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Previous Volume 331:1331-1337 November 17, 1994 Number 20 Next

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ABSTRACT

Background Experimental and clinical observations suggest that lowering serum lipid levels may reduce the risk of restenosis after coronary angioplasty. We report the results of a prospective, randomized, double-blind trial evaluating whether lowering lipid levels with lovastatin can prevent or delay restenosis after angioplasty.

Methods Seven to 10 days before angioplasty, we randomly assigned eligible patients to receive lovastatin (40 mg orally twice daily) or placebo. Patients who underwent successful, complication-free, first-time angioplasty of a native vessel (the index lesion) continued to receive therapy for six months, when a second coronary angiogram was obtained. The primary end point was the extent of restenosis of the index lesion, as assessed by quantitative coronary arteriography. Of 404 patients randomly assigned to study groups, 384 underwent angioplasty; 354 of the procedures were successful, and 321 patients underwent angiographic restudy at six months.

Results At base line, the patients in the lovastatin group (n = 203) and the placebo group (n = 201) were similar with respect to demographic clinical, angiographic, and laboratory characteristics. At base line the mean (±SD) degree of stenosis, expressed as a percentage of the diameter of the vessel, was 64 ±11 percent in the lovastatin group, as compared with 63 ±11 percent in the placebo group (P = 0.22). Despite a 42 percent reduction in the serum level of low-density lipoprotein cholesterol in the lovastatin group, after six months of treatment the amount of stenosis seen in the second angiogram was 46 ±20 percent in the placebo group, as compared with 44 ±21 percent in the lovastatin group (P = 0.50). Similarly, there were no significant differences in minimal luminal diameter or other measures of restenosis. A trend was noted toward more myocardial infarctions in the lovastatin group, as a result of acute vessel closure or restenosis at the site of angioplasty, but there were no other important differences between the two groups in the frequency of fatal or nonfatal events at six months.

Conclusions Treatment with high-dose lovastatin initiated before coronary angioplasty does not prevent or delay the process of restenosis in the first six months after the procedure.

Source Information

From the Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta (W.S.W., J.L.K., S.B.K., C.L.C.-B., R.W.A.); the Biostatistics Department, Emory University School of Public Health, Atlanta (A.S.K.); Merck Research Laboratories, Rahway, N.J. (S.J.B.); Florida Hospital, Orlando (R.I.); Charlotte Memorial Hospital, Charlotte, N.C. (J.C.C.); the Medical Center of Delaware, Wilmington (M.E.S.); the University of Louisville, Louisville, Ky. (J.D.T.); Baylor Hospital, Dallas (S.J.D.); William Beaumont Hospital, Royal Oak, Mich. (W.W.O.); Allegheny Medical Center, Pittsburgh (J.E.F.); Washington Hospital Center, Washington, D.C. (D.C.R.); and Piedmont Hospital, Atlanta (C.L.B.). Presented in part at the 66th Scientific Sessions of the American Heart Association, Atlanta, November 10, 1993.The institutions and investigators participating in the Lovastatin Restenosis Trial are listed in the Appendix.

Address reprint requests to Dr. Weintraub at the Division of Cardiology, Emory University Hospital, 1364 Clifton Rd., N.E., Atlanta, GA 30322.

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