Safety Profile and Complication Rates in Emergency Off-label Use of Tirofiban in Interventional Neuroradiology : An Observational Dual Center Study.

Purpose: Tirofiban has been approved for the treatment of acute coronary syndrome. Meanwhile, tirofiban is frequently applied in emergency situations in interventional neuroradiology (INR). The objective of this study was to analyze the risk profile for the off-label use of tirofiban in INR patients.

Methods: Data of 86 patients, who underwent neurointerventional therapy and were treated with tirofiban at 2 neuroendovascular centers between January 2016 and July 2017 were retrospectively analyzed. Despite off-label use, recent stroke (< 30 days), recent hemorrhage, thrombocytopenia (< 150,000/µl), activated partial thromboplastin time (aPTT) > 1.3-fold, internation normalised ratio (INR) < 1.5, severe liver insufficiency (Child-Pugh C), and preceding intravenous thrombolysis were considered as contraindications.

Results: Median patient age was 62 years (range 26-88 years). Patients received tirofiban for extracranial (n = 35) or intracranial stenting (n = 35), coiling of ruptured cerebral aneurysms (n = 6), continuous intra-arterial nimodipine infusion via microcatheters for subarachnoid hemorrhage (SAH)-related vasospasm (n = 5), or thrombotic complications during neuroendovascular procedures (n = 5). The desired effect of preventing thrombotic complications when applying tirofiban off-label was achieved in 81 of 86 patients (94.2%). Relevant tirofiban-associated complications occurred in 14 patients (16.3%), of which 9 patients received i.v. thrombolysis for treatment of acute ischemic stroke shortly before starting therapy with tirofiban. Of the 86 patients 12 died, while the overall tirofiban-related mortality was 2.3% (2 patients died due to ICH). Logistic regression analysis revealed age to be the only parameter significantly associated with development of tirofiban-associated complications (p = 0.026).

Conclusion: Whereas the safety profile of tirofiban when applied off-label in INR is acceptable, the highest risk for relevant tirofiban-associated complications is observed in older patients treated by emergency stenting for acute stroke.