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15 November 1993 | Volume 119 Issue 10 | Pages 969-976
Objective: To assess the effects of lipid-lowering therapy with lovastatin on coronary angiographic findings in patients with coronary artery disease and to compare the findings with those of two lipid-lowering angiographic trials using similar end points.
Design: Randomized, double-blind, placebo-controlled, multicenter coronary angiographic trial.
Setting: Community- and university-based cardiac catheterization laboratories.
Participants: A total of 270 patients, 37 to 67 years old, with total cholesterol ranging from 4.92 to 7.64 mmol/L (190 to 295 mg/dL) and angiographically defined coronary artery disease.
Intervention: A cholesterol-lowering diet and either lovastatin, 80 mg/day, or placebo.
Outcome: Per-patient change in percent diameter stenosis as determined by quantitative coronary angiography (primary end point). Global change score, based on the consensus of blinded expert readers regarding angiographic change (secondary endpoint).
Results: Lovastatin lowered total cholesterol level by 32%, low-density lipoprotein cholesterol by 38%, and the apolipoprotein B by 26% and raised the high-density lipoprotein cholesterol by 8.5% (P < 0.001). Average percent diameter stenosis increased 2.2% in placebo recipients and 1.6% in lovastatin recipients (P > 0.20). For lesions 50% or greater, average percent diameter stenosis increased 0.9% in placebo recipients and decreased 4.1% in lovastatin recipients (P = 0.005). The mean global change score was +0.9 (indicating progression) in the placebo group and +0.4 in the lovastatin group (P = 0.002); 13 placebo recipients and 28 lovastatin recipients had global change scores indicating regression (P < 0.02).
Conclusion: Treatment with lovastatin plus diet slows the rate of progression and increases the frequency of regression in coronary artery lesions (by global change score), especially in more severe lesions (by quantitative angiography). This is the third lipid-lowering trial to show a benefit using the global change score, an end point predictive of clinical coronary events. Differences between two of these trials, using quantitative coronary angiographic end points, may have theoretical bearing on the mechanisms by which lipid-lowering therapy operates at the level of the arterial wall.
* For current author affiliations and addresses, see end of text. See the appendix for a listing of the members of the MARS Research Group.
Author and Article Information
Requests for Reprints: Stanley P. Azen, PhD, Department of Preventive Medicine, 1420 San Pablo Street, PM B101, Los Angeles, CA 90033.
ARTICLE
Coronary Angiographic Changes with Lovastatin Therapy: The Monitored Atherosclerosis Regression Study (MARS)
Dr. Blankenhorn died on 9 May 1993.
Acknowledgments: The authors thank the angiographers (Miguel E. Sanmarco, MD, Peter R. Mahrer, MD, Robert B. Chesne, MD, Thomas D. Gaarder, MD, Stanley Kawanishi, MD, and Stanley N. Snyder, MD); the panelists (Miguel E. Sanmarco, MD, George G. Rowe, MD, William J. French, MD, Thomas D. Gaarder, MD, David W. Hunter, MD, W. David Johnston, MD, Peter R. Mahrer, MD, Malcolm Pearce, MD, K. Ramaswamy, MD, Anthony Reid, MD, Henry S. Sawin, Jr., MD, Dale G. Senior, MD, Douglas K. Stewart, MD, and Bonnie H. Weiner, MD); and those who assisted in manuscript preparation (Elizabeth J. Bochynski, Jo Darnall, Patricia Huezo, and Maria Kanellos).
Grant Support: In part by Merck Research Laboratories and National Institutes of Health grant NHLBI-1-HL45005. None of the MARS investigators have any financial interest in Merck. The University of Southern California investigators were responsible for data management, data reporting, and the statistical analysis in this article. Representatives of Merck, as well as the University of Southern California and University of Wisconsin investigators and clinic staff, were blinded to treatment assignment and all interim data analyses presented to the external Data and Safety Monitoring Committee, which consisted of experts in angiography, atherosclerosis, and statistics and did not represent in any way the interests of Merck. Members of the Committee included Daniel Steinberg, MD, Chair (University of California at San Diego); Leo T. Chylack, MD (Harvard University); Harold T. Dodge, MD (University of Washington); Elmer C. Hall, PhD (Emory University); and Telfer B. Reynolds, MD (University of Southern California).
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A. L. Gould, J. E. Rossouw, N. C. Santanello, J. F. Heyse, and C. D. Furberg Cholesterol Reduction Yields Clinical Benefit : Impact of Statin Trials Circulation, March 17, 1998; 97(10): 946 - 952. [Abstract] [Full Text] [PDF]
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S. Perreault, V. H. Hamilton, F. Lavoie, and S. A. Grover Treating Hyperlipidemia for the Primary Prevention of Coronary Disease: Are Higher Dosages of Lovastatin Cost-effective? Arch Intern Med, February 23, 1998; 158(4): 375 - 381. [Abstract] [Full Text] [PDF]
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J. A. Kuivenhoven, J. W. Jukema, A. H. Zwinderman, P. de Knijff, R. McPherson, A. V.G. Bruschke, K. I. Lie, J. J.P. Kastelein, and The Regression Growth Evaluation Statin Study Grou The Role of a Common Variant of the Cholesteryl Ester Transfer Protein Gene in the Progression of Coronary Atherosclerosis N. Engl. J. Med., January 8, 1998; 338(2): 86 - 93. [Abstract] [Full Text] [PDF]
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J. Niebauer, R. Hambrecht, T. Velich, K. Hauer, C. Marburger, B. Kalberer, C. Weiss, E. von Hodenberg, G. Schlierf, G. Schuler, et al. Attenuated Progression of Coronary Artery Disease After 6 Years of Multifactorial Risk Intervention : Role of Physical Exercise Circulation, October 21, 1997; 96(8): 2534 - 2541. [Abstract] [Full Text]
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M. H. Frick, M. Syvanne, M. S. Nieminen, H. Kauma, S. Majahalme, V. Virtanen, Y. A. Kesaniemi, A. Pasternack, and M.-R. Taskinen Prevention of the Angiographic Progression of Coronary and Vein-Graft Atherosclerosis by Gemfibrozil After Coronary Bypass Surgery in Men With Low Levels of HDL Cholesterol Circulation, October 7, 1997; 96(7): 2137 - 2143. [Abstract] [Full Text]
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P. R. Hebert, J. M. Gaziano, K. S. Chan, and C. H. Hennekens Cholesterol Lowering With Statin Drugs, Risk of Stroke, and Total Mortality: An Overview of Randomized Trials JAMA, July 23, 1997; 278(4): 313 - 321. [Abstract] [PDF]
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W. R. M. Aengevaeren, G. J. H. Uijen, J. W. Jukema, A. V. G. Bruschke, and T. van der Werf Functional Evaluation of Lipid-Lowering Therapy by Pravastatin in the Regression Growth Evaluation Statin Study (REGRESS) Circulation, July 15, 1997; 96(2): 429 - 435. [Abstract] [Full Text]
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J. R. Crouse III, R. P. Byington, H. M. Hoen, and C. D. Furberg Reductase Inhibitor Monotherapy and Stroke Prevention Arch Intern Med, June 23, 1997; 157(12): 1305 - 1310. [Abstract] [PDF]
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G. J. Blauw, A. M. Lagaay, A. H. M. Smelt, and R. G. J. Westendorp Stroke, Statins, and Cholesterol : A Meta-Analysis of Randomized, Placebo-Controlled, Double-Blind Trials With HMG-CoA Reductase Inhibitors Stroke, May 1, 1997; 28(5): 946 - 950. [Abstract] [Full Text]
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H. N. Hodis, W. J. Mack, M. Dunn, C.-r. Liu, C.-h. Liu, R. H. Selzer, and R. M. Krauss Intermediate-Density Lipoproteins and Progression of Carotid Arterial Wall Intima-Media Thickness Circulation, April 15, 1997; 95(8): 2022 - 2026. [Abstract] [Full Text]
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P. Alaupovic, W. J. Mack, C. Knight-Gibson, and H. N. Hodis The Role of Triglyceride-Rich Lipoprotein Families in the Progression of Atherosclerotic Lesions as Determined by Sequential Coronary Angiography From a Controlled Clinical Trial Arterioscler. Thromb. Vasc. Biol., April 1, 1997; 17(4): 715 - 722. [Abstract] [Full Text]
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S. Colli, S. Eligini, M. Lalli, M. Camera, R. Paoletti, and E. Tremoli Vastatins Inhibit Tissue Factor in Cultured Human Macrophages: A Novel Mechanism of Protection Against Atherothrombosis Arterioscler. Thromb. Vasc. Biol., February 1, 1997; 17(2): 265 - 272. [Abstract] [Full Text]
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The Post Coronary Artery Bypass Graft Trial Invest The Effect of Aggressive Lowering of Low-Density Lipoprotein Cholesterol Levels and Low-Dose Anticoagulation on Obstructive Changes in Saphenous-Vein Coronary-Artery Bypass Grafts N. Engl. J. Med., January 16, 1997; 336(3): 153 - 163. [Abstract] [Full Text] [PDF]
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E. Stein, D. Sprecher, K.S. Allenby, R.L. Tosiello, E. Whalen, and S.R. Ripa Cerivastatin, a New Potent Synthetic HMG Co-A Reductase Inhibitor: Effect of 0.2 mg Daily in Subjects With Primary Hypercholesterolemia Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 1997; 2(1): 7 - 16. [Abstract] [PDF]
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B. D. Miller, E. L. Alderman, W. L. Haskell, J. M. Fair, and R. M. Krauss Predominance of Dense Low-Density Lipoprotein Particles Predicts Angiographic Benefit of Therapy in the Stanford Coronary Risk Intervention Project Circulation, November 1, 1996; 94(9): 2146 - 2153. [Abstract] [Full Text]
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D. Waters, J. Lesperance, P. Gladstone, S. J. Boccuzzi, T. Cook, R. Hudgin, G. Krip, and L. Higginson Effects of Cigarette Smoking on the Angiographic Evolution of Coronary Atherosclerosis: A Canadian Coronary Atherosclerosis Intervention Trial (CCAIT) Substudy Circulation, August 15, 1996; 94(4): 614 - 621. [Abstract] [Full Text]
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J. Wouter Jukema, A. J. van Boven, A. H. Zwinderman, E. T. Bal, J. H. C. Reiber, and A. V. G. Bruschke The Influence of Angiographic Endpoints on the Outcome of Lipid Intervention Studies: A Proposal for Standardization Angiology, July 1, 1996; 47(7): 633 - 642. [Abstract] [PDF]
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R. S. Rosenson Beyond Low-Density Lipoprotein Cholesterol: A Perspective on Low High-Density Lipoprotein Disorders and Lp(a) Lipoprotein Excess Arch Intern Med, June 24, 1996; 156(12): 1278 - 1284. [Abstract] [PDF]
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R. Marchioli, R. M. Marfisi, F. Carinci, and G. Tognoni Meta-analysis, Clinical Trials, and Transferability of Research Results Into Practice: The Case of Cholesterol-Lowering Interventions in the Secondary Prevention of Coronary Heart Disease Arch Intern Med, June 10, 1996; 156(11): 1158 - 1172. [Abstract] [PDF]
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A. A. Kroon, W. R.M. Aengevaeren, T. van der Werf, G. J.H. Uijen, J. H.C. Reiber, A. V.G. Bruschke, and A. F.H. Stalenhoef LDL-Apheresis Atherosclerosis Regression Study (LAARS) : Effect of Aggressive Versus Conventional Lipid Lowering Treatment on Coronary Atherosclerosis Circulation, May 15, 1996; 93(10): 1826 - 1835. [Abstract] [Full Text]
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W. J. Mack, R. M. Krauss, and H. N. Hodis Lipoprotein Subclasses in the Monitored Atherosclerosis Regression Study (MARS) : Treatment Effects and Relation to Coronary Angiographic Progression Arterioscler. Thromb. Vasc. Biol., May 1, 1996; 16(5): 697 - 704. [Abstract] [Full Text]
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D.R. Illingworth, E.A. Stein, R.H. Knopp, D.B. Hunninghake, M.H. Davidson, C.A. Dujovne, V.T. Miller, J.A. Tobert, P.M. Laskarzewski, J.L. Isaacsohn, et al. A Randomized Multicenter Trial Comparing the Efficacy of Simvastatin and Fluvastatin Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 1996; 1(1): 23 - 29. [Abstract] [PDF]
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L. Lacoste, J. Y.T. Lam, J. Hung, G. Letchacovski, C. B. Solymoss, and D. Waters Hyperlipidemia and Coronary Disease : Correction of the Increased Thrombogenic Potential With Cholesterol Reduction Circulation, December 1, 1995; 92(11): 3172 - 3177. [Abstract] [Full Text]
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M. Shiomi, T. Ito, T. Tsukada, T. Yata, Y. Watanabe, Y. Tsujita, M. Fukami, J.-i. Fukushige, T. Hosokawa, and A. Tamura Reduction of Serum Cholesterol Levels Alters Lesional Composition of Atherosclerotic Plaques : Effect of Pravastatin Sodium on Atherosclerosis in Mature WHHL Rabbits Arterioscler. Thromb. Vasc. Biol., November 1, 1995; 15(11): 1938 - 1944. [Abstract] [Full Text]
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D. Waters, L. Higginson, P. Gladstone, S. J. Boccuzzi, T. Cook, and J. Lesperance Effects of Cholesterol Lowering on the Progression of Coronary Atherosclerosis in Women : A Canadian Coronary Atherosclerosis Intervention Trial (CCAIT) Substudy Circulation, November 1, 1995; 92(9): 2404 - 2410. [Abstract] [Full Text]
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A. M. Shircore, W. J. Mack, R. H. Selzer, P. L. Lee, S. P. Azen, P. Alaupovic, and H. N. Hodis Compensatory Vascular Changes of Remote Coronary Segments in Response to Lesion Progression as Observed by Sequential Angiography From a Controlled Clinical Trial Circulation, November 1, 1995; 92(9): 2411 - 2418. [Abstract] [Full Text]
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Y. Ozaki, D. Keane, and P. W. Serruys Progression and Regression of Coronary Stenosis in the Long-term Follow-up of Vasospastic Angina Circulation, November 1, 1995; 92(9): 2446 - 2456. [Abstract] [Full Text]
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K. L. Gould, D. Ornish, L. Scherwitz, S. Brown, R. P. Edens, M. J. Hess, N. Mullani, L. Bolomey, F. Dobbs, W. T. Armstrong, et al. Changes in Myocardial Perfusion Abnormalities by Positron Emission Tomography After Long-term, Intense Risk Factor Modification JAMA, September 20, 1995; 274(11): 894 - 901. [Abstract] [PDF]
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A. M. Gotto Jr Lipid Lowering, Regression, and Coronary Events : A Review of the Interdisciplinary Council on Lipids and Cardiovascular Risk Intervention, Seventh Council Meeting Circulation, August 1, 1995; 92(3): 646 - 656. [Full Text]
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J. W. Jukema, A. V.G. Bruschke, A. J. van Boven, J. H.C. Reiber, E. T. Bal, A. H. Zwinderman, H. Jansen, G. J.M. Boerma, F. M. van Rappard, and K. I. Lie Effects of Lipid Lowering by Pravastatin on Progression and Regression of Coronary Artery Disease in Symptomatic Men With Normal to Moderately Elevated Serum Cholesterol Levels : The Regression Growth Evaluation Statin Study (REGRESS) Circulation, May 15, 1995; 91(10): 2528 - 2540. [Abstract] [Full Text]
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S. E. Andrade, A. M. Walker, L. K. Gottlieb, N. K. Hollenberg, M. A. Testa, G. M. Saperia, and R. Platt Discontinuation of Antihyperlipidemic Drugs -- Do Rates Reported in Clinical Trials Reflect Rates in Primary Care Settings? N. Engl. J. Med., April 27, 1995; 332(17): 1125 - 1131. [Abstract] [Full Text] [PDF]
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C. B. Treasure, J. L. Klein, W. S. Weintraub, J. D. Talley, M. E. Stillabower, A. S. Kosinski, J. Zhang, S. J. Boccuzzi, J. C. Cedarholm, and R. W. Alexander Beneficial Effects of Cholesterol-Lowering Therapy on the Coronary Endothelium in Patients with Coronary Artery Disease N. Engl. J. Med., February 23, 1995; 332(8): 481 - 487. [Abstract] [Full Text] [PDF]
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G. N. Levine, J. F. Keaney, and J. A. Vita Cholesterol Reduction in Cardiovascular Disease -- Clinical Benefits and Possible Mechanisms N. Engl. J. Med., February 23, 1995; 332(8): 512 - 521. [Full Text] [PDF]
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W. S. Weintraub, S. J. Boccuzzi, J. L. Klein, A. S. Kosinski, S. B. King, R. Ivanhoe, J. C. Cedarholm, M. E. Stillabower, J. D. Talley, S. J. DeMaio, et al. Lack of Effect of Lovastatin on Restenosis after Coronary Angioplasty N. Engl. J. Med., November 17, 1994; 331(20): 1331 - 1337. [Abstract] [Full Text]
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D. R. Illingworth, E. A. Stein, Y. B. Mitchel, C. A. Dujovne, P. H. Frost, R. H. Knopp, P. Tun, R. V. Zupkis, and R. A. Greguski Comparative Effects of Lovastatin and Niacin in Primary Hypercholesterolemia: A Prospective Trial Arch Intern Med, July 25, 1994; 154(14): 1586 - 1595. [Abstract] [PDF]
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