Revacept may not Reduce Incidence of Myocardial Injury in patients undergoing PCI: JAMA

In a previous Phase 1 trial researchers of Germany, developed a novel competitive antagonist to collagen-GPVI signalling named revacept (advanceCOR GmbH). Revacept is a dimeric, soluble fusion protein composed of the extracellular domain of the GPVI receptor and the human Fc-fragment. As a lesion-directed drug, revacept does not interfere with the function of circulating platelets beyond the atherosclerotic lesion. As a consequence, revacept inhibits atherothrombosis but has little effect on systemic hemostasis or bleeding in animal models and a phase 1 clinical trial. For further evaluation, researchers conducted a phase 2 trial to test the efficacy and safety of revacept.

The Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept in Patients With Chronic Coronary Syndromes Undergoing Percutaneous Coronary Intervention (ISAR-PLASTER) trial is a randomized, double-blind phase 2 trial in 334 patients with stable ischemic heart disease undergoing elective PCI from 9 centres in Germany. Researchers randomly assigned 120 patients to receive the 160-mg dose of revacept, 121 patients to receive the 80-mg dose, and 93 patients to received a placebo before the start of PCI on top of standard antithrombotic therapy. The major outcome assessed was the composite of death or myocardial injury, defined as an increase in high-sensitivity cardiac troponin to at least 5 times the upper limit of normal within 48 hours from randomization. The safety outcome was bleeding type 2 to 5 according to the Bleeding Academic Research Consortium criteria at 30 days.