Colchicine reduced angiographic in-stent restenosis compared to placebo (16% vs 33%; OR 0.38; 95% CI 0.18-0.79; p=0.007) in diabetic patients after PCI with a bare-metal stent.
RCT (n=196)
Randomized
Does colchicine reduce angiographic in-stent restenosis in diabetic patients undergoing PCI with a bare-metal stent?
Colchicine significantly reduces angiographic and IVUS-defined in-stent restenosis when administered to diabetic patients after PCI with a bare-metal stent.
Effect estimate: OR 0.38 (95% CI 0.18 to 0.79)
Absolute Event Rate: 16% vs 33%
p-value: p=0.007
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.
Deftereos et al. (Mon,) conducted a rct in Diabetic patients undergoing PCI with a bare-metal stent (n=196). colchicine vs. placebo was evaluated on angiographic in-stent restenosis (ISR) (OR 0.38, 95% CI 0.18 to 0.79, p=0.007). Colchicine reduced angiographic in-stent restenosis compared to placebo (16% vs 33%; OR 0.38; 95% CI 0.18-0.79; p=0.007) in diabetic patients after PCI with a bare-metal stent.