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Characteristics and Outcomes of Patients With Cerebral Venous Sinus Thrombosis in SARS-CoV-2 Vaccine–Induced Immune Thrombotic Thrombocytopenia

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To identify the key insights or developments described in this article
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Key Points

Question  What are the clinical characteristics and outcomes of patients with cerebral venous sinus thrombosis with thrombocytopenia syndrome after SARS-CoV-2 vaccination?

Findings  In this cohort study of 116 patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination, 78 (67.2%) had thrombosis with thrombocytopenia syndrome. Patients with thrombosis with thrombocytopenia syndrome were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%), and 47% died during hospitalization.

Meaning  Patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination who met criteria for thrombosis with thrombocytopenia syndrome had a distinct clinical profile and high mortality rate.

Abstract

Importance  Thrombosis with thrombocytopenia syndrome (TTS) has been reported after vaccination with the SARS-CoV-2 vaccines ChAdOx1 nCov-19 (Oxford–AstraZeneca) and Ad26.COV2.S (Janssen/Johnson & Johnson).

Objective  To describe the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis (CVST) after SARS-CoV-2 vaccination with and without TTS.

Design, Setting, and Participants  This cohort study used data from an international registry of consecutive patients with CVST within 28 days of SARS-CoV-2 vaccination included between March 29 and June 18, 2021, from 81 hospitals in 19 countries. For reference, data from patients with CVST between 2015 and 2018 were derived from an existing international registry. Clinical characteristics and mortality rate were described for adults with (1) CVST in the setting of SARS-CoV-2 vaccine–induced immune thrombotic thrombocytopenia, (2) CVST after SARS-CoV-2 vaccination not fulling criteria for TTS, and (3) CVST unrelated to SARS-CoV-2 vaccination.

Exposures  Patients were classified as having TTS if they had new-onset thrombocytopenia without recent exposure to heparin, in accordance with the Brighton Collaboration interim criteria.

Main Outcomes and Measures  Clinical characteristics and mortality rate.

Results  Of 116 patients with postvaccination CVST, 78 (67.2%) had TTS, of whom 76 had been vaccinated with ChAdOx1 nCov-19; 38 (32.8%) had no indication of TTS. The control group included 207 patients with CVST before the COVID-19 pandemic. A total of 63 of 78 (81%), 30 of 38 (79%), and 145 of 207 (70.0%) patients, respectively, were female, and the mean (SD) age was 45 (14), 55 (20), and 42 (16) years, respectively. Concomitant thromboembolism occurred in 25 of 70 patients (36%) in the TTS group, 2 of 35 (6%) in the no TTS group, and 10 of 206 (4.9%) in the control group, and in-hospital mortality rates were 47% (36 of 76; 95% CI, 37-58), 5% (2 of 37; 95% CI, 1-18), and 3.9% (8 of 207; 95% CI, 2.0-7.4), respectively. The mortality rate was 61% (14 of 23) among patients in the TTS group diagnosed before the condition garnered attention in the scientific community and 42% (22 of 53) among patients diagnosed later.

Conclusions and Relevance  In this cohort study of patients with CVST, a distinct clinical profile and high mortality rate was observed in patients meeting criteria for TTS after SARS-CoV-2 vaccination.

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Article Information

Accepted for Publication: August 13, 2021.

Published Online: September 28, 2021. doi:10.1001/jamaneurol.2021.3619

Corresponding Author: Jonathan M. Coutinho, MD, PhD, Department of Neurology, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands (j.coutinho@amsterdamumc.nl).

The Cerebral Venous Sinus Thrombosis With Thrombocytopenia Syndrome Study Group: Aarti R. Sharma; Ahmed Elkady, MD, MSc; Alberto Negro, MD, PhD; Albrecht Günther, MD; Alexander Gutschalk, MD; Silvia Schönenberger, MD; Alina Buture, MD; Sean Murphy, MD; Ana Paiva Nunes, MD; Andreas Tiede, MD, PhD; Anemon Puthuppallil Philip, MD; Annerose Mengel, MD; Antonio Medina, MD; Åslög Hellström Vogel, MD; Audrey Tawa, MD; Avinash Aujayeb, MBBS, MRCP; Barbara Casolla, MD, PhD; Brian Buck, MD; Carla Zanferrari, MD; Carlos Garcia-Esperon, MD, PhD; Caroline Vayne, PharmD, PhD; Catherine Legault, MD; Christian Pfrepper, MD; Clement Tracol, MD; Cristina Soriano, MD; Daniel Guisado-Alonso, MD; David Bougon, MD; Domenico S. Zimatore, MD; Dominik Michalski, MD; Dylan Blacquiere, MD; Elias Johansson, MD, PhD; Elisa Cuadrado-Godia, MD, PhD; Emmanuel De Maistre, MD, PhD; Emmanuel Carrera, MD; Fabrice Vuillier, MD, PhD; Fabrice Bonneville, MD, PhD; Fabrizio Giammello, MD; Felix J. Bode, MD; Julian Zimmerman, MD; Florindo d’Onofrio, MD; Francesco Grillo, MD, PhD; Francois Cotton, MD, PhD; François Caparros, MD; Laurent Puy, MD; Frank Maier, MD; Giosue Gulli, MD; Giovanni Frisullo, MD, PhD; Gregory Polkinghorne, MBBS; Guillaume Franchineau, MD; Hakan Cangür, MD, PhD; Hans Katzberg, MD; Igor Sibon, MD, PhD; Irem Baharoglu, MD, MSc; Jaskiran Brar, MD; Jean-François Payen, MD, PhD; Jim Burrow, MD; João Fernandes, MD; Judith Schouten, MD, PhD; Katharina Althaus, MD; Katia Garambois, MD, PhD; Laurent Derex, MD, PhD; Lisa Humbertjean, MD, PhD; Lucia Lebrato Hernandez, MD; Lukas Kellermair, MD; Mar Morin Martin, MD; Marco Petruzzellis, MD; Maria Cotelli, MD; Marie-Cécile Dubois, MD; Marta Carvalho, MD; Matthias Wittstock, MD, PhD; Miguel Miranda, MD, MSc; Mona Skjelland, MD, PhD; Monica Bandettini di Poggio, MD, PhD; Moritz J. Scholz, MD; Nicolas Raposo, MD, PhD; Robert Kahnis, MD; Nyika Kruyt, MD, PhD; Olivier Huet, MD, PhD; Pankaj Sharma, MD, PhD; Paolo Candelaresi, MD; Peggy Reiner, MD; Ricardo Vieira, MD; Roberto Acampora, MD; Rolf Kern, MD, PhD; Ronen Leker, MD; Shelagh Coutts, MD; Simerpreet Bal, MD; Shyam S. Sharma; Sophie Susen, MD, PhD; Thomas Cox, MD; Thomas Geeraerts, MD, PhD; Thomas Gattringer, MD, PhD; Thorsten Bartsch, MD, PhD; Timothy J. Kleinig, MBBS(Hons), PhD; Vanessa Dizonno, MSc; Yıldız Arslan, MD, MSc.

Affiliations of The Cerebral Venous Sinus Thrombosis With Thrombocytopenia Syndrome Study Group: Imperial College London School of Medicine, Imperial College London, London, United Kingdom (A. R. Sharma); Department of Neurology, Saudi German Hospital, Jeddah, Saudi Arabia (Elkady); Department of Neuroradiology, Ospedale del Mare, Naples, Italy (Negro); Department of Neurology, Jena University Hospital, Jena, Germany (Günther); Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany (Gutschalk, Schönenberger); Acute Stroke Service, Mater Misericordiae University Hospital, Dublin, Ireland (Buture, Murphy); UCD School of Medicine, University College Dublin, Dublin, Ireland (Murphy); School of Medicine, University of Medicine and Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland (Murphy); Department of Neurology, Centro Hospitalar de Lisboa Central, Lisbon, Portugal (Paiva Nunes); Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany (Tiede); Department of Neurology, Hamilton General Hospital, Hamilton, Ontario, Canada (Puthuppallil Philip); Department of Neurology and Stroke, University Hospital Tuebingen, Tuebingen, Germany (Mengel); Department of Neurology, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain (Medina); Department of Internal Medicine, Skåne University Hospital, Lund, Sweden (Hellström Vogel); Department of Anesthesia and Intensive Care, University Hospital of Rennes, Rennes, France (Tawa); Respiratory Department, Northumbria Healthcare NHS Foundation Trust, Cramlington, United Kingdom (Aujayeb, Casolla); Stroke Unit, Hôpital Pasteur 2, URRIS - UR2CA, Unité de Recherche Clinique Cote d’Azur, Cote d’Azur University, Nice, France (Casolla); Division of Neurology, University of Alberta Hospital, Edmonton, Alberta, Canada (Buck); Department of Neurology, Azienda Ospedaliera di Melegnano e della Martesana, Melegnano, Italy (Zanferrari); Department of Neurology, John Hunter Hospital, Newcastle, Australia (Garcia-Esperon); Department of Hematology and Hemostasis, Tours University Hospital, Tours, France (Vayne); Department of Neurology and Neurosurgery, McGill University Health Centre, Montreal, Quebec, Canada (Legault); Division of Hemostaseology, Leipzig University Hospital, Leipzig, Germany (Pfrepper); Department of Neurology, CHU Rennes, Rennes, France (Tracol); Department of Neurology, Hospital General de Castellón, Castelló, Spain (Soriano); Department of Neurology, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain (Guisado-Alonso); Department of Critical Care, Annecy Genevois Hospital, Annecy, France (Bougon); Department of Neuroradiology, Policlinico di Bari, Bari, Italy (Zimatore); Department of Neurology, Leipzig University Hospital, Leipzig, Germany (Michalski); Division of Neurology, The Ottawa Hospital, Ottawa, Ontario, Canada (Blacquiere); Department Clinical Science, Wallenberg Center for Molecular Medicine, Umeå University, Umeå, Sweden (Johansson); Department of Neurology, University Hospital del Mar, Barcelona, Spain (Cuadrado-Godia); Department of Biological Haematology, CHU Dijon, Dijon, France (De Maistre); Department of Neurology, Hôpitaux Universitaires de Genève, Geneva, Switzerland (Carrera); Stroke Unit, University Hospital of Besancon, Besancon, France (Vuillier); Department of Neuroradiology, Toulouse University Hospital, Toulouse, France (Bonneville); Translational Molecular Medicine and Surgery, XXXV Cycle, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy (Giammello); Department of Neurology, Universitätsklinikum Bonn, Bonn, Germany (Bode, Zimmerman); Department of Neurology, San Giuseppe Moscati Hospital, Avellino, Italy (d’Onofrio); Stroke Unit, Department of Clinical and Experimental Medicine, University Hospital G. Martino, Messina, Italy (Grillo); Department of Radiology, Lyon University Hospital, Lyon, France (Cotton); Department of Neurosciences and Cognition, Lille University Hospital, Lille, France (Caparros, Puy); Department of Neurology, Caritas Hospital Saarbrücken, Saarbrücken, Germany (Maier); Department of Medicine, Ashford and St Peters Hospital NHS Foundation Trust, Surrey, United Kingdom (Gulli); Department of Neurology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy (Frisullo); Princess Alexandra Hospital, Brisbane, Australia (Polkinghorne); Department of Intensive Care, Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye, Poissy, France (Franchineau); Department of Neurology, Hospital of the City of Wolfsburg, Wolfsburg, Germany (Cangür); Department of Neuromuscular Medicine, Toronto General Hospital, Toronto, Ontario, Canada (Katzberg); Department of Neurology, Bordeaux University Hospital, Bordeaux, France (Sibon); Department of Neurology, Haga Hospital, The Hague, the Netherlands (Baharoglu); Department of Neurology, Surrey Memorial Hospital, Surrey, British Columbia, Canada (Brar); Department of Anesthesia and Critical Care, CHU Grenoble, Grenoble, France (Payen); Department of Neurology, Royal Darwin Hospital, Tiwi, Australia (Burrow); Department of Neurology, Norra Älvsborgs Länssjukhus, Trollhattan, Sweden (Fernandes); Department of Neurology, Rijnstate Hospital Arnhem, Arnhem, the Netherlands (Schouten); Department of Neurology, Ulm University Hospital, Ulm, Germany (Althaus); Stroke Unit, University Hospital of Grenoble, Grenoble, France (Garambois); Department of Neurology, Hospices Civils de Lyon, Lyon, France (Derex); Stroke Unit, University Hospital of Nancy, Nancy, France (Humbertjean); Department of Neurology, Virgen del Rocio University Hospital, Seville, Spain (Lebrato Hernandez); Department of Neurology, Johannes Kepler University Linz, Linz, Austria (Kellermair); Department of Neurology, Hospital Complex of Toledo, Toledo, Spain (Morin Martin); Department of Neurology, AOU Consorziale Policlinico di Bari, Bari, Italy (Petruzzellis); Department of Neurology, ASL Vallecamonica-Sebino, Breno, Italy (Cotelli); Department of Anesthesia and Intensive Care, University Hospital of Poitiers, Poitiers, France (Dubois); Department of Neurology, Centro Hospitalar Universitário de São João, Faculdade de Medicina da Universidade do Porto, Porto, Portugal (Carvalho); Department of Neurology, University Hospital Rostock, Rostock, Germany (Wittstock); Department of Neurology, Hospital de Cascais Dr José de Almeida, Cascais, Portugal (Miranda); Department of Neurology, Oslo University Hospital, Oslo, Norway (Skjelland); Department of Neuroscience, Policlinic San Martino Hospital, Genoa, Italy (Bandettini di Poggio); Department of Neurology, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany (Scholz); Department of Neurology, Toulouse University Hospital, Toulouse, France (Raposo, Kahnis); Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands (Kruyt); UFR de Bio-médecine, Hospital de la Cavale Blanche, CHRU de Brest, Brest, France (Huet); Institute of Cardiovascular Research, Royal Holloway University of London, London, United Kingdom (P. Sharma); Department of Neurology and Stroke, Cardarelli Hospital, Naples, Italy (Candelaresi); Department of Neurology, Lariboisière Hospital, Paris, France (Reiner); Department of Hematology, Universidade Federal do Cariri, Juazeiro do Norte, Brazil (Vieira); Department of Neurology, Ospedale del Mare, Naples, Italy (Acampora); Department of Neurology, Kempten Hospital, Kempten, Germany (Kern); Department of Neurology, Hadassah University Medical Center, Jerusalem, Israel (Leker); Department of Clinical Neurosciences, Radiology, and Community Health Sciences, Foothills Medical Centre, Calgary, Alberta, Canada (Coutts, Bal); Edinburgh Medical School, University of Edinburgh, Edinburgh, United Kingdom (S. S. Sharma); Department of Hematology and Transfusion, Lille University Hospital, Lille, France (Susen); Department of Neurology, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom (Cox); Department of Anesthesiology and Critical Care, Toulouse University Hospital, Toulouse, France (Geeraerts); Department of Neurology, Medical University of Graz, Graz, Austria (Gattringer); Department of Neurology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany (Bartsch); Department of Neurology, Royal Adelaide Hospital, Adelaide, Australia (Kleinig); Division of Neurology, University of British Columbia, Vancouver Stroke Program, Vancouver, British Columbia, Canada (Dizonno); Neurology Clinic, Medicana İzmir International Hospital, Izmir, Turkey (Arslan).

Author Contributions: Drs Sánchez van Kammen and van de Munckhof had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Sánchez van Kammen and Aguiar de Sousa contributed equally as co–first authors, and Drs Arnold and Coutinho contributed equally as co–last authors.

Study concept and design: Sánchez van Kammen, Aguiar de Sousa, Middeldorp, Levi, Field, Tatlisumak, Ferro, Arnold, Coutinho, Vuillier, d’Onofrio, Cotelli, Arslan.

Acquisition, analysis, or interpretation of data: Sánchez van Kammen, Aguiar de Sousa, Poli, Cordonnier, Heldner, van de Munckhof, Krzywicka, van Haaps, Ciccone, Levi, Kremer Hovinga, Silvis, Hiltunen, Mansour, Barboza, Field, Tsivgoulis, Nagel, Lindgren, Tatlisumak, Jood, Putaala, Ferro, Arnold, Coutinho, A. Sharma, Elkady, Negro, Günther, Gutschalk, Buture, Paiva Nunes, Tiede, Puthuppallil Philip, Mengel, Medina, Hellström Vogel, Tawa, Aujayeb, Casolla, Buck, Zanferrari, Garcia-Esperon, Vayne, Legault, Pfrepper, Tracol, Soriano, Guisado-Alonso, Bougon, Zimatore, Michalski, Blacquiere, Johansson, Cuadrado-Godia, De Maistre, Carrera, Bonneville, Giammello, Bode, d’Onofrio, Grillo, Cotton, Caparros, Puy, Maier, Gulli, Frisullo, Polkinghorne, Franchineau, Cangür, Katzberg, Sibon, Baharoglu, Brar, Payen, Burrow, Fernandes, Schouten, Zimmermann, Althaus, Garambois, Derex, Humbertjean, Lebrato Hernandez, Kellermair, Morin Martin, Petruzzellis, Dubois, Carvalho, Wittstock, Miranda, Skjelland, Bandettini di Poggio, Scholz, Raposo, Kruyt, Huet, P. Sharma, Candelaresi, Reiner, Vieira, Kahnis, Acampora, Kern, Leker, Murphy, Coutts, S. Sharma, Schönenberger, Bal, Susen, Cox, Geeraerts, Gattringer, Bartsch, Kleinig, Dizonno.

Drafting of the manuscript: Sánchez van Kammen, Aguiar de Sousa, Heldner, Barboza, Coutinho, A. Sharma, Hellström Vogel, Tawa, Zimatore, Bonneville, d’Onofrio, Cotton, Brar, Humbertjean, Cotelli, Scholz, Arslan.

Critical revision of the manuscript for important intellectual content: Aguiar de Sousa, Poli, Cordonnier, Heldner, van de Munckhof, Krzywicka, van Haaps, Ciccone, Middeldorp, Levi, Kremer Hovinga, Silvis, Hiltunen, Mansour, Barboza, Field, Tsivgoulis, Nagel, Lindgren, Tatlisumak, Jood, Putaala, Ferro, Arnold, Coutinho, Elkady, Negro, Günther, Gutschalk, Buture, Paiva Nunes, Tiede, Puthuppallil Philip, Mengel, Medina, Aujayeb, Casolla, Buck, Zanferrari, Garcia-Esperon, Vayne, Legault, Pfrepper, Tracol, Soriano, Guisado-Alonso, Bougon, Michalski, Blacquiere, Johansson, Cuadrado-Godia, De Maistre, Carrera, Vuillier, Giammello, Bode, d’Onofrio, Grillo, Caparros, Puy, Maier, Gulli, Frisullo, Polkinghorne, Franchineau, Cangür, Katzberg, Sibon, Baharoglu, Payen, Burrow, Fernandes, Schouten, Zimmermann, Althaus, Garambois, Derex, Lebrato Hernandez, Kellermair, Morin Martin, Petruzzellis, Cotelli, Dubois, Carvalho, Wittstock, Miranda, Skjelland, Bandettini di Poggio, Raposo, Kruyt, Huet, P. Sharma, Candelaresi, Reiner, Vieira, Kahnis, Acampora, Kern, Leker, Murphy, Coutts, S. Sharma, Schönenberger, Bal, Susen, Cox, Geeraerts, Gattringer, Bartsch, Kleinig, Dizonno.

Statistical analysis: Sánchez van Kammen, Aguiar de Sousa, van Haaps, Aujayeb.

Obtained funding: Cordonnier, Tiede, Buck, Vuillier, Humbertjean.

Administrative, technical, or material support: Sánchez van Kammen, Cordonnier, Heldner, van de Munckhof, Krzywicka, Levi, Silvis, Barboza, Field, Tatlisumak, Putaala, Ferro, Buture, Tiede, Aujayeb, Buck, Zanferrari, Garcia-Esperon, Pfrepper, Michalski, Carrera, Bode, d’Onofrio, Cotton, Baharoglu, Burrow, Schouten, Zimmermann, Althaus, Cotelli, Carvalho, Miranda, Skjelland, P. Sharma, Candelaresi, Kern, Murphy, S. Sharma, Schönenberger, Bal, Susen, Cox, Geeraerts, Dizonno, Arslan.

Study supervision: Ciccone, Levi, Kremer Hovinga, Silvis, Hiltunen, Putaala, Arnold, Coutinho, Tiede, Medina, Zimatore, De Maistre, d’Onofrio, Frisullo, Morin Martin, Bandettini di Poggio, Acampora, Geeraerts, Bartsch.

Conflict of Interest Disclosures: Dr Aguiar de Sousa has received travel support from Boehringer Ingelheim and personal fees for advisory board participation from AstraZeneca. Dr Poli has received personal fees from AstraZeneca, Werfen, Portola, Bristol Myers Squibb/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, and Bayer; grants from the German Federal Ministry of Education and Research (REVISION randomized trial), German Federal Joint Committee Innovation Fund (APICES project), Daiichi Sankyo (SPOCT-DOAC 1 study), Bristol Myers Squibb/Pfizer (ATTICUS randomized trial), and European Union (PROOF randomized trial); and nonfinancial support from Werfen and Boehringer Ingelheim (REVISION randomized trial). Dr Cordonnier has received speaker honoraria from Boehringer Ingelheim, personal fees for advisory board participation from AstraZeneca and Biogen, and personal fees for steering committee participation from Biogen and Bristol Myers Squibb. Dr Heldner has received grants from the Swiss Heart Foundation and Bangerter Foundation; travel support from Bayer; personal fees for data safety monitoring board or advisory board participation from Amgen; and is a member of the European Stroke Organisation Board of Directors and European Stroke Organisation Education Committee. Dr Krzywicka has received travel support from Amgen. Dr Middeldorp has received grants from Bayer, Pfizer, Boehringer Ingelheim, and Daiichi Sankyo paid to her institution and personal fees from Bayer, Bristol Myers Squibb/Pfizer, Boehringer Ingelheim, AbbVie, Portola/Alexion, and Daiichi Sankyo paid to her institution. Dr Kremer Hovinga has received grants from Baxalta as well as personal fees paid to her institution from Shire, Ablynx, Roche, Sobi, and the Swiss Federal Office of Public Health. Dr Barboza has received payment or honoraria from Abbott, Pfizer, Roche, and Bayer. Dr Field has received grants and nonfinancial support from Bayer Canada as well as personal fees from Servier. Dr Nagel has received personal fees from Brainomix, Boehringer Ingelheim, and Pfizer. Dr Lindgren has received grants from the Swedish Neurological Society Academic, Elsa and Gustav Lindh’s Foundation, Per Olof Ahl’s Foundation, and Ulla Amlöv Foundation. Dr Tatlisumak has received personal fees from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, and Portola Pharmaceuticals. Dr Putaala has received personal fees from Boehringer Ingelheim, Bayer, Herantis Pharma, and Abbott and owns stock in Vital Signum. Dr Ferro has received personal fees from Boehringer Ingelheim, Bayer, and Daiichi Sankyo as well as grants from Bayer. Dr Arnold has received personal fees from AstraZeneca, Bayer, Bristol Myers Squibb, Covidien, Daiichi Sankyo, Medtronic, Novartis, Sanofi, Pfizer, and Amgen and grants from the Swiss National Science Foundation and Swiss Heart Foundation. Dr Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer. Dr Günther has received personal fees from Bayer Vital, Bristol Myers Squibb, and Daiichi Sankyo. Dr Blacquiere has received personal fees from Servier Canada. Dr Johansson has received grants from WCMM Umeå, Region Västerbotten, Svenska Läkaresällskapet, Strokeriskförbundet, and Hjärt-lungfonden. Dr d’Onofrio has received personal fees from Lilly, Teva, and Novartis. Dr Kern has received personal fees from Bristol Myers Squibb/Pfizer and Sanofi Genzyme. Dr Leker has received personal fees from Boehringer Ingelheim, Abbott, and Janssen. Dr Bartsch has received personal fees from Roche and Biogen and grants from Novartis. Dr Kleinig has received personal fees from Boehringer Ingelheim. No other disclosures were reported.

Additional Contributions: We thank Laura van Meenen, MD (Department of Neurology, Amsterdam UMC, Amsterdam, the Netherlands), for her help with the construction of the online case record form. She did not receive any compensation for her assistance.

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