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)

• Published in: The International Journal of Cardiovascular Imaging Vol. 28; no. 3; pp. 455 - 465
• Main Authors: García-García, Héctor M., Garg, Scot, Brugaletta, Salvatore, Morocutti, Giorgio, Ratner, Robert E., Kolatkar, Nikheel S., Kravitz, Barbara G., Miller, Diane M., Huang, Chun, Nesto, Richard W., Serruys, Patrick W.
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.03.2012; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Analysis of Variance; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Cardiac Imaging; Cardiology; Coronary Angiography; Coronary Artery Disease - diagnosis; Coronary Artery Disease - etiology; Coronary Artery Disease - therapy; Coronary Restenosis - diagnosis; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Coronary Vessels - diagnostic imaging; Coronary Vessels - drug effects; Coronary Vessels - pathology; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetic Angiopathies - diagnosis; Diabetic Angiopathies - etiology; Diabetic Angiopathies - therapy; Double-Blind Method; Drug-Eluting Stents; Female; Glipizide - therapeutic use; Humans; Hyperplasia; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Imaging; Male; Medicine; Medicine & Public Health; Metals; Middle Aged; Neointima; Original Paper; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Radiology; Rosiglitazone; Stents; Thiazolidinediones - adverse effects; Thiazolidinediones - therapeutic use; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Restenosis; Type 2 diabetes; IVUS; Atherosclerosis
• ISSN: 1569-5794; 1573-0743; 1875-8312
• DOI: 10.1007/s10554-011-9836-z

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.