Pravastatin and endothelium dependent vasomotion after coronary angioplasty: the PREFACE trial

Objective To test the hypothesis that the 3-hydroxy-3-methylglutaryl coenzy me-A reductase inhibitor pravastatin ameliorates endothelium mediated respo nses of dilated coronary segments: the PREFACE (pravastatin related effects following angioplasty on coronary endothelium) trial. Design-A double blind, randomised, placebo controlled, multicentre study. Setting Four hospitals in the Netherlands. Patients-63 non-smoking, non-hypercholesterolaemic patients scheduled for e lective balloon angioplasty (pravastatin 34, placebo 29). Interventions-The effects of three months of pravastatin treatment (40 mg d aily) on endothelium dependent vasomotor function were studied. Balloon ang ioplasty was undertaken one month after randomisation, and coronary vasomot or function tests using acetylcholine were performed two months after ballo on angioplasty. The angiograms were analysed quantitatively. Main outcome measures-The efficacy measure was the acetylcholine induced ch ange in mean arterial diameter, determined in the dilated segment and in an angiographically normal segment of an adjacent non-manipulated coronary ar tery. Results-Increasing acetylcholine doses produced vasoconstriction in the dil ated segments (p = 0.004) but not in the normal segments. Pravastatin did n ot affect the vascular response to acetylcholine in either the dilated segm ents (p = 0.09) or the non-dilated sites. Endothelium dependent vasomotion in normal segments was correlated with that in dilated segments (r = 0.47, p < 0.001). There were fewer procedure related events in the pravastatin gr oup than in the placebo group (p < 0.05). Conclusions-Endothelium dependent vasomotion in normal segments is correlat ed with that in dilated segments. A significant beneficial effect of pravas tatin on endothelial function could not be shown, but in the dilated segmen ts there was a trend towards a beneficial treatment effect in the pravastat in group.