Adverse consequences of immediate thrombolysis-related complications: a multi-centre registry-based cohort study of acute stroke

Background: Immediate thrombolysis-related complications (TRC) including haemorrhage, orolingual angioedema and anaphylaxis are serious adverse effects of thrombolysis treatment for acute ischaemic stroke (AIS). However, little is known about consequences following these immediate TRC.Methods: Prospectively collected data from the Sentinel Stroke National Audit Programme were analysed. Thrombolysis was performed in 451 patients (52.1% men; 75.3yrs ±13.2) admitted with AIS in four UK centres between 2014 and 2016. Adverse consequences following immediate TRC were assessed using logistic regression, adjusted for age, sex and co-morbidities.Results: Twenty-nine patients (6.4%) acquired immediate TRC. Compared to patients without, individuals with immediate TRC had greater adjusted risks of: moderately-severe or severe stroke (National Institutes of Health for Stroke Scale >16) at 24-hours (5.7% vs 24.7%, OR=3.9, 95%CI=1.4-11.1); worse level of consciousness (LOC) in the first 7days (score ≥1; 25.0 vs 60.7, OR=4.6, 95%CI=2.1-10.2); urinary tract infection or pneumonia within 7-days of admission (13.5% vs 39.3%, OR=3.2, 95%CI=1.3-7.7); length of stay (LOS) on hyperacute stroke unit (HASU) >2weeks (34.7% vs 66.7%, OR=5.2, 95%CI=1.5-18.4); mortality (13.0% vs 41.4%, OR=3.7, 95%CI=1.6-8.4); moderately-severe or severe disability (modified Rankin Scale) ≥4 at discharge (26.8% vs 65.5%, OR=4.7, 95%CI=2.1-10.9); palliative care by discharge date (5.1% vs 24.1%, OR=5.1, 95%CI=1.7-15.7). The median LOS on the HASU was longer (7days vs 30days, Kruskal-Wallis test: 2=8.9, p=0.003) while stroke severity did not improve (NIHSS at 24-hours post-thrombolysis minus NIHSS at arrival =-4 vs 0, 2=24.3, p<0.001).Conclusions: The risk of nosocomial infections, worsening of stroke severity, longer HASU stay, disability and death is increased following immediate TRC.