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1. Sex differences in cerebral venous sinus thrombosis after adenoviral vaccination against COVID-19

Author

Scutelnic, Adrian, van de Munckhof, Anita, Krzywicka, Katarzyna, van Kammen, Mayte Sánchez, Lindgren, Erik, Cordonnier, Charlotte, Kleinig, Timothy J., Field, Thalia S., Poli, Sven, Lemmens, Robin, Middeldorp, Saskia, Aaron, Sanjith, Borhani-Haghighi, Afshin, Arauz, Antonio, Kremer Hovinga, Johanna A., Günther, Albrecht, Putaala, Jukka, Wasay, Mohammad, Conforto, Adriana Bastos, de Sousa, Diana Aguiar, Jood, Katarina, Tatlisumak, Turgut, Ferro, José M., Coutinho, Jonathan M., Arnold, Marcel, Heldner, Mirjam R., Antonenko, Kateryna, Mbroh, Joshua, Brodard, Justine, Hooshmandi, Etrat, Dizonno, Vanessa, Devroye, Annemie, Ciccone, Alfonso, Wittstock, Matthias, Zimmermann, Julian, Bode, Felix J., Skjelland, Mona, Duan, Jiangang, Hiltunen, Sini, Zuurbier, Susanna M., Petruzzellis, Marco, Sharma, Aarti R., Ghoreishi, Abdoreza, Elkady, Ahmed, Negro, Alberto, Gutschalk, Alexander, Schoenenberger, Silvia, Nagel, Simon, Buture, Alina, Cervera, Alvaro, Paiva Nunes, Ana, Romina Montané Baños, Ana, Tiede, Andreas, Puthuppallil, Anemon, Tuladhar, Anil M., Mengel, Annerose, Medina, Antonio, Hellström Vogel, Åslög, Tawa, Audrey, Aujayeb, Avinash, Ramasamy, Balakrishnan, Casolla, Barbara, Lim Alvin Chew, Beng, Ziaadini, Bentalhoda, Varkey Maramattom, Boby, Buck, Brian, Zanferrari, Carla, Garcia-Esperon, Carlos, Vayne, Caroline, Legault, Catherine, Jacobi, Christian, Pfrepper, Christian, Pelz, Johann, Wahl, Christoph, Kern, Rolf, Tracol, Clement, Soriano, Cristina, Guisado-Alonso, Daniel, Bougon, David, Bal, Deepti, Sergio Zimatore, Domenico, Michalski, Dominik, Blacquiere, Dylan, Johansson, Elias, Cuadrado-Godia, Elisa, Sadeghi-Hokmabadi, Elyar, Carrera, Emmanuel, De Maistre, Emmanuel, Saxhaug Kristoffersen, Espen, Bonneville, Fabrice, Geeraerts, Thomas, Vuillier, Fabrice, Giammello, Fabrizio, D’Onofrio, Florindo, Grillo, Francesco, Caparros, François, Susen, Sophie, Maier, Frank, Tsivgoulis, Georgios, Gulli, Giosue, Frisullo, Giovanni, Franchineau, Guillaume, Cangür, Hakan, Katzberg, Hans, Mozhdehipanah, Hossein, Sibon, Igor, Baharoglu, M. Irem, Masjuan, Jaime, Brar, Jaskiran, Payen, Jean Francois, Burrow, Jim, Fernandes, João, Octavio López Esparza, Jorge, Oen, Joyce, Schouten, Judith, Ng, Karl, Chatterton, Sophie, Wronski, Miriam, Althaus, Katharina, Garambois, Katia, Derex, Laurent, Puy, Laurent, Poorsaadat, Leila, Valler, Lenise, Januzi de Almeida Rocha, Letícia, Humbertjean, Lisa, Lebrato Hernandez, Lucia, Murillo-Bonilla, Luis, Kellermair, Lukas, Morin Martin, Mar, Sofia Cotelli, Maria, Hernandez Perez, Maria, Zedde, Marialuisa, Carvalho Dias, Mariana, Dubois, Marie Cecile, Carvalho, Marta, Ghiasian, Masoud, Umaiorubahan, Meenakshisundaram, Kumar Karunakaran, Ravi, Roozbeh, Mehrdad, Romoli, Michele, Miranda, Miguel, Saadatnia, Mohammad, Bandettini di Poggio, Monica, Scholz, Moritz J., Kahnis, Robert, Almasi-Dooghaee, Mostafa, Hoseininejad Mir, Nahid, Ichaporia, Nasli R., Kumar Paramasivan, Naveen, Erat Sreedharan, Sapna, Sylaja, P. N., Raposo, Nicolas, Fadakar, Nima, Kruyt, Nyika, Detante, Olivier, Cuisenier, Pauline, Huet, Olivier, Sharma, Pankaj, Candelaresi, Paolo, Scoppettuolo, Pasquale, Reiner, Peggy, Nemati, Reza, Vieira, Ricardo, Goh, Rudy, Murphy, Seán, Timsit, Serge, Coutts, Shelagh, Sharma, Shyam S., Bal, Simerpreet, Kaul, Subhash, Karapanayiotides, Theodoros, Cox, Thomas, Gattringer, Thomas, Mathew, Thomas, Bartsch, Thorsten, Shaygannejad, Vahid, Garcia-Talavera, Veronica, Palma, Vincenzo, Arslan, Yıldız, Mirzaasgari, Zahra, Yavari, Zeinab, Zamani, Zohreh, Bakchoul, Tamam, Levi, Marcel, van Gorp, Eric C.M., Scutelnic, Adrian, van de Munckhof, Anita, Krzywicka, Katarzyna, van Kammen, Mayte Sánchez, Lindgren, Erik, Cordonnier, Charlotte, Kleinig, Timothy J., Field, Thalia S., Poli, Sven, Lemmens, Robin, Middeldorp, Saskia, Aaron, Sanjith, Borhani-Haghighi, Afshin, Arauz, Antonio, Kremer Hovinga, Johanna A., Günther, Albrecht, Putaala, Jukka, Wasay, Mohammad, Conforto, Adriana Bastos, de Sousa, Diana Aguiar, Jood, Katarina, Tatlisumak, Turgut, Ferro, José M., Coutinho, Jonathan M., Arnold, Marcel, Heldner, Mirjam R., Antonenko, Kateryna, Mbroh, Joshua, Brodard, Justine, Hooshmandi, Etrat, Dizonno, Vanessa, Devroye, Annemie, Ciccone, Alfonso, Wittstock, Matthias, Zimmermann, Julian, Bode, Felix J., Skjelland, Mona, Duan, Jiangang, Hiltunen, Sini, Zuurbier, Susanna M., Petruzzellis, Marco, Sharma, Aarti R., Ghoreishi, Abdoreza, Elkady, Ahmed, Negro, Alberto, Gutschalk, Alexander, Schoenenberger, Silvia, Nagel, Simon, Buture, Alina, Cervera, Alvaro, Paiva Nunes, Ana, Romina Montané Baños, Ana, Tiede, Andreas, Puthuppallil, Anemon, Tuladhar, Anil M., Mengel, Annerose, Medina, Antonio, Hellström Vogel, Åslög, Tawa, Audrey, Aujayeb, Avinash, Ramasamy, Balakrishnan, Casolla, Barbara, Lim Alvin Chew, Beng, Ziaadini, Bentalhoda, Varkey Maramattom, Boby, Buck, Brian, Zanferrari, Carla, Garcia-Esperon, Carlos, Vayne, Caroline, Legault, Catherine, Jacobi, Christian, Pfrepper, Christian, Pelz, Johann, Wahl, Christoph, Kern, Rolf, Tracol, Clement, Soriano, Cristina, Guisado-Alonso, Daniel, Bougon, David, Bal, Deepti, Sergio Zimatore, Domenico, Michalski, Dominik, Blacquiere, Dylan, Johansson, Elias, Cuadrado-Godia, Elisa, Sadeghi-Hokmabadi, Elyar, Carrera, Emmanuel, De Maistre, Emmanuel, Saxhaug Kristoffersen, Espen, Bonneville, Fabrice, Geeraerts, Thomas, Vuillier, Fabrice, Giammello, Fabrizio, D’Onofrio, Florindo, Grillo, Francesco, Caparros, François, Susen, Sophie, Maier, Frank, Tsivgoulis, Georgios, Gulli, Giosue, Frisullo, Giovanni, Franchineau, Guillaume, Cangür, Hakan, Katzberg, Hans, Mozhdehipanah, Hossein, Sibon, Igor, Baharoglu, M. Irem, Masjuan, Jaime, Brar, Jaskiran, Payen, Jean Francois, Burrow, Jim, Fernandes, João, Octavio López Esparza, Jorge, Oen, Joyce, Schouten, Judith, Ng, Karl, Chatterton, Sophie, Wronski, Miriam, Althaus, Katharina, Garambois, Katia, Derex, Laurent, Puy, Laurent, Poorsaadat, Leila, Valler, Lenise, Januzi de Almeida Rocha, Letícia, Humbertjean, Lisa, Lebrato Hernandez, Lucia, Murillo-Bonilla, Luis, Kellermair, Lukas, Morin Martin, Mar, Sofia Cotelli, Maria, Hernandez Perez, Maria, Zedde, Marialuisa, Carvalho Dias, Mariana, Dubois, Marie Cecile, Carvalho, Marta, Ghiasian, Masoud, Umaiorubahan, Meenakshisundaram, Kumar Karunakaran, Ravi, Roozbeh, Mehrdad, Romoli, Michele, Miranda, Miguel, Saadatnia, Mohammad, Bandettini di Poggio, Monica, Scholz, Moritz J., Kahnis, Robert, Almasi-Dooghaee, Mostafa, Hoseininejad Mir, Nahid, Ichaporia, Nasli R., Kumar Paramasivan, Naveen, Erat Sreedharan, Sapna, Sylaja, P. N., Raposo, Nicolas, Fadakar, Nima, Kruyt, Nyika, Detante, Olivier, Cuisenier, Pauline, Huet, Olivier, Sharma, Pankaj, Candelaresi, Paolo, Scoppettuolo, Pasquale, Reiner, Peggy, Nemati, Reza, Vieira, Ricardo, Goh, Rudy, Murphy, Seán, Timsit, Serge, Coutts, Shelagh, Sharma, Shyam S., Bal, Simerpreet, Kaul, Subhash, Karapanayiotides, Theodoros, Cox, Thomas, Gattringer, Thomas, Mathew, Thomas, Bartsch, Thorsten, Shaygannejad, Vahid, Garcia-Talavera, Veronica, Palma, Vincenzo, Arslan, Yıldız, Mirzaasgari, Zahra, Yavari, Zeinab, Zamani, Zohreh, Bakchoul, Tamam, Levi, Marcel, and van Gorp, Eric C.M.

Abstract

Introduction: Cerebral venous sinus thrombosis associated with vaccine-induced immune thrombotic thrombocytopenia (CVST-VITT) is a severe disease with high mortality. There are few data on sex differences in CVST-VITT. The aim of our study was to investigate the differences in presentation, treatment, clinical course, complications, and outcome of CVST-VITT between women and men. Patients and methods: We used data from an ongoing international registry on CVST-VITT. VITT was diagnosed according to the Pavord criteria. We compared the characteristics of CVST-VITT in women and men. Results: Of 133 patients with possible, probable, or definite CVST-VITT, 102 (77%) were women. Women were slightly younger [median age 42 (IQR 28–54) vs 45 (28–56)], presented more often with coma (26% vs 10%) and had a lower platelet count at presentation [median (IQR) 50x109/L (28–79) vs 68 (30–125)] than men. The nadir platelet count was lower in women [median (IQR) 34 (19–62) vs 53 (20–92)]. More women received endovascular treatment than men (15% vs 6%). Rates of treatment with intravenous immunoglobulins were similar (63% vs 66%), as were new venous thromboembolic events (14% vs 14%) and major bleeding complications (30% vs 20%). Rates of good functional outcome (modified Rankin Scale 0-2, 42% vs 45%) and in-hospital death (39% vs 41%) did not differ. Discussion and conclusions: Three quarters of CVST-VITT patients in this study were women. Women were more severely affected at presentation, but clinical course and outcome did not differ between women and men. VITT-specific treatments were overall similar, but more women received endovascular treatment.

Published
2023

2. Cerebral venous sinus thrombosis due to vaccine-induced immune thrombotic thrombocytopenia in middle-income countries

Author

van de Munckhof, Anita, Borhani-Haghighi, Afshin, Aaron, Sanjith, Krzywicka, Katarzyna, van Kammen, Mayte Sánchez, Cordonnier, Charlotte, Kleinig, Timothy J., Field, Thalia S., Poli, Sven, Lemmens, Robin, Scutelnic, Adrian, Lindgren, Erik, Duan, Jiangang, Arslan, Yıldız, van Gorp, Eric C.M., Kremer Hovinga, Johanna A., Günther, Albrecht, Jood, Katarina, Tatlisumak, Turgut, Putaala, Jukka, Heldner, Mirjam R., Arnold, Marcel, de Sousa, Diana Aguiar, Wasay, Mohammad, Arauz, Antonio, Conforto, Adriana Bastos, Ferro, José M., Coutinho, Jonathan M., Mbroh, Joshua, Ciccone, Alfonso, Wittstock, Matthias, Zimmermann, Julian, Bode, Felix J., Skjelland, Mona, Dizonno, Vanessa, Devroye, Annemie, Hiltunen, Sini, Petruzzellis, Marco, Bakchoul, Tamam, Levi, Marcel, Middeldorp, Saskia, Sharma, Aarti R., Ghoreishi, Abdoreza, Elkady, Ahmed, Negro, Alberto, Gutschalk, Alexander, Buture, Alina, Cervera, Alvaro, Paiva Nunes, Ana, Romina Montané Baños, Ana, Tiede, Andreas, Tuladhar, Anil M., Mengel, Annerose, Medina, Antonio, Aujayeb, Avinash, Ramasamy, Balakrishnan, Casolla, Barbara, Spratt, Neil, Ziaadini, Bentolhoda, Varkey Maramattom, Boby, Buck, Brian, Garcia-Esperon, Carlos, Vayne, Caroline, Jacobi, Christian, Pfrepper, Christian, Bal, Deepti, Sergio Zimatore, Domenico, Michalski, Dominik, Blacquiere, Dylan, Johansson, Elias, Cuadrado-Godia, Elisa, Sadeghi-Hokmabadi, Elyar, Carrera, Emmanuel, Maistre, Emmanuel De, Saxhaug Kristoffersen, Espen, Hooshmandi, Etrat, Bonneville, Fabrice, Vuillier, Fabrice, Giammello, Fabrizio, D’Onofrio, Florindo, Tsivgoulis, Georgios, Gulli, Giosue, Katzberg, Hans, Sibon, Igor, Baharoglu, Irem, Masjuan, Jaime, Fernandes, João, Pelz, Johann, Octavio López Esparza, Jorge, Schouten, Judith, Ng, Karl, Derex, Laurent, Puy, Laurent, Poorsaadat, Leila, Valler, Lenise, Januzi de Almeida Rocha, Letícia, Murillo-Bonilla, Luis, Kellermair, Lukas, Morin Martin, Mar, Sofia Cotelli, Maria, Hernandez Perez, Maria, Zedde, Marialuisa, Carvalho Dias, Mariana, Carvalho, Marta, Ghiasian, Masoud, Umaiorubahan, Meenakshisundaram, Roozbeh, Mehrdad, Romoli, Michele, Miranda, Miguel, Wronski, Miriam, Saadatnia, Mohammad, Bandettini di Poggio, Monica, Almasi-Dooghaee, Mostafa, Hoseininejad Mir, Nahid, Ichaporia, Nasli R., Kumar Paramasivan, Naveen, Raposo, Nicolas, Fadakar, Nima, Kruyt, Nyika, Detante, Olivier, Sharma, Pankaj, Candelaresi, Paolo, Scoppettuolo, Pasquale, Reiner, Peggy, Sylaja, P. N., Kumar Karunakaran, Ravi, Vieira, Ricardo, Kern, Rolf, Goh, Rudy, Erat Sreedharan, Sapna, Murphy, Seán, Timsit, Serge, Coutts, Shelagh, Sharma, Shyam S., Schoenenberger, Silvia, Nagel, Simon, Kaul, Subhash, Karapanayiotides, Theodoros, Gattringer, Thomas, Mathew, Thomas, Bartsch, Thorsten, Palma, Vincenzo, Mirzaasgari, Zahra, Zamani, Zohreh, Mirahmadizadeh, Alireza, Gutierrez-Romero, Alonso, Iván Valdes-Ferrer, Ivan, Elizabeth Ceballos-Liceaga, Santa, Maria Santibañez-Copado, Ana, van de Munckhof, Anita, Borhani-Haghighi, Afshin, Aaron, Sanjith, Krzywicka, Katarzyna, van Kammen, Mayte Sánchez, Cordonnier, Charlotte, Kleinig, Timothy J., Field, Thalia S., Poli, Sven, Lemmens, Robin, Scutelnic, Adrian, Lindgren, Erik, Duan, Jiangang, Arslan, Yıldız, van Gorp, Eric C.M., Kremer Hovinga, Johanna A., Günther, Albrecht, Jood, Katarina, Tatlisumak, Turgut, Putaala, Jukka, Heldner, Mirjam R., Arnold, Marcel, de Sousa, Diana Aguiar, Wasay, Mohammad, Arauz, Antonio, Conforto, Adriana Bastos, Ferro, José M., Coutinho, Jonathan M., Mbroh, Joshua, Ciccone, Alfonso, Wittstock, Matthias, Zimmermann, Julian, Bode, Felix J., Skjelland, Mona, Dizonno, Vanessa, Devroye, Annemie, Hiltunen, Sini, Petruzzellis, Marco, Bakchoul, Tamam, Levi, Marcel, Middeldorp, Saskia, Sharma, Aarti R., Ghoreishi, Abdoreza, Elkady, Ahmed, Negro, Alberto, Gutschalk, Alexander, Buture, Alina, Cervera, Alvaro, Paiva Nunes, Ana, Romina Montané Baños, Ana, Tiede, Andreas, Tuladhar, Anil M., Mengel, Annerose, Medina, Antonio, Aujayeb, Avinash, Ramasamy, Balakrishnan, Casolla, Barbara, Spratt, Neil, Ziaadini, Bentolhoda, Varkey Maramattom, Boby, Buck, Brian, Garcia-Esperon, Carlos, Vayne, Caroline, Jacobi, Christian, Pfrepper, Christian, Bal, Deepti, Sergio Zimatore, Domenico, Michalski, Dominik, Blacquiere, Dylan, Johansson, Elias, Cuadrado-Godia, Elisa, Sadeghi-Hokmabadi, Elyar, Carrera, Emmanuel, Maistre, Emmanuel De, Saxhaug Kristoffersen, Espen, Hooshmandi, Etrat, Bonneville, Fabrice, Vuillier, Fabrice, Giammello, Fabrizio, D’Onofrio, Florindo, Tsivgoulis, Georgios, Gulli, Giosue, Katzberg, Hans, Sibon, Igor, Baharoglu, Irem, Masjuan, Jaime, Fernandes, João, Pelz, Johann, Octavio López Esparza, Jorge, Schouten, Judith, Ng, Karl, Derex, Laurent, Puy, Laurent, Poorsaadat, Leila, Valler, Lenise, Januzi de Almeida Rocha, Letícia, Murillo-Bonilla, Luis, Kellermair, Lukas, Morin Martin, Mar, Sofia Cotelli, Maria, Hernandez Perez, Maria, Zedde, Marialuisa, Carvalho Dias, Mariana, Carvalho, Marta, Ghiasian, Masoud, Umaiorubahan, Meenakshisundaram, Roozbeh, Mehrdad, Romoli, Michele, Miranda, Miguel, Wronski, Miriam, Saadatnia, Mohammad, Bandettini di Poggio, Monica, Almasi-Dooghaee, Mostafa, Hoseininejad Mir, Nahid, Ichaporia, Nasli R., Kumar Paramasivan, Naveen, Raposo, Nicolas, Fadakar, Nima, Kruyt, Nyika, Detante, Olivier, Sharma, Pankaj, Candelaresi, Paolo, Scoppettuolo, Pasquale, Reiner, Peggy, Sylaja, P. N., Kumar Karunakaran, Ravi, Vieira, Ricardo, Kern, Rolf, Goh, Rudy, Erat Sreedharan, Sapna, Murphy, Seán, Timsit, Serge, Coutts, Shelagh, Sharma, Shyam S., Schoenenberger, Silvia, Nagel, Simon, Kaul, Subhash, Karapanayiotides, Theodoros, Gattringer, Thomas, Mathew, Thomas, Bartsch, Thorsten, Palma, Vincenzo, Mirzaasgari, Zahra, Zamani, Zohreh, Mirahmadizadeh, Alireza, Gutierrez-Romero, Alonso, Iván Valdes-Ferrer, Ivan, Elizabeth Ceballos-Liceaga, Santa, and Maria Santibañez-Copado, Ana

Abstract

Background: Adenovirus-based COVID-19 vaccines are extensively used in low- and middle-income countries (LMICs). Remarkably, cases of cerebral venous sinus thrombosis due to vaccine-induced immune thrombotic thrombocytopenia (CVST-VITT) have rarely been reported from LMICs. Aims: We studied the frequency, manifestations, treatment, and outcomes of CVST-VITT in LMICs. Methods: We report data from an international registry on CVST after COVID-19 vaccination. VITT was classified according to the Pavord criteria. We compared CVST-VITT cases from LMICs to cases from high-income countries (HICs). Results: Until August 2022, 228 CVST cases were reported, of which 63 were from LMICs (all middle-income countries [MICs]: Brazil, China, India, Iran, Mexico, Pakistan, Turkey). Of these 63, 32 (51%) met the VITT criteria, compared to 103 of 165 (62%) from HICs. Only 5 of the 32 (16%) CVST-VITT cases from MICs had definite VITT, mostly because anti-platelet factor 4 antibodies were often not tested. The median age was 26 (interquartile range [IQR] 20–37) versus 47 (IQR 32–58) years, and the proportion of women was 25 of 32 (78%) versus 77 of 103 (75%) in MICs versus HICs, respectively. Patients from MICs were diagnosed later than patients from HICs (1/32 [3%] vs. 65/103 [63%] diagnosed before May 2021). Clinical manifestations, including intracranial hemorrhage, were largely similar as was intravenous immunoglobulin use. In-hospital mortality was lower in MICs (7/31 [23%, 95% confidence interval (CI) 11–40]) than in HICs (44/102 [43%, 95% CI 34–53], p = 0.039). Conclusions: The number of CVST-VITT cases reported from LMICs was small despite the widespread use of adenoviral vaccines. Clinical manifestations and treatment of CVST-VITT cases were largely similar in MICs and HICs, while mortality was lower in patients from MICs.

Published
2023

3. Characteristics and Outcomes of Patients with Cerebral Venous Sinus Thrombosis in SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia

Author

Sánchez Van Kammen, Mayte, Aguiar De Sousa, Diana, Poli, Sven, Cordonnier, Charlotte, Heldner, Mirjam R., Van De Munckhof, Anita, Krzywicka, Katarzyna, Van Haaps, Thijs, Ciccone, Alfonso, Middeldorp, Saskia, Levi, Marcel M., Kremer Hovinga, Johanna A., Silvis, Suzanne, Hiltunen, Sini, Mansour, Maryam, Arauz, Antonio, Barboza, Miguel A., Field, Thalia S., Tsivgoulis, Georgios, Nagel, Simon, Lindgren, Erik, Tatlisumak, Turgut, Jood, Katarina, Putaala, Jukka, Ferro, Jose M., Arnold, Marcel, Coutinho, Jonathan M., Sharma, Aarti R., Elkady, Ahmed, Negro, Alberto, Günther, Albrecht, Gutschalk, Alexander, Schönenberger, Silvia, Buture, Alina, Murphy, Sean, Paiva Nunes, Ana, Tiede, Andreas, Puthuppallil Philip, Anemon, Mengel, Annerose, Medina, Antonio, Hellström Vogel, Åslög, Tawa, Audrey, Aujayeb, Avinash, Casolla, Barbara, Buck, Brian, Zanferrari, Carla, Garcia-Esperon, Carlos, Vayne, Caroline, Legault, Catherine, Pfrepper, Christian, Tracol, Clement, Soriano, Cristina, Guisado-Alonso, Daniel, Bougon, David, Zimatore, Domenico S., Michalski, Dominik, Blacquiere, Dylan, Johansson, Elias, Cuadrado-Godia, Elisa, De Maistre, Emmanuel, Carrera, Emmanuel, Vuillier, Fabrice, Bonneville, Fabrice, Giammello, Fabrizio, Bode, Felix J., Zimmerman, Julian, D'Onofrio, Florindo, Grillo, Francesco, Cotton, Francois, Caparros, François, Puy, Laurent, Maier, Frank, Gulli, Giosue, Frisullo, Giovanni, Polkinghorne, Gregory, Franchineau, Guillaume, Cangür, Hakan, Katzberg, Hans, Sibon, Igor, Baharoglu, Irem, Brar, Jaskiran, Payen, Jean-François, Burrow, Jim, Fernandes, João, Schouten, Judith, Althaus, Katharina, Garambois, Katia, Derex, Laurent, Humbertjean, Lisa, Lebrato Hernandez, Lucia, Kellermair, Lukas, Morin Martin, Mar, Petruzzellis, Marco, Cotelli, Maria, Dubois, Marie-Cécile, Carvalho, Marta, Wittstock, Matthias, Miranda, Miguel, Skjelland, Mona, Bandettini Di Poggio, Monica, Scholz, Moritz J., Raposo, Nicolas, Kahnis, Robert, Kruyt, Nyika, Huet, Olivier, Sharma, Pankaj, Candelaresi, Paolo, Reiner, Peggy, Vieira, Ricardo, Acampora, Roberto, Kern, Rolf, Leker, Ronen, Coutts, Shelagh, Bal, Simerpreet, Sharma, Shyam S., Susen, Sophie, Cox, Thomas, Geeraerts, Thomas, Gattringer, Thomas, Bartsch, Thorsten, Kleinig, Timothy J., Dizonno, Vanessa, Arslan, Yildiz, Sánchez Van Kammen, Mayte, Aguiar De Sousa, Diana, Poli, Sven, Cordonnier, Charlotte, Heldner, Mirjam R., Van De Munckhof, Anita, Krzywicka, Katarzyna, Van Haaps, Thijs, Ciccone, Alfonso, Middeldorp, Saskia, Levi, Marcel M., Kremer Hovinga, Johanna A., Silvis, Suzanne, Hiltunen, Sini, Mansour, Maryam, Arauz, Antonio, Barboza, Miguel A., Field, Thalia S., Tsivgoulis, Georgios, Nagel, Simon, Lindgren, Erik, Tatlisumak, Turgut, Jood, Katarina, Putaala, Jukka, Ferro, Jose M., Arnold, Marcel, Coutinho, Jonathan M., Sharma, Aarti R., Elkady, Ahmed, Negro, Alberto, Günther, Albrecht, Gutschalk, Alexander, Schönenberger, Silvia, Buture, Alina, Murphy, Sean, Paiva Nunes, Ana, Tiede, Andreas, Puthuppallil Philip, Anemon, Mengel, Annerose, Medina, Antonio, Hellström Vogel, Åslög, Tawa, Audrey, Aujayeb, Avinash, Casolla, Barbara, Buck, Brian, Zanferrari, Carla, Garcia-Esperon, Carlos, Vayne, Caroline, Legault, Catherine, Pfrepper, Christian, Tracol, Clement, Soriano, Cristina, Guisado-Alonso, Daniel, Bougon, David, Zimatore, Domenico S., Michalski, Dominik, Blacquiere, Dylan, Johansson, Elias, Cuadrado-Godia, Elisa, De Maistre, Emmanuel, Carrera, Emmanuel, Vuillier, Fabrice, Bonneville, Fabrice, Giammello, Fabrizio, Bode, Felix J., Zimmerman, Julian, D'Onofrio, Florindo, Grillo, Francesco, Cotton, Francois, Caparros, François, Puy, Laurent, Maier, Frank, Gulli, Giosue, Frisullo, Giovanni, Polkinghorne, Gregory, Franchineau, Guillaume, Cangür, Hakan, Katzberg, Hans, Sibon, Igor, Baharoglu, Irem, Brar, Jaskiran, Payen, Jean-François, Burrow, Jim, Fernandes, João, Schouten, Judith, Althaus, Katharina, Garambois, Katia, Derex, Laurent, Humbertjean, Lisa, Lebrato Hernandez, Lucia, Kellermair, Lukas, Morin Martin, Mar, Petruzzellis, Marco, Cotelli, Maria, Dubois, Marie-Cécile, Carvalho, Marta, Wittstock, Matthias, Miranda, Miguel, Skjelland, Mona, Bandettini Di Poggio, Monica, Scholz, Moritz J., Raposo, Nicolas, Kahnis, Robert, Kruyt, Nyika, Huet, Olivier, Sharma, Pankaj, Candelaresi, Paolo, Reiner, Peggy, Vieira, Ricardo, Acampora, Roberto, Kern, Rolf, Leker, Ronen, Coutts, Shelagh, Bal, Simerpreet, Sharma, Shyam S., Susen, Sophie, Cox, Thomas, Geeraerts, Thomas, Gattringer, Thomas, Bartsch, Thorsten, Kleinig, Timothy J., Dizonno, Vanessa, and Arslan, Yildiz

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

Published
2021
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4. Safety and outcomes of routine endovascular thrombectomy in large artery occlusion recorded in the SITS Register: An observational study

Author

Karolinska Institute, Stockholm County Council, Swedish Heart-Lung Foundation, Order of Saint John in Sweden, Friends of Karolinska Institute, Boehringer Ingelheim Fonds, European Commission, Biogen, Stryker, Covidien, Phenox, Ragnar Söderberg Foundation, Torsten Söderberg Foundation, The Erling-Persson Family Foundation, VINNOVA (Sweden), Junta de Andalucía, Ministry of Health of the Czech Republic, Charles University (Czech Republic), Ahmed, Niaz, Mazya, Michael, Paiva Nunes, Ana, Moreira, T., Ollikainen, J. P., Escudero-Martínez, Irene, Bigliardi, G., Dorado, L., Dávalos, Antonio, Egido, J.A., Tassi, R., Strbian, Daniel, Zini, A., Nichelli, P., Herzig, R., Jurák, L., Hurtikova, E., Tsivgoulis, Georgios, Peeters, André, Nevšímalová, M., Brozman, M., Cavallo, R., Lees, K. R., Mikulik, R., Toni, Danilo, Holmin, S., Karolinska Institute, Stockholm County Council, Swedish Heart-Lung Foundation, Order of Saint John in Sweden, Friends of Karolinska Institute, Boehringer Ingelheim Fonds, European Commission, Biogen, Stryker, Covidien, Phenox, Ragnar Söderberg Foundation, Torsten Söderberg Foundation, The Erling-Persson Family Foundation, VINNOVA (Sweden), Junta de Andalucía, Ministry of Health of the Czech Republic, Charles University (Czech Republic), Ahmed, Niaz, Mazya, Michael, Paiva Nunes, Ana, Moreira, T., Ollikainen, J. P., Escudero-Martínez, Irene, Bigliardi, G., Dorado, L., Dávalos, Antonio, Egido, J.A., Tassi, R., Strbian, Daniel, Zini, A., Nichelli, P., Herzig, R., Jurák, L., Hurtikova, E., Tsivgoulis, Georgios, Peeters, André, Nevšímalová, M., Brozman, M., Cavallo, R., Lees, K. R., Mikulik, R., Toni, Danilo, and Holmin, S.

Abstract

[Background and objective] We aimed to evaluate the safety and outcomes of thrombectomy in anterior circulation acute ischaemic stroke recorded in the SITS–International Stroke Thrombectomy Register (SITS-ISTR) and compare them with pooled randomized controlled trials (RCTs) and two national registry studies., [Methods] We identified centres recording ≥10 consecutive patients in the SITS-ISTR with at least 70% of available modified Rankin Scale (mRS) at 3 months during 2014–2019. We defined large artery occlusion as intracranial internal carotid artery, first and second segment of middle cerebral artery and first segment of anterior cerebral artery. Outcome measures were functional independence (mRS score 0-2) and death at 3 months and symptomatic intracranial haemorrhage (SICH) per modified SITS-MOST., [Results] Results are presented in the following order: SITS-ISTR, RCTs, MR CLEAN Registry and German Stroke Registry (GSR). Median age was 73, 68, 71 and 75 years; baseline NIHSS score was 16, 17, 16 and 15; prior intravenous thrombolysis was 62%, 83%, 78% and 56%; onset to reperfusion time was 289, 285, 267 and 249 min; successful recanalization (mTICI score 2b or 3) was 86%, 71%, 59% and 83%; functional independence at 3 months was 45.5% (95% CI: 44–47), 46.0% (42–50), 38% (35–41) and 37% (35–41), respectively; death was 19.2% (19–21), 15.3% (12.7–18.4), 29.2% (27–32) and 28.6% (27–31); and SICH was 3.6% (3–4), 4.4% (3.0–6.4), 5.8% (4.7–7.1) and not available., [Conclusion] Thrombectomy in routine clinical use registered in the SITS-ISTR showed safety and outcomes comparable to RCTs, and better functional outcomes and lower mortality than previous national registry studies.

Published
2021

5. Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry

Author

Escudero-Martinez, I, Mazya, M, Teutsch, C, Lesko, N, Gdovinova, Z, Barbarini, L, Fryze, W, Karlinski, M, Kobayashi, A, Krastev, G, Paiva Nunes, A, Pasztoova, K, Peeters, Anna, Sobolewski, P, Vilionskis, A, Toni, D, Ahmed, N, Escudero-Martinez, I, Mazya, M, Teutsch, C, Lesko, N, Gdovinova, Z, Barbarini, L, Fryze, W, Karlinski, M, Kobayashi, A, Krastev, G, Paiva Nunes, A, Pasztoova, K, Peeters, Anna, Sobolewski, P, Vilionskis, A, Toni, D, and Ahmed, N

Abstract

BACKGROUND AND OBJECTIVE: The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF). DESIGN: Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018. PARTICIPANTS: European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke. SETTING: A multinational, observational monitoring register. INTERVENTION: Dabigatran initiation within 3 months after the ischaemic stroke. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event. METHODS: We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation. RESULTS: In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index

Published
2020

6. Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

Author

UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/NEUR - Clinical Neuroscience, UCL - (SLuc) Service de neurologie, Escudero-Martinez, Irene, Mazya, Michael, Teutsch, Christine, Lesko, Norbert, Gdovinova, Zuzana, Barbarini, Leonardo, Fryze, Waldemar, Karlinski, Michal, Kobayashi, Adam, Krastev, Georgi, Paiva Nunes, Ana, Pasztoova, Katarina, Peeters, André, Sobolewski, Piotr, Vilionskis, Aleksandras, Toni, Danilo, Ahmed, Niaz, SITS Investigators, UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/NEUR - Clinical Neuroscience, UCL - (SLuc) Service de neurologie, Escudero-Martinez, Irene, Mazya, Michael, Teutsch, Christine, Lesko, Norbert, Gdovinova, Zuzana, Barbarini, Leonardo, Fryze, Waldemar, Karlinski, Michal, Kobayashi, Adam, Krastev, Georgi, Paiva Nunes, Ana, Pasztoova, Katarina, Peeters, André, Sobolewski, Piotr, Vilionskis, Aleksandras, Toni, Danilo, Ahmed, Niaz, and SITS Investigators

Abstract

BACKGROUND AND OBJECTIVE: The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF). DESIGN: Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018. PARTICIPANTS: European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke. SETTING: A multinational, observational monitoring register. INTERVENTION: Dabigatran initiation within 3 months after the ischaemic stroke. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event. METHODS: We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation. RESULTS: In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index eve

Published
2020

7. Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry

Author

Boehringer Ingelheim Fonds, Karolinska Institute, Stockholm County Council, Swedish Heart-Lung Foundation, Order of Saint John in Sweden, European Commission, Stryker, Covidien, Phenox, Fundación Progreso y Salud, Junta de Andalucía, Escudero-Martínez, Irene, Mazya, Michael, Teutsch, Christine, Lesko, Norbert, Gdovinova, Zuzana, Barbarini, Leonardo, Fryze, Waldemar, Karlinski, Michal, Kobayashi, Adam, Krastev, Georgi, Paiva Nunes, Ana, Pasztoova, Katarina, Peeters, André, Sobolewski, Piotr, Vilionskis, Aleksandras, Toni, Danilo, Ahmed, Niaz, Boehringer Ingelheim Fonds, Karolinska Institute, Stockholm County Council, Swedish Heart-Lung Foundation, Order of Saint John in Sweden, European Commission, Stryker, Covidien, Phenox, Fundación Progreso y Salud, Junta de Andalucía, Escudero-Martínez, Irene, Mazya, Michael, Teutsch, Christine, Lesko, Norbert, Gdovinova, Zuzana, Barbarini, Leonardo, Fryze, Waldemar, Karlinski, Michal, Kobayashi, Adam, Krastev, Georgi, Paiva Nunes, Ana, Pasztoova, Katarina, Peeters, André, Sobolewski, Piotr, Vilionskis, Aleksandras, Toni, Danilo, and Ahmed, Niaz

Abstract

[Background and objective] The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF)., [Design] Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018., [Participants] European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke., [Setting] A multinational, observational monitoring register., [Intervention] Dabigatran initiation within 3 months after the ischaemic stroke., [Primary and secondary outcomes] The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians’ reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event., [Methods] We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation., [Results] In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6–13) if initiated within 7 days to NIHSS 15 (9–19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index event (20 of 926 patients, 2.2% with the available data)., [Conclusions] Our findings, together with previous observational studies, indicate that dabigatran initiated within the first days after an AIS is safe in patients treated with intravenous thrombolysis, endovascular thrombectomy or both., [Trial registration number] SITS Thrombolysis and Thrombectomy Registry (NCT03258645).

Published
2020

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