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RESEARCH PRODUCT

Abstract TMP17: Revacept, an Inhibitor of Platelet Adhesion in Patients With Symptomatic Carotid Artery Stenosis. Safety Data From the International Randomized Multicenter Revacept CS02 Phase 2 Study

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Introduction: Revacept is a novel vascular lesion-directed inhibitor of platelet adhesion and thrombus formation, exhibiting no effects on the homeostatic functions of circulating platelets. Objective: The effects of Revacept on plaque-mediated thrombosis were investigated in patients with symptomatic stenosis of the internal carotid artery (at least 50%, following ECST-criteria). Methods: Within an international, prospective, multicenter (n=16), randomized trial 158 patients could be randomized to receive placebo, or 40/120 mg Revacept by intravenous infusion over 20 minutes. Cerebrovascular events and cardiovascular complications were followed up to 3 months. Results: 158 patients were finally included in the study. Of these, 127 (80.4%) received carotid endarterectomy, 12 received carotid stenting (7.6%) and 19 were referred to intensified conservative treatment (12.0%). Safety data showed cardiovascular events such as transitory ischemic attack (TIA) and ischemic stroke 24 hours after drug administration in 1 (0.6%) and 5 (3.1%) patients, and 3 months after drug administration in 5 (3.1%) and 9 (5.7%) patients, respectively. With regard to bleeding complications, intracerebral hemorrhage was not observed in any of the patients within 24 hours, and in 1 patient (0.6%) at 3 months follow up. Postoperative hematoma of any kind was observed in 9 patients (5.7%). Two other bleeding events (GI-bleeding and ear-bleeding) occurred within 3 months follow up. Coronary vascular events, defined as Troponin-I-elevation, were observed in 2 patients (1.3%) at 24 hours, and in 7 patients (4.4%) at 3 months after drug administration. Coronary intervention was necessary in 1 patient (0.6%) and 5 patients (3.1%), 24 hours and 3 months after Revacept infusion, respectively. These complications rates are comparable to the rate at day 30 follow up within the ICSS-study: ischemic stroke (91 patients 5.3%), intracerebral hemorrhage (8 patients, 0.5%) and any wound hematoma (81 patients, 4.7%) Conclusions: The addition of Revacept to guideline-recommended anti-thrombotic therapy in patients with symptomatic stenosis of the internal carotid artery did not increase bleeding complications within the overall study population compared to previous studies.