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Evaluation of in-stent restenosis in the APPROACH trial (assessment on the prevention of progression by Rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history)

By H.M. (Hector) Garcia-Garcia, S.A. (Scot) Garg, S. (Salvatore) Brugaletta, G. (Giorgio) Morocutti, R.E. (Robert) Ratner, N.S. (Nikheel) Kolatkar, B.G. (Barbara) Kravitz, D.M. (Diane) Miller, C. (Chunmei) Huang, R.W. (Richard) Nesto, P.W.J.C. (Patrick) Serruys, R.P. (R.) Aftring, N.S. (Nikheel) Kolatkar, B.G. (Barbara) Kravitz, J. (Jane) Wolstenholme, J. (Jari) Saarinen, R. (R.) Fowler, J. (Jonathan) Hoffman, D. (D.) Steele-Norwood, R. (Robert) Russell, S. (S.) Young, Y.F. Chou, S. (Steve) McMorn, C. (Courtney) Kirsch, B. (Bonnie) Louridas, T. (Teresa) Olivieria, D. (Debra) Mattioli, D. (D.) Miller, C. (Chunmei) Huang, C. (C.) Nguyen, K. (Kristoph) Jahnke, G.S. (Gary) Mintz, J. (J.) Lachin, M. (M.) Abrahamson, P. (P.) Carson and P. Jones

Abstract

To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease. A total of 462 patients with T2DM were randomized to rosiglitazone or glipizide for up to 18 months in the APPROACH trial, and had evaluable baseline and follow-up IVUS examinations. There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm 3 vs. 1.9 mm 3; P = 0.61) or with a drug-eluting stent (12.1mm 3 vs. 5.5 mm 3; P = 0.09). Similarly, there was no significant difference in percentage intimal hyperplasia volume between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (24.1% vs. 19.8%; P = 0.38) or with a drug-eluting stent (9.8% vs. 8.3%; P = 0.57). QCA data (intra-stent late loss, intra-stent diameter stenosis or binary restenosis) were not different between the rosiglitazone and glipizide groups. This study suggests that both rosiglitazone and glipizide have a similar effect on neointimal growth at medium term follow-up, a finding that warrants investigation in dedicated randomized trials

Topics: Atherosclerosis, IVUS, Restenosis, Type 2 diabetes
Year: 2012
DOI identifier: 10.1007/s10554-011-9836-z
OAI identifier: oai:repub.eur.nl:62843
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