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01.03.2012 | Original Paper | Ausgabe 3/2012 Open Access

The International Journal of Cardiovascular Imaging 3/2012

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)

Zeitschrift:
The International Journal of Cardiovascular Imaging > Ausgabe 3/2012
Autoren:
Héctor M. García-García, Scot Garg, Salvatore Brugaletta, Giorgio Morocutti, Robert E. Ratner, Nikheel S. Kolatkar, Barbara G. Kravitz, Diane M. Miller, Chun Huang, Richard W. Nesto, Patrick W. Serruys, The APPROACH study group
Wichtige Hinweise
Trial Registration: Clinicaltrials.gov NCT00116831. http://​clinicaltrials.​gov/​ct2/​show/​NCT00116831.
The members of the APPROACH study group are given in “Appendix”.

Abstract

To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intra-vascular 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 mm3 vs. 1.9 mm3; P = 0.61) or with a drug-eluting stent (12.1 mm3 vs. 5.5 mm3; 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.

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