Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention (PGEACS)

• The primary objective of the present study is to assess the effects of lipo-PGE1 on postprocedural changes of cardiac biomarker levels in patients with non-ST-segment elevation ACS following hospital admission for early PCI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  

• The secondary objectives are to evaluate the efficacy of lipo-PGE1 in improving cardiovascular outcomes, and the safety and tolerability profile of lipo-PGE1 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  

Ever since the inception of percutaneous coronary intervention (PCI), it has been apparent that some myocardial injury was often associated with the procedure, and even asymptomatic minor post-procedural myocardial necrosis does have an important prognostic signification. The possible mechanisms of periprocedural myocardial injury were often attributed to distal embolisation of atheromatous material during the procedure, occlusion of minute side branches, occlusive dissection or no-reflow.

Prostaglandin E1 incorporated in lipid microspheres (lipo-PGE1) is a new galenic form of PGE1, with PGE1 incorporated into soybean oil microspheres 0.2 micron in diameter, using lecithin as surfactant. This drug preparation can protect PGE1 against inactivation in the lung and has targeting effect to tissues injured by arterial occlusion. It was shown in the experiments that, by the pharmacological effects such as improving endothelial function, dilating coronary and systemic microvessels, inhibiting platelet aggregation and reducing ischemia-reperfusion injury, lipo-PGE1 had a more marked protective effect in arterial occlusive tissue injury and a more potent platelet aggregation inhibitory effect than free PGE1. Clinical studies have demonstrated that lipo-PGE1 is a very valuable agent for the treatment of peripheral vascular disorders and diabetic neuropathy.