Restenosis is a major complication leading to the failure of vascular procedures, including surgery, angioplasty and stenting. Major efforts including over 100 clinical trials have been made to overcome this complication, with little success to date. Issues relating to trial rationale, design, measurement and biology are addressed in this review.
Beatt KJ, Serruys PW, Hugenholtz PGRestenosis after coronary angioplasty: new standards for clinical studies . J Am Coll Cardiol1990;15:491-8.
2.
Fischman DL, Leon MB, Baim DS et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med1994;331:496-501.
3.
Emanuelsson H., Beatt KJ, Bagger JP et al. Long-term effects of angiopeptin treatment in coronary angioplasty. Reduction of clinical events but not angiographic restenosis. European Angiopeptin Study Group. Circulation1995:91(6):1689-96.
4.
Sahni R., Maniet AR, Voci G., Banka VSPrevention of restenosis by lovastatin after successful coronary angioplasty . Am Heart J1991;121:1600-08.
5.
Weintraub WS , Boccuzzi SJ, Klein JL et al. Lack of effect of lovastatin on restenosis after coronary angioplasty. Lovastatin Restenosis Trial Study Group. N Engl J Med1994;331(20): 1331-7.
6.
Teirstein PS , Massullo V., Jani S. et al. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med1997;336(24):1697-703.
7.
Teirstein PS , Massullo V., Jani S. et al. Three-year clinical and angiographic follow-up after intracoronary radiation: results of a randomized clinical trial. Circulation2000; 101(4):360-5.
8.
Serruys PW, Emanuelsson H., van der Giessen W. et al. Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study. Circulation1996;93(3):412-22.
9.
Serruys PW, van Hout B., Bonnier H. et al. Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II). Lancet1998;352(9129):673-81.
10.
Vrolix MC, Legrand VM, Reiber JH et al. Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators. Am J Cardiol2000;86(4):385-9.
11.
Sousa JE, Costa MA,Abizaid AC et al. Sustained suppression of neo-intimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up. Circulation2001;104:2007-11.
12.
Teirstein PSLiving the dream of no restenosis. Circulation2001;104:1996-98.
13.
Berger PB, Holmes DR Jr, Ohman EM et al. 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 Transluminal Coronary Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MARCATOR). J Am Coll Cardiol1996;27(1):1-7.
14.
Multicenter European Research Trial with Cilazapril after Angioplasty Prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group.Does the new angiotensin converting enzyme inhibitor cilazapril prevent restenosis after percutaneous transluminal coronary angioplasty? Results of the MERCATOR study: a multicenter, randomised, double-blind placebo-controlled trial. Circulation1992;86: 100-10.
15.
Peters S., Gottins B., Trummel M., Rust H., Brattstrom A.Valsartan for prevention of restenosis after stenting of type B2/C lesions: the VAL-PREST trial. J Invasive Cardiol2001 ; 13(2):93-7.
16.
Amant C., Bauters C., Bodart JC et al. Bertrand MED allele of the angiotensin I-converting enzyme is a major risk factor for restenosis after coronary stenting. Circulation1997;96(1):56-60.
17.
Koch W., Kastrati A., Mehilli J., Bottiger C., von Beckerath N., Schomig A.Insertion/deletion polymorphism of the angiotensin I-converting enzyme gene is not associated with restenosis after coronary stent placement. Circulation2000;102(2):197-202.
18.
Samani NJ, Martin DS, Brack M. et al. Insertion/deletion polymorphism in the angiotensin-converting enzyme gene and risk of restenosis after coronary angioplasty. Lancet1995;345 (8956):1013-16.
19.
Hamon M.,Amant C., Bauters C. et al. Dual determination of angiotensin-converting enzyme and angiotensin-II type 1 receptor genotypes as predictors of restenosis after coronary angioplasty . Am J Cardiol1998;81(1):79-81.
20.
Meurice T., Bauters C., Hermant X. et al. Effect of ACE inhibitors on angiographic restenosis after coronary stenting (PARIS): a randomised, double blind placebo-controlled trial. Lancet2001;357(9265):1321-4.
21.
Pratt RE, Dzau VJPharmacological strategies to prevent restenosis: lessons learned from Blockade of the Renin-Angiotensin System. Circulation1996;93:848-52.
22.
Mann MJ, Whittemore AD, Donaldson MC et al. Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial. Lancet1999;354(9189):1493-8.
23.
Chan P., Patel M., Betteridge L. et al.Abnormal growth regulation of vascular smooth muscle cells by heparin in patients with restenosis. Lancet1993;341:341-2.
24.
McCaffreyTA , Du B., Consigli S. et al. Genomic instability in the type II TGF-beta1 receptor gene in atherosclerotic and restenotic vascular cells. J Clin Invest1997;100(9):2182-8.
25.
Scott S., O'Sullivan M., Hafizi S., Shapiro LM, Bennett MRHuman vascular smooth muscle cells from restenosis or in-stent stenosis sites demonstrate enhanced responses to p53: implications for brachytherapy and drug treatment for restenosis. Circ Res2002 ;90:398-404.
26.
Kondo J., Sone T., Tsuboi H. et al. Effect of quinapril on intimal hyperplasia after coronary stenting as assessed by intravascular ultrasound. Am J Cardiol2001;87(4):443-5,A6.
27.
. Keegan J.The First World War . Pimlico, London; ISBN: 0712666451, November 1999.