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3. Oral anticoagulants in the oldest old with recent stroke and atrial fibrillation

Author

Polymeris, A. A., Macha, K., Paciaroni, M., Wilson, D., Koga, M., Cappellari, M., Schaedelin, S., Zietz, A., Peters, N., Seiffge, D. J., Haupenthal, D., Gassmann, L., De Marchis, G. M., Wang, R., Gensicke, H., Stoll, S., Thilemann, S., Avramiotis, N. S., Bonetti, B., Tsivgoulis, G., Ambler, G., Alberti, A., Yoshimura, S., Brown, M. M., Shiozawa, M., Lip, G. Y. H., Venti, M., Acciarresi, M., Tanaka, K., Mosconi, M. G., Takagi, M., Jager, R. H., Muir, K., Inoue, M., Schwab, S., Bonati, L. H., Lyrer, P. A., Toyoda, K., Caso, V., Werring, D. J., Kallmunzer, B., Engelter, S. T., Traenka, C., Hert, L., Wagner, B., Schaub, F., Meya, L., Fladt, J., Dittrich, T., Fisch, U., Volbers, B., Siedler, G., Bovi, P., Tomelleri, G., Micheletti, N., Zivelonghi, C., Emiliani, A., Parry-Jones, A., Patterson, C., Price, C., Elmarimi, A., Parry, A., Nallasivam, A., Nor, A. M., Esis, B., Bruce, D., Bhaskaran, B., Roffe, C., Cullen, C., Holmes, C., Cohen, D., Hargroves, D., Mangion, D., Chadha, D., Vahidassr, D., Manawadu, D., Giallombardo, E., Warburton, E., Flossman, E., Gunathilagan, G., Proschel, H., Emsley, H., Anwar, I., Burger, I., Okwera, J., Putterill, J., O'Connell, J., Bamford, J., Corrigan, J., Scott, J., Birns, J., Kee, K., Saastamoinen, K., Pasco, K., Dani, K., Sekaran, L., Choy, L., Iveson, L., Mamun, M., Sajid, M., Cooper, M., Burn, M., Smith, M., Power, M., Davis, M., Smyth, N., Veltkamp, R., Sharma, P., Guyler, P., O'Mahony, P., Wilkinson, P., Datta, P., Aghoram, P., Marsh, R., Luder, R., Meenakishundaram, S., Subramonian, S., Leach, S., Ispoglou, S., Andole, S., England, T., Manoj, A., Harrington, F., Rehman, H., Sword, J., Staals, J., Mahawish, K., Harkness, K., Shaw, L., Mccormich, M., Sprigg, N., Mansoor, S., Krishnamurthy, V., Giustozzi, M., Agnelli, G., Becattini, C., D'Amore, C., Cimini, L. A., Bandini, F., Liantinioti, C., Chondrogianni, M., Yaghi, S., Furie, K. L., Tadi, P., Zedde, M., Abdul-Rahim, A. H., Lees, K. R., Carletti, M., Rigatelli, A., Putaala, J., Tomppo, L., Tatlisumak, T., Marcheselli, S., Pezzini, A., Poli, L., Padovani, A., Vannucchi, V., Masotti, L., Sohn, S. -I., Lorenzini, G., Tassi, R., Guideri, F., Acampa, M., Martini, G., Ntaios, G., Athanasakis, G., Makaritsis, K., Karagkiozi, E., Vadikolias, K., Mumoli, N., Galati, F., Sacco, S., Tiseo, C., Corea, F., Ageno, W., Bellesini, M., Colombo, G., Silvestrelli, G., Ciccone, A., Lanari, A., Scoditti, U., Denti, L., Mancuso, M., Maccarrone, M., Ulivi, L., Orlandi, G., Giannini, N., Tassinari, T., De Lodovici, M. L., Rueckert, C., Baldi, A., Toni, D., Letteri, F., Pieroni, A., Giuntini, M., Lotti, E. M., Flomin, Y., Kargiotis, O., Karapanayiotides, T., Monaco, S., Baronello, M. M., Csiba, L., Szabo, L., Chiti, A., Giorli, E., Del Sette, M., Imberti, D., Zabzuni, D., Doronin, B., Volodina, V., Michel, P., Vanacker, P., Barlinn, K., Pallesen, L. -P., Barlinn, J., Deleu, D., Melikyan, G., Ibrahim, F., Akhtar, N., Gourbali, V., Todo, K., Kimura, K., Shibazaki, K., Yagita, Y., Furui, E., Itabashi, R., Terasaki, T., Shiokawa, Y., Hirano, T., Suzuki, R., Kamiyama, K., Nakagawara, J., Takizawa, S., Homma, K., Okuda, S., Okada, Y., Maeda, K., Kameda, T., Kario, K., Nagakane, Y., Hasegawa, Y., Akiyama, H., Shibuya, S., Mochizuki, H., Ito, Y., Nakashima, T., Matsuoka, H., Takamatsu, K., Nishiyama, K., Endo, K., Miyagi, T., Osaki, M., Kobayashi, J., Okata, T., Tanaka, E., Sakamoto, Y., Tokunaga, K., Takizawa, H., Takasugi, J., Matsubara, S., Higashida, K., Matsuki, T., Kinoshita, N., Ide, T., Yoshimoto, T., Ando, D., Fujita, K., Kumamoto, M., Kamimura, T., Kikuno, M., Mizoguchi, T., and Sato, T.

Subjects
Male, medicine.medical_specialty, Vitamin K, medicine.drug_class, 610 Medicine & health, Aged, 80 and over, Atrial Fibrillation, Factor Xa Inhibitors, Female, Humans, Stroke, Continuous variable, Internal medicine, 80 and over, medicine, Aged, Proportional hazards model, business.industry, Anticoagulant, Confounding, Atrial fibrillation, Patient data, medicine.disease, Oldest old, Neurology, Neurology (clinical), 610 Medizin und Gesundheit, business
Abstract

Objective: To investigate the safety and effectiveness of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) after recent stroke in patients with atrial fibrillation (AF) aged ≥85 years. Methods: Individual patient data analysis from seven prospective stroke cohorts. We compared DOAC versus VKA treatment among patients with AF and recent stroke (≥85y = 0.65, 95%-CI [0.52, 0.81]) and < 85 years (HR = 0.79, 95%-CI [0.66, 0.95]) in simple (p interaction = 0.129), adjusted (p interaction = 0.094) or weighted (p interaction = 0.512) models. Analyses on recurrent stroke, ICH and death separately were consistent with the primary analysis, as were sensitivity analyses using age dichotomized at 90 years and as a continuous variable. DOAC had a similar net clinical benefit in patients aged ≥85 (+1.73 to +2.66) and < 85 years (+1.90 to +3.36 events/100 patient-years for ICH-weights 1.5 to 3.1). Interpretation: The favorable profile of DOAC over VKA in patients with AF and recent stroke was maintained in the oldest old. ANN NEUROL 2021.

Published
2022

4. Oral Anticoagulants in the Oldest Old with Recent Stroke and Atrial Fibrillation

Author

Polymeris, A.A. Macha, K. Paciaroni, M. Wilson, D. Koga, M. Cappellari, M. Schaedelin, S. Zietz, A. Peters, N. Seiffge, D.J. Haupenthal, D. Gassmann, L. De Marchis, G.M. Wang, R. Gensicke, H. Stoll, S. Thilemann, S. Avramiotis, N.S. Bonetti, B. Tsivgoulis, G. Ambler, G. Alberti, A. Yoshimura, S. Brown, M.M. Shiozawa, M. Lip, G.Y.H. Venti, M. Acciarresi, M. Tanaka, K. Mosconi, M.G. Takagi, M. Jäger, R.H. Muir, K. Inoue, M. Schwab, S. Bonati, L.H. Lyrer, P.A. Toyoda, K. Caso, V. Werring, D.J. Kallmünzer, B. Engelter, S.T. Engelter, S.T. Lyrer, P.A. Bonati, L.H. Seiffge, D.J. Traenka, C. Polymeris, A.A. Zietz, A. Peters, N. De Marchis, G.M. Thilemann, S. Avramiotis, N.S. Gensicke, H. Hert, L. Wagner, B. Schaub, F. Meya, L. Fladt, J. Dittrich, T. Fisch, U. Macha, K. Haupenthal, D. Gassmann, L. Wang, R. Stoll, S. Schwab, S. Volbers, B. Siedler, G. Kallmünzer, B. Cappellari, M. Bonetti, B. Bovi, P. Tomelleri, G. Micheletti, N. Zivelonghi, C. Emiliani, A. Parry-Jones, A. Patterson, C. Price, C. Elmarimi, A. Parry, A. Nallasivam, A. Nor, A.M. Esis, B. Bruce, D. Bhaskaran, B. Roffe, C. Cullen, C. Holmes, C. Cohen, D. Hargroves, D. Mangion, D. Chadha, D. Vahidassr, D. Manawadu, D. Giallombardo, E. Warburton, E. Flossman, E. Gunathilagan, G. Proschel, H. Emsley, H. Anwar, I. Burger, I. Okwera, J. Putterill, J. O’Connell, J. Bamford, J. Corrigan, J. Scott, J. Birns, J. Kee, K. Saastamoinen, K. Pasco, K. Dani, K. Sekaran, L. Choy, L. Iveson, L. Mamun, M. Sajid, M. Cooper, M. Burn, M. Smith, M. Power, M. Davis, M. Smyth, N. Veltkamp, R. Sharma, P. Guyler, P. O’Mahony, P. Wilkinson, P. Datta, P. Aghoram, P. Marsh, R. Luder, R. Meenakishundaram, S. Subramonian, S. Leach, S. Ispoglou, S. Andole, S. England, T. Manoj, A. Harrington, F. Rehman, H. Sword, J. Staals, J. Mahawish, K. Harkness, K. Shaw, L. McCormich, M. Sprigg, N. Mansoor, S. Krishnamurthy, V. Giustozzi, M. Acciarresi, M. Agnelli, G. Becattini, C. Alberti, A. D’Amore, C. Cimini, L.A. Bandini, F. Tsivgoulis, G. Liantinioti, C. Chondrogianni, M. Yaghi, S. Furie, K.L. Tadi, P. Zedde, M. Abdul-Rahim, A.H. Lees, K.R. Bovi, P. Carletti, M. Rigatelli, A. Cappellari, M. Putaala, J. Tomppo, L. Tatlisumak, T. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Vannucchi, V. Masotti, L. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Athanasakis, G. Makaritsis, K. Karagkiozi, E. Vadikolias, K. Mumoli, N. Galati, F. Sacco, S. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Colombo, G. Silvestrelli, G. Ciccone, A. Lanari, A. Scoditti, U. Denti, L. Mancuso, M. Maccarrone, M. Ulivi, L. Orlandi, G. Giannini, N. Tassinari, T. De Lodovici, M.L. Rueckert, C. Baldi, A. Toni, D. Letteri, F. Pieroni, A. Giuntini, M. Lotti, E.M. Flomin, Y. Kargiotis, O. Karapanayiotides, T. Monaco, S. Baronello, M.M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Del Sette, M. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel, P. Vanacker, P. Barlinn, K. Pallesen, L.-P. Barlinn, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Gourbali, V. Todo, K. Kimura, K. Shibazaki, K. Yagita, Y. Furui, E. Itabashi, R. Terasaki, T. Shiokawa, Y. Hirano, T. Suzuki, R. Kamiyama, K. Nakagawara, J. Takizawa, S. Homma, K. Okuda, S. Okada, Y. Maeda, K. Kameda, T. Kario, K. Nagakane, Y. Hasegawa, Y. Akiyama, H. Shibuya, S. Mochizuki, H. Ito, Y. Nakashima, T. Matsuoka, H. Takamatsu, K. Nishiyama, K. Tanaka, K. Endo, K. Miyagi, T. Osaki, M. Kobayashi, J. Okata, T. Tanaka, E. Sakamoto, Y. Tokunaga, K. Takizawa, H. Takasugi, J. Matsubara, S. Higashida, K. Matsuki, T. Kinoshita, N. Shiozawa, M. Ide, T. Yoshimoto, T. Ando, D. Fujita, K. Kumamoto, M. Kamimura, T. Kikuno, M. Mizoguchi, T. Sato, T. NOACISP-LONGTERM, Erlangen Registry, CROMIS-2, RAF, RAF-DOAC, SAMURAI-NVAF Verona Registry Collaborators

Abstract

Objective: To investigate the safety and effectiveness of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) after recent stroke in patients with atrial fibrillation (AF) aged ≥85 years. Methods: Individual patient data analysis from seven prospective stroke cohorts. We compared DOAC versus VKA treatment among patients with AF and recent stroke (

Published
2022

5. Risk Factors for Intracerebral Hemorrhage in Patients with Atrial Fibrillation on Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention

Author

Paciaroni, M. Agnelli, G. Giustozzi, M. Caso, V. Toso, E. Angelini, F. Canavero, I. Micieli, G. Antonenko, K. Rocco, A. Diomedi, M. Katsanos, A.H. Shoamanesh, A. Giannopoulos, S. Ageno, W. Pegoraro, S. Putaala, J. Strbian, D. Sallinen, H. Mac Grory, B.C. Furie, K.L. Stretz, C. Reznik, M.E. Alberti, A. Venti, M. Mosconi, M.G. Vedovati, M.C. Franco, L. Zepponi, G. Romoli, M. Zini, A. Brancaleoni, L. Riva, L. Silvestrelli, G. Ciccone, A. Zedde, M.L. Giorli, E. Kosmidou, M. Ntais, E. Palaiodimou, L. Halvatsiotis, P. Tassinari, T. Saia, V. Ornello, R. Sacco, S. Bandini, F. Mancuso, M. Orlandi, G. Ferrari, E. Pezzini, A. Poli, L. Cappellari, M. Forlivesi, S. Rigatelli, A. Yaghi, S. Scher, E. Frontera, J.A. Masotti, L. Grifoni, E. Caliandro, P. Zauli, A. Reale, G. Marcheselli, S. Gasparro, A. Terruso, V. Arnao, V. Aridon, P. Abdul-Rahim, A.H. Dawson, J. Saggese, C.E. Palmerini, F. Doronin, B. Volodina, V. Toni, D. Risitano, A. Schirinzi, E. Del Sette, M. Lochner, P. Monaco, S. Mannino, M. Tassi, R. Guideri, F. Acampa, M. Martini, G. Lotti, E.M. Padroni, M. Pantoni, L. Rosa, S. Bertora, P. Ntaios, G. Sagris, D. Baldi, A. D'Amore, C. Mumoli, N. Porta, C. Denti, L. Chiti, A. Corea, F. Acciarresi, M. Flomin, Y. Popovic, N. Tsivgoulis, G.

Subjects
cardiovascular diseases
Abstract

Background and Purpose: Clinical trials on stroke prevention in patients with atrial fibrillation have consistently shown clinical benefit from either warfarin or non-vitamin K antagonist oral anticoagulants (NOACs). NOAC-treated patients have consistently reported to be at lower risk for intracerebral hemorrhage (ICH) than warfarin-treated patients. The aims of this prospective, multicenter, multinational, unmatched, case-control study were (1) to investigate for risk factors that could predict ICH occurring in patients with atrial fibrillation during NOAC treatment and (2) to evaluate the role of CHA2DS2-VASc and HAS-BLED scores in the same setting. Methods: Cases were consecutive patients with atrial fibrillation who had ICH during NOAC treatment. Controls were consecutive patients with atrial fibrillation who did not have ICH during NOAC treatment. As within the CHA2DS2-VASc and HAS-BLED scores there are some risk factors in common, several multivariable logistic regression models were performed to identify independent prespecified predictors for ICH events. Results: Four hundred nineteen cases (mean age, 78.8±8.1 years) and 1526 controls (mean age, 76.0±10.3 years) were included in the study. From the different models performed, independent predictors of ICH were increasing age, concomitant use of antiplatelet agents, active malignancy, high risk of fall, hyperlipidemia, low clearance of creatinine, peripheral artery disease, and white matter changes. Low doses of NOACs (given according to label or not) and congestive heart failure were inversely associated with the risk of ICH. HAS-BLED and CHA2DS2-VASc scores performed poorly in predicting ICH with areas under the curves of 0.496 (95% CI, 0.468-0.525) and 0.530 (95% CI, 0.500-0.560), respectively. Conclusions: Several risk factors were associated to ICH in patients treated with NOACs for stroke prevention but not HAS-BLED and CHA2DS2-VASc scores. © 2021 Lippincott Williams and Wilkins. All rights reserved.

Published
2021

6. Safety of Anticoagulation in Patients Treated with Urgent Reperfusion for Ischemic Stroke Related to Atrial Fibrillation

Author

Giustozzi, M. Acciarresi, M. Agnelli, G. Caso, V. Bandini, F. Tsivgoulis, G. Yaghi, S. Furie, K.L. Tadi, P. Becattini, C. Zedde, M. Abdul-Rahim, A.H. Lees, K.R. Alberti, A. Venti, M. D'Amore, C. Giulia Mosconi, M. Anna Cimini, L. Bovi, P. Carletti, M. Rigatelli, A. Cappellari, M. Putaala, J. Tomppo, L. Tatlisumak, T. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Vannucchi, V. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Athanasakis, G. Makaritsis, K. Karagkiozi, E. Vadikolias, K. Liantinioti, C. Theodorou, A. Halvatsiotis, P. Mumoli, N. Galati, F. Sacco, S. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Silvestrelli, G. Ciccone, A. Lanari, A. Scoditti, U. Denti, L. Mancuso, M. Ferrari, E. Ulivi, L. Orlandi, G. Giannini, N. Tassinari, T. Luisa De Lodovici, M. Rueckert, C. Baldi, A. Toni, D. Letteri, F. Giuntini, M. Maria Lotti, E. Flomin, Y. Pieroni, A. Kargiotis, O. Karapanayiotides, T. Monaco, S. Maimone Baronello, M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Del Sette, M. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel, P. Vanacker, P. Barlinn, K. Barlinn, J. Deleu, D. Gourbali, V. Paciaroni, M. Masotti, L.

Abstract

Background and Purpose: The optimal timing for starting oral anticoagulant after an ischemic stroke related to atrial fibrillation remains a challenge, mainly in patients treated with systemic thrombolysis or mechanical thrombectomy. We aimed at assessing the incidence of early recurrence and major bleeding in patients with acute ischemic stroke and atrial fibrillation treated with thrombolytic therapy and/or thrombectomy, who then received oral anticoagulants for secondary prevention. Methods: We combined the dataset of the RAF and the RAF-NOACs (Early Recurrence and Major Bleeding in Patients With Acute Ischemic Stroke and Atrial Fibrillation Treated With Non-Vitamin K Oral Anticoagulants) studies, which were prospective observational studies carried out from January 2012 to March 2014 and April 2014 to June 2016, respectively. We included consecutive patients with acute ischemic stroke and atrial fibrillation treated with either Vitamin K antagonists or nonVitamin K oral anticoagulants. Primary outcome was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding within 90 days from the inclusion. Treated-patients were propensity matched to untreated-patients in a 1:1 ratio after stratification by baseline clinical features. Results: A total of 2159 patients were included, 564 (26%) patients received acute reperfusion therapies. After the index event, 505 (90%) patients treated with acute reperfusion therapies and 1287 of 1595 (81%) patients untreated started oral anticoagulation. Timing of starting oral anticoagulant was similar in reperfusion-treated and untreated patients (median 7.5 versus 7.0 days, respectively). At 90 days, the primary study outcome occurred in 37 (7%) patients treated with reperfusion and in 146 (9%) untreated patients (odds ratio, 0.74 [95% CI, 0.50-1.07]). After propensity score matching, risk of primary outcome was comparable between the 2 groups (odds ratio, 1.06 [95% CI, 0.53-2.02]). Conclusions: Acute reperfusion treatment did not influence the risk of early recurrence and major bleeding in patients with atrial fibrillation-related acute ischemic stroke, who started on oral anticoagulant. © 2020 The Authors.

Published
2020

7. Timing of initiation of oral anticoagulants in patients with acute ischemic stroke and atrial fibrillation comparing posterior and anterior circulation strokes

Author

Paciaroni, M. Agnelli, G. Giustozzi, M. Tsivgoulis, G. Yaghi, S. Grory, B.M. Furie, K.L. Tadi, P. Zedde, M. Abdul-Rahim, A.H. Dawson, J. Lees, K.R. Alberti, A. Venti, M. Acciarresi, M. D’Amore, C. Mosconi, M.G. Bogini, V. Cappellari, M. Rigatelli, A. Bonetti, B. Putaala, J. Tomppo, L. Tatlisumak, T. Bandini, F. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Masotti, L. Grifoni, E. Vannucchi, V. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Athanasakis, G. Makaritsis, K. Karagkiozi, E. Vadikolias, K. Liantinioti, C. Palaiodimou, L. Mumoli, N. Porta, C. Galati, F. Sacco, S. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Silvestrelli, G. Ciccone, A. Scoditti, U. Denti, L. Mancuso, M. Caselli, M.C. Maccarrone, M. Ulivi, L. Orlandi, G. Giannini, N. Tassinari, T. Lodovici, M.L.D. Rueckert, C. Baldi, A. Toni, D. Gentile, L. Letteri, F. Giuntini, M. Lotti, E.M. Flomin, Y. Pieroni, A. Kargiotis, O. Karapanayiotides, T. Monaco, S. Mannino, M. Baronello, M.M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Sette, M.D. Schirinzi, E. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel, P. Eskandari, A. Vanacker, P. Barlinn, K. Barlinn, J. Deleu, D. Gourbali, V. Caso, V.

Abstract

Introduction: The aim of this study in patients with acute posterior ischaemic stroke (PS) and atrial fibrillation (AF) was to evaluate (1) the risks of recurrent ischaemic event and severe bleeding and (2) these risks in relation with oral anticoagulant therapy (OAT) and its timing. Materials and Methods: Patients with PS were prospectively included; the outcome events of these patients were compared with those of patients with anterior stroke (AS) which were taken from previous registries. The primary outcome was the composite of stroke recurrence, transient ischaemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding and major extracranial bleeding occurring within 90 days from acute stroke. Results: A total of 2470 patients were available for the analysis: 473 (19.1%) with PS and 1997 (80.9%) with AS. Over 90 days, 213 (8.6%) primary outcome events were recorded: 175 (8.7%) in patients with AS and 38 (8.0%) in those with PS. In patients who initiated OAT within 2 days, the primary outcome occurred in 5 out of 95 patients (5.3%) with PS compared to 21 out of 373 patients (4.3%) with AS (OR 1.07; 95% CI 0.39–2.94). In patients who initiated OAT between days 3 and 7, the primary outcome occurred in 3 out of 103 patients (2.9%) with PS compared to 26 out of 490 patients (5.3%) with AS (OR 0.54; 95% CI 0.16–1.80). Discussion: our findings suggest that, when deciding the time to initiate oral anticoagulation, the location of stroke, either anterior or posterior, does not predict the risk of outcome events. Conclusions: Patients with PS or AS and AF appear to have similar risks of ischaemic or haemorrhagic events at 90 days with no difference concerning the timing of initiation of OAT. © European Stroke Organisation 2020.

Published
2020

14. Anticoagulation after Stroke in Patients with Atrial Fibrillation: To Bridge or Not with Low-Molecular-Weight Heparin?

Author

Altavilla, R. Caso, V. Bandini, F. Agnelli, G. Tsivgoulis, G. Yaghi, S. Furie, K.L. Tadi, P. Becattini, C. Zedde, M. Abdul-Rahim, A.H. Lees, K.R. Alberti, A. Venti, M. Acciarresi, M. D'Amore, C. Giulia Mosconi, M. Anna Cimini, L. Fusaro, J. Bovi, P. Carletti, M. Rigatelli, A. Cappellari, M. Putaala, J. Tomppo, L. Tatlisumak, T. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Masotti, L. Vannucchi, V. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Athanasakis, G. Makaritsis, K. Karagkiozi, E. Vadikolias, K. Liantinioti, C. Chondrogianni, M. Mumoli, N. Consoli, D. Galati, F. Sacco, S. Carolei, A. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Silvestrelli, G. Ciccone, A. Lanari, A. Scoditti, U. Denti, L. Mancuso, M. MacCarrone, M. Ulivi, L. Orlandi, G. Giannini, N. Gialdini, G. Tassinari, T. De Lodovici, M.L. Bono, G. Rueckert, C. Baldi, A. D'Anna, S. Toni, D. Letteri, F. Giuntini, M. Lotti, E.M. Flomin, Y. Pieroni, A. Kargiotis, O. Karapanayiotides, T. Monaco, S. Baronello, M.M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Del Sette, M. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel, P. Vanacker, P. Barlinn, K. Pallesen, L.-P. Barlinn, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Gourbali, V. Paciaroni, M.

Abstract

Background and Purpose-Bridging therapy with low-molecular-weight heparin reportedly leads to a worse outcome for acute cardioembolic stroke patients because of a higher incidence of intracerebral bleeding. However, this practice is common in clinical settings. This observational study aimed to compare (1) the clinical profiles of patients receiving and not receiving bridging therapy, (2) overall group outcomes, and (3) outcomes according to the type of anticoagulant prescribed. Methods-We analyzed data of patients from the prospective RAF and RAF-NOACs studies. The primary outcome was defined as the composite of ischemic stroke, transient ischemic attack, systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding observed at 90 days after the acute stroke. Results-Of 1810 patients who initiated oral anticoagulant therapy, 371 (20%) underwent bridging therapy with full-dose low-molecular-weight heparin. Older age and the presence of leukoaraiosis were inversely correlated with the use of bridging therapy. Forty-two bridged patients (11.3%) reached the combined outcome versus 72 (5.0%) of the nonbridged patients (P=0.0001). At multivariable analysis, bridging therapy was associated with the composite end point (odds ratio, 2.3; 95% CI, 1.4-3.7; P

Published
2019

15. Early recurrence in paroxysmal versus sustained atrial fibrillation in patients with acute ischaemic stroke

Author

Paciaroni, M. Angelini, F. Agnelli, G. Tsivgoulis, G. Furie, K.L. Tadi, P. Becattini, C. Falocci, N. Zedde, M. Abdul-Rahim, A.H. Lees, K.R. Alberti, A. Venti, M. Acciarresi, M. Altavilla, R. D’Amore, C. Mosconi, M.G. Cimini, L.A. Bovi, P. Carletti, M. Rigatelli, A. Cappellari, M. Putaala, J. Tomppo, L. Tatlisumak, T. Bandini, F. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Masotti, L. Vannucchi, V. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Karagkiozi, E. Athanasakis, G. Makaritsis, K. Vadikolias, K. Liantinioti, C. Chondrogianni, M. Mumoli, N. Consoli, D. Galati, F. Sacco, S. Carolei, A. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Silvestrelli, G. Ciccone, A. Scoditti, U. Denti, L. Mancuso, M. Maccarrone, M. Orlandi, G. Giannini, N. Gialdini, G. Tassinari, T. Lodovici, M.L.D. Bono, G. Rueckert, C. Baldi, A. Toni, D. Letteri, F. Giuntini, M. Lotti, E.M. Flomin, Y. Pieroni, A. Kargiotis, O. Karapanayiotides, T. Monaco, S. Baronello, M.M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Sette, M.D. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel Pd-Mer, P. Vanacker, P. Barlinn, K. Pallesen, L.P. Kepplinger, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Gourbali, V. Yaghi, S. Caso, V.

Subjects
cardiovascular system, macromolecular substances, cardiovascular diseases
Abstract

Background: The relationship between different patterns of atrial fibrillation and early recurrence after an acute ischaemic stroke is unclear. Purpose: In a prospective cohort study, we evaluated the rates of early ischaemic recurrence after an acute ischaemic stroke in patients with paroxysmal atrial fibrillation or sustained atrial fibrillation which included persistent and permanent atrial fibrillation. Methods: In patients with acute ischaemic stroke, atrial fibrillation was categorised as paroxysmal atrial fibrillation or sustained atrial fibrillation. Ischaemic recurrences were the composite of ischaemic stroke, transient ischaemic attack and symptomatic systemic embolism occurring within 90 days from acute index stroke. Results: A total of 2150 patients (1155 females, 53.7%) were enrolled: 930 (43.3%) had paroxysmal atrial fibrillation and 1220 (56.7%) sustained atrial fibrillation. During the 90-day follow-up, 111 ischaemic recurrences were observed in 107 patients: 31 in patients with paroxysmal atrial fibrillation (3.3%) and 76 with sustained atrial fibrillation (6.2%) (hazard ratio (HR) 1.86 (95% CI 1.24–2.81)). Patients with sustained atrial fibrillation were on average older, more likely to have diabetes mellitus, hypertension, history of stroke/ transient ischaemic attack, congestive heart failure, atrial enlargement, high baseline NIHSS-score and implanted pacemaker. After adjustment by Cox proportional hazard model, sustained atrial fibrillation was not associated with early ischaemic recurrences (adjusted HR 1.23 (95% CI 0.74–2.04)). Conclusions: After acute ischaemic stroke, patients with sustained atrial fibrillation had a higher rate of early ischaemic recurrence than patients with paroxysmal atrial fibrillation. After adjustment for relevant risk factors, sustained atrial fibrillation was not associated with a significantly higher risk of recurrence, thus suggesting that the risk profile associated with atrial fibrillation, rather than its pattern, is determinant for recurrence. © European Stroke Organisation 2018.

Published
2019

16. Causes and Risk Factors of Cerebral Ischemic Events in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention: The RENo Study

Author

Paciaroni, M. Agnelli, G. Caso, V. Silvestrelli, G. Seiffge, D.J. Engelter, S. De Marchis, G.M. Polymeris, A. Zedde, M.L. Yaghi, S. Michel, P. Eskandari, A. Antonenko, K. Sohn, S.-I. Cappellari, M. Tassinari, T. Tassi, R. Masotti, L. Katsanos, A.H. Giannopoulos, S. Acciarresi, M. Alberti, A. Venti, M. Mosconi, M.G. Vedovati, M.C. Pierini, P. Giustozzi, M. Lotti, E.M. Ntaios, G. Kargiotis, O. Monaco, S. Lochner, P. Bandini, F. Liantinioti, C. Palaiodimou, L. Abdul-Rahim, A.H. Lees, K. Mancuso, M. Pantoni, L. Rosa, S. Bertora, P. Galliazzo, S. Ageno, W. Toso, E. Angelini, F. Chiti, A. Orlandi, G. Denti, L. Flomin, Y. Marcheselli, S. Mumoli, N. Rimoldi, A. Verrengia, E. Schirinzi, E. Del Sette, M. Papamichalis, P. Komnos, A. Popovic, N. Zarkov, M. Rocco, A. Diomedi, M. Giorli, E. Ciccone, A. Grory, B.C.M. Furie, K.L. Bonetti, B. Saia, V. Guideri, F. Acampa, M. Martini, G. Grifoni, E. Padroni, M. Karagkiozi, E. Perlepe, K. Makaritsis, K. Mannino, M. MacCarrone, M. Ulivi, L. Giannini, N. Ferrari, E. Pezzini, A. Doronin, B. Volodina, V. Baldi, A. D'Amore, C. Deleu, D. Corea, F. Putaala, J. Santalucia, P. Nardi, K. Risitano, A. Toni, D. Tsivgoulis, G.

Abstract

Background and Purpose-Despite treatment with oral anticoagulants, patients with nonvalvular atrial fibrillation (AF) may experience ischemic cerebrovascular events. The aims of this case-control study in patients with AF were to identify the pathogenesis of and the risk factors for cerebrovascular ischemic events occurring during non-Vitamin K antagonist oral anticoagulants (NOACs) therapy for stroke prevention. Methods-Cases were consecutive patients with AF who had acute cerebrovascular ischemic events during NOAC treatment. Controls were consecutive patients with AF who did not have cerebrovascular events during NOACs treatment. Results-Overall, 713 cases (641 ischemic strokes and 72 transient ischemic attacks; median age, 80.0 years; interquartile range, 12; median National Institutes of Health Stroke Scale on admission, 6.0; interquartile range, 10) and 700 controls (median age, 72.0 years; interquartile range, 8) were included in the study. Recurrent stroke was classified as cardioembolic in 455 cases (63.9%) according to the A-S-C-O-D (A, atherosclerosis; S, small vessel disease; C, cardiac pathology; O, other causes; D, dissection) classification. On multivariable analysis, off-label low dose of NOACs (odds ratio [OR], 3.18; 95% CI, 1.95-5.85), atrial enlargement (OR, 6.64; 95% CI, 4.63-9.52), hyperlipidemia (OR, 2.40; 95% CI, 1.83-3.16), and CHA2DS2-VASc score (OR, 1.72 for each point increase; 95% CI, 1.58-1.88) were associated with ischemic events. Among the CHA2DS2-VASc components, age was older and presence of diabetes mellitus, congestive heart failure, and history of stroke or transient ischemic attack more common in patients who had acute cerebrovascular ischemic events. Paroxysmal AF was inversely associated with ischemic events (OR, 0.45; 95% CI, 0.33-0.61). Conclusions-In patients with AF treated with NOACs who had a cerebrovascular event, mostly but not exclusively of cardioembolic pathogenesis, off-label low dose, atrial enlargement, hyperlipidemia, and high CHA2DS2-VASc score were associated with increased risk of cerebrovascular events. © 2019 American Heart Association, Inc.

Published
2019

19. Hemorrhagic transformation in patients with acute ischemic stroke and atrial fibrillation: Time to initiation of oral anticoagulant therapy and outcomes

Author

Paciaroni, M. Bandini, F. Agnelli, G. Tsivgoulis, G. Yaghi, S. Furie, K.L. Tadi, P. Becattini, C. Zedde, M. Abdul-Rahim, A.H. Lees, K.R. Alberti, A. Venti, M. Acciarresi, M. D’Amore, C. Mosconi, M.G. Cimini, L.A. Altavilla, R. Volpi, G. Bovi, P. Carletti, M. Rigatelli, A. Cappellari, M. Putaala, J. Tomppo, L. Tatlisumak, T. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Masotti, L. Vannucchi, V. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Athanasakis, G. Makaritsis, K. Karagkiozi, E. Vadikolias, K. Liantinioti, C. Chondrogianni, M. Mumoli, N. Consoli, D. Galati, F. Sacco, S. Carolei, A. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Colombo, G. Silvestrelli, G. Ciccone, A. Lanari, A. Scoditti, U. Denti, L. Mancuso, M. Maccarrone, M. Ulivi, L. Orlandi, G. Giannini, N. Gialdini, G. Tassinari, T. De Lodovici, M.L. Bono, G. Rueckert, C. Baldi, A. D'Anna, S. Toni, D. Letteri, F. Giuntini, M. Lotti, E.M. Flomin, Y. Pieroni, A. Kargiotis, O. Karapanayiotides, T. Monaco, S. Baronello, M.M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Del Sette, M. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel, P. Vanacker, P. Barlinn, K. Pallesen, L.-P. Barlinn, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Gourbali, V. Caso, V.

Abstract

Background—In patients with acute ischemic stroke and atrial fibrillation, early anticoagulation prevents ischemic recurrence but with the risk of hemorrhagic transformation (HT). The aims of this study were to evaluate in consecutive patients with acute stroke and atrial fibrillation (1) the incidence of early HT, (2) the time to initiation of anticoagulation in patients with HT, (3) the association of HT with ischemic recurrences, and (4) the association of HT with clinical outcome at 90 days. Methods and Results—HT was diagnosed by a second brain computed tomographic scan performed 24 to 72 hours after stroke onset. The incidence of ischemic recurrences as well as mortality or disability (modified Rankin Scale scores >2) were evaluated at 90 days. Ischemic recurrences were the composite of ischemic stroke, transient ischemic attack, or systemic embolism. Among the 2183 patients included in the study, 241 (11.0%) had HT. Patients with and without HT initiated anticoagulant therapy after a mean 23.3 and 11.6 days, respectively, from index stroke. At 90 days, 4.6% (95% confidence interval, 2.3-8.0) of the patients with HT had ischemic recurrences compared with 4.9% (95% confidence interval, 4.0-6.0) of those without HT; 53.1% of patients with HT were deceased or disabled compared with 35.8% of those without HT. On multivariable analysis, HT was associated with mortality or disability (odds ratio, 1.71; 95% confidence interval, 1.24-2.35). Conclusions—In patients with HT, anticoagulation was initiated about 12 days later than patients without HT. This delay was not associated with increased detection of ischemic recurrence. HT was associated with increased mortality or disability. © 2018 The Authors.

Published
2018

22. Prediction of Early Recurrent Thromboembolic Event and Major Bleeding in Patients with Acute Stroke and Atrial Fibrillation by a Risk Stratification Schema: The ALESSA Score Study

Author

Paciaroni, M. Agnelli, G. Caso, V. Tsivgoulis, G. Furie, K.L. Tadi, P. Becattini, C. Falocci, N. Zedde, M. Abdul-Rahim, A.H. Lees, K.R. Alberti, A. Venti, M. Acciarresi, M. D'Amore, C. Mosconi, M.G. Cimini, L.A. Procopio, A. Bovi, P. Carletti, M. Rigatelli, A. Cappellari, M. Putaala, J. Tomppo, L. Tatlisumak, T. Bandini, F. Marcheselli, S. Pezzini, A. Poli, L. Padovani, A. Masotti, L. Vannucchi, V. Sohn, S.-I. Lorenzini, G. Tassi, R. Guideri, F. Acampa, M. Martini, G. Ntaios, G. Karagkiozi, E. Athanasakis, G. Makaritsis, K. Vadikolias, K. Liantinioti, C. Chondrogianni, M. Mumoli, N. Consoli, D. Galati, F. Sacco, S. Carolei, A. Tiseo, C. Corea, F. Ageno, W. Bellesini, M. Colombo, G. Silvestrelli, G. Ciccone, A. Scoditti, U. Denti, L. Mancuso, M. Maccarrone, M. Orlandi, G. Giannini, N. Gialdini, G. Tassinari, T. De Lodovici, M.L. Bono, G. Rueckert, C. Baldi, A. D'Anna, S. Toni, D. Letteri, F. Giuntini, M. Lotti, E.M. Flomin, Y. Pieroni, A. Kargiotis, O. Karapanayiotides, T. Monaco, S. Baronello, M.M. Csiba, L. Szabó, L. Chiti, A. Giorli, E. Del Sette, M. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Michel, P. Vanacker, P. Barlinn, K. Pallesen, L.-P. Kepplinger, J. Bodechtel, U. Gerber, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Gourbali, V. Yaghi, S.

Abstract

Background and Purposes - This study was designed to derive and validate a score to predict early ischemic events and major bleedings after an acute ischemic stroke in patients with atrial fibrillation. Methods - The derivation cohort consisted of 854 patients with acute ischemic stroke and atrial fibrillation included in prospective series between January 2012 and March 2014. Older age (hazard ratio 1.06 for each additional year; 95% confidence interval, 1.00-1.11) and severe atrial enlargement (hazard ratio, 2.05; 95% confidence interval, 1.08-2.87) were predictors for ischemic outcome events (stroke, transient ischemic attack, and systemic embolism) at 90 days from acute stroke. Small lesions (≤1.5 cm) were inversely correlated with both major bleeding (hazard ratio, 0.39; P=0.03) and ischemic outcome events (hazard ratio, 0.55; 95% confidence interval, 0.30-1.00). We assigned to age ≥80 years 2 points and between 70 and 79 years 1 point; ischemic index lesion >1.5 cm, 1 point; severe atrial enlargement, 1 point (ALESSA score). A logistic regression with the receiver-operating characteristic graph procedure (C statistic) showed an area under the curve of 0.697 (0.632-0.763; P=0.0001) for ischemic outcome events and 0.585 (0.493-0.678; P=0.10) for major bleedings. Results - The validation cohort consisted of 994 patients included in prospective series between April 2014 and June 2016. Logistic regression with the receiver-operating characteristic graph procedure showed an area under the curve of 0.646 (0.529-0.763; P=0.009) for ischemic outcome events and 0.407 (0.275-0.540; P=0.14) for hemorrhagic outcome events. Conclusions - In acute stroke patients with atrial fibrillation, high ALESSA scores were associated with a high risk of ischemic events but not of major bleedings. © 2017 American Heart Association, Inc.

Published
2017

23. Sex-related differences in risk factors, type of treatment received and outcomes in patients with atrial fibrillation and acute stroke: results from the RAF-study (Recurrence and Cerebral Bleeding in Patients with Acute Ischemic Stroke and Atrial Fibrillation)

Author

Antonenko, K, Paciaroni, M, Agnelli, G, Falocci, N, Becattini, C, Marcheselli, S, Rueckert, C, Pezzini, A, Poli, L, Padovani, A, Csiba, L, Szabó, L, Sohn, Si, Tassinari, T, Abdul Rahim, A, Michel, P, Cordier, M, Vanacker, P, Remillard, S, Alberti, A, Venti, M, Acciarresi, M, D’Amore, C, Scoditti, U, Denti, L, Orlandi, G, Chiti, A, Gialdini, G, Bovi, P, Carletti, M, Rigatelli, A, Putaala, J, Tatlisumak, T, Masotti, L, Lorenzini, G, Tassi, R, Guideri, F, Martini, G, Tsivgoulis, G, Vadikolias, K, Papageorgiou, Sg, Corea, F, Del Sette, M, Ageno, W, De Lodovici, Ml, Bono, G, Baldi, A, D’Anna, S, Sacco, Simona, Carolei, A, Tiseo, C, Imberti, D, Zabzuni, D, Doronin, B, Volodina, V, Consoli, D, Galati, F, Pieroni, A, Toni, D, Monaco, S, Maimone Baronello, M, Barlinn, K, Pallesen, Lp, Kepplinger, J, Bodechtel, U, Gerber, J, Deleu, D, Melikyan, G, Ibrahim, F, Akhtar, N, Mosconi, Mg, Lees, Kr, and Caso, V.

Published
2017

24. Prestroke CHA2DS2-VASc Score and Severity of Acute Stroke in Patients with Atrial Fibrillation: Findings from RAF Study

Author

Acciarresi, M. Paciaroni, M. Agnelli, G. Falocci, N. Caso, V. Becattini, C. Marcheselli, S. Rueckert, C. Pezzini, A. Morotti, A. Costa, P. Padovani, A. Csiba, L. Szabó, L. Sohn, S.-I. Tassinari, T. Abdul-Rahim, A.H. Michel, P. Cordier, M. Vanacker, P. Remillard, S. Alberti, A. Venti, M. D'Amore, C. Scoditti, U. Denti, L. Orlandi, G. Chiti, A. Gialdini, G. Bovi, P. Carletti, M. Rigatelli, A. Putaala, J. Tatlisumak, T. Masotti, L. Lorenzini, G. Tassi, R. Guideri, F. Martini, G. Tsivgoulis, G. Vadikolias, K. Liantinioti, C. Corea, F. Del Sette, M. Ageno, W. De Lodovici, M.L. Bono, G. Baldi, A. D'Anna, S. Sacco, S. Carolei, A. Tiseo, C. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Consoli, D. Galati, F. Pieroni, A. Toni, D. Monaco, S. Baronello, M.M. Barlinn, K. Pallesen, L.-P. Kepplinger, J. Bodechtel, U. Gerber, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Mosconi, M.G. Lees, K.R.

Subjects
cardiovascular diseases
Abstract

Background and Purpose The aim of this study was to investigate for a possible association between both prestroke CHA2DS2-VASc score and the severity of stroke at presentation, as well as disability and mortality at 90 days, in patients with acute stroke and atrial fibrillation (AF). Methods This prospective study enrolled consecutive patients with acute ischemic stroke, AF, and assessment of prestroke CHA2DS2-VASc score. Severity of stroke was assessed on admission using the National Institutes of Health Stroke Scale (NIHSS) score (severe stroke: NIHSS ≥10). Disability and mortality at 90 days were assessed by the modified Rankin Scale (mRS

Published
2017

25. Sex-related differences in risk factors, type of treatment received and outcomes in patients with atrial fibrillation and acute stroke: Results from the RAF-study (Early Recurrence and Cerebral Bleeding in Patients with Acute Ischemic Stroke and Atrial Fibrillation)

Author

Antonenko, K. Paciaroni, M. Agnelli, G. Falocci, N. Becattini, C. Marcheselli, S. Rueckert, C. Pezzini, A. Poli, L. Padovani, A. Csiba, L. Szabó, L. Sohn, S.-I. Tassinari, T. Abdul-Rahim, A.H. Michel, P. Cordier, M. Vanacker, P. Remillard, S. Alberti, A. Venti, M. Acciarresi, M. D’Amore, C. Scoditti, U. Denti, L. Orlandi, G. Chiti, A. Gialdini, G. Bovi, P. Carletti, M. Rigatelli, A. Putaala, J. Tatlisumak, T. Masotti, L. Lorenzini, G. Tassi, R. Guideri, F. Martini, G. Tsivgoulis, G. Vadikolias, K. Papageorgiou, S.G. Corea, F. Sette, M.D. Ageno, W. Lodovici, M.L.D. Bono, G. Baldi, A. D’Anna, S. Sacco, S. Carolei, A. Tiseo, C. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Consoli, D. Galati, F. Pieroni, A. Toni, D. Monaco, S. Baronello, M.M. Barlinn, K. Pallesen, L.-P. Kepplinger, J. Bodechtel, U. Gerber, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Mosconi, M.G. Lees, K.R. Caso, V.

Subjects
cardiovascular diseases
Abstract

Introduction: Atrial fibrillation is an independent risk factor of thromboembolism. Women with atrial fibrillation are at a higher overall risk for stroke compared to men with atrial fibrillation. The aim of this study was to evaluate for sex differences in patients with acute stroke and atrial fibrillation, regarding risk factors, treatments received and outcomes. Methods: Data were analyzed from the “Recurrence and Cerebral Bleeding in Patients with Acute Ischemic Stroke and Atrial Fibrillation” (RAF-study), a prospective, multicenter, international study including only patients with acute stroke and atrial fibrillation. Patients were followed up for 90 days. Disability was measured by the modified Rankin Scale (0–2 favorable outcome, 3–6 unfavorable outcome). Results: Of the 1029 patients enrolled, 561 were women (54.5%) (p < 0.001) and younger (p < 0.001) compared to men. In patients with known atrial fibrillation, women were less likely to receive oral anticoagulants before index stroke (p = 0.026) and were less likely to receive anticoagulants after stroke (71.3% versus 78.4%, p = 0.01). There was no observed sex difference regarding the time of starting anticoagulant therapy between the two groups (6.4 ± 11.7 days for men versus 6.5 ± 12.4 days for women, p = 0.902). Men presented with more severe strokes at onset (mean NIHSS 9.2 ± 6.9 versus 8.1 ± 7.5, p < 0.001). Within 90 days, 46 (8.2%) recurrent ischemic events (stroke/TIA/systemic embolism) and 19 (3.4%) symptomatic cerebral bleedings were found in women compared to 30 (6.4%) and 18 (3.8%) in men (p = 0.28 and p = 0.74). At 90 days, 57.7% of women were disabled or deceased, compared to 41.1% of the men (p < 0.001). Multivariate analysis did not confirm this significance. Conclusions: Women with atrial fibrillation were less likely to receive oral anticoagulants prior to and after stroke compared to men with atrial fibrillation, and when stroke occurred, regardless of the fact that in our study women were younger and with less severe stroke, outcomes did not differ between the sexes. © 2016, © European Stroke Organisation 2016.

Published
2017

27. Prognostic value of trans-thoracic echocardiography in patients with acute stroke and atrial fibrillation: findings from the RAF study

Author

Paciaroni, M. Agnelli, G. Falocci, N. Caso, V. Becattini, C. Marcheselli, S. Rueckert, C. Pezzini, A. Poli, L. Padovani, A. Csiba, L. Szabó, L. Sohn, S.-I. Tassinari, T. Abdul-Rahim, A.H. Michel, P. Cordier, M. Vanacker, P. Remillard, S. Alberti, A. Venti, M. Acciarresi, M. D’Amore, C. Mosconi, M.G. Scoditti, U. Denti, L. Orlandi, G. Chiti, A. Gialdini, G. Bovi, P. Carletti, M. Rigatelli, A. Putaala, J. Tatlisumak, T. Masotti, L. Lorenzini, G. Tassi, R. Guideri, F. Martini, G. Tsivgoulis, G. Vadikolias, K. Liantinioti, C. Corea, F. Del Sette, M. Ageno, W. De Lodovici, M.L. Bono, G. Baldi, A. D’Anna, S. Sacco, S. Carolei, A. Tiseo, C. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Consoli, D. Galati, F. Pieroni, A. Toni, D. Monaco, S. Baronello, M.M. Barlinn, K. Pallesen, L.-P. Kepplinger, J. Bodechtel, U. Gerber, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Lees, K.R.

Subjects
cardiovascular diseases
Abstract

Anticoagulant therapy is recommended for the secondary prevention of stroke in patients with atrial fibrillation (AF). The identification of patients at high risk for early recurrence, which are potential candidates to prompt anticoagulation, is crucial to justify the risk of bleeding associated with early anticoagulant treatment. The aim of this study was to evaluate in patients with acute ischemic stroke and AF the association between findings at trans-thoracic echocardiography (TTE) and 90 days recurrence. In consecutive patients with acute ischemic stroke and AF, TTE was performed within 7 days from hospital admission. Study outcomes were recurrent ischemic cerebrovascular events (stroke or TIA) and systemic embolism. 854 patients (mean age 76.3 ± 9.5 years) underwent a TTE evaluation; 63 patients (7.4 %) had at least a study outcome event. Left atrial thrombosis was present in 11 patients (1.3 %) among whom 1 had recurrent ischemic event. Left atrial enlargement was present in 548 patients (64.2 %) among whom 51 (9.3 %) had recurrent ischemic events. The recurrence rate in the 197 patients with severe left atrial enlargement was 11.7 %. On multivariate analysis, the presence of atrial enlargement (OR 2.13; 95 % CI 1.06–4.29, p = 0.033) and CHA2DS2-VASc score (OR 1.22; 95 % CI 1.04–1.45, p = 0.018, for each point increase) were correlated with ischemic recurrences. In patients with AF-associated acute stroke, left atrial enlargement is an independent marker of recurrent stroke and systemic embolism. The risk of recurrence is accounted for by severe atrial enlargement. TTE-detected left atrial thrombosis is relatively uncommon. © 2015, Springer-Verlag Berlin Heidelberg.

Published
2016

28. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

Author

Paul, O'Connor, Wolinsky, Jerry S., Christian, Confavreux, Giancarlo, Comi, Ludwig, Kappos, Olsson, Tomas P., Hadj, Benzerdjeb, Philippe, Truffinet, Lin, Wang, Aaron, Miller, Temso Trial Group Reingold, Freedman Ms S., Cutter, G., Antel, J., Barkhof, F., Maddrey, W., Ravnborg, M., Schenker, S., O'Connor, P., Wolinsky, J. S., Confavreux, C., Comi, G., Kappos, L., Olsson, T. P., Miller, A., Freedman, Mark S., Narayana, P. A., Nelson, F., Vainrub, I., Datta, S., He, R., Gates, B., Ton, K., Wamil, B., Truffinet, P., Igau, B., Nicolas, V., Notelet, L., Payrard, S., Wijnand, P., Devore, S., H. H., Li, Osho, T., Wang, L., Wei, L., Dukovic, D., Ling, Y., Benzerdjeb, H., Mednikova, Z., Trabelsi, N., Musset, M., Merrill, D., Turpault, S., Williams, B., Nortmeyer, H., Kirst, E., Witthaus, E., Chen, S., Maida, E., Auff, E., Fazekas, F., Berger, T., Bhan, V., Bouchard, J. P., Duquette, P., Freedman, M., Grand'Maison, F., Kremenchutzky, M., Bourque, C., Marrie, R. A., Melanson, M., Patry, D., Oger, J., Stefanelli, M., Jacques, F., Venegas, P., Miranda, M., Barrientos, N., Tenhamm, E., Gloger, S., Rohde, G., Mares, J., Frederiksen, J., Stenager, E., Haldre, S., Gross Paju, K., Elovaara, I., Sumelahti, M. L., Erälinna, J. P., Farkkila, M., Harno, H., Reunanen, M., Jolma, T., Camu, W., Clavelou, P., Magy, L., Debouverie, M., Edan, G., Lebrun Frenay, C., Moreau, T., Pelletier, J., Roullet, E., Alamowitch, S., Clanet, M., Hautecoeur, P., Damier, P., Rumbach, L., Chan, A., Schimrigk, S., Haas, J., Lensch, E., Diener, H., Limmroth, V., Anders, D., Berghoff, M., Oschmann, P., Stangel, M., Frese, A., Kiefer, R., Marziniak, M., Zettl, U., Stark, E., Jendroska, K., Reifschneider, G., Amato, M. P., Cosi, V., Gallo, P., Gasperini, Claudio, Ghezzi, A., Trojano, M., Pozzilli, Carlo, Montanari, E., Zwanikken, C. P., Jongen, P. J., Van Munster, E. T., Hupperts, R. M., Anten, B., Sanders, E. A., Celius, E., Hovdal, H., Krogseth, S. B., Kozubski, W., Kwiecinski, H., Czlonkowska, A., Stelmasiak, Z., Selmaj, K., Hasiec, T., Fryze, W., Drozdowski, W., Kochanowicz, J., Cunha, L., De Sa, J., Sena, A. H., Odinak, M., Skoromets, A., Gusev, E., Boiko, A., Lashch, N., Stolyarov, I., Belova, A., Malkova, N., Doronin, B., Yakupov, E., Brundin, L., Hillert, J., Karabudak, R., Irkec, C., Idiman, E., Turan, O., Efendi, H., Gedizlioglu, M., Buchakchyyska, N., Goloborodko, A., Ipatov, A., Kobets, S., Lebedynets, V., Moskovko, S., Sanotskyy, Y., Smolanka, V., Yavorskaya, V., Bates, D., Evangelou, N., Hawkins, C., Mclean, B., O'Riordan, J., Price, S., Turner, B., Barnes, D., Zajicek, J., Honeycutt, W., Khan, O., Spikol, L., Stevens, J., Klinische Neurowetenschappen, and RS: MHeNs School for Mental Health and Neuroscience

Subjects
medicine.medical_specialty, biology, Nausea, business.industry, Incidence (epidemiology), Placebo-controlled study, General Medicine, Placebo, Gastroenterology, Surgery, chemistry.chemical_compound, Alanine transaminase, chemistry, Internal medicine, Relative risk, Teriflunomide, medicine, biology.protein, medicine.symptom, business, Leflunomide, medicine.drug
Abstract

Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teri flunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P

Published
2011

30. Early recurrence and cerebral bleeding in patients with acute ischemic stroke and atrial fibrillation: Effect of anticoagulation and its timing: The RAF study

Author

Paciaroni, M. Agnelli, G. Falocci, N. Caso, V. Becattini, C. Marcheselli, S. Rueckert, C. Pezzini, A. Poli, L. Padovani, A. Csiba, L. Szabó, L. Sohn, S.-I. Tassinari, T. Abdul-Rahim, A.H. Michel, P. Cordier, M. Vanacker, P. Remillard, S. Alberti, A. Venti, M. Scoditti, U. Denti, L. Orlandi, G. Chiti, A. Gialdini, G. Bovi, P. Carletti, M. Rigatelli, A. Putaala, J. Tatlisumak, T. Masotti, L. Lorenzini, G. Tassi, R. Guideri, F. Martini, G. Tsivgoulis, G. Vadikolias, K. Liantinioti, C. Corea, F. Del Sette, M. Ageno, W. De Lodovici, M.L. Bono, G. Baldi, A. D'Anna, S. Sacco, S. Carolei, A. Tiseo, C. Acciarresi, M. D'Amore, C. Imberti, D. Zabzuni, D. Doronin, B. Volodina, V. Consoli, D. Galati, F. Pieroni, A. Toni, D. Monaco, S. Baronello, M.M. Barlinn, K. Pallesen, L.-P. Kepplinger, J. Bodechtel, U. Gerber, J. Deleu, D. Melikyan, G. Ibrahim, F. Akhtar, N. Mosconi, M.G. Bubba, V. Silvestri, I. Lees, K.R.

Abstract

Background and Purpose - The best time for administering anticoagulation therapy in acute cardioembolic stroke remains unclear. This prospective cohort study of patients with acute stroke and atrial fibrillation, evaluated (1) the risk of recurrent ischemic event and severe bleeding; (2) the risk factors for recurrence and bleeding; and (3) the risks of recurrence and bleeding associated with anticoagulant therapy and its starting time after the acute stroke. Methods - The primary outcome of this multicenter study was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding and major extracranial bleeding within 90 days from acute stroke. Results - Of the 1029 patients enrolled, 123 had 128 events (12.6%): 77 (7.6%) ischemic stroke or transient ischemic attack or systemic embolism, 37 (3.6%) symptomatic cerebral bleeding, and 14 (1.4%) major extracranial bleeding. At 90 days, 50% of the patients were either deceased or disabled (modified Rankin score ≥3), and 10.9% were deceased. High CHA2DS2-VASc score, high National Institutes of Health Stroke Scale, large ischemic lesion and type of anticoagulant were predictive factors for primary study outcome. At adjusted Cox regression analysis, initiating anticoagulants 4 to 14 days from stroke onset was associated with a significant reduction in primary study outcome, compared with initiating treatment before 4 or after 14 days: hazard ratio 0.53 (95% confidence interval 0.30-0.93). About 7% of the patients treated with oral anticoagulants alone had an outcome event compared with 16.8% and 12.3% of the patients treated with low molecular weight heparins alone or followed by oral anticoagulants, respectively (P=0.003). Conclusions - Acute stroke in atrial fibrillation patients is associated with high rates of ischemic recurrence and major bleeding at 90 days. This study has observed that high CHA2DS2-VASc score, high National Institutes of Health Stroke Scale, large ischemic lesions, and type of anticoagulant administered each independently led to a greater risk of recurrence and bleedings. Also, data showed that the best time for initiating anticoagulation treatment for secondary stroke prevention is 4 to 14 days from stroke onset. Moreover, patients treated with oral anticoagulants alone had better outcomes compared with patients treated with low molecular weight heparins alone or before oral anticoagulants. © 2015 American Heart Association, Inc.

Published
2015

36. Magnetic resonance imaging outcomes from a phase III trial of teriflunomide

Author

Wolinsky, Js, Narayana, Pa, Nelson, F, Datta, S, O'Connor, P, Confavreux, C, Comi, G, Kappos, L, Olsson, Tp, Truffinet, P, Wang, L, Miller, A, Freedman MSMaida, E, Auff, E, Fazekas, F, Berger, T, Bhan, V, Bouchard, Jp, Duquette, P, Freedman, M, Grand'Maison, F, Kremenchutzky, M, Bourque, C, Marrie, Ra, Melanson, M, Patry, D, Oger, J, Stefanelli, M, Jacques, F, Venegas, P, Miranda, M, Barrientos, N, Tenhamm, E, Gloger, S, Rohde, G, Mares, J, Frederiksen, J, Stenager, E, Haldre, S, Gross Paju, K, Elovaara, I, Sumelahti, Ml, Erälinna, Jp, Färkkilä, M, Harno, H, Reunanen, M, Jolma, T, Camu, W, Clavelou, P, Magy, L, Debouverie, M, Edan, G, Lebrun Frenay, C, Moreau, T, Pelletier, J, Roullet, E, Alamowitch, S, Clanet, M, Hautecoeur, P, Damier, P, Rumbach, L, Chan, A, Schimrigk, S, Haas, J, Lensch, E, Diener, H, Limmroth, V, Anders, D, Berghoff, M, Oschmann, P, Stangel, M, Frese, A, Kiefer, R, Marziniak, M, Zettl, U, Stark, E, Jendroska, K, Reifschneider, G, Amato, Mp, Cosi, V, Gallo, Paolo, Gasperini, C, Ghezzi, A, Trojano, M, Pozzilli, C, Montanari, E, Zwanikken, Cp, Jongen, Pj, Centrum, Ms, Van Munster ET, Hupperts, Rm, Anten, B, Sanders, Ea, Celius, E, Hovdal, H, Krogseth, Sb, Kozubski, W, Kwiecinski, H, Czlonkowska, A, Stelmasiak, Z, Selmaj, K, Hasiec, T, Fryze, W, Drozdowski, W, Kochanowicz, J, Cunha, L, De Sá, J, Harrington Sena, A, Odinak, M, Skoromets, A, Gusev, E, Boiko, A, Lashch, N, Stolyarov, I, Belova, A, Malkova, N, Doronin, B, Yakupov, E, Brundin, L, Hillert, J, Karabudak, R, Irkec, C, Idiman, E, Turan, O, Efendi, H, Gedizlioglu, M, Buchakchyyska, N, Goloborodko, A, Ipatov, A, Kobets, S, Lebedynets, V, Moskovko, S, Yushchenko, Oi, Sanotskyy, Y, Smolanka, V, Yavorskaya, V, Bates, D, Evangelou, N, Hawkins, C, Mclean, B, O'Riordan, J, Price, S, Turner, B, Barnes, D, Zajicek, J, Honeycutt, W, Khan, O, Spikol, L, and Stevens, J.

Published
2013

37. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

Author

O'Connor, P, Wolinsky, Js, Confavreux, C, Comi, G, Kappos, L, Olsson, Tp, Benzerdjeb, H, Truffinet, P, Wang, L, Miller, A, Freedman, Ms, Reingold, S, Cutter, G, Antel, J, Barkhof, F, Maddrey, W, Ravnborg, M, Schenker, S, Narayana, Pa, Nelson, F, Vainrub, I, Datta, S, He, R, Gates, B, Ton, K, Wamil, B, Igau, B, Nicolas, V, Notelet, L, Payrard, S, Wijnand, P, Devore, S, Li, Hh, Osho, T, Wei, L, Dukovic, D, Ling, Y, Mednikova, Z, Trabelsi, N, Musset, M, Merrill, D, Turpault, S, Williams, B, Nortmeyer, H, Kirst, E, Witthaus, E, Chen, S, Maida, E, Auff, E, Fazekas, F, Berger, T, Bhan, V, Bouchard, Jp, Duquette, P, Grand'Maison, F, Kremenchutzky, M, Bourque, C, Marrie, Ra, Melanson, M, Patry, D, Oger, J, Stefanelli, M, Jacques, F, Venegas, P, Miranda, M, Barrientos, N, Tenhamm, E, Gloger, S, Rohde, G, Mares, J, Frederiksen, J, Stenager, E, Haldre, S, Gross Paju, K, Elovaara, I, Sumelahti, Ml, Erälinna, Jp, Färkkilä, M, Harno, H, Reunanen, M, Jolma, T, Camu, W, Clavelou, P, Magy, L, Debouverie, M, Edan, G, Lebrun Frenay, C, Moreau, T, Pelletier, J, Roullet, E, Alamowitch, S, Clanet, M, Hautecoeur, P, Damier, P, Rumbach, L, Chan, A, Schimrigk, S, Haas, J, Lensch, E, Diener, H, Limmroth, V, Anders, D, Berghoff, M, Oschmann, P, Stangel, M, Frese, A, Kiefer, R, Marziniak, M, Zettl, U, Stark, E, Jendroska, K, Reifschneider, G, Amato, Mp, Cosi, V, Gallo, Paolo, Gasperini, C, Ghezzi, A, Trojano, M, Pozzilli, C, Montanari, E, Zwanikken, Cp, Jongen, Pj, Van Munster ET, Hupperts, Rm, Anten, B, Sanders, Ea, Celius, E, Hovdal, H, Krogseth, Sb, Kozubski, W, Kwiecinski, H, Czlonkowska, A, Stelmasiak, Z, Selmaj, K, Hasiec, T, Fryze, W, Drozdowski, W, Kochanowicz, J, Cunha, L, De Sá, J, Sena, Ah, Odinak, M, Skoromets, A, Gusev, E, Boiko, A, Lashch, N, Stolyarov, I, Belova, A, Malkova, N, Doronin, B, Yakupov, E, Brundin, L, Hillert, J, Karabudak, R, Irkec, C, Idiman, E, Turan, O, Efendi, H, Gedizlioglu, M, Buchakchyyska, N, Goloborodko, A, Ipatov, A, Kobets, S, Lebedynets, V, Moskovko, S, Sanotskyy, Y, Smolanka, V, Yavorskaya, V, Bates, D, Evangelou, N, Hawkins, C, Mclean, B, O'Riordan, J, Price, S, Turner, B, Barnes, D, Zajicek, J, Honeycutt, W, Khan, O, Spikol, L, and Stevens, J.

Published
2011

40. Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study

Author

Bousser, M, Amarenco, P, Chamorro, A, Fisher, M, Ford, I, Fox, K, Hennerici, M, Mattle, H, Rothwell, P, Julian, D, Fieschi, G, Fieschi, C, Boysen, G, Pocock, S, Conard, J, Orgogozo, J, Inzitari, D, Erkinjuntti, T, Pasquier, F, O'Brien, J, Mas, J, Gueret, P, Lenzi, G, Leys, D, Lopez Sendon, J, Norrving, B, Ferro, J, Thygesen, K, Cowpply, B, P, Ameriso, S, Donnan, D, Lang, W, Thijs, V, Fernandes, J, Stamenova, P, Teal, P, Lavados, P, Lu, C, Poljakovic, Z, Kalita, Z, Kaste, M, Moulin, T, Vemmos, K, Diener, H, Wong, L, Nagy, Z, Chopra, J, Mccormack, P, Gensini, G, Budrys, V, Droste, D, Tan, K, Benomar, A, Cantu Brito, C, Barber, A, Koudstaal, P, Thomassen, L, Czlonkowska, A, Cunha, L, Bajenaru, O, Yakhno, N, Chen, C, Lisy, L, Zvan, B, Bryer, A, Kim, J, Vivancos, J, Wahlgren, N, Liu, S, Poungvarin, N, Hentati, F, Bahar, S, Mischenko, T, Lees, K, Abdel Masih, M, Barboza, A, Cirio, J, Crespo, E, Escaray, G, Esnaola, M, Rojas Estol, C, Ferrari, J, Fraiman, H, Garrote, M, Gatto, E, Giannaula, R, Gori, H, Herrera, G, Ioli, P, Losano, J, Povedano Reich, E, Rey, R, Rotta Escalante, R, Saredo, G, Zurru, M, Anderson, C, Bladin, C, Crimmins, D, Davis, S, Donnan, G, Dunbabin, D, Frayne, J, Gates, P, Hankey, G, Helme, R, Herkes, G, Karrasch, J, Kimber, T, Jannes, J, Landau, P, Levi, C, Lueck, C, Markus, R, Phan, T, Schwartz, R, Schultz, D, Blacker, D, Read, S, Williams, M, Aichner, F, Auff, E, Bancher, C, Binder, H, Brainin, M, Brucke, T, Eggers, C, Fertl, E, Ladurner, G, Lalouschek, W, Mamoli, B, Mitrovic, N, Noisternig, G, Schmidt, R, Vosko, M, Willeit, J, Zaruba, E, Boon, P, Bourgeois, P, Caekebeke, J, Cals, N, Cras, P, Desfontaines, P, De Deyn, P, Dieudonne, L, De Klippel, N, Laloux, P, Maertens de Noordhout, A, Merlevede, K, Michotte, A, Pandolfo, M, Peeters, A, Peeters, D, Tack, P, Van Buggenhout, E, Van Landegem, W, Vanhooren, G, Vermylen, P, Annes, M, Brondani, R, De Carvalho, J, Cendes, F, Fabio, S, Ferraz, A, De Freitas, G, Gagliardi, R, Gomes Neto, A, Haussen, S, Kowacs, P, Martins, S, Minelli, C, Moro, C, Noujaim, J, Rocha, M, Da Silva, M, Silveira, J, Yamamoto, F, Zetola, V, Baldaranov, D, Deleva, N, Haralanov, L, Milanov, I, Mintchev, D, Petrova, N, Shotekov, P, Stamenov, B, Zahariev, Z, Arts, R, Bayer, N, Beaudry, M, Berger, L, Bozek, C, Collier, T, Cote, R, Desai, H, Durocher, A, Hachinski, V, Hill, M, Hoppe, B, Howse, D, Mackey, A, Maharaj, M, Minuk, J, Moddel, G, Novak, D, Penn, A, Rabinovitch, H, Selchen, D, Shuaib, A, Silva, J, Silver, F, Spence, D, Stotts, G, Tamayo, A, Teitelbaum, J, Veloso, F, Voll, C, Winder, T, Barrientos Uribe, N, Galdames Poblete, D, Garcia Figueroa, P, Gasic Yaconi, K, Jaramillo Munoz, A, Lavados Germain, P, Lavados Montes, M, Nancupil Bello, C, Prina Pacheco, L, Vargas Canas, A, Venegas, F, Chen, P, H, Cheng, Y, Cui, L, Di, Q, Dong, Q, Fan, D, Feng, H, Huang, Y, Li, J, Li, W, Li, Z, Lin, H, Liu, M, Miao, L, Ren, H, Wang, Y, Wu, J, Zhang, W, Zhao, G, Zhao, H, Zhou, H, Antoncic, I, Demarin, V, Lusic, I, Pavlicek, I, Soldo Butkovic, S, Bar, M, Bauer, J, Kalina, M, Kanovsky, P, Jura, R, Neumann, J, Rektor, I, Skoda, O, Vaclavik, D, Eerola, A, Hillbom, M, Kinnunen, E, Koivisto, K, Numminen, H, Rissanen, A, Roine, R, Sivenius, J, Alamowitch, S, Autret, A, Avendano, S, Bataillard, M, Berthier, E, Besson, G, Bille Turc, F, Boulliat, J, Boulesteix, J, Brosset, C, Cesaro, P, Albucher, J, Clavelou, P, Colamarino, R, Crassard, I, de Broucker, T, de Bray, J, Desbordes, P, Diot, E, Ducrocq, X, Ellie, E, Faucheux, J, Giroud, M, Godefroy, O, Guillon, B, Huttin, H, Just, A, Lamy, C, Lejeune, P, Lucas, C, Macian Montoro, F, Mackowiak, A, Maillet Vioud, M, Pico, F, Milandre, L, Milhaud, D, Malbec, M, Neau, J, Pinel, J, Robin, C, Rodier, G, Rosolacci, T, Rouanet, F, Rouhart, F, Sablot, D, Servan, J, Smadja, D, Trouillas, P, Valance, J, Viader, F, Viallet, F, Wolff, V, Zagnoli, F, Zuber, M, Angerer, M, Becker, U, Berlit, P, Berrouschot, J, Biniek, R, Bitsch, A, Brodhun, R, Dichgans, M, Druschky, K, Dux, R, Faiss, J, Ferbert, A, Gahn, G, Grotemeyer, K, Goertler, M, Grau, A, Griewing, B, Grond, M, Haan, J, Haberl, R, Hamann, G, Hamer, H, Harms, L, Heide, W, Henningsen, H, Hetzel, A, Hoffmann, F, Huber, R, Isenmann, S, Jander, S, Joerg, J, Kaps, M, Kastrup, A, Kessler, C, Koehler, W, Koelmel, H, Lichy, C, Luckner, K, Malessa, R, Mallmann, A, Meyding Lamade, U, Molitor, H, Mueller Jensen, A, Muellges, W, Noth, J, Nueckel, M, Ochs, G, Poppert, H, Roether, J, Rosenkranz, M, Sander, D, Schaebitz, W, Schlachetzki, F, Schlegel, U, Schmid, E, Schneider, D, Schwarz, M, Seidel, G, Sieble, M, Sliwka, U, Stingele, R, Stoegbauer, F, Szabo, K, Topper, R, Treib, J, Weissenborn, K, Widder, B, Witte, O, Karageorgiou, K, Mitsikostas, D, Papadimitriou, A, Papathanasopoulos, P, Chan, H, Ng, P, Tsoi, T, Bartos, L, Csanyi, A, Csiba, L, Csornai, M, Dioszeghy, P, Fazekas, A, Harcos, P, Horvath, S, Kaposzta, Z, Kerenyi, L, Kincses, J, Koves, A, Nikl, J, Panczel, G, Pongracz, E, Sebestyen, K, Semjen, J, Szabo, M, Szegedi, N, Valikovics, A, Varszegi, R, Vecsei, L, Borah, N, Ichaporia, N, Kaul, S, Meenakshi Sundaram, S, Mehndiratta, M, Misra, U, Murthy, J, Nayak, D, Poncha, F, Shah, A, Singh, G, Srinivasa, R, Venkateswarlu, K, Wadia, R, Collins, R, Harbison, J, Hickey, P, Kelly, P, Murphy, S, Adami, A, Agnelli, G, Agostoni, E, Anzola, G, Arnaboldi, M, Bassi, P, Billo, G, Bottacchi, E, Bovi, P, Cappa, S, Cappelletti, C, Carolei, A, Cavallini, A, Chiodo Grandi, F, Comi, G, Consoli, D, Corsi, F, Costanzo, E, De Falco, F, Devetag, F, Di Lazzaro, V, Di Piero, V, Diomedi, M, Fattorello Salimbeni, C, Federico, F, Feleppa, M, Ferrarese, C, Gandolfo, C, Giaccaglini, E, Giaquinto, S, Giobbe, D, Giometto, B, Greco, G, Guidetti, D, Guidotti, M, Iudice, A, Lembo, G, Marengo, C, Marini, P, Melis, M, Micieli, G, Musolino, R, Mutani, R, Neri, G, Parati, E, Pastore, L, Porazzi, D, Prati, P, Procaccianti, G, Rasura, M, Rossini, P, Santilli, I, Semplicini, A, Silvestrini, M, Tanganelli, P, Tedeschi, G, Tezzon, F, Tola, M, Villani, A, Zanferrari, C, Zarcone, D, Bickuviene, I, Gumbrevicius, G, Obelieniene, D, Skaringa, A, Virketiene, I, Tharakan, J, Aleman Pedroza, J, Escamilla Garza, J, Fernandez Vera, J, Leal Cantu, R, Leon Flores, L, Lopez Ruiz, M, Reyes Gutierrez, G, Reyes Morales, S, Rivera Castano, L, Rodrigues Leyva, I, Ruiz Sandoval, J, Vega Boada, F, Belahsen, F, Kissani, N, Mosseddaq, R, Slassi, I, Yahyaoui, M, Boiten, J, Bornebroek, M, De Kort, P, De Leeuw, H, Donders, R, Franke, C, Hertzberger, L, Jansen, B, Kappelle, L, Keizer, K, Kuster, J, Limburg, M, Mulleners, W, Pop, P, Van Den Berg, J, Van Gemert, H, Verbiest, H, Weinstein, H, Clark, M, Fink, J, Gommans, J, Jayathissa, S, Kilfoyle, D, Kumar, A, Hurtig, U, Indredavik, B, Kloster, R, Salvesen, R, Drozdowski, W, Fryze, W, Klimek, A, Kochanowski, J, Kozubski, W, Ksiazkiewicz, B, Kwiecinski, H, Kuczynska Zardzewialy, A, Motta, E, Nowacki, P, Nyka, W, Opala, G, Pierzchala, K, Pniewski, J, Podemski, R, Selmaj, K, Stelmasiak, Z, Stepien, A, Strzelecka Gorzynska, M, Szczudlik, A, Wajgt, A, Wiszniewska, M, Wlodek, A, Canhao, P, Correia, C, Grilo Goncalves, J, Machado Candido, J, Salgado, A, Bulboaca, A, Campeanu, A, Lazar, T, Marginean, I, Minea, D, Pascu, I, Pereanu, M, Perju Dumbrava, L, Popescu, C, Simu, M, Stefanache, F, Toldisan, I, Tuta, S, Zaharia, C, Alifirova, V, Arkhipov, S, Balunov, O, Balyazin, V, Belkin, A, Belova, A, Boiko, A, Bogdanov, E, Butko, D, Chukhlovina, M, Doronin, B, Ermilova, E, Evzelman, M, Fedin, A, Fedorova, N, Golikov, K, Golovkin, V, Gusev, E, Gustov, A, Jakupov, E, Kamchatnov, P, Khabirov, F, Kirienko, A, Klimov, I, Klocheva, E, Kotov, S, Kuznetsov, A, Laskov, V, Levin, Y, Mashkova, N, Nazarov, A, Novikova, L, Odinak, M, Parfenov, V, Pilipenko, P, Pokrovsky, A, Poverennova, I, Rodoman, G, Roshkovskaya, L, Shirokov, E, Shmyriov, V, Sholomov, I, Skoromets, A, Skvortsova, V, Spirin, N, Stakhovskaya, L, Sharov, M, Sherman, M, Shutov, A, Strachunskaya, E, Stulin, I, Suslina, Z, Volosevitch, A, 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Subjects
perform study, Male, Thromboxane, International Cooperation, Receptors, Thromboxane, antiplatelet therapy, terutroban, Cardiovascular Disease, Receptors, 80 and over, Stroke, Aged, 80 and over, Aspirin, Ischemic Attack, Transient, Ischemic Attack, Transient, Double-Blind Method, Endpoint Determination, Dose-Response Relationship, Drug, Humans, Aged, Propionates, Naphthalenes, Treatment Outcome, Platelet Aggregation Inhibitors, Cardiovascular Diseases, Middle Aged, Female, Propionic Acids, Neurology, Terutroban, Anesthesia, tp receptor antagonist, stroke, secondary prevention, aspirin, Cardiology, Platelet aggregation inhibitor, Settore MED/26 - Neurologia, stroke prevention, Drug, Cardiology and Cardiovascular Medicine, medicine.drug, Human, medicine.medical_specialty, Dose-Response Relationship, Internal medicine, medicine, Dementia, In patient, business.industry, Platelet Aggregation Inhibitor, schemic, medicine.disease, DementiaI, transient ischemic attack, Ischemic stroke, Human medicine, Neurology (clinical), business, Propionic Acid, Naphthalene
Abstract

Background: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. Methods and Results: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged ≥55 years, having suffered an ischemic stroke (≤3 months) or a transient ischemic attack (≤8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2–4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. Conclusions: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.

Published
2009

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