Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial
| العنوان: | Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial |
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| المؤلفون: | Daniel F Hanley, Richard E Thompson, Michael Rosenblum, Gayane Yenokyan, Karen Lane, Nichol McBee, Steven W Mayo, Amanda J Bistran-Hall, Dheeraj Gandhi, W Andrew Mould, Natalie Ullman, Hasan Ali, J Ricardo Carhuapoma, Carlos S Kase, Kennedy R Lees, Jesse Dawson, Alastair Wilson, Joshua F Betz, Elizabeth A Sugar, Yi Hao, Radhika Avadhani, Jean-Louis Caron, Mark R Harrigan, Andrew P Carlson, Diederik Bulters, David LeDoux, Judy Huang, Cully Cobb, Gaurav Gupta, Ryan Kitagawa, Michael R Chicoine, Hiren Patel, Robert Dodd, Paul J Camarata, Stacey Wolfe, Agnieszka Stadnik, P Lynn Money, Patrick Mitchell, Rosario Sarabia, Sagi Harnof, Pal Barzo, Andreas Unterberg, Jeanne S Teitelbaum, Weimin Wang, Craig S Anderson, A David Mendelow, Barbara Gregson, Scott Janis, Paul Vespa, Wendy Ziai, Mario Zuccarello, Issam A Awad, Azmil Abdul-Rahim, Amal Abou-Hamden, Michael Abraham, Azam Ahmed, Carlos Alarcon Alba, E. Francois Aldrich, David Altschul, Sepideh Amin-Hanjani, Doug Anderson, Safdar Ansari, David Antezana, Agnieszka Ardelt, Fuat Arikan, Marcelino Baguena, Alexandra Baker, Steven J. Barrer, Kyra J. Becker, Thomas Bergman, Azize Boström, Jamie Braun, Peter Brindley, William C. Broaddus, Robert Brown, Andras Buki, Bing Cao, Ying Cao, Julian Carrion-Penagos, Julio Chalela, Tiffany Chang, Indalecio Moran Chorro, Shakeel Chowdhry, Luisa Corral, Laszlo Csiba, Jason Davies, Alberto Torres Díaz, Colin P. Derdeyn, Michael Diringer, Rachel Dlugash, Robert Ecker, Tracey Economas, Pedro Enriquez, Erzsebet Ezer, Yuhua Fan, Hua Feng, Douglas Franz, W. David Freeman, Matthew Fusco, Walter Galicich, Mary Leigh Gelea, Joshua Goldstein, Alejandro Carrasco Gonzalez, Christina Grabarits, Steven Greenberg, Daryl Gress, Eugene Gu, Christiana Hall, Fernando Muñoz Hernandez, Robert Hoesch, Brian L. Hoh, Jennifer Houser, Rong Hu, Yi Huang, Mohammed Akbar Hussain, Salvatore Insinga, Ashutosh Jadhav, Jennifer Jaffe, Babak S. Jahromi, Jack Jallo, Michael James, Robert F. James, Brian Jankowitz, Esther Jeon, Draga Jichici, Karin Jonczak, Ben Jonker, Nicki Karlen, Naureen Keric, Thomas Kerz, Jared Knopman, Carolyn Koenig, Satish Krishnamurthy, Avinash Kumar, Inam Kureshi, John Laidlaw, Arun Lakhanpal, Julius Gene Latorre, Dana Leifer, James Leiphart, Sarah Lenington, Yunke Li, George Lopez, Darren Lovick, Christianto Lumenta, Jinbiao Luo, Matthew B. Maas, Joel MacDonald, Larami MacKenzie, Vikram Madan, Ryan Majkowski, Otto Major, Rishi Malhorta, Marc Malkoff, Halinder Mangat, Ahmed Maswadeh, Charles Matouk, Kate McArthur, Scott McCaul, Joshua Medow, Geza Mezey, Janet Mighty, David Miller, Krishna K. Mohan, Keith Muir, Lorenzo Muñoz, Peter Nakaji, Alex Nee, Saman Nekoovaght-Tak, Paul Nyquist, Roddy O'Kane, Mohamed Okasha, Cian O'Kelly, Noeleen Ostapkovich, Aditya Pandey, Adrian Parry-Jones, Krissia Rivera Perla, Ania Pollack, Sean Polster, Nader Pouratian, Terry Quinn, Ventatakrishna Rajajee, Kesava Reddy, Mohammed Rehman, Ronald Reimer, Fred Rincon, Igor Rybinnik, Baltasar Sanchez, Lauren Sansing, Michael Schneck, Ludwig Schuerer, David Schul, Jeffrey Schweitzer, David B. Seder, Donald Seyfried, Kevin Sheth, Alejandro Spiotta, Michael Stechison, Katalin Szabo, Gonzalo Tamayo, Krisztian Tanczos, Philipp Taussky, John Terry, Fernando Testai, Kathrine Thomas, Carol B. Thompson, Gregory Thompson, James C. Torner, Huy Tran, Kristi Tucker, Lior Ungar, Panos Varelas, Nataly Montano Vargas, Hartmut Vatter, Chitra Venkatasubramanian, Krista Vermillion, Dennis Vollmer, Yan Wang, Ying Wang, Jiajun Wen, Louis Tony Whitworth, Byron Willis, Myriha Wrencher, Shawn E. Wright, Yongge Xu, Lisa Yanase, Xuxia Yi, Zhiyuan Yu, Ali Zomorodi |
| المصدر: | Dipòsit Digital de la UB Universidad de Barcelona |
| بيانات النشر: | Elsevier B.V., 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Catheters, medicine.medical_treatment, Population, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Clinical trials, Randomized controlled trial, Modified Rankin Scale, law, Internal medicine, medicine, Mortalitat, Humans, Minimally Invasive Surgical Procedures, Thrombolytic Therapy, 030212 general & internal medicine, Mortality, education, Stroke, Aged, Cerebral Hemorrhage, education.field_of_study, Intention-to-treat analysis, business.industry, Glasgow Coma Scale, Catèters, General Medicine, Odds ratio, Thrombolysis, Middle Aged, Infart cerebral, medicine.disease, Intention to Treat Analysis, Treatment Outcome, Cerebral infarctio, Female, business, Assaigs clínics |
| الوصف: | Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage. MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0-3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046. Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012). For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons. National Institute of Neurological Disorders and Stroke and Genentech. [Abstract copyright: Copyright © 2019 Elsevier Ltd. All rights reserved.] |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1474-547X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d2aef9b42e450a11e8cb18246c6209eTest http://hdl.handle.net/2445/186066Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....3d2aef9b42e450a11e8cb18246c6209e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1474547X |
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