Haemodynamic effects, safety, and tolerability of haemoglobin-based oxygen carrier-201 in patients undergoing PCI for

Patrick W Serruys1, Pascal Vranckx, Ton Slagboom

  • 1Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

Insights

Haemoglobin-based oxygen carriers (HBOCs) did not compromise coronary blood flow in patients undergoing percutaneous coronary intervention. While HBOC-201 showed vasoactive effects, safety and coronary physiology require further study in acute coronary syndromes.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacology

Background:

  • Haemoglobin-based oxygen carriers (HBOCs) are being investigated for treating acute coronary syndromes (ACS) during percutaneous coronary intervention (PCI).
  • HBOCs possess potential vasopressor and colloidal properties requiring evaluation of their impact on coronary physiology, safety, and tolerability.

Purpose of the Study:

  • To assess the effects of HBOC-201 on coronary physiology, systemic haemodynamics, and safety in patients with ACS undergoing PCI.
  • To establish the tolerability and potential risks associated with HBOC-201 administration in this patient population.

Main Methods:

  • A phase II, double-blind, randomized pilot trial involving 45 patients with ACS undergoing PCI.
  • Patients received intravenous (IV) infusions of HBOC-201 (15 or 30 g) or a colloid control for 30 minutes.
  • Systemic, pulmonary, and coronary haemodynamics were monitored during infusion.

Main Results:

  • HBOC-201 increased systolic blood pressure and systemic vascular resistance, while decreasing cardiac output and mixed venous saturation.
  • No significant coronary vasoconstriction or adverse effects on coronary blood flow, diameter, or resistance were observed.
  • Adverse event rates were similar between HBOC-201 and control groups, with one drug-related serious adverse event (hypertension).

Conclusions:

  • HBOC-201 administration did not compromise coronary blood flow or left ventricular stroke work index in ACS patients undergoing PCI.
  • The clinical significance of observed inflammatory marker changes and potential adverse effects of plasma haemoglobin in ACS warrants further investigation.
Abstract

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