Colchicine treatment for the prevention of bare-metal stent restenosis in diabetic patients.

Abstract

OBJECTIVES:

This study sought to test the hypothesis that colchicine treatment after percutaneous coronary intervention (PCI) can lead to a decrease in in-stent restenosis (ISR).

BACKGROUND:

ISR rates are particularly high in certain patient subsets, including diabetic patients, especially when a bare-metal stent (BMS) is used. Pharmacological interventions to decrease ISR could be of clinical relevance.

METHODS:

Diabetic patients with contraindication to a drug-eluting stent, undergoing PCI with a BMS, were randomized to receive colchicine 0.5 mg twice daily or placebo for 6 months. Restenosis and neointima formation were studied with angiography and intravascular ultrasound 6 months after the index PCI.

RESULTS:

A total of 196 patients (63.6 ± 7.0 years of age, 128 male) were available for analysis. The angiographic ISR rate was 16% in the colchicine group and 33% in the control group (p = 0.007; odds ratio: 0.38, 95% confidence interval: 0.18 to 0.79). The number needed to treat to avoid 1 case of angiographic ISR was 6 (95% confidence interval: 3.4 to 18.7). The results were similar for IVUS-defined ISR (odds ratio: 0.42; 95% confidence interval: 0.22 to 0.81; number needed to treat = 5). Lumen area loss was 1.6 mm(2) (interquartile range: 1.0 to 2.9 mm(2)) in colchicine-treated patients and 2.9 mm(2) (interquartile range: 1.4 to 4.8 mm(2)) in the control group (p = 0.002). Treatment-related adverse events were largely limited to gastrointestinal symptoms.

CONCLUSIONS:

Colchicine is associated with less neointimal hyperplasia and a decreased ISR rate when administered to diabetic patients after PCI with a BMS. This observation may prove useful in patients undergoing PCI in whom implantation of a drug-eluting stent is contraindicated or undesirable.

• Authors: Spyridon Deftereos, Georgios Giannopoulos, Konstantinos Raisakis, Charalambos Kossyvakis, Andreas Kaoukis, Vasiliki Panagopoulou, Metaxia Driva, George Hahalis, Vlasios Pyrgakis, Dimitrios Alexopoulos, Antonis S Manolis, Christodoulos Stefanadis, Michael W Cleman
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 61 Issue 16 Pg. 1679-85 (Apr 23 2013) ISSN: 1558-3597 [Electronic] United States
• PMID: 23500260 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Colchicine

Topics

• Adult
• Aged
• Aged, 80 and over
• Colchicine (adverse effects, therapeutic use)
• Coronary Angiography
• Coronary Restenosis (diagnostic imaging, drug therapy, prevention & control)
• Coronary Vessels (drug effects, pathology, surgery)
• Diabetes Mellitus, Type 2 (complications)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Neointima (drug therapy)
• Percutaneous Coronary Intervention (adverse effects)
• Prospective Studies
• Stents (adverse effects)
• Treatment Outcome