The effects of lovastatin on neointimal hyperplasia following injury in a porcine coronary artery model

OBJECTIVE: To assess the effectiveness of lovastatin, an HMGCoA reductase inhibitor, in the inhibition of coronary arterial restenosis post-balloon angioplasty. DESIGN: Randomized single blind study comparing the degree of restenosis in a control and lovastatin group of animals with similar degree of arterial injury. ANIMALS: Seventeen domestic cross-bred pigs received either oral lovastatin (11 animals) or no lovastatin (six animals). INTERVENTIONS: The pigs received 20 mg of oral lovastatin twice daily or no drug. All pigs received acetylsalicylic acid and verapamil preprocedure. One or more coronary arteries were injured by deployment of tantalum wire stents delivered on oversized percutaneous transluminal coronary angioplasty balloons. The balloons were intentionally overexpanded to create arterial injury. The animals were sacrificed at 28 days. The arteries were cross-sectioned and evaluated blindly by quantitative histomorphometry. The amounts of arterial injury and neointimal thickening were quantitated. A series of linear regression models was used to control for the degree of injury. MAIN RESULTS: The reduction of neointimal thickness for the lovastatin group compared with the control animals was 0.08 mm, a statistically significant result (P < 0.05). CONCLUSIONS: Although lovastatin produced a statistically significant decrease in neointimal thickness post-balloon angioplasty, when extrapolated to angiographical end-points, the differences would not be clinically significant. These data suggest that lovastatin may be of marginal use in humans for limiting restenosis.