Georgios Tsivgoulis1,2, Aristeidis H Katsanos1,3, Pitchaiah Mandava4,5, Martin Köhrmann6, Lauri Soinne7, Andrew D Barreto8, Vijay K Sharma9, Robert Mikulik10, Keith W Muir11, Travis Rothlisberger12, James C Grotta13, Christopher R Levi14, Carlos A Molina15, Maher Saqqur16,17, Dimitris Mavridis18, Theodora Psaltopoulou19, Milan R Vosko20, Jochen B Fiebach21, Else Charlotte Sandset22, Thomas A Kent23,24, Anne W Alexandrov2, Peter D Schellinger25, Andrei V Alexandrov2. 1. Second Department of Neurology, 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece. 2. Department of Neurology, University of Tennessee Health Science Center, Memphis, Tennessee, USA. 3. Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada. 4. Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine. 5. Michael E. DeBakey VA Medical Center Stroke Program and Center for Translational Research on Inflammatory Diseases, Houston, Texas, USA. 6. Department of Neurology, University Duisburg-Essen, Essen, Germany. 7. Department of Neurology, Helsinki University Hospital and Clinical Neurosciences, University of Helsinki, Helsinki, Finland. 8. Department of Neurology, University of Texas Health Science Center at Houston, Houston, Texas, USA. 9. Yong Loo Lin School of medicine, National University of Singapore and Division of Neurology, Department of Medicine, National University Hospital, Singapore, Singapore. 10. International Clinical Research Centre and Department of Neurology, St. Anne's University Hospital in Brno and Medical Faculty, Masaryk University, Brno, Czech Republic. 11. Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom. 12. Cerevast Medical, Inc., Bothell, Washington. 13. Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, Texas, USA. 14. Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia. 15. Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain. 16. Department of Medicine (Neurology), University of Alberta, Edmonton, Alberta, Canada. 17. Neuroscience Institute, Hamad Medical Corporation, Doha, Qatar. 18. Department of Primary Education, School of Education, University of Ioannina, Ioannina. 19. Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece. 20. Department of Neurology 2, Med Campus III, Kepler University Hospital, Linz, Austria. 21. Center for Stroke Research Berlin, Charité-University Medicine Berlin, Berlin, Germany. 22. Department of Neurology, Stroke Unit, Oslo University Hospital, Oslo, Norway. 23. Texas A&M Health Science Center-Houston campus, University of Texas. 24. Department of Neurology, Houston Methodist Hospital, Houston, Texas, USA. 25. Departments of Neurology and Neurogeriatry, John Wesling Medical Center Minden, Ruhr University Bochum, Minden, Germany.
Abstract
OBJECTIVE: To investigate the association of blood pressure BP excursions, defined as greater than 185 SBP or greater than 105 DBP, with the probability of intracranial hemorrhage (ICH) and worse functional outcomes in patients with acute ischemic stroke (AIS) treated with tissue plasminogen activator (tPA). METHODS: We performed a post hoc analysis of the CLOTBUST-ER trial. Serial BP measurements were conducted using automated cuff recording according to the recommended BP protocol guidelines for tPA administration. The outcomes were prespecified efficacy and safety endpoints of CLOTBUST-ER. RESULTS: The mean number of serial BP recordings per patient was 37. Of the 674 patients, 227 (34%) had at least one BP excursion (>185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80-0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81-0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87-0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88-0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82-0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04-1.53). CONCLUSION: BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.
OBJECTIVE: To investigate the association of blood pressure BP excursions, defined as greater than 185 SBP or greater than 105 DBP, with the probability of intracranial hemorrhage (ICH) and worse functional outcomes in patients with acute ischemic stroke (AIS) treated with tissue plasminogen activator (tPA). METHODS: We performed a post hoc analysis of the CLOTBUST-ER trial. Serial BP measurements were conducted using automated cuff recording according to the recommended BP protocol guidelines for tPA administration. The outcomes were prespecified efficacy and safety endpoints of CLOTBUST-ER. RESULTS: The mean number of serial BP recordings per patient was 37. Of the 674 patients, 227 (34%) had at least one BP excursion (>185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80-0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81-0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87-0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88-0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82-0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04-1.53). CONCLUSION: BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.