The glycoprotein IIb/IIIa receptor inhibitor tirofiban (Aggrastat) generally failed to improve clinical outcomes for stroke patients undergoing endovascular therapy (EVT), according to the Chinese RESCUE BT trial.
People randomized to tirofiban or placebo shared a similar distribution in modified Rankin scale (mRS) scores at 90 days, with a median score of 3 for both groups (adjusted common OR 1.09, 95% CI 0.87-1.37). Furthermore, there was no difference either in secondary outcomes such as mRS 0-1 or mRS 0-2, reported Raul Nogueira, MD, of University of Pittsburgh School of Medicine.
Safety events did not favor the tirofiban group, which tended toward excesses in symptomatic intracerebral hemorrhaging (9.7% vs 6.4%, P=0.06), any cranial hemorrhage (34.9% vs 28.0%, P=0.02), and 90-day mortality (18.1% vs 16.9%, P=0.62).
Yet subgroup analysis delivered a somewhat redeeming data point for the antiplatelet in the form of an apparent benefit for stroke patients with large artery atherosclerosis in particular (adjusted common OR 1.43, 95% CI 1.02-2.00), Nogueira said in a presentation at the American Stroke Association International Stroke Conference.
Whether tirofiban really improves EVT outcomes in this subgroup will be further investigated, he stated.
The glycoprotein IIb/IIIa receptor inhibitor is highly selective and features high affinity, reversibility of inhibition, rapid onset of action, and a short half-life, according to Nogueira. The rationale for its use in stroke is that tirofiban may help with potential thrombotic complications and re-occlusion after stroke thrombectomy.
Tirofiban has long been as a safe and effective treatment for acute coronary syndrome (ACS). Notably, the tirofiban bolus used in that setting is more concentrated than the one tested for stroke by Nogueira's group.
was a phase III randomized double-blind trial conducted at 55 hospitals in China.
Eligible participants were stroke patients presenting with acute ischemic stroke within 24 hours of time last known well (median age 67; 41.2% women).
All were undergoing EVT and were not receiving IV thrombolysis. Patients had to have a large vessel occlusion (LVO) in the internal carotid artery or middle cerebral artery segments M1/M2, an NIH Stroke Scale score of 30 or below, and score 6 or higher on ASPECTS imaging at baseline. People on dual antiplatelet therapy within 1 week of stroke were excluded.
Nogueira's group had 950 individuals randomized to tirofiban (IV bolus 10 μg/kg before EVT followed by continuous infusion for 24 hours) or placebo.
Patients got antiplatelets at hour 20 after starting their assigned study drug.
Tirofiban and placebo groups were well-balanced except there was a greater preponderance of large artery atherosclerosis in the latter (49.1% vs 42.6%).
Beyond tirofiban, Nogueira and his Chinese collaborators are also studying the effects of methylprednisolone after EVT in the study and IV tenecteplase bridging in .
Disclosures
The study was supported by Lunan Pharmaceutical Group, the National Natural Science Foundation of China, and Army Medical University.
Nogueira disclosed personal fees from Anaconda, Biogen, Cerenovus, Genentech, Hybernia, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, Synchron, Astrocyte, Brainomix, Cerebrotech, Ceretrieve, Corindus Vascular Robotics, Vesalio, Viz-AI, RapidPulse, Perfuze, Reist/Q'Apel Medical, Truvic, and Viseon.
Primary Source
International Stroke Conference
Qiu Z, et al "Endovascular treatment with versus without tirofiban for stroke patients with large vessel occlusion (RESCUE BT trial)" ISC 2022.