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).
Citation: The International Journal of Cardiovascular Imaging. 28(3):455-65, 2012 Mar.PMID: 21359834Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Angioplasty, Balloon, Coronary/is [Instrumentation] | *Coronary Artery Disease/th [Therapy] | *Coronary Restenosis/pc [Prevention & Control] | *Coronary Vessels/de [Drug Effects] | *Coronary Vessels/pa [Pathology] | *Diabetes Mellitus, Type 2/dt [Drug Therapy] | *Diabetic Angiopathies/th [Therapy] | *Hypoglycemic Agents/tu [Therapeutic Use] | *Stents | *Thiazolidinediones/tu [Therapeutic Use] | Adult | Aged | Aged, 80 and over | Analysis of Variance | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | Coronary Angiography | Coronary Artery Disease/di [Diagnosis] | Coronary Artery Disease/et [Etiology] | Coronary Restenosis/di [Diagnosis] | Coronary Restenosis/et [Etiology] | Coronary Vessels/us [Ultrasonography] | Diabetes Mellitus, Type 2/co [Complications] | Diabetic Angiopathies/di [Diagnosis] | Diabetic Angiopathies/et [Etiology] | Double-Blind Method | Drug-Eluting Stents | Female | Glipizide/tu [Therapeutic Use] | Humans | Hyperplasia | Hypoglycemic Agents/ae [Adverse Effects] | Male | Metals | Middle Aged | Neointima | Predictive Value of Tests | Prospective Studies | Prosthesis Design | Thiazolidinediones/ae [Adverse Effects] | Time Factors | Treatment Outcome | Ultrasonography, InterventionalYear: 2012ISSN:- 1569-5794
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 21359834 | Available | 21359834 |
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.
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