Safety and Efficacy of a Platelet Glycoprotein Ib Inhibitor for Patients with Non-ST Segment Elevation Myocardial Infarction: A Phase Ib-IIa Study

Link to article at PubMed

Pharmacotherapy. 2021 Sep 3. doi: 10.1002/phar.2620. Online ahead of print.


BACKGROUND: The platelet receptor glycoprotein Ib (GP Ib) plays a crucial role in the first step of platelet adhesion and thrombus formation. This study aimed to determine the safety and efficacy of a GP Ib receptor inhibitor, anfibatide, in patients with non-ST segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI).

METHOD: Ninety Chinese patients with NSTEMI who underwent PCI at six Chinese hospitals were randomly assigned to the low-dose (n=20, 2 IU/60 kg), moderate-dose (n=20, 3 IU/60 kg), or high-dose anfibatide group (n=20, 5 IU/60 kg), or the placebo group (n=30). Anfibatide was administered for up to 48 hours along with standard aspirin and clopidogrel therapy.

RESULTS: All three doses of anfibatide showed dose-dependent antiplatelet activity as measured by ex vivo platelet aggregation at 5 minutes, 24 hours, and 48 hours during infusion, and 4 hours post-infusion compared with placebo. Higher inhibition of platelet aggregation occurred in all anfibatide groups compared with the placebo group. The post-procedural TIMI grade flow, myocardial blush grade, and corrected TIMI frame count were not significantly different among the four groups. Thirty-day mortality, non-fatal myocardial infarction, and major bleeding were rare and comparable between patients who received anfibatide and placebo. There was no significant difference in the platelet count among the groups during follow-up.

CONCLUSIONS: This study shows that intravenous administration of the platelet receptor GP Ib antagonist anfibatide is feasible and safe to inhibit platelet aggregation without increasing the risk of bleeding and thrombocytopeniain patients with NSTEMI undergoing PCI.

PMID:34478577 | DOI:10.1002/phar.2620

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