isasti Aizpurua, G, Marin, F, Nieto, J, Fernandez Portales, J, Alvarez Garcia, P, Torstensson, I, Cederin, B, Kalm, T, Rosenqvist, U, Thulin, J, Hajimirsadeghi, A, Crisby, M, Manoj, A, Bakhai, A, Mistri, A, Krishnan, M, Kumar, S, Kirubakaran, S, Thomas, H, Camm, J, Ahmed, F, Ross, A, Barry, K, Stockwell, R, Broadley, A, Mamun, M, Chatterjee, K, Cooke, J, Mccready, J, Dutta, D, John, K, Pandya, P, Howlett, R, Vinson, P, Lim, Foley, P, Bruce, D, Dixit, A, Broughton, D, Taylor, J, Schilling, R, Leon, K, Saeed, K, Shaheen, S, Tawfik, M, Mortadda, A, Seleem, M, Aly, M, Kazamel, G, Elbadry, M, Kamal, S, Hassan, M, Mostafa, M, Medhat, M, Ekhlas, Ghaleb, R, Taha, M, Daoud, I, Al Din, H, Imam, A, El Hameed, M, Helmy, Al-Murayeh, M, Akhtar, N, Matto, B, Ghani, M, Amoudi, O, Morsy, M, Bashir, A, Al Hossni, Y, Al Ghamdi, B, Zia-Ul-Sabah, Mir, S, Dardir, D, Masswary, A, Al Shehri, A, Iqbal, J, Almansori, M, Venkitachalam, C, Kurian, J, Rao, J, Aisheh, A, Albawab, A, Subbaraman, B, Amanat, A, Esfehani, K, Lochan, R, Bin Brek, A, Mittal, B, Ghazi, Y, Krishna, M, Tabatabaei, S, Thoppil, P, Nasim, S, El Khider Nour, S, Barros, P, Almeida, A, Andrade, M, Garbelini, B, Silvestrini, T, Alves, A, De Lima, C, Kormann, A, De Lima, G, Halperin, C, Salvadori Junior, D, Freitas, A, Gemelli, J, Ornelas, C, Dantas, J, Aziz, J, Backes, L, Barroso, W, Paiva, M, De Figueiredo Neto, J, Dos Santos, F, De Lima Neto, J, Bergo, R, Salvador Junior, P, Lopez, A, Alva, J, Gamba, M, Padilla-Padilla, F, Ruiz, A, Berlingieri, J, Bakbak, A, Gupta, M, Saunders, K, Costa-Vitali, A, Beaudry, P, Bhargava, R, Khaykin, Y, Healey, J, Crystal, E, Nadeau, D, Begg, A, Anderson, C, Baveja, S, Cross, D, Catanchin, A, Brieger, D, Lim, K, Davidson, P, Tan, R, Bhindi, R, Hickey, J, Layland, J, Bloch, M, Itty, C, Singh, B, Carroll, P, Lee, A, Starmer, G, Lehman, R, Beyer-Westendorf J., Camm A. J., Fox K. A. A., Le Heuzey J. -Y., Haas S., Turpie A. G. G., Virdone S., Kakkar A. K., Pieper K. S., Kayani G., Gersh B. J., Hildebrandt P., Dominguez H., Comuth W., Frost L., Moller D. S., Christensen H., Bruun L. M., Milhem A., Gauthier J., Mielot C., Chanseaume S., Chopra S., Amlaiky A., Tricot O., Sierra V., Dompnier A., Zannad N., Pinzani A., Quatre A., Mansourati J., Fauchier L., Badenco N., Gandjbakhch E., Chachoua K. F., Malquarti V., Pierron F., Sacher F., Taieb J., Davy J. M., Marijon E., Lellouche N., Leenhardt A., Salem A., Lesto I., Muller J. J., Garcia R., Neau J. P., Berneau J. B., Schon N., Gulba D., Appel K. F., Merke J., Dshabrailov J., Bauknecht C., Scheuermann O., Schroder T., Jung W., Kopf A., Brachmann J., Leschke M., Taggeselle J., Seige M., Lassig T., Appel S., Schmiedl M., Muller K., Heinz G. U., Axthelm C., Eberhard K., Hugl B., Schwarz T., Sechtem U., Falanga A., Rubino V., Calo L., Ageno W., Massari F., Imberti D., Di Gennaro L., Gaita F., Margonato A., Cannava G., Capasso F., Diemberger I., Pelliccia F., Cafolla A., Bardari S., Mattei L., Ruocco L., Boriani G., Poli D., Testa S., Indolfi C., Quintavalla R., Mos L., Ladyjanskaia G., Aksoy I., Van De Wetering M., Theunissen L., Den Hartog F., Nijmeijer R., Van De Wal R., Reinders S., Patterson M., Melker E. D., Troquay R., Korecki J., Szyszka A., Diks F., Sumis J., Cygler J., Miklaszewicz B., Litwiejko-Pietrynczak E., Napora P., Drelich G., Kawka-Urbanek T., Wranicz J. K., Mierzejewski M., Drzewiecka A., Wronska D., Fares I., Baska J., Stania K., Krzyzanowski W., Miekus P., Tyminski M., Dronov D., Zenin S., Isaeva E., Lopukhov A., Yakusevich V., Kuznetsov D., Kameneva T., Pokushalov E., Karetnikova V., Dik I., Karpushina I., Nikolin D., Doletsky A., Ardashev A., Timofeeva A., Miller O., Lyamina N., Shubik Y., Boldueva S., Blanco Coronado J. L., Gonzalez Juanatey C., Otero E., Alonso D., Torres Llergo J., Gonzalez Lama J., De Prada Tiffe J. A. V., Garcia Seara F. J., Gomez Doblas J. J., Riancho J. A., Clua-Espuny J. L., Motero J., Arrarte V. I., Martin Raymondi D., Isasti Aizpurua G., Marin F., Nieto J. A., Fernandez Portales J., Alvarez Garcia P., Torstensson I., Cederin B., Kalm T., Rosenqvist U., Thulin J., Hajimirsadeghi A., Crisby M., Manoj A., Bakhai A., Mistri A., Krishnan M., Kumar S., Kirubakaran S., Thomas H., Camm J., Ahmed F., Ross A. M., Barry K., Stockwell R., Broadley A., Mamun M., Chatterjee K., Cooke J., McCready J., Dutta D., John K., Pandya P., Howlett R., Vinson P., Foley P., Bruce D., Dixit A., Broughton D., Taylor J., Schilling R., Leon K., Saeed K., Shaheen S., Tawfik M., Mortadda A., Seleem M., Aly M. S. I., Kazamel G., Elbadry M., Kamal S., Hassan M., Mostafa M., Medhat M. E. S., Ghaleb R., Taha M. O., Daoud I., Al Din H., Imam A. M., El Hameed M. A., Al-Murayeh M., Akhtar N., Matto B. M., Ghani M. A., Amoudi O. A., Morsy M. M., Bashir A. A. F., Al Hossni Y. M., Al Ghamdi B., Mir S., Dardir D., Masswary A., Al Shehri A. R., Iqbal J., Almansori M. A. J., Venkitachalam C. G., Kurian J., Rao J., Aisheh A., Albawab A. A., Subbaraman B., Amanat A., Esfehani K. J., Lochan R., Bin Brek A., Mittal B., Ghazi Y., Krishna M., Tabatabaei S. B., Thoppil P. S., Nasim S., El Khider Nour S., Barros P., Almeida A. P., Andrade M., Garbelini B., Silvestrini T. L., Alves A. R., De Lima C. E. B., Kormann A., De Lima G. G., Halperin C., Salvadori Junior D., Freitas A. F., Gemelli J. R., Ornelas C. E., Dantas J. M. M., Aziz J. L., Backes L. M., Barroso W. S., Paiva M. S., De Figueiredo Neto J. A., Dos Santos F. R., De Lima Neto J. A., Bergo R., Salvador Junior P. R., Lopez A. G., Alva J. C. P., Gamba M. A. A., Padilla-Padilla F. G., Ruiz A. E. B., Berlingieri J., Bakbak A., Gupta M., Saunders K., Costa-Vitali A., Beaudry P. R., Bhargava R., Khaykin Y., Healey J. S., Crystal E., Nadeau Dhillon, Begg A., Anderson C., Baveja S., Cross D., Catanchin A., Brieger D., Lim K. T., Davidson P., Tan R., Bhindi R., Hickey J., Layland J., Bloch M., Itty C., Singh B., Carroll P., Lee A., Starmer G., Lehman R., Beyer-Westendorf, J, Camm, A, Fox, K, Le Heuzey, J, Haas, S, Turpie, A, Virdone, S, Kakkar, A, Pieper, K, Kayani, G, Gersh, B, Hildebrandt, P, Dominguez, H, Comuth, W, Frost, L, Moller, D, Christensen, H, Bruun, L, Milhem, A, Gauthier, J, Mielot, C, Chanseaume, S, Chopra, S, Amlaiky, A, Tricot, O, Sierra, V, Dompnier, A, Zannad, N, Pinzani, A, Quatre, A, Mansourati, J, Fauchier, L, Badenco, N, Gandjbakhch, E, Chachoua, K, Malquarti, V, Pierron, F, Sacher, F, Taieb, J, Davy, J, Marijon, E, Lellouche, N, Leenhardt, A, Salem, A, Lesto, I, Muller, J, Garcia, R, Neau, J, Berneau, J, Schon, N, Gulba, D, Appel, K, Merke, J, Dshabrailov, J, Bauknecht, C, Scheuermann, O, Schroder, T, Jung, W, Kopf, A, Brachmann, J, Leschke, M, Taggeselle, J, Seige, M, Lassig, T, Appel, S, Schmiedl, M, Muller, K, Heinz, G, Axthelm, C, Eberhard, K, Hugl, B, Schwarz, T, Sechtem, U, Falanga, A, Rubino, V, Calo, L, Ageno, W, Massari, F, Imberti, D, Di Gennaro, L, Gaita, F, Margonato, A, Cannava, G, Capasso, F, Diemberger, I, Pelliccia, F, Cafolla, A, Bardari, S, Mattei, L, Ruocco, L, Boriani, G, Poli, D, Testa, S, Indolfi, C, Quintavalla, R, Mos, L, Ladyjanskaia, G, Aksoy, I, Van De Wetering, M, Theunissen, L, Den Hartog, F, Nijmeijer, R, Van De Wal, R, Reinders, S, Patterson, M, Melker, E, Troquay, R, Korecki, J, Szyszka, A, Diks, F, Sumis, J, Cygler, J, Miklaszewicz, B, Litwiejko-Pietrynczak, E, Napora, P, Drelich, G, Kawka-Urbanek, T, Wranicz, J, Mierzejewski, M, Drzewiecka, A, Wronska, D, Fares, I, Baska, J, Stania, K, Krzyzanowski, W, Miekus, P, Tyminski, M, Dronov, D, Zenin, S, Isaeva, E, Lopukhov, A, Yakusevich, V, Kuznetsov, D, Kameneva, T, Pokushalov, E, Karetnikova, V, Dik, I, Karpushina, I, Nikolin, D, Doletsky, A, Ardashev, A, Timofeeva, A, Miller, O, Lyamina, N, Shubik, Y, Boldueva, S, Blanco Coronado, J, Gonzalez Juanatey, C, Otero, E, Alonso, D, Torres Llergo, J, Gonzalez Lama, J, De Prada Tiffe, J, Garcia Seara, F, Gomez Doblas, J, Riancho, J, Clua-Espuny, J, Motero, J, Arrarte, V, Martin Raymondi, D, Isasti Aizpurua, G, Marin, F, Nieto, J, Fernandez Portales, J, Alvarez Garcia, P, Torstensson, I, Cederin, B, Kalm, T, Rosenqvist, U, Thulin, J, Hajimirsadeghi, A, Crisby, M, Manoj, A, Bakhai, A, Mistri, A, Krishnan, M, Kumar, S, Kirubakaran, S, Thomas, H, Camm, J, Ahmed, F, Ross, A, Barry, K, Stockwell, R, Broadley, A, Mamun, M, Chatterjee, K, Cooke, J, Mccready, J, Dutta, D, John, K, Pandya, P, Howlett, R, Vinson, P, Lim, Foley, P, Bruce, D, Dixit, A, Broughton, D, Taylor, J, Schilling, R, Leon, K, Saeed, K, Shaheen, S, Tawfik, M, Mortadda, A, Seleem, M, Aly, M, Kazamel, G, Elbadry, M, Kamal, S, Hassan, M, Mostafa, M, Medhat, M, Ekhlas, Ghaleb, R, Taha, M, Daoud, I, Al Din, H, Imam, A, El Hameed, M, Helmy, Al-Murayeh, M, Akhtar, N, Matto, B, Ghani, M, Amoudi, O, Morsy, M, Bashir, A, Al Hossni, Y, Al Ghamdi, B, Zia-Ul-Sabah, Mir, S, Dardir, D, Masswary, A, Al Shehri, A, Iqbal, J, Almansori, M, Venkitachalam, C, Kurian, J, Rao, J, Aisheh, A, Albawab, A, Subbaraman, B, Amanat, A, Esfehani, K, Lochan, R, Bin Brek, A, Mittal, B, Ghazi, Y, Krishna, M, Tabatabaei, S, Thoppil, P, Nasim, S, El Khider Nour, S, Barros, P, Almeida, A, Andrade, M, Garbelini, B, Silvestrini, T, Alves, A, De Lima, C, Kormann, A, De Lima, G, Halperin, C, Salvadori Junior, D, Freitas, A, Gemelli, J, Ornelas, C, Dantas, J, Aziz, J, Backes, L, Barroso, W, Paiva, M, De Figueiredo Neto, J, Dos Santos, F, De Lima Neto, J, Bergo, R, Salvador Junior, P, Lopez, A, Alva, J, Gamba, M, Padilla-Padilla, F, Ruiz, A, Berlingieri, J, Bakbak, A, Gupta, M, Saunders, K, Costa-Vitali, A, Beaudry, P, Bhargava, R, Khaykin, Y, Healey, J, Crystal, E, Nadeau, D, Begg, A, Anderson, C, Baveja, S, Cross, D, Catanchin, A, Brieger, D, Lim, K, Davidson, P, Tan, R, Bhindi, R, Hickey, J, Layland, J, Bloch, M, Itty, C, Singh, B, Carroll, P, Lee, A, Starmer, G, Lehman, R, Beyer-Westendorf J., Camm A. J., Fox K. A. A., Le Heuzey J. -Y., Haas S., Turpie A. G. G., Virdone S., Kakkar A. K., Pieper K. S., Kayani G., Gersh B. J., Hildebrandt P., Dominguez H., Comuth W., Frost L., Moller D. S., Christensen H., Bruun L. M., Milhem A., Gauthier J., Mielot C., Chanseaume S., Chopra S., Amlaiky A., Tricot O., Sierra V., Dompnier A., Zannad N., Pinzani A., Quatre A., Mansourati J., Fauchier L., Badenco N., Gandjbakhch E., Chachoua K. F., Malquarti V., Pierron F., Sacher F., Taieb J., Davy J. M., Marijon E., Lellouche N., Leenhardt A., Salem A., Lesto I., Muller J. J., Garcia R., Neau J. P., Berneau J. B., Schon N., Gulba D., Appel K. F., Merke J., Dshabrailov J., Bauknecht C., Scheuermann O., Schroder T., Jung W., Kopf A., Brachmann J., Leschke M., Taggeselle J., Seige M., Lassig T., Appel S., Schmiedl M., Muller K., Heinz G. U., Axthelm C., Eberhard K., Hugl B., Schwarz T., Sechtem U., Falanga A., Rubino V., Calo L., Ageno W., Massari F., Imberti D., Di Gennaro L., Gaita F., Margonato A., Cannava G., Capasso F., Diemberger I., Pelliccia F., Cafolla A., Bardari S., Mattei L., Ruocco L., Boriani G., Poli D., Testa S., Indolfi C., Quintavalla R., Mos L., Ladyjanskaia G., Aksoy I., Van De Wetering M., Theunissen L., Den Hartog F., Nijmeijer R., Van De Wal R., Reinders S., Patterson M., Melker E. D., Troquay R., Korecki J., Szyszka A., Diks F., Sumis J., Cygler J., Miklaszewicz B., Litwiejko-Pietrynczak E., Napora P., Drelich G., Kawka-Urbanek T., Wranicz J. K., Mierzejewski M., Drzewiecka A., Wronska D., Fares I., Baska J., Stania K., Krzyzanowski W., Miekus P., Tyminski M., Dronov D., Zenin S., Isaeva E., Lopukhov A., Yakusevich V., Kuznetsov D., Kameneva T., Pokushalov E., Karetnikova V., Dik I., Karpushina I., Nikolin D., Doletsky A., Ardashev A., Timofeeva A., Miller O., Lyamina N., Shubik Y., Boldueva S., Blanco Coronado J. L., Gonzalez Juanatey C., Otero E., Alonso D., Torres Llergo J., Gonzalez Lama J., De Prada Tiffe J. A. V., Garcia Seara F. J., Gomez Doblas J. J., Riancho J. A., Clua-Espuny J. L., Motero J., Arrarte V. I., Martin Raymondi D., Isasti Aizpurua G., Marin F., Nieto J. A., Fernandez Portales J., Alvarez Garcia P., Torstensson I., Cederin B., Kalm T., Rosenqvist U., Thulin J., Hajimirsadeghi A., Crisby M., Manoj A., Bakhai A., Mistri A., Krishnan M., Kumar S., Kirubakaran S., Thomas H., Camm J., Ahmed F., Ross A. M., Barry K., Stockwell R., Broadley A., Mamun M., Chatterjee K., Cooke J., McCready J., Dutta D., John K., Pandya P., Howlett R., Vinson P., Foley P., Bruce D., Dixit A., Broughton D., Taylor J., Schilling R., Leon K., Saeed K., Shaheen S., Tawfik M., Mortadda A., Seleem M., Aly M. S. I., Kazamel G., Elbadry M., Kamal S., Hassan M., Mostafa M., Medhat M. E. S., Ghaleb R., Taha M. O., Daoud I., Al Din H., Imam A. M., El Hameed M. A., Al-Murayeh M., Akhtar N., Matto B. M., Ghani M. A., Amoudi O. A., Morsy M. M., Bashir A. A. F., Al Hossni Y. M., Al Ghamdi B., Mir S., Dardir D., Masswary A., Al Shehri A. R., Iqbal J., Almansori M. A. J., Venkitachalam C. G., Kurian J., Rao J., Aisheh A., Albawab A. A., Subbaraman B., Amanat A., Esfehani K. J., Lochan R., Bin Brek A., Mittal B., Ghazi Y., Krishna M., Tabatabaei S. B., Thoppil P. S., Nasim S., El Khider Nour S., Barros P., Almeida A. P., Andrade M., Garbelini B., Silvestrini T. L., Alves A. R., De Lima C. E. B., Kormann A., De Lima G. G., Halperin C., Salvadori Junior D., Freitas A. F., Gemelli J. R., Ornelas C. E., Dantas J. M. M., Aziz J. L., Backes L. M., Barroso W. S., Paiva M. S., De Figueiredo Neto J. A., Dos Santos F. R., De Lima Neto J. A., Bergo R., Salvador Junior P. R., Lopez A. G., Alva J. C. P., Gamba M. A. A., Padilla-Padilla F. G., Ruiz A. E. B., Berlingieri J., Bakbak A., Gupta M., Saunders K., Costa-Vitali A., Beaudry P. R., Bhargava R., Khaykin Y., Healey J. S., Crystal E., Nadeau Dhillon, Begg A., Anderson C., Baveja S., Cross D., Catanchin A., Brieger D., Lim K. T., Davidson P., Tan R., Bhindi R., Hickey J., Layland J., Bloch M., Itty C., Singh B., Carroll P., Lee A., Starmer G., and Lehman R.

Abstract

Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet the

Published
2019

14. Monitoring of warfarin therapy: Preliminary results from a longitudinal pilot study

Author

Lomonaco, T, Ghimenti, S, Piga, I, Biagini, D, Onor, M, Fuoco, R, Paolicchi, A, Ruocco, L, Pellegrini, G, Trivella, M, Di Francesco, F, Lomonaco, T., Ghimenti, S., Piga, I., Biagini, D., Onor, M., Fuoco, R., Paolicchi, A., Ruocco, L., Pellegrini, G., Trivella, M. G., Di Francesco, F., Lomonaco, T, Ghimenti, S, Piga, I, Biagini, D, Onor, M, Fuoco, R, Paolicchi, A, Ruocco, L, Pellegrini, G, Trivella, M, Di Francesco, F, Lomonaco, T., Ghimenti, S., Piga, I., Biagini, D., Onor, M., Fuoco, R., Paolicchi, A., Ruocco, L., Pellegrini, G., Trivella, M. G., and Di Francesco, F.

Abstract

The aim of this study was to investigate the relationship between warfarin dosage, international normalized ratio, plasma and oral fluid concentrations of warfarin, and its metabolites, namely RR/SS- and RS/SR-warfarin alcohols. Nine patients on long-term warfarin therapy (4 with stable and 5 with unstable international normalized ratio values) were longitudinally monitored for over two months by recording warfarin dosage and measuring international normalized ratio, warfarin and warfarin alcohols concentrations in oral fluid and in plasma. At equivalent dose (20–30 mg week− 1), the international normalized ratio was in the range 2.0–2.5 and 1.5–3.1 for stable and unstable patients, respectively. Moreover, stable patients showed nearly double total and unbound plasma warfarin concentration, and nearly triple oral fluid warfarin concentrations compared to unstable patients. Correlations between warfarin dosage and total plasma concentration of warfarin (r = 0.65, p < 0.01) or RS/SR-warfarin alcohols (r = 0.66, p < 0.01), as well as between stimulated oral fluid and total plasma concentrations of warfarin (r = 0.72, p < 0.01) and RS/SR-warfarin alcohols (r = 0.95, p < 0.01) suggest that the relative changes of the oral fluid concentrations of these species may provide clinically useful information for monitoring individual patients. Follow-up data revealed that even in the absence of changes of warfarin dose, the oscillations of plasma and oral fluid of WAR and RS/SR-warfarin alcohols parallel oscillations of international normalized ratio. Due to the long delay of its biological action, monitoring the plasma concentration of warfarin might help to predict variations of international normalized ratio and prevent the risk of thrombotic or haemorrhagic events. The information collected suggests that non-invasive monitoring of warfarin in oral fluid might represent a suitable tool for this purpose

Published
2018

21. The -670G> A polymorphism in the FAS gene promoter region influences the susceptibility to systemic sclerosis

Author

Liakouli, V., Manetti, M., Pacini, A., Tolusso, B., Fatini, C., Toscano, A., Cipriani, P., Guiducci, S., Bazzichi, L., Codullo, V., Ruocco, L., Dell'Orso, L., Carubbi, F., Marrelli, A., Abbate, R., Bombardieri, S., Ferraccioli, G., Montecucco, C., Valentini, G., Matucci-Cerinic, M., Ibba-Manneschi, L., and Giacomelli, R.

Subjects
Promoters (Genetics) -- Research, Genetic polymorphisms -- Research, Scleroderma (Disease) -- Genetic aspects, Scleroderma (Disease) -- Research, Scleroderma (Disease) -- Risk factors, Systemic scleroderma -- Genetic aspects, Systemic scleroderma -- Research, Systemic scleroderma -- Risk factors, Health
Published
2009

27. Vitamin K antagonist therapy: changes in the treated populations and in management results in Italian anticoagulation clinics compared with those recorded 20 years ago

Author

Palareti, G, Antonucci, E, Migliaccio, L, Erba, N, Marongiu, F, Pengo, V, Poli, D, Testa, S, Tosetto, A, Tripodi, A, Moia, M, Paoletti, O, Guazzaloca, G, Marcucci, R, Falanga, A, Lerede, T, Piana, A, Cibecchini, F, Martini, G, Ruocco, L, Pedrini, S, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Bucherini, E, Toma, A, Barbera, P, Insana, A, Paparo, C, Rupoli, S, Malcangi, G, Sangiorgio, R, Zighetti, M, Mangione, C, Agostinelli, E, Ageno, W, Oriana, V, Liberato, N, Casasco, P, Palareti G, Antonucci E, Migliaccio L, Erba N, Marongiu F, Pengo V, Poli D, Testa S, Tosetto A, Tripodi A, Moia M, Paoletti O, Guazzaloca G, Marcucci R, Falanga A, Lerede T, Piana A, Cibecchini F, Martini G, Ruocco L, Pedrini S, Masciocco L, Saracino P, Benvenuto A, Vasselli C, Bucherini E, Toma A, Barbera P, Insana A, Paparo C, Rupoli S, Malcangi G, Sangiorgio R, Zighetti ML, Mangione C, Agostinelli E, Ageno W, Oriana V, Liberato NL, Casasco P, Palareti, G, Antonucci, E, Migliaccio, L, Erba, N, Marongiu, F, Pengo, V, Poli, D, Testa, S, Tosetto, A, Tripodi, A, Moia, M, Paoletti, O, Guazzaloca, G, Marcucci, R, Falanga, A, Lerede, T, Piana, A, Cibecchini, F, Martini, G, Ruocco, L, Pedrini, S, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Bucherini, E, Toma, A, Barbera, P, Insana, A, Paparo, C, Rupoli, S, Malcangi, G, Sangiorgio, R, Zighetti, M, Mangione, C, Agostinelli, E, Ageno, W, Oriana, V, Liberato, N, Casasco, P, Palareti G, Antonucci E, Migliaccio L, Erba N, Marongiu F, Pengo V, Poli D, Testa S, Tosetto A, Tripodi A, Moia M, Paoletti O, Guazzaloca G, Marcucci R, Falanga A, Lerede T, Piana A, Cibecchini F, Martini G, Ruocco L, Pedrini S, Masciocco L, Saracino P, Benvenuto A, Vasselli C, Bucherini E, Toma A, Barbera P, Insana A, Paparo C, Rupoli S, Malcangi G, Sangiorgio R, Zighetti ML, Mangione C, Agostinelli E, Ageno W, Oriana V, Liberato NL, and Casasco P

Abstract

Vitamin K antagonists (VKA) are the most widely used anticoagulants in the world. An appropriate management of treated patients is crucial for their efficacy and safety. The prospective, observational, multicenter, inception-cohort FCSA-START Register, a branch of START Register (NCT02219984) included VKA-treated patients managed by centers of Italian Federation of anticoagulation clinics (AC). Baseline patient characteristics and data during treatment were analyzed and compared with those of ISCOAT study, performed by the Federation and published in 1996/7. 5707 naïve patients [53% males, mean age 73.0 years (28.1% >80 years)], 61.6% treated for atrial fibrillation (AF), and 28.0% for venous thromboembolism were included. During the 8906 patient-years (pt-yrs) of observation, 123 patients had major bleeding (MB) (1.38% pt-yrs; fatal: 0.11% pt-yrs), while non-major clinically relevant bleeds were 144 (1.62% pt-yrs). Bleeding was more frequent in elderly (≥70 years; p = 0.04), and during initial 3-month therapy (p = 0.02). Bleeding rate was 2.5% pt-yrs for temporally related INR results <3.0, increasing to 12.5% for INR ≥ 4.5. Thrombotic events were 47 (0.53% pt-yrs; 4 fatal 0.04% pt-yrs). Compared with ISCOAT-1996/7 results, patients older than 80 y are increased from 8 to 28% (p < 0.01), and those treated for AF are increased from 17 to 61%. The quality of anticoagulation control and incidence of MB are not different. However, thrombotic complications fell drastically from 3.5 to 0.53% pt-yrs (p < 0.01), with lower mortality (p = 0.01). VKA-treated patients monitored in Italian AC have good clinical results, with low bleeding and thrombotic complications rates. Important changes in the treated population and improvement in thrombotic complications are detected compared with the ISCOAT-1996/7 study

Published
2017

32. Thrombocytopenia and Mortality Risk in Patients With Atrial Fibrillation: An Analysis From the START Registry

Author

Pastori, D, Antonucci, E, Violi, F, Palareti, G, Pignatelli, P, Testa, S, Paoletti, O, Cosmi, B, Guazzaloca, G, Migliaccio, L, Poli, D, Marcucci, R, Maggini, N, Pengo, V, Falanga, A, Lerede, T, Ruocco, L, Martini, G, Pedrini, S, Bertola, F, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Grandone, E, Colaizzo, D, Marzolo, M, Pinelli, M, Mastroiacovo, D, Ageno, W, Colombo, G, Bucherini, E, Serra, D, Toma, A, Barbera, P, Paparo, C, Insana, A, Rupoli, S, Malcangi, G, Zighetti, M, Mangione, C, Lione, D, Casasco, P, Nante, G, Tosetto, A, Oriana, V, Liberato, N, Zighetti, ML, Liberato, NL, Pastori, D, Antonucci, E, Violi, F, Palareti, G, Pignatelli, P, Testa, S, Paoletti, O, Cosmi, B, Guazzaloca, G, Migliaccio, L, Poli, D, Marcucci, R, Maggini, N, Pengo, V, Falanga, A, Lerede, T, Ruocco, L, Martini, G, Pedrini, S, Bertola, F, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Grandone, E, Colaizzo, D, Marzolo, M, Pinelli, M, Mastroiacovo, D, Ageno, W, Colombo, G, Bucherini, E, Serra, D, Toma, A, Barbera, P, Paparo, C, Insana, A, Rupoli, S, Malcangi, G, Zighetti, M, Mangione, C, Lione, D, Casasco, P, Nante, G, Tosetto, A, Oriana, V, Liberato, N, Zighetti, ML, and Liberato, NL

Abstract

Background Thrombocytopenia is associated with increased mortality in the general population, but few data exist in patients with atrial fibrillation (AF) taking oral anticoagulants. We investigated factor determinants of thrombocytopenia in a large cohort of patients affected by AF and its association with total mortality. Methods and Results Multicenter prospective cohort study, including 5215 patients with AF from the START (Survey on Anticoagulated Patients Register) registry, 3877 (74.3%) and 1338 (25.7%) on vitamin K or non-vitamin K antagonist oral anticoagulants, respectively. Thrombocytopenia was defined by a platelet count <150×109/L. Determinants of thrombocytopenia were investigated, and all-cause mortality was the primary survival end point of the study. Thrombocytopenia was present in 592 patients (11.4%). At multivariable logistic regression analysis, chronic kidney disease (odds ratio [OR], 1.257; P=0.030), active cancer (OR, 2.065; P=0.001), liver cirrhosis (OR, 7.635; P<0.001), and the use of diuretics (OR, 1.234; P=0.046) were positively associated with thrombocytopenia, whereas female sex (OR, 0.387; P<0.001) and the use of calcium channel blockers (OR, 0.787; P=0.032) were negatively associated. During a median follow-up of 19.2 months (9942 patient-years), 391 deaths occurred (rate, 3.93%/year). Mortality rate increased from 3.8%/year to 9.9%/year in patients with normal platelet count and in those with moderate-severe thrombocytopenia, respectively (log-rank test, P=0.009). The association between moderate-severe thrombocytopenia and mortality persisted after adjustment for CHA2DS2 VASc score (hazard ratio, 2.431; 95% CI, 1.254-4.713; P=0.009), but not in the fully adjusted multivariable Cox regression analysis model. Conclusions Thrombocytopenia is common in patients with AF. Despite an increased incidence of mortality, thrombocytopenia was not associated with mortality at multivariable analysis. Thrombocytopenia may reflect the pres

Published
2019

33. Mechanical prosthetic heart valves: Quality of anticoagulation and thromboembolic risk. The observational multicenter PLECTRUM study

Author

Poli, D., Antonucci, E., Pengo, V., Migliaccio, L., Testa, S., Lodigiani, C., Coffetti, N., Facchinetti, R., Serricchio, G., Falco, P., Mangione, C., Masottini, S., Ruocco, L., De Caterina, R., Palareti, G., and Italian Federation of Anticoagulation Clinics

Subjects
Male, medicine.medical_specialty, medicine.drug_class, Hemorrhage, 030204 cardiovascular system & hematology, Mechanical heart valves, 03 medical and health sciences, Anticoagulation, 0302 clinical medicine, Postoperative Complications, Risk Factors, Internal medicine, Thromboembolism, Outcome Assessment, Health Care, medicine, Humans, In patient, Bleeding, Stroke, Vitamin K antagonists, 030212 general & internal medicine, International Normalized Ratio, Blood Coagulation, Prosthetic heart, Aged, Retrospective Studies, Heart Valve Prosthesis Implantation, business.industry, Anticoagulants, Atrial fibrillation, Retrospective cohort study, Vitamin K antagonist, Middle Aged, medicine.disease, Thromboembolic risk, Italy, Heart Valve Prosthesis, Cardiology, Observational study, Female, Warfarin, Drug Monitoring, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors
Abstract

Patients with a mechanical prosthetic heart valve implantation need to be treated with a vitamin K antagonist (VKA) due to a substantially high risk of thromboembolism. In this study we report data on patients with mechanical heart valves (MV), with the aim of evaluating the thromboembolic risk in relation to the type and site of implantation, quality of anticoagulation and risk factors associated with thromboembolism.Observational retrospective multicenter study among Centers affiliated to the Italian Federation of Anticoagulation Clinics (FCSA) on patients with MV implanted after 1990 and followed for the management of anticoagulation.We analyzed 2357 patients with mechanical heart valves (55.2% males), followed for 24,081 years. During the follow-up, 164 thromboembolic events (0.67/100 pt-yrs) and 243 major bleedings (1.0/100 pt-yrs) occurred. The median Time in Therapeutic Range (TTR), calculated in all intended INR classes, was 60% (IQR 47-74%). The rates of thrombotic events were significantly higher in patients intended to stay at therapeutic rangesINR 2.0-3.0. The presence of atrial fibrillation, history of thromboembolism and of mitral prosthesis were independently associated with thromboembolism. However, a bad quality of anticoagulation (TTR47%, 25°percentile of our population) was not correlated with thromboembolism.A low rate of bleeding and thromboembolic events in patients with mechanical heart valves were found, despite the sub-optimal anticoagulation control. The thromboembolic risk was not associated with the low TTR.

Published
2018

34. Micobatteri tubercolari negli animali e implicazioni di sanità pubblica in Italia

Author

Graziani, C., Bellino, S., Busani, L., Pasquali, P., Pacciarini, M. L., Boniotti, M. B., Zanoni, M. G., Bollo, E., De Carlo, E., Vendetti, S., Pezzotti, P., Amadori, M., Gibelli, L., D'Incau, M., Zanardi, G., Borrello, S., Ruocco, L., Lomolino, R., and Primavera, A.

Subjects
Tubercolosi, Tubercolosi, animali, micobatteri, animali, micobatteri
Published
2018

35. Safety of vitamin K antagonist treatment for splanchnic vein thrombosis: a multicenter cohort study

Author

Riva, N, Ageno, W, Poli, D, Testa, S, Rupoli, S, Santoro, R, Lerede, T, Piana, A, Carpenedo, M, Nicolini, A, Ferrini, P, Tosetto, A, Paoletti, O, Rancan, E, Federici, I, Canafoglia, L, Lancisi, G, Salesi, G, Maggioni, A, Falanga, A, Martini, G, Mangione, C, Contino, L, Bonfanti, C, Gresele, P, Marigo, L, Nante, G, Sivera, P, Pasca, S, Malcangi, G, Ettorre, C, Cavallero, B, Falco, P, Ruocco, L, Paparo, C, Bucherini, E, Suriano, L, Crisantemo, R, Toma, A, Insana, A, Zanatta, N, Iannone, A, Oriana, V, Pezzo, M, Isu, G, Molinatti, M, Riva N, Ageno W, Poli D, Testa S, Rupoli S, Santoro R, Lerede T, Piana A, Carpenedo M, Nicolini A, Ferrini PM, Tosetto A, Paoletti O, Rancan E, Federici I, Canafoglia L, Lancisi GM, Salesi G, Maggioni A, Falanga A, Martini G, Mangione C, Contino L, Bonfanti C, Gresele P, Marigo L, Nante G, Sivera P, Pasca S, Malcangi G, Ettorre CP, Cavallero B, Falco P, Ruocco L, Paparo C, Bucherini E, Suriano L, Crisantemo R, Toma A, Insana A, Zanatta N, Iannone AM, Oriana V, Pezzo MP, Isu G, Molinatti M, Riva, N, Ageno, W, Poli, D, Testa, S, Rupoli, S, Santoro, R, Lerede, T, Piana, A, Carpenedo, M, Nicolini, A, Ferrini, P, Tosetto, A, Paoletti, O, Rancan, E, Federici, I, Canafoglia, L, Lancisi, G, Salesi, G, Maggioni, A, Falanga, A, Martini, G, Mangione, C, Contino, L, Bonfanti, C, Gresele, P, Marigo, L, Nante, G, Sivera, P, Pasca, S, Malcangi, G, Ettorre, C, Cavallero, B, Falco, P, Ruocco, L, Paparo, C, Bucherini, E, Suriano, L, Crisantemo, R, Toma, A, Insana, A, Zanatta, N, Iannone, A, Oriana, V, Pezzo, M, Isu, G, Molinatti, M, Riva N, Ageno W, Poli D, Testa S, Rupoli S, Santoro R, Lerede T, Piana A, Carpenedo M, Nicolini A, Ferrini PM, Tosetto A, Paoletti O, Rancan E, Federici I, Canafoglia L, Lancisi GM, Salesi G, Maggioni A, Falanga A, Martini G, Mangione C, Contino L, Bonfanti C, Gresele P, Marigo L, Nante G, Sivera P, Pasca S, Malcangi G, Ettorre CP, Cavallero B, Falco P, Ruocco L, Paparo C, Bucherini E, Suriano L, Crisantemo R, Toma A, Insana A, Zanatta N, Iannone AM, Oriana V, Pezzo MP, Isu G, and Molinatti M

Abstract

Background: The treatment of splanchnic vein thrombosis (SVT) is challenging, due to the increased risk of bleeding and potentially life-threatening complications. Current recommendations are based on evidence from the treatment of venous thrombosis in usual sites, but small observational studies in SVT population suggest that the bleeding risk may offset the benefit of anticoagulant treatment in this setting. The aim of this study was to evaluate the safety of vitamin K antagonists (VKAs) in SVT patients. Methods: We retrospectively included SVT patients treated with VKAs followed by 37 Italian anticoagulation clinics, until June 2013. The primary outcome was the incidence of major bleeding (MB), according to the ISTH definition, during VKA treatment. Vascular events, including both arterial and venous thrombosis, and mortality were also documented. Results: Three hundred and seventy-five patients were included (median age 53 years; 54.7% males). During a median VKA treatment duration of 1.98 years, 15 MB events occurred, corresponding to an incidence rate of 1.24 (95% confidence interval [CI], 0.75-2.06) per 100 patient-years. Gastrointestinal bleeding represented 40% of all MB events. At multivariate analysis, the presence of esophageal varices emerged as independent predictor of MB (hazard ratio 5.4; 95% CI, 1.4-21.1). The incidence rate of vascular events on treatment was 1.37 (95% CI, 0.84-2.23) per 100 patient-years and the mortality rate was 0.83 (95% CI, 0.44-1.54) per 100 patient-years. Conclusions: Selected SVT patients followed by anticoagulation clinics for the management of VKA treatment show a low rate of major bleeding and vascular events.

Published
2015

36. The Italian START-Register on anticoagulation with focus on atrial fibrillation

Author

Antonucci, E, Poli, D, Tosetto, A, Pengo, V, Tripodi, A, Magrini, N, Marongiu, F, Palareti, G, Testa, S, Paoletti, O, Falanga, A, Lerede, T, Guazzaloca, G, Marcucci, R, Piana, A, Cibecchini, F, Ruocco, L, Lucarelli, G, Paparo, C, Martini, G, Scovoli, G, Bradamante, S, Malcangi, G, Lombardi, M, Insana, A, Toma, A, Barbera, P, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Sangiorgio, R, Crippa, L, Pedrini, S, Bertola, F, Rupoli, S, Lion,e D, Pasca, S, Roldan, V, Rossi, V, Bucherini, E, Gresele, P, Mangione C, Cicconi, S, Casasco, P, Castaman, G, Liberato, NL, Bendotti, C, Oriana, V, Manotti, P, Zighetti, ML, Pedico, P, Fidone, E, Lombardo, C, Paci, OO, Pezzella, S, Pezzo, M, Ciampa, A, Maccaroni, I, Molini, G, Ciardiello, A, Marietta, M, Turrini, A, Barcellona, D, Antonucci, E, Poli, D, Tosetto, A, Pengo, V, Tripodi, A, Magrini, N, Marongiu, F, Palareti, G, Testa, S, Paoletti, O, Falanga, A, Lerede, T, Guazzaloca, G, Marcucci, R, Piana, A, Cibecchini, F, Ruocco, L, Lucarelli, G, Paparo, C, Martini, G, Scovoli, G, Bradamante, S, Malcangi, G, Lombardi, M, Insana, A, Toma, A, Barbera, P, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Sangiorgio, R, Crippa, L, Pedrini, S, Bertola, F, Rupoli, S, Lion, E, Pasca, S, Roldan, V, Rossi, V, Bucherini, E, Gresele, P, Mangione, C, Cicconi, S, Casasco, P, Castaman, G, Liberato, N, Bendotti, C, Oriana, V, Manotti, P, Zighetti, M, Pedico, P, Fidone, E, Lombardo, C, Paci, O, Pezzella, S, Pezzo, M, Ciampa, A, Maccaroni, I, Molini, G, Ciardiello, A, Marietta, M, Turrini, A, and Barcellona, D

Subjects
Genetics and Molecular Biology (all), Male, medicine.medical_specialty, lcsh:Medicine, Renal function, Hemorrhage, Biochemistry, Atrial Fibrillation, coagulation, anticoagulation, Cohort Studies, chemistry.chemical_compound, Interquartile range, Risk Factors, Internal medicine, Atrial Fibrillation, medicine, 80 and over, Humans, Registries, Renal Insufficiency, lcsh:Science, Stroke, Aged, Aged, 80 and over, Creatinine, Multidisciplinary, business.industry, Anticoagulants, Female, Italy, Middle Aged, Medicine (all), lcsh:R, Atrial fibrillation, medicine.disease, Surgery, Clinical trial, Agricultural and Biological Sciences (all), chemistry, Biochemistry, Genetics and Molecular Biology (all), lcsh:Q, Observational study, business, Research Article, Cohort study
Abstract

START-Register - Survey on anTicoagulated pAtients RegisTer - is an independent, inception-cohort, observational, collaborative database aimed at recording prospectively the clinical history of adult patients starting anticoagulant treatment for any reason and using whatever drug. In this article we present the START-Register and give cross section baseline data focusing on non valvular atrial fibrillation (NVAF). Participants are asked to insert prospectively consecutive patients recorded as electronic file on the web-site of the registry. Required data are: demographic and clinical characteristics of patients, associated risk factors for stroke and bleeding, laboratory routine data, clinical indication for treatment, expected therapeutic range (in cases of treatment with vitamin K antagonists -VKAs). The follow-up is carried out to record: quality of treatment (for patients on VKAs), bleeding complications, thrombotic events, and the onset of any type of associated disease. To date 5252 patients have been enrolled; 97.6% were on VKAs because direct oral anticoagulants (DOAC) have been available in Italy only recently. The median age was 74 years [interquartile range (IQR) 64-80]; males 53.7%. This analysis is focused on the 3209 (61.1%) NVAF patients. Mean CHADS2 score was 2.1±1.1, CHADSVASc score was 3.1±1.3;median age was 76 years (IQR 70-81); 168 patients (5.3%) had severe renal failure [Creatinine clearance (CrCl) 80 years with high prevalence of renal failure.

Published
2015

37. Bleeding Risk in Very Old Patients on Vitamin K Antagonist Treatment

Author

Polimanti, David, Antonucci, Eva, Testa, S., Tosetto, A., Ageno, W., Palareti, G., Collaborators: Poli, Italian Federation Of Anticoagulation C. l. i. n. i. c. s., Paoletti, O., Nante, G., Pengo, V., Carini, U., Guazzaloca, G., Scortechini, A. R., Canafoglia, L., Tomassetti, S., Restifo, D., Ciampa, A., Pignatelli, Pasquale, Basili, Stefania, Saliola, M., Di Gennaro, L., De Cristofaro, R., Caprioli, M., Pedrini, S., Orlandini, F., Benedetti, R., Ruocco, L., Tiraferri, E., Cappelli, R., Piana, A., Armani, U., Porcu, A., Falco, P., Da Col, P., Marongiu, F., Barcellona, D., Falanga, A., Lerede, T., Galbo, L., Bucherini, E., Insana, A., Grasso, M. V., Masciocco, L., and Pini, F.

Subjects
Male, Pediatrics, medicine.medical_specialty, Vitamin K, medicine.drug_class, venous thromboembolism, Hemorrhage, elderly, atrial fibrillation, hemorrhage, warfarin, Age Distribution, Aged, 80 and over, Anticoagulants, Atrial Fibrillation, Cooperative Behavior, Female, Humans, Incidence, Italy, Proportional Hazards Models, Prospective Studies, Risk Factors, Stroke, Venous Thromboembolism, Physiology (medical), Cardiology and Cardiovascular Medicine, oral anticoagulation, 80 and over, medicine, Medical prescription, Prospective cohort study, Aged, Proportional hazards model, business.industry, Incidence (epidemiology), Warfarin, Atrial fibrillation, Vitamin K antagonist, medicine.disease, Surgery, business, medicine.drug
Abstract

Background— Vitamin K antagonist (VKA) therapy is increasingly being used for the prevention of venous thromboembolism and stroke in atrial fibrillation. Bleeds are the major concern for VKA prescription, especially in very old patients who carry many risk factors for bleeding. We performed a large multicenter prospective observational study that enrolled very old patients to evaluate the quality of anticoagulation and the incidence of bleedings. Methods and Results— The study included 4093 patients ≥80 years of age who were naïve to VKA for thromboprophylaxis of atrial fibrillation or after venous thromboembolism. Patients' demographic and clinical data were collected, and the quality of anticoagulation and the incidence of bleeding were recorded. The follow-up was 9603 patient-years; median age at the beginning of follow-up was 84 years (range, 80 to 102 years). We recorded 179 major bleedings (rate, 1.87 per 100 patient-years), 26 fatal (rate, 0.27 per 100 patient-years). The rate of bleeding was higher in men compared with women (relative risk, 1.4; 95% confidence interval, 1.12 to 1.72; P =0.002) and among patients ≥85 years of age compared with younger patients (relative risk, 1.3; 95% confidence interval, 1.0 to 1.65; P =0.048). Time in therapeutic range was 62% (interquartile range, 49% to 75%). History of bleeding, active cancer, and history of falls were independently associated with bleeding risk in Cox regression analysis. Conclusion— In this large study on very old patients on VKA carefully monitored by anticoagulation clinics, the rate of bleedings was low, suggesting that age in itself should not be considered a contraindication to treatment. Adequate management of VKA therapy in specifically trained center allows very old and frail patients to benefit from VKA thromboprophylaxis.

Published
2011
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38. C0513: A Non-Invasive Approach for Monitoring Patients Undergoing Anticoagulant Therapy

Author

Ruocco, L, Lomonaco, T, Ghimenti, S, Piga, I, Onor, M, Fuoco, R, Paolicchi, A, Pellegrini, G, Giovanna Trivella, M, Di Francesco, F, Ruocco, L., Lomonaco, T., Ghimenti, S., Piga, I., Onor, M., Fuoco, R., Paolicchi, A., Pellegrini, G., Giovanna Trivella, M., Di Francesco, F., Ruocco, L, Lomonaco, T, Ghimenti, S, Piga, I, Onor, M, Fuoco, R, Paolicchi, A, Pellegrini, G, Giovanna Trivella, M, Di Francesco, F, Ruocco, L., Lomonaco, T., Ghimenti, S., Piga, I., Onor, M., Fuoco, R., Paolicchi, A., Pellegrini, G., Giovanna Trivella, M., and Di Francesco, F.

Published
2014

39. Emotional and risk seeking behavior after prepuberal subchronic or adult acute stimulation of 5-HT7-Rs in Naples High Excitability rats

Author

RUOCCO L. A., ROMANO E., TRENO C., LACIVITA E., ARRA C., GIRONI CARNEVALE U. A., TRAVAGLINI D., LEOPOLDO M., LAVIOLA G., ADRIANI W., SADILE, Adolfo, Ruocco, L. A., Romano, E., Treno, C., Lacivita, E., Arra, C., GIRONI CARNEVALE, U. A., Travaglini, D., Leopoldo, M., Laviola, G., Sadile, Adolfo, and Adriani, W.

Subjects
Male, Rats, Sprague-Dawley, Risk-Taking, Receptors, Serotonin, Emotions, Age Factors, Animals, Attention, Piperazines, Rats, Serotonin Receptor Agonists
Abstract

We report here the results of studies aimed to investigate the involvement of serotonin receptor 7 subtype (5-HT7-R) in the modulation of emotional response in Naples High-Excitability (NHE) rat, a validated model for hyperactivity and impaired attention. A range of dosages (0.0, 0.125, 0.250, or 0.500 mg/kg) of LP-211, a selective agonist of 5-HT7-Rs, has been evaluated in animals at different age (adolescence and adulthood). Male NHE and random bred (NRB) control rats were tested in an Elevated Zero-Maze (EZM) after LP-211 treatment in two different regimens: at the issue of adolescent, subchronic exposure (14 intraperitoneal [i.p.] injections, once/day, pnd 31-44, tested on pnd 45--Exp. 1) or as adult, acute effect (15 min after i.p. injection--Exp. 2). Adolescent, subchronic LP-211 at 0.500 mg/kg dosage increased the frequency of head-dips only in NHE rats. Drug effect on time spent and entries in open EZM quadrants were revealed with adult, acute administration of 0.125 mg/kg LP-211 (both strains), indicating a tendency toward anxiolytic effects. In conclusion, data demonstrate that subchronic stimulation of 5-HT7-Rs during prepuberal period increases novelty-seeking/risk-taking propensity in NHE adults. These sequels are revealing increased disinhibition and/or motivation to explore in the NHE rats, which are characterized by a hyperactive dopaminergic system. These data may open new perspectives in studying mechanism of risk-seeking behavior.

Published
2013

40. Legislazione e programmi di controllo nella tubercolosi bovina

Author

PELI, ANGELO, CINOTTI, STEFANO, Ruocco L., Talone T., Ferri G., F. Guarda, E. Bollo, G. Loris Alborali, Peli A., Ruocco L., Talone T., Ferri G., and Cinotti S.

Subjects
tubercolosi bovina, LEGISLAZIONE, sicuzza alimentare, POLIZIA SANITARIA, bovino
Abstract

Nel contributo è individuata ed esaminata la legislazione nazionale e dell'UE sulla tubercolosi bovina. In aprticolare sono trattati gli aspetti legati a:le metodiche di diagnosi ufficiale di tbc, la definizione di animale infetto e sospetto d'infezione, i provvedimenti per gli animali sospetti ed infetti conseguenti alla denuncia di focolaio, le modalità e tempi per il ripopolamento dell'allevamento, la definizione di allevamento ufficialmente indenne da tbc, la sospensione e la revoca della qualifica di allevamento ufficialmente indenne da tbc, le disposizioni particolari, i laboratori ufficiali di riferimento, la sistuazione epidemiologica ed i territiori italiani indenni, l'indenniotà di abbattimento, le norme sulla movimentazione di animali tra paesi UE e per l'importazione da paesi terzi, gli aspetti di sicurezza alimentare.

Published
2013

41. Determination of Warfarin and Warfarin alcohols in oral fluid and plasma samples for monitoring patients undergoing anticoagulant therapy

Author

Tommaso Lomonaco, Ghimenti, Silvia, Piga, I., Biagini, D., Onor, Massimo, Roger Fuoco, ALDO PAOLICCHI, Ruocco, L., Pellegrini, G., Trivella, M. G., Fabio Di Francesco, Lomonaco, T, Ghimenti, S, Piga, I, Biagini, D, Onor, M, Fuoco, R, Paolicchi, A, Ruocco, L, Pellegrini, G, Trivella, M, and Di Francesco, F

Subjects
HPLC, WARFARIN, Warfarin alcohols, oral fluid, plasma
Published
2013

44. The predictive ability of bleeding risk stratification models in very old patients on vitamin K antagonist treatment for venous thromboembolism: results of the prospective collaborative EPICA study

Author

Poli, D., Antonucci, E., Testa, S., Cosmi, B., Palareti, G., Ageno, W., Italian Federation Of Anticoagulation Clinics Poli, Fcsa D., Paoletti, O., Nante, G., Pengo, V., Carini, U., Guazzaloca, G., Scortechini, A. R., Canafoglia, L., Tomassetti, S., Restifo, D., Desio Vimercate, A. O., Ciampa, A., Pignatelli, Pasquale, Basili, Stefania, Saliola, Mirella, Di Gennaro, L., De Cristofaro, R., Caprioli, M., Pedrini, S., Orlandini, F., Benedetti, R., Ruocco, L., Tiraferri, E., Cappelli, R., Piana, A., Armani, U., Porcu, A., Falco, P., Da Col, P., Marongiu, F., Barcellona, D., Falanga, A., Lerede, T., Galbo, L., Bucherini, E., Insana, A., Masciocco, L., Pini, F., D. Poli, E. Antonucci, S. Testa, B. Cosmi, G. Palareti, W. Ageno, Poli, D, Antonucci, E, Testa, S, Cosmi, B, Palareti, G, Ageno, W, Paoletti, O, Nante, G, Pengo, V, Carini, U, Guazzaloca, G, Scortechini, A, Canafoglia, L, Tomassetti, S, Restifo, D, Ciampa, A, Pignatelli, P, Basili, S, Saliola, M, Di Gennaro, L, De Cristofaro, R, Caprioli, M, Pedrini, S, Orlandini, F, Benedetti, R, Ruocco, L, Tiraferri, E, Cappelli, R, Piana, A, Armani, U, Porcu, A, Falco, P, Dal Col, P, Marongiu, F, Barcellona, D, Falanga, A, Lerede, T, Galbo, L, Bucherini, E, Insana, A, Masciocco, L, and Pini, F

Subjects
bleeding, bleeding scores, elderly venous thromboembolism, vitamin K, antagonist, Predictive validity, Bleeding, Bleeding scores, Elderly, Venous thromboembolism, Vitamin K antagonist, medicine.medical_specialty, vitamin K antagonist, medicine.drug_class, Internal medicine, Atrial Fibrillation, Medicine, Prospective cohort study, Old patients, business.industry, Proportional hazards model, Risk Factor, Mortality rate, Hematology, Surgery, bleeding score, bleeding, bleeding scores, elderly, venous thromboembolism, vitamin k antagonist, Risk stratification, business
Abstract

BACKGROUND: The optimal duration of anticoagulant treatment after venous thromboembolism (VTE) should be evaluated in relation to bleeding risk. This assessment is particularly difficult with elderly patients, because of their increased risk of both recurrences and hemorrhages. Bleeding risk stratification models have been proposed, but their predictive ability in very elderly patients is unknown. We aimed to assess six bleeding stratification models in this setting, by using information available in our dataset. PATIENTS AND METHODS: Patients aged >/= 80 years receiving vitamin K antagonists (VKAs) for the secondary prevention of VTE were eligible for this prospective cohort study. All patients were followed at Italian anticoagulation clinics for monitoring of VKA treatment. Risk factors for bleeding were collected, and major bleeding events and mortality were documented during follow-up. The association of bleeding events with the available risk factors was tested by means of Cox regression analysis; the c-statistic was used to quantify the predictive validity of the classification schemes. RESULTS: A total of 1078 patients (37.2% males; mean age, 84 years) were enrolled in the study, for a total observation period of 1981 patient-years. The rate of major bleeding was 2.4 per 100 patient-years (47 events; one was fatal). The mortality rate was 5.2 per 100 patient-years. None of the considered risk factors were significantly associated with bleeding events. The predictive validity of the risk stratification models was low, and the most accurate model was not specifically developed for VTE patients (HEMORR2 HAGES, c-statistic 0.60, 95% confidence interval 0.49-0.70). CONCLUSIONS: Bleeding risk stratification models appear to have little accuracy in very elderly VTE patients.

Published
2013

45. Histamine H1 receptor knockout mice exhibit impaired spatial memory in the eight-arm radial maze

Author

ZLOMUZICA A., RUOCCO L. A., HUSTON J., DERE E., SADILE, Adolfo, Zlomuzica, A., Ruocco, L. A., Sadile, Adolfo, Huston, J., and Dere, E.

Subjects
Histamine H1 receptor, hippocampu, tuberomammillary nucleu, Morris water maze, working memory
Abstract

Background and purpose: In the mammalian brain, histaminergic neurotransmission is mediated by the postsynaptic histamine H1 and H2 receptors and the presynaptic H3 autoreceptor, which also acts as a heteroreceptor. The H1 receptor has been implicated in spatial learning and memory formation. However, pharmacological and lesion studies have revealed conflicting results. To examine the involvement of histamine H1 receptor in spatial reference and working memory formation, H1 receptor knockout mice (KO) were tested in the eight-arm radial maze. Previously, we found that the H1 receptor-KO mice showed reduced emotionality when confronted with spatial novelty. As it is known that emotions can have an impact on spatial learning and memory performance, we also evaluated H1 receptor-KO mice in terms of emotional behaviour in the light–dark box. Experimental approach: Mice lacking the H1 receptor and wild-type mice (WT) were tested for spatial reference and working memory in an eight-arm radial maze with three arms baited and one trial per day. Emotional behaviour was measured using the light–dark test. Key results: The H1 receptor-KO mice showed impaired spatial reference and working memory in the radial maze task. No significant differences between H1 receptor-KO and WT mice were observed in the light–dark test. Conclusions and implications: The spatial memory deficits of the H1 receptor-KO mice might be due to the reported changes in cholinergic neurochemical parameters in the frontal cortex and the CA1 subregion of the hippocampus, to impaired synaptic plasticity in the hippocampus, and/or to a dysfunctional brain reward/reinforcement system.

Published
2009

46. Intranasal Application of Dopamine Reduces Activity and Improves Attention in Naples High Excitability Rats that Feature the Mesocortical Variant of ADHD

Author

RUOCCO L. A., MARIA A., DE SOUZA SILVA M., BIANCATOPIC A., MATTERN C., HUSTON J. P., SADILE, Adolfo, Ruocco, L. A., Maria, A., DE SOUZA SILVA, M., Biancatopic, A., Mattern, C., Huston, J. P., and Sadile, Adolfo

Subjects
Male, medicine.medical_specialty, Intranasal route, Radial maze, Dopamine, Rat model, Striatum, Hyperkinesis, Motor Activity, Random Allocation, Animal model, Internal medicine, NHE rat, medicine, Animals, ADHD, Pharmacology (medical), Attention, Maze Learning, Biological Psychiatry, Administration, Intranasal, Pharmacology, Rats, Inbred Strains, Làt maze, Rats, Psychiatry and Mental health, Disease Models, Animal, Endocrinology, Neurology, Attention Deficit Disorder with Hyperactivity, Anesthesia, Attention deficit, Nasal administration, Olton maze, Neurology (clinical), Psychology, After treatment, medicine.drug
Abstract

Based on findings of a profound action of intranasally applied dopamine (DA) on dopamine release in the striatum, we examined the possibility that intranasal application of DA would influence indices of attention and activity in juvenile male rats of the Naples High Excitability line. This rat model features the main aspects of Attention Deficit/Hyperactivity Disorder (ADHD). Juvenile NHE rats received an intranasal application of either DA (0.075 mg/kg, 0.15 mg/kg and 0.3 mg/kg) or vehicle into both nostrils daily for 15 days. On day 14, 1 h after treatment, they were tested in the Lat maze, and one day later, in the eight arm radial maze. Activity in the Lat maze: The highest dose of DA (0.3 mg/kg) decreased horizontal (HA) and vertical (VA) activity during the first 10 min of the test. No effect was found for rearing duration (RD), which indexes non-selective attention (NSA). Activity in the radial maze: No treatment effects were found for HA and VA components, and for RD. Attention indices: The intermediate dose of DA (0.15 mg/kg) significantly improved the number of arms visited before the first repetitive arm entry in the radial maze, an index of selective spatial attention (SSA). In conclusion, intranasal application of DA reduced hyperactivity at the highest dose used, whereas the intermediate dose improved attention in an animal model of ADHD. These results suggest the potential of employing intranasal DA for therapeutic purposes.

Published
2009

47. The histamine H1-receptor mediates the motivational effects of novelty

Author

ZLOMUZICA A., VIGGIANO D., DE SOUZA SILVA M., ISHIZUKA T., GIRONI U., CARNEVALE U., RUOCCO L. A., WATANABE T., HUSTON J., DERE E., SADILE, Adolfo, Zlomuzica, A., Viggiano, D., DE SOUZA SILVA, M., Ishizuka, T., Gironi, U., Carnevale, U., Ruocco, L. A., Watanabe, T., Sadile, Adolfo, HUSTON J, ., and Dere, E.

Subjects
Male, Histamine H1 receptor, Amygdala, Arousal, Mice, Reward, Dopamine, medicine, Animals, Attention, histamine H1-receptor, Receptors, Histamine H1, conditioned place-preference, Mice, Knockout, Motivation, General Neuroscience, Novelty, Conditioned place preference, acetylcholine, Mice, Inbred C57BL, medicine.anatomical_structure, Exploratory Behavior, Brain stimulation reward, Wakefulness, amygdala, arousal, dopamine, Psychology, Neuroscience, medicine.drug
Abstract

Novelty-induced arousal has motivational effects and can reinforce behavior. The mechanisms by which novelty acts as a reinforcer are unknown. Novelty-induced arousal can be either rewarding or aversive dependent on its intensity and the preceding state of arousal. The brainfs histamine system has been implicated in both arousal and reinforcement. Histamine and histamine-1-receptor (H1R) agonists induced arousal and wakefulness in humans and rodents, e.g. by stimulating cortical acetylcholine (ACh) release. The H1R has also been implicated in processes of brain reward via interactions with the nigrostriatal- and mesolimbic dopamine (DA) systems. We asked whether the motivational effects of novelty-induced arousal are compromised in H1R knockout (KO) mice. The H1R-KO mice failed to develop a conditioned place-preference induced by novel objects. Even though they still explore novel objects, their reinforcing value is diminished. Furthermore, they showed impaired novelty-induced alternation in the Y-maze. Rearing activity and emotional behavior in a novel environment was also altered in H1R-KO mice, whereas object-place recognition was unaffected. The H1R-KO mice had higher ACh concentrations in the frontal cortex and amygdala (AMY). In the latter, the H1R-KO mice had also increased levels of DA, but a lower dihydrophenylacetic acid . DA ratio. Furthermore, the H1R-KO mice had also increased tyrosine hydroxylase immunoreactivity in the basolateral anterior, basolateral ventral and cortical AMY nuclei. We conclude that the motivational effects of novelty are diminished in H1R-KO mice, possibly due to reduced novelty-induced arousal and . or a dysfunctional brain reward system.

Published
2008

49. Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR Scleroderma Trials And Research group database

Author

Walker U. A., Tyndall A., Czirják L, Denton C. ., Farge Bancel D., Kowal Bielecka O., Müller Ladner U., Bocelli Tyndall C., Matucci Cerinic M., Riemekasten G. ., Brückner C. ., Airó P. ., Scarsi M. ., Scorza R. ., Beretta L. ., Cozzi F. ., Tiso F., Vonk Mc M. C., Hoogen Van Den, Fhj F. H. J., Wigley Fm F. M., Hummers L. ., Nevskaya T. ., Ananieva L. ., Miniati I. ., Tartaglia N. ., Lomater C. ., Balbir Gurman A. ., Braun Moscovici Y. ., Bambara Lm L. M., Caramaschi P. ., Ruocco L. ., Krieg T. ., Hunzelmann N. ., Varjú C. ., Carriera Pe P. E., Joven B. ., Iannone F. ., Lapadula G. ., Kahan A. ., Allanore Y. ., Gabrielli A. ., Imperatore M. ., Scheja A. ., Wollheim F. ., Damjanov N. ., Ostojic P. ., Saar P. ., Tarner Ih I. H., Kötter I. ., Bombardieri S. ., Bazzichi L. ., Papa Del N. ., Comina Dp D. P., Monaco Lo A. ., Corte La R. ., Hachulla E. ., Launay D. ., Distler O. ., Ciurea A. ., Sierakowski S. ., Mitchell H. ., Silver Rm R. M., Krasowska D. ., Michalska Jakubus M. ., Tikly M. ., Aboo N. ., Worm M. ., Klaus P. ., Rovenský J. ., Lukáčová O. ., Rozman B. ., Sipek A. ., Clemente Coelho P. ., Shoenfeld Y. ., Langewitch P. ., José Da Silva Ap A. P., Salvador Mj M. J., Kuhn A. ., Erdmann G. ., Bečvář R. ., Friedl E. ., Graninger W. ., Riccieri V. ., Caporali R. ., Montecucco C. ., Vlachoyiannopoulos P. ., Distler M. ., Reich K. ., Majdan M. ., Wielosz E. ., Rednic S. ., Laar Van Jm J. M., Heitmann S. ., Bruckner A. ., Himsel A. ., Riemann J. ., Meyringer R. ., Müller A. ., Martinovic D. ., Radic M. ., Sticherling M. ., Szekanecz Z. ., Szücs G. ., Giacomelli R. ., Marrelli A. ., Stamenkovic B. ., Stankovic A. ., Aringer M. ., Smolen Js J. S., Kucharz Ej E. J., Kotulska At A. T., Jablonska S. ., Blasczik M. ., Jun J. B. J. B., Mallia C. ., Coleiro B. ., Santamaria Vo V. O., Hinrichs R. ., Nielsen H. ., Cossutta R. ., Ionescu R. ., Opris D. ., Steinbrink K. ., Grundt B. ., Bajocchi G. ., Jiří Š. ., Lefebvre Pgdlp P. G. D. L. P., Mendoza ZeaAc A. C., Ribi C. ., Chizzolini C. ., Wisłowska M. ., Novak S. ., Indiveri F. ., Jacobsen S. ., Frandsen Pb P. B., Gorska Iz I. Z., Gran Tore J. ., Midtvedt Ø. ., Ramos Fo F. O., Rajcevska Ld L. D., Bozinovski G. ., Schöffel D. ., Sunderkötter C. ., Böhm M. ., Morović Vergles J. ., Čulo M. I. M. I., Cutolo M. ., Sulli A. ., Derk Ct C. T., Jimenez Sa S. A., Siakka P. ., Søndergaard K. ., Stengaard Pedersen K. ., Cabane J. ., Tiev Kp K. P., Mihai C. ., Sfrent Cornateanu R. ., Jendro M. ., Tuvik P. ., Antivalle M. ., Randisi G. ., Seidel M. ., Clarenbach R. ., Simsek I. ., Dinc A. ., Inanc M. ., Capraru Ms M. S., Capraru D. ., Bañegil I. ., Richter J. ., Alhasani S. ., Földvari I. ., Pinto S. ., Brandão F. ., VALENTINI, Gabriele, Walker, U. A., Tyndall, A., Czirják, L, Denton, C. ., Farge Bancel, D., Kowal Bielecka, O., Müller Ladner, U., Bocelli Tyndall, C., Matucci Cerinic, M., Riemekasten, G. ., Brückner, C. ., Airó, P. ., Scarsi, M. ., Scorza, R. ., Beretta, L. ., Cozzi, F. ., Tiso, F., Vonk Mc, M. C., Hoogen Van, Den, Fhj, F. H. J., Wigley Fm, F. M., Hummers, L. ., Nevskaya, T. ., Ananieva, L. ., Miniati, I. ., Tartaglia, N. ., Lomater, C. ., Balbir Gurman, A. ., Braun Moscovici, Y. ., Bambara Lm, L. M., Caramaschi, P. ., Valentini, Gabriele, Ruocco, L. ., Krieg, T. ., Hunzelmann, N. ., Varjú, C. ., Carriera Pe, P. E., Joven, B. ., Iannone, F. ., Lapadula, G. ., Kahan, A. ., Allanore, Y. ., Gabrielli, A. ., Imperatore, M. ., Scheja, A. ., Wollheim, F. ., Damjanov, N. ., Ostojic, P. ., Saar, P. ., Tarner Ih, I. H., Kötter, I. ., Bombardieri, S. ., Bazzichi, L. ., Papa Del, N. ., Comina Dp, D. P., Monaco Lo, A. ., Corte La, R. ., Hachulla, E. ., Launay, D. ., Distler, O. ., Ciurea, A. ., Sierakowski, S. ., Mitchell, H. ., Silver Rm, R. M., Krasowska, D. ., Michalska Jakubus, M. ., Tikly, M. ., Aboo, N. ., Worm, M. ., Klaus, P. ., Rovenský, J. ., Lukáčová, O. ., Rozman, B. ., Sipek, A. ., Clemente Coelho, P. ., Shoenfeld, Y. ., Langewitch, P. ., José Da Silva Ap, A. P., Salvador Mj, M. J., Kuhn, A. ., Erdmann, G. ., Bečvář, R. ., Friedl, E. ., Graninger, W. ., Riccieri, V. ., Caporali, R. ., Montecucco, C. ., Vlachoyiannopoulos, P. ., Distler, M. ., Reich, K. ., Majdan, M. ., Wielosz, E. ., Rednic, S. ., Laar Van Jm, J. M., Heitmann, S. ., Bruckner, A. ., Himsel, A. ., Riemann, J. ., Meyringer, R. ., Müller, A. ., Martinovic, D. ., Radic, M. ., Sticherling, M. ., Szekanecz, Z. ., Szücs, G. ., Giacomelli, R. ., Marrelli, A. ., Stamenkovic, B. ., Stankovic, A. ., Aringer, M. ., Smolen Js, J. S., Kucharz Ej, E. J., Kotulska At, A. T., Jablonska, S. ., Blasczik, M. ., Jun, J. B. J. B., Mallia, C. ., Coleiro, B. ., Santamaria Vo, V. O., Hinrichs, R. ., Nielsen, H. ., Cossutta, R. ., Ionescu, R. ., Opris, D. ., Steinbrink, K. ., Grundt, B. ., Bajocchi, G. ., Jiří, Š. ., Lefebvre Pgdlp, P. G. D. L. P., Mendoza ZeaAc, A. C., Ribi, C. ., Chizzolini, C. ., Wisłowska, M. ., Novak, S. ., Indiveri, F. ., Jacobsen, S. ., Frandsen Pb, P. B., Gorska Iz, I. Z., Gran Tore, J. ., Midtvedt, Ø. ., Ramos Fo, F. O., Rajcevska Ld, L. D., Bozinovski, G. ., Schöffel, D. ., Sunderkötter, C. ., Böhm, M. ., Morović Vergles, J. ., Čulo, M. I. M. I., Cutolo, M. ., Sulli, A. ., Derk Ct, C. T., Jimenez Sa, S. A., Siakka, P. ., Søndergaard, K. ., Stengaard Pedersen, K. ., Cabane, J. ., Tiev Kp, K. P., Mihai, C. ., Sfrent Cornateanu, R. ., Jendro, M. ., Tuvik, P. ., Antivalle, M. ., Randisi, G. ., Seidel, M. ., Clarenbach, R. ., Simsek, I. ., Dinc, A. ., Inanc, M. ., Capraru Ms, M. S., Capraru, D. ., Bañegil, I. ., Richter, J. ., Alhasani, S. ., Földvari, I. ., Pinto, S. ., Brandão, F. ., Ribi, Camillo, and Chizzolini, Carlo

Subjects
Male, Systemic disease, Databases, Factual, Cross-sectional study, Scleroderma, Immunopathology, Immunology and Allergy, Age of Onset, skin and connective tissue diseases, ddc:616, integumentary system, Nuclear Proteins, Orvostudományok, Middle Aged, Connective tissue disease, Extended Report, Raynaud Disease/etiology/immunology, DNA Topoisomerases, Type I, Nuclear Proteins/immunology, Female, Adult, medicine.medical_specialty, Scleroderma, Diffuse/complications/immunology, Immunology, Klinikai orvostudományok, Scleroderma, Systemic/complications/immunology, Risk Assessment, General Biochemistry, Genetics and Molecular Biology, systemic sclerosis, EULAR, risk assessment, Age Distribution, Sex Factors, Rheumatology, Scleroderma, Limited, medicine, Humans, Risk factor, Aged, Autoantibodies, Scleroderma, Systemic, business.industry, Autoantibody, Raynaud Disease, medicine.disease, Dermatology, Cross-Sectional Studies, Scleroderma, Diffuse, Scleroderma, Limited/complications/immunology, Age of onset, business, Autoantibodies/blood
Abstract

Background: Systemic sclerosis (SSc) is a multisystem autoimmune disease which is classified into a diffuse cutaneous (dcSSc) and a limited cutaneous (lcSSc) subset according to the skin involvement. In order to better understand the vascular, immunological and fibrotic processes of SSc and to guide its treatment the EULAR Scleroderma Trials And Research (EUSTAR) group was formed in June 2004. Aims and Methods: EUSTAR collects prospectively the Minimal Essential Data Set (MEDS) on all sequential patients fulfilling the ACR diagnostic criteria in participating centres. We aimed to characterize demographic, clinical and laboratory characteristics of disease presentation in SSc and analysed EUSTAR baseline visits. Results: In April 2006, a total of 3656 patients (1349 with dcSSc and 2101 with lcSSc) were enrolled in 102 centres and 30 countries. 1330 individuals had autoantibodies against Scl70 and 1106 against anticentromere antibodies. 87% of patients were female. On multivariate analysis, scleroderma subsets (dcSSc vs. lcSSc), antibody status and age at onset of Raynaud’s phenomenon, but not gender were independently associated with the prevalence of organ manifestations. Autoantibody status in this analysis appeared more closely associated with clinical manifestations than were SSc subsets. Conclusion: dcSSc and lcSSc subsets are associated with particular organ manifestations, but in this analysis the clinical distinction appeared superseded by an antibody based classification in predicting some scleroderma complications. The EUSTAR MEDS data base facilitates the analysis of clinical patterns in SSc and contributes to the standardised assessment and monitoring of SSc internationally.

Published
2007

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