Abstract | BACKGROUND: Diabetes status is an independent marker of restenosis after percutaneous coronary intervention (PCI). Previous studies suggest that metabolic abnormalities associated with diabetes increase stent restenosis by promoting intimal hyperplasia. Preclinical studies have indicated that insulin therapy reduces intimal hyperplasia. The objective of this study was to determine whether insulin-mediated glucose lowering reduces in- stent restenosis in patients with diabetes undergoing PCIs. METHODS: We conducted a prospective, randomized, multicenter, open-labeled study with blinded outcomes. Patients were randomized 1:1 to daily bedtime subcutaneous NPH insulin (Novo Nordisk) versus usual therapy with oral hypoglycemic agents. The main outcomes were change in volume of intimal hyperplasia within the stent measured by intravascular ultrasound and late lumen loss by quantitative coronary angiography at 6 months post-PCI. RESULTS: Seventy-eight patients (36 insulin, 42 usual care) were randomized. Eight patients in each group received drug-eluting stents. The insulin group achieved greater reductions in both glycosylated hemoglobin A1c (mean±S.D.) ( insulin: 8.0%±1.2% to 6.7%±0.7% vs. control: 7.5%±1.2% to 7.1%±1.0 %, P=.0038) and fasting glucose ( insulin: 9.3±3.8 to 5.8±1.7 vs. usual care: 8.4±2.4 to 7.7±2.0 mmol/l, P<.0001). There were no hypoglycemic events. At 6 months, there were no significant differences in either intravascular-ultrasound-determined neointimal volume ( insulin: 41.2±38.9 vs. usual care: 48.4±40.2 mm(3), P=.33) or late lumen loss by angiography ( insulin: 1.29±0.74 mm vs. usual care: 1.02±0.71 mm, P=.17). CONCLUSIONS: Addition of a single bedtime dose of insulin in patients with diabetes does not influence in- stent restenosis.
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Authors | Madhu K Natarajan, Bradley H Strauss, Michael Rokoss, Christopher E Buller, G B John Mancini, Changchun Xie, Tej N Sheth, David Goodhart, Eric A Cohen, Peter Seidelin, William Harper, Hertzel C Gerstein |
Journal | Cardiovascular revascularization medicine : including molecular interventions
(Cardiovasc Revasc Med)
2012 Mar-Apr
Vol. 13
Issue 2
Pg. 95-100
ISSN: 1878-0938 [Electronic] United States |
PMID | 22296781
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 Elsevier Inc. All rights reserved. |
Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin, Isophane
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Topics |
- Angioplasty, Balloon, Coronary
- Blood Glucose
(metabolism)
- Coronary Angiography
- Coronary Restenosis
(blood, diagnosis, prevention & control)
- Diabetes Mellitus, Type 1
(blood, complications, drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Electrocardiography
- Female
- Follow-Up Studies
- Glycated Hemoglobin
(metabolism)
- Graft Occlusion, Vascular
(blood, diagnosis, prevention & control)
- Humans
- Hypoglycemic Agents
(administration & dosage, therapeutic use)
- Insulin, Isophane
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Prognosis
- Prospective Studies
- Time Factors
- Treatment Failure
- Ultrasonography, Interventional
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