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

J Am Coll Cardiol. 2013 Apr 23;61(16):1679-85. doi: 10.1016/j.jacc.2013.01.055. Epub 2013 Apr 2.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Colchicine / adverse effects
  • Colchicine / therapeutic use*
  • Coronary Angiography
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / drug therapy*
  • Coronary Restenosis / prevention & control
  • Coronary Vessels / drug effects
  • Coronary Vessels / pathology*
  • Coronary Vessels / 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

Substances

  • Colchicine