OBJECTIVE: To study the safety of off-label IV thrombolysis in @entity1 with very severe @entity64 (NIH @entity64 Scale [NIHSS] scores >25) compared with severe @entity64 (NIHSS scores 15-25), where treatment is within European regulations. METHODS: Data were analyzed from 57,247 @entity1 with acute @entity385 receiving IV tissue plasminogen activator in 793 hospitals participating in the Safe Implementation of Thrombolysis in @entity64 (SITS) International @entity64 Thrombolysis Registry (2002-2013). Eight hundred sixty-eight @entity1 (1.5%) had NIHSS scores >25 and 19,995 (34.9%) had NIHSS scores 15-25. Outcome measures were @entity548 , symptomatic @entity1779 , mortality, and functional outcome. RESULTS: @entity548 occurred in 10.7% vs 11.0% (p = 0.79), symptomatic @entity1779 per SITS-MOST (SITS-Monitoring Study) in 1.4% vs 2.5% (p = 0.052), @entity204 at 3 months in 50.4% vs 26.9% (p < 0.001), and functional independence at 3 months in 14.0% vs 29.0% (p < 0.001) of @entity1 with NIHSS scores >25 and NIHSS scores 15-25, respectively. Multivariate adjustment did not change findings from univariate comparisons. Posterior circulation @entity64 was more common in @entity1 with NIHSS scores >25 (36.2% vs 7.4%, p < 0.001), who were also more often obtunded or @entity772 on presentation (58.4% vs 7.1%, p < 0.001). Of @entity1 with NIHSS scores >25, 26.2% were treated >3 hours from symptom onset vs 14.5% with NIHSS scores of 15-25. CONCLUSIONS: Our data show no excess risk of @entity1779 in @entity1 with NIHSS score >25 compared to score 15-25, suggesting that the European contraindication to IV tissue plasminogen activator treatment at NIHSS levels >25 may be unwarranted. Increased mortality and lower rates of functional independence in @entity1 with NIHSS score >25 are explained by higher @entity64 severity, @entity1662 on presentation due to posterior circulation @entity63 , and longer treatment delays.

IV thrombolysis in very severe and severe XXXX : Results from the SITS-ISTR Registry.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke', 'Stroke'] @entity548 :: ('MESH:D006470', 'Disease') :: ['parenchymal hemorrhage', 'Parenchymal hemorrhage'] @entity63 :: ('MESH:D007511', 'Disease') :: ['ischemia'] @entity772 :: ('MESH:D003128', 'Disease') :: ['comatose'] @entity1662 :: ('MESH:D003244', 'Disease') :: ['impaired consciousness'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity1779 :: ('MESH:D002543', 'Disease') :: ['cerebral hemorrhage', 'intracerebral hemorrhage'] @entity385 :: ('MESH:D002544', 'Disease') :: ['ischemic stroke']
@entity385 :: (MESH:D002544,Disease) :: ['ischemic stroke']
