title: Colchicine treatment for the prevention of bare-metal stent restenosis in diabetic patients.
abstract: OBJECTIVE
  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.affiliation: Department of Cardiology, Athens General Hospital "G. Gennimatas," Athens, Greece.
authors.forename: Spyridon
authors.initials: S
authors.lastname: Deftereos
authors.forename: Georgios
authors.initials: G
authors.lastname: Giannopoulos
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Raisakis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Kossyvakis
authors.forename: Andreas
authors.initials: A
authors.lastname: Kaoukis
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Panagopoulou
authors.forename: Metaxia
authors.initials: M
authors.lastname: Driva
authors.forename: George
authors.initials: G
authors.lastname: Hahalis
authors.forename: Vlasios
authors.initials: V
authors.lastname: Pyrgakis
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Alexopoulos
authors.forename: Antonis S
authors.initials: AS
authors.lastname: Manolis
authors.forename: Christodoulos
authors.initials: C
authors.lastname: Stefanadis
authors.forename: Michael W
authors.initials: MW
authors.lastname: Cleman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003078:Colchicine / Q000009:adverse effects / Q000627:therapeutic use*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000517:prevention & control; D003331:Coronary Vessels / Q000187:drug effects / Q000473:pathology* / Q000601:surgery; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000188:drug therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D003078:Colchicine