Skip Navigation

European Heart Journal 1999 20(19):1393-1406; doi:10.1053/euhj.1999.1483
Copyright © 1999 by the European Society of Cardiology.
This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (16)
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Kleemann, A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Kleemann, A.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Effects of lovastatin on progression of non-dilated and dilated coronary segments and on restenosis in patients after PTCA. The Cholesterol Lowering Atherosclerosis PTCA Trial (CLAPT)

A. Kleemanna,b,f2, S. Eckertc, A. von Eckardsteina,d, W. Leppere, U. Schernikauf, U. Gleichmannc, P. Hanrathe, E. Fleckf, A. Neissg, S. Kerbera,b, G. Assmanna,d and G. Breithardt and the CLAPT Study Groupa,b CLAPT Study-Groupf1

a Institute for Arteriosclerosis Research, Münster
b Departments of Cardiology, University of Münster, Münster
c University of Bochum and Heart Center of North-Rhine Westphalia, Bad Oeynhausen
e University of Aachen, Aachen
f German Heart Institute Berlin, Berlin
d Institute of Clinical Chemistry and Laboratory Medicine, Münster
g Institute of Medical Statistics and Epidemiology, Technical University Munich, Munich, Germany

Received December 8, 1998; accepted December 16, 1998

Abstract

Objectives The Cholesterol Lowering Atherosclerosis PTCA Trial (CLAPT) is a prospective, randomized trial with blinded angiographic end-points to assess the effect of 2-year's treatment with lovastatin initiated 4 weeks prior to PTCA, compared to usual care on non-dilated coronary segments and on dilated coronary lesions in male patients with total cholesterol between 200 and 300mg.dl–1who underwent elective PTCA.

Methods and Results Two hundred and twenty six patients were randomized 4 weeks prior to PTCA to special care (diet plus lovastatin n=112) or usual care (diet; n=114). One hundred and ninety-nine patients underwent PTCA at baseline and were finally included in the study. Quantitative coronary angiographic assessment was performed on blinded cinefilms at baseline (PTCA) and repeated after 4 and 24 months in 91% and 81% of the patients. The primary end-point was a change in the mean segment diameter of non-dilated segments. The mean lovastatin dose was 33mg.day–1. Total- and LDL-cholesterol decreased by 21% and 29% in the special care group and by 7% and 11% in the usual care patients.

After 2 years, the mean segment diameter of non-dilated segments decreased by 0·03mm in the usual care group and 0·004mm in the special care group (P=0·27). The decrease in the mean segment diameter of dilated lesions was 0·17mm (usual care) and 0·06mm (special care) (P=0·04) after 4 months; 0·16mm (usual care) and 0·002mm (special care) after 24 months, respectively (P=0·05). In both groups, the mean segment diameter of dilated lesions increased between 4 and 24 months after PTCA compared to a decrease in mean segment diameter of non-dilated segments (P<0·05). Restenosis (>50% diameter stenosis at follow-up) occurred in 28·4% of usual care and 22·2% of special care patients (P=0·17).

Conclusions Lovastatin reduced the progression of dilated lesions in men with elective PTCA. Independent of treatment allocation, the dilated lesions regressed and the non-dilated segments progressed during the study follow-up. Four weeks of pre-treatment with lovastatin did not influence the rate of restenosis. Lovastatin had no statistically significant effect on non-dilated segments.

Key Words: Atherosclerosis, restenosis, lovastatin, clinical trial

f2 Correspondence: Dr Andreas Kleemann, Department of Cardiology, University of Münster, 48129 Münster, Germany.

f1 See Appendix for complete listing of CLAPT study personnel. The CLAPT study was sponsored by Merck, Sharp & Dohme, Germany.

References

  1. Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effect of combined colestipol niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987;257:3233–3240[Abstract]
  2. Blankenhorn DH, Azen SP, Kramsch DM. The Monitored Atherosclerosis Regression Study (MARS): coronary angiographic changes with lovastatin therapy. Ann Intern Med. 1993;119:969–976[Abstract/Free Full Text]
  3. Brown BG, Albers JJ, Fisher LD. Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B. N Engl J Med. 1990;323:1289–1298[Abstract]
  4. Waters D, Higginson L, Gladstone P. Effects of monotherapy with an HMG-CoA reductase inhibitor on the progression of coronary atherosclerosis as assessed by serial quantitative arteriography: the Canadian Coronary Atherosclerosis Intervention Trial. Circulation. 1994;89:959–968[Abstract/Free Full Text]
  5. Bestehorn HP, Rensing UFE, Roskamm H. The effect of simvastatin on progression of coronary artery disease. The Multicenter Coronary Intervention Study (CIS). Eur Heart J. 1997;18:226–234[Abstract/Free Full Text]
  6. Buchwald H, Varco RL, Matts JP. Effect of partial ileal bypass surgery on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia. N Engl J Med. 1990;323:946–955[Abstract]
  7. Schuler G, Hambrecht R, Schlierf G. Regular physical exercise and low-fat diet: effects on progression of coronary artery disease. Circulation. 1992;86:1–11[Abstract/Free Full Text]
  8. Watts GF, Lewis B, Brunt JNH. Effects on coronary artery disease of lipid-lowering diet or diet plus cholestyramine in the St Thomas' Atherosclerosis Regression Study (STARS). Lancet. 1992;339:563–569[CrossRef][ISI][Medline]
  9. Haskell WL, Alderman EL, Fair JM. Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease: the Stanford Coronary Risk intervention Project (SCRIP). Circulation. 1994;89:975–990[Abstract/Free Full Text]
  10. Sacks FM, Pasternal RC, Gibson CM, Rosner B, Stone PH. Effect on coronary atherosclerosis of decrease in plasma cholesterol concentrations in normocholesterolaemic patients. Lancet. 1994;344:1182–1186[CrossRef][ISI][Medline]
  11. Lancet. 1994;344:633–638[CrossRef][ISI][Medline]
  12. Pitt B, Mancini GB, Ellis SG, Rosman HS, Park JS, McGovern ME. Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I): reduction in atherosclerosis progression and clinical events. PLAC I investigation. J Am Coll Cardiol. 1995;26:1133–1139[Abstract]
  13. Herd JA, Ballantyne CM, Farmer JA. Effects of fluvastatin on coronary atherosclerosis in patients with mild to moderate cholesterol elevations (Lipoprotein and Coronary Atherosclerosis Study [LCAS]. Am J Cardiol. 1997;80:278–286[CrossRef][ISI][Medline]
  14. Jukema JW, Bruschke AVG, Van Boven AJ. 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. 1995;91:2528–2540[Abstract/Free Full Text]
  15. Holmes DR Jr, Vliestra RE, Smith HC. Restenosis after percutaneous transluminal coronary angioplasty (PTCA): a report from the PTCA registry of the National Heart, Lung and Blood Institute. Am J Cardiol. 1984;53:77C–81C[CrossRef][Medline]
  16. Eckardt H, Völker W, Brüning T, Faber V, Buddecke E. Lovastatin reduces myointimal proliferation after vascular injury. Eur Heart J. 1991;12:
  17. Gellman J, Ezekowitz MD, Sarembock IJ. Effect of lovastatin on intimal hyperplasia after balloon angioplasty: a study in an atherosclerotic hypercholesterolemic rabbit. J Am Coll Cardiol. 1991;17:251–259[Abstract]
  18. Sahni R, Maniet AR, Voci G, Banka VS. Prevention of restenosis by lovastatin after successful coronary angioplasty. Am Heart J. 1991;121:1600–1608[CrossRef][ISI][Medline]
  19. Weintraub WS, Boccuzzi SJ, Klein JL. Lack of effect of lovastatin on restenosis after coronary angioplasty. Lovastatin Restenosis Trial Study Group. N Engl J Med. 1994;331:1331–1337[Abstract/Free Full Text]
  20. Kraus RM, Deckelbaum RJ, Ernst N. Dietary guidelines for healthy American adults. A statement for health professionals from the Nutrition Committee, American Heart Association. Circulation. 1996;94:1795–1800[Free Full Text]
  21. Assmann G, Schriewer H, Schmitz G, Hagele E. Quantification of high-density lipoprotein cholesterol by precipitation with phosphotungstic acid/MgC12. Clin Chem. 1983;29:2025–2029
  22. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low density lipoprotein in plasma without use of a preparative ultracentrifuge. Clin Chem. 1972;18:449–456[Abstract]
  23. Sandkamp M, Tambyrajah B, Schriewer H, Assmann G. Simplified turbidimetric determination of apolipoproteins A-I, A-II and B using a microtitre method. J Clin Chem Clin Biochem. 1988;26:685–689[ISI][Medline]
  24. Reiber JHC, Van der Zwet PMJ, Koning G. Accuracy and precision of quantitative digital coronary arteriography: Observer-, short-, and medium-term variabilities. Catheter Cardiovasc Diagn. 1993;28/3:187–198
  25. DeFeyter PJ, Serruys PW, Davies MJ, Richardson P, Lubsen J, Oliver MF. Quantitative coronary angiography to measure progression and regression of coronary atherosclerosis: Value, limitations, and implications for clinical trials. Circulation. 1991;84:412–423[Free Full Text]
  26. Kleemann, A, Karbenn, U, Budde, T, 1992
  27. SAS/Stat user's guide. Cary: SAS Institute; 1990.
  28. Serruys PW, Foley DP, Kirkeeide RL, Spencer BK III. Restenosis revisited: insights provided by quantitative coronary angiography. Am Heart J. 1993;126:1243–1267[CrossRef][ISI][Medline]
  29. Foley DP, Bonnier H, Jackson G. Prevention of restenosis after coronary angioplasty: rationale and design of the Fluvastatin Angioplasty Restenosis (FLARE) Trial. The Flare Study Group. Am J Cardiol. 1994;73:50D–61D[CrossRef][Medline]
  30. Bertrand ME, McFadden EP, Fruchart JC. Effect of pravastatin on angiographic restenosis after coronary balloon angioplasty. J Am Coll Cardiol. 1997;30:863–869[Abstract]
  31. Serruys PW, Rutsch W, Heyndrickx GR. Prevention of restenosis after percutaneous transluminal coronary angioplasty with thromboxan A2receptor blockade. A randomized, double-blind, placebo controlled trial. Circulation. 1981;84:1568–1581
  32. Circulation. 1992;86:100–111[Abstract/Free Full Text]
  33. Foley DP, Serruys PW. Fluvastatin for the prevention of restenosis after coronary balloon angioplasty: Angiographic and methodological background of the fluvastatin angioplasty restenosis trial. Br J Clin Pract. 1994;48:39–50
  34. Berger PB, Holmes DR Jr, Ohman EM. Restenosis, reocclusion and adverse cardiovascular events after successful balloon angioplasty of occluded versus nonoccluded coronary arteries. Results from the multicenter American research trial with cilazapril after angioplasty to prevent transluminal coronary obstruction and restenosis (MARCATOR). J Am Coll Cardiol. 1996;27:1–7[Abstract]
  35. Circulation. 1992;86:100–111
  36. Kimura T, Yokoi H, Nakagawa Y. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996;334:561–566[Abstract/Free Full Text]
  37. Ormiston JA, Stewart FM, Roche AH, Webber BJ, Whitlock RM, Webster MW. Late regression of the dilated site after coronary angioplasty: a 5-year quantitative angiographic study. Circulation. 1997;96:468–474[Abstract/Free Full Text]
  38. Pedersen TR, Kjekkshus J, Berg K. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease; the Scandi>avian Simvastatin Survival Study (4S)/13. Lancet. 1997;344:1383–1389

Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Ann. Thorac. Surg.Home page
N. Suzuki, K. Kozuma, Y. Ueno, K. Nagaoka, H. Kyono, S. Ishikawa, H. Watanabe, N. Yokoyama, S. Takeshita, and T. Isshiki
Serial Quantitative Coronary Analyses for the Evaluation of One-Year Change in Saphenous Vein Grafts
Ann. Thorac. Surg., February 1, 2008; 85(2): 525 - 529.
[Abstract] [Full Text] [PDF]

Home page
 Arch Intern MedHome page
T. J. Wilt, H. E. Bloomfield, R. MacDonald, D. Nelson, I. Rutks, M. Ho, G. Larsen, A. McCall, S. Pineros, and A. Sales
Effectiveness of Statin Therapy in Adults With Coronary Heart Disease
Arch Intern Med, July 12, 2004; 164(13): 1427 - 1436.
[Abstract] [Full Text] [PDF]

Home page
 Cardiovasc ResHome page
G. Theilmeier, R. Quarck, P. Verhamme, M.-L. Bochaton-Piallat, M. Lox, H. Bernar, S. Janssens, M. Kockx, G. Gabbiani, D. Collen, et al.
Hypercholesterolemia impairs vascular remodelling after porcine coronary angioplasty
Cardiovasc Res, August 1, 2002; 55(2): 385 - 395.
[Abstract] [Full Text] [PDF]

Home page
 Eur Heart JHome page
P.J. de Feyter
Editorials: Lipids and coronary restenosis: an elusive link
Eur. Heart J., October 1, 1999; 20(19): 1371 - 1374.
[PDF]

This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (16)
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Kleemann, A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Kleemann, A.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?