What is the clinical evidence from this study?

Study design: RCT. Population: restenosis after coronary angioplasty (n=197). Intervention: colchicine vs. placebo. Primary outcome: Restenosis in at least one lesion (p=NS).

What question did this study set out to answer?

This trial aimed to evaluate the effectiveness of colchicine in preventing restenosis following coronary angioplasty.

April 25, 2026

Ineffectiveness of colchicine for the prevention of restenosis after coronary angioplasty

Key Result

Colchicine was ineffective for preventing restenosis after coronary angioplasty, with 41% of treated patients developing restenosis compared to 45% in the placebo group (p = NS).

Key Points

This trial aimed to evaluate the effectiveness of colchicine in preventing restenosis following coronary angioplasty.
Prospective trial involving 197 patients randomized to colchicine or placebo for 6 months.
Patients received 0.6 mg colchicine twice daily starting 12 hours before until 24 hours after angioplasty.
Quantitative angiographic follow-up was conducted to assess lumen diameter changes.
Restenosis rates were 41% in colchicine-treated patients and 45% in placebo, p = NS.
Lumen diameter narrowing at 6 months was 46% for colchicine and 47% for placebo, p = NS.
A dropout rate of 6.9% was noted due to side effects in the colchicine group.

Study Design

Type

RCT (n=197)

Randomization

2:1

Structured PICO

Does oral colchicine prevent restenosis in patients undergoing elective coronary angioplasty?

Population

197 patients undergoing elective coronary angioplasty

Intervention

Oral colchicine 0.6 mg twice daily for 6 months, starting between 12 hours before and 24 hours after angioplasty

Comparator

Placebo for 6 months

Outcome

Restenosis (lumen diameter narrowing) at 6 months measured by quantitative angiographysurrogate

Oral colchicine is ineffective for preventing angiographic restenosis after elective coronary angioplasty.

Main Result

Absolute Event Rate: 41% vs 45%

p-value: p=NS

Abstract

Colchicine, an antimitogenic agent, has shown promise in preventing restenosis after coronary angioplasty in experimental animal models. A prospective trial was conducted involving 197 patients randomized in a 2:1 fashion to treatment with oral colchicine, 0.6 mg twice daily (130 patients), or placebo (67 patients) for 6 months after elective coronary angioplasty. Treatment in all patients began between 12 h before angioplasty and 24 h after angioplasty. Compliance monitoring revealed that 96% of all prescribed pills were ingested. Demographic characteristics were similar in colchicine- and placebo-treated groups. A mean of 2.7 lesions/patient were dilated. Side effects resulted in a 6.9% dropout rate in the colchicine-treated patients. Complete quantitative angiographic follow-up was obtained in 145 patients (74%) with 393 dilated lesions. Quantitative angiographic measurements were obtained in two orthogonal views at baseline before angioplasty and immediately and at 6 months after angioplasty. The quantitative mean lumen diameter stenosis before angioplasty was 67% both in the 152 lesions in the placebo-treated group and in the 241 lesions in the colchicine-treated group; this value was reduced to 24% immediately after angioplasty in the lesions in both treatment groups. At the 6-month angiogram, lesions had restenosed to 47% lumen diameter narrowing in the placebo-treated group compared with 46% in the colchicine-treated group (p = NS). Forty-one percent of colchicine-treated patients developed restenosis in at least one lesion compared with 45% of the placebo-treated group (p = NS). In conclusion, colchicine was ineffective for preventing restenosis after coronary angioplasty.