Abstract
BackgroundOne quarter to one third of patients eligible for systemic thrombolysis are on antiplatelet therapy at presentation. In this study, we aimed to assess the safety and efficacy of intravenous thrombolysis in stroke patients on prescribed antiplatelet therapy in the WAKE-UP trial.MethodsWAKE-UP was a multicenter, randomized, double-blind, placebo-controlled clinical trial to study the efficacy and safety of MRI-guided intravenous thrombolysis with alteplase in patients with an acute stroke of unknown onset time. The medication history of all patients randomized in the WAKE-UP trial was documented. The primary safety outcome was any sign of hemorrhagic transformation on follow-up MRI. The primary efficacy outcome was favorable functional outcome defined by a score of 0–1 on the modified Rankin scale at 90 days after stroke, adjusted for age and baseline stroke severity. Logistic regression models were fitted to study the association of prior antiplatelet treatment with outcome and treatment effect of intravenous alteplase.ResultsOf 503 randomized patients, 164 (32.6%) were on antiplatelet treatment. Patients on antiplatelet treatment were older (70.3 vs. 62.8 years, p < 0.001), and more frequently had a history of hypertension, atrial fibrillation, diabetes, hypercholesterolemia, and previous stroke or transient ischaemic attack. Rates of symptomatic intracranial hemorrhage and hemorrhagic transformation on follow-up imaging did not differ between patients with and without antiplatelet treatment. Patients on prior antiplatelet treatment were less likely to achieve a favorable outcome (37.3% vs. 52.6%, p = 0.014), but there was no interaction of prior antiplatelet treatment with intravenous alteplase concerning favorable outcome (p = 0.355). Intravenous alteplase was associated with higher rates of favorable outcome in patients on prior antiplatelet treatment with an adjusted odds ratio of 2.106 (95% CI 1.047–4.236).ConclusionsTreatment benefit of intravenous alteplase and rates of post-treatment hemorrhagic transformation were not modified by prior antiplatelet intake among MRI-selected patients with unknown onset stroke. Worse functional outcome in patients on antiplatelets may result from a higher load of cardiovascular co-morbidities in these patients.
Highlights
One quarter to one third of patients eligible for systemic thrombolysis are on antiplatelet therapy at presentation
Treatment benefit of intravenous alteplase and rates of post-treatment hemorrhagic transformation were not modified by prior antiplatelet intake among Magnetic Resonance Imaging (MRI)-selected patients with unknown onset stroke
Worse functional outcome in patients on antiplatelets may result from a higher load of cardiovascular co-morbidities in these patients
Summary
One quarter to one third of patients eligible for systemic thrombolysis are on antiplatelet therapy at presentation. One quarter to one third of all patients receiving intravenous thrombolytic therapy with alteplase (recombinant human tissue plasminogen activator, rt-PA) for the treatment of acute ischemic stroke are on prescribed antiplatelet treatment (APT) [7, 10, 15]. The fact that both antiplatelets and alteplase interfere substantially with the natural hemostasis raises concern about an increased risk of hemorrhagic complications, and in the ARTIS trial a high rate of symptomatic intracerebral hemorrhage (sICH) was observed with simultaneous administration of intravenous alteplase and aspirin [20]. Evidence regarding a possible interaction as to functional outcome remains contradictory [4, 7, 15, 17]
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