Dual antiplatelet therapy (DAPT) is given to patients who have undergone percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) or SIHD. For periprocedural and postprocedural ischemic events, DAPT is a combination of aspirin and a P2Y12 inhibitor.
In the randomized, double-blind, placebo-controlled ISAR-PLASTER phase 2 trial, Katharina Mayer, Technical University of Munich, Munich, Germany, and colleagues sought to determine the safety and efficacy of Revacept, a novel, lesion-directed antithrombotic drug that acts as a competitive antagonist to platelet glycoprotein VI.
Patients were included in the trial across nine sites in Germany from November 20, 2017, to February 27, 2020, and follow-up terminated on March 27, 2020. The study comprised 334 individuals with SIHD who were having PCI. Two-hundred-forty-one patients were given a single intravenous infusion of Revacept, 160 mg (n-120), 80 mg (n=121), while 93 patients received a placebo prior to starting PCI on top of conventional antithrombotic medication.
Death or myocardial injury within 48 hours from randomization were the primary endpoints of the study.
No significant differences were observed between the Revacept and placebo group on the primary endpoint: 24.4%, 25%, and 23.3%, respectively, in the Revacept, 160 mg, Revacept, 80 mg, and placebo groups. Reduction in high-concentration collagen-induced platelet aggregation with a median 26.5 AU × min (interquartile range, 0.5-62.2 AU × min) was observed with high dose of Revacept (160mg), 43.5 AU × min (interquartile range, 22.8-99.5 AU × min) with 8mg of Revacept and 41.0 AU × min (interquartile range, 31.2-101.0 AU × min) in the placebo group. However, there was no effect on adenosine 5′-diphosphate–induced aggregation. When compared to placebo, Revacept did not increase Bleeding Academic Research Consortium type 2 or greater bleeding after 30 days: 5% with 160mg Revacept, 5.9% with 80mg Revacept, and 8.6% in placebo groups.
Revacept did not reduce the incidence of an acute coronary syndrome (ACS) in individuals with stable ischemic heart disease who underwent percutaneous coronary intervention, according to the study's authors. There were just a few instances of bleeding, and there were no significant differences between the therapy groups.