BACKGROUND AND PURPOSE: Only 2% to 4% of patients with acute ischemic stroke receive thrombolytic therapy resulting from the current strict inclusion criteria among other issues. Safety of intravenous and intraarterial thrombolysis in off-label situations is controversially discussed. We sought to review the reports on such patients regarding intra- and extracranial hemorrhage. SUMMARY OF REVIEW: A MEDLINE search for off-label uses of thrombolysis revealed reports on 273 patients treated with intraarterial or intravenous thrombolysis for ischemic stroke. Symptomatic intracranial hemorrhage occurred in 19 of 273 patients (6.95%) and extracranial hemorrhage in 17 of 273 (6.22%). CONCLUSIONS: These data suggest that the overall bleeding risk in off-label thrombolysis may not be as high as presumed. However, the small number of patients in each group and the likely underreporting of worse outcomes preclude drawing any conclusion as to specific treatment recommendations. Selected patients might benefit, however, from thrombolysis in situations not currently considered in the inclusion criteria. To obtain a meaningful database, a registry for off-label thrombolysis should be created.
BACKGROUND AND PURPOSE: Only 2% to 4% of patients with acute ischemic stroke receive thrombolytic therapy resulting from the current strict inclusion criteria among other issues. Safety of intravenous and intraarterial thrombolysis in off-label situations is controversially discussed. We sought to review the reports on such patients regarding intra- and extracranial hemorrhage. SUMMARY OF REVIEW: A MEDLINE search for off-label uses of thrombolysis revealed reports on 273 patients treated with intraarterial or intravenous thrombolysis for ischemic stroke. Symptomatic intracranial hemorrhage occurred in 19 of 273 patients (6.95%) and extracranial hemorrhage in 17 of 273 (6.22%). CONCLUSIONS: These data suggest that the overall bleeding risk in off-label thrombolysis may not be as high as presumed. However, the small number of patients in each group and the likely underreporting of worse outcomes preclude drawing any conclusion as to specific treatment recommendations. Selected patients might benefit, however, from thrombolysis in situations not currently considered in the inclusion criteria. To obtain a meaningful database, a registry for off-label thrombolysis should be created.
Authors: Felipe De Los Rios; Dawn O Kleindorfer; Amy Guzik; Santiago Ortega-Gutierrez; Navdeep Sangha; Gyanendra Kumar; James C Grotta; Jin-Moo Lee; Brett C Meyer; Lee H Schwamm; Pooja Khatri Journal: J Stroke Cerebrovasc Dis Date: 2014-08-10 Impact factor: 2.136
Authors: Michael J Lyerly; Karen C Albright; Amelia K Boehme; Reza Bavarsad Shahripour; James T Houston; Pawan V Rawal; Niren Kapoor; Muhammad Alvi; April Sisson; Anne W Alexandrov; Andrei V Alexandrov Journal: J Stroke Cerebrovasc Dis Date: 2013-08-15 Impact factor: 2.136
Authors: Lee S Chung; Aleksander Tkach; Erin M Lingenfelter; Sarah B Dehoney; Jeannie Rollo; Adam de Havenon; L Dana DeWitt; Matthew R Grantz; Haimei Wang; Jana J Wold; Peter M Hannon; Natalie R Weathered; Jennifer J Majersik Journal: J Stroke Cerebrovasc Dis Date: 2015-12-11 Impact factor: 2.136
Authors: Eric E Adelman; Phillip A Scott; Lesli E Skolarus; Allison K Fox; Shirley M Frederiksen; William J Meurer Journal: J Stroke Cerebrovasc Dis Date: 2015-09-26 Impact factor: 2.136
Authors: Sanjith Aaron; N K Shyamkumar; Sunithi Alexander; P Suresh Babu; A T Prabhakar; Vinu Moses; T V Murthy; Mathew Alexander Journal: Ann Indian Acad Neurol Date: 2016 Apr-Jun Impact factor: 1.383
Authors: Louise E Craig; Sandy Middleton; Helen Hamilton; Fern Cudlip; Victoria Swatzell; Andrei V Alexandrov; Elizabeth Lightbody; Dame Caroline Watkins; Sheeba Philip; Dominique A Cadilhac; Elizabeth McInnes; Simeon Dale; Anne W Alexandrov Journal: Interv Neurol Date: 2018-09-25