title: 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).
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 mm(3) vs. 1.9 mm(3); P = 0.61) or with a drug-eluting stent (12.1 mm(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.
authors.affiliation: Erasmus Medical Center, Z120 Thoraxcentre, Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands. h.garciagarcia@erasmusmc.nl
authors.forename: Héctor M
authors.initials: HM
authors.lastname: García-García
authors.forename: Scot
authors.initials: S
authors.lastname: Garg
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.forename: Giorgio
authors.initials: G
authors.lastname: Morocutti
authors.forename: Robert E
authors.initials: RE
authors.lastname: Ratner
authors.forename: Nikheel S
authors.initials: NS
authors.lastname: Kolatkar
authors.forename: Barbara G
authors.initials: BG
authors.lastname: Kravitz
authors.forename: Diane M
authors.initials: DM
authors.lastname: Miller
authors.forename: Chun
authors.initials: C
authors.lastname: Huang
authors.forename: Richard W
authors.initials: RW
authors.lastname: Nesto
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D005913:Glipizide / Q000627:therapeutic use; D006801:Humans; D006965:Hyperplasia; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008670:Metals; D008875:Middle Aged; D058426:Neointima; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D000077154:Rosiglitazone; D015607:Stents; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D007004:Hypoglycemic Agents; D008670:Metals; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D005913:Glipizide