Colchicine May Reduce One-Year Postablation AF Recurrence

Marlene Busko

February 13, 2014

ATHENS, GREECE — Among patients with paroxysmal atrial fibrillation (AF) who had a single ablation, those who then received a short course of colchicine were less likely to have AF recurrence and more likely to have higher quality of life a year later, researchers report[1].

This study, a planned extension of a three-month trial published earlier, reported by heartwire , was published online Feb 12, 2014, in Heart Rhythm.

The mid-term results from the current study were "impressive," senior author Dr Michael W Cleman (Yale University School of Medicine, New Haven, CT) told heartwire , noting that only six patients needed to be treated to avoid one AF recurrence.

The generic drug colchicine—which has been used "a gazillion years," is approved for gout and familial Mediterranean fever, and has been studied for resistant pericarditis—"seems to be a rather simple and powerful approach to reducing subsequent effects" in people with paroxysmal AF, he continued.

The study showed that colchicine "is a durable, long-lasting, preventive measure associated with isolated pulmonary vein ablation," he said. "What's really incredible is it's a really cheap addition to a very expensive procedure."

"Early Recurrence" vs "AF Recurrence"

According to current consensus, the first three months after ablation is considered a "blanking" period—that is, any AF or atrial flutter during this time is considered "early recurrence" and is not considered as part of "AF recurrence." The researchers hypothesized that colchicine might help reduce inflammation after ablation and thus decrease AF recurrence, Cleman explained.

In fact, the earlier study did demonstrate "proof of principle." There was a significant reduction in the incidence of early AF recurrence and smaller increases in the proinflammatory biomarkers C-reactive protein (CRP) and interleukin-6 (IL-6) in patients who had received colchicine compared with those who received placebo after ablation for AF.

The primary outcome in the current study was efficacy at 12 months after the blanking period. The secondary outcome was change in scores for physical and psychological health in the World Health Organization Quality of Life scale at three and 12 months compared with baseline.

What's really incredible is it's a really cheap addition to a very expensive procedure.

The researchers analyzed data from 206 patients with paroxysmal AF who were seen in three centers in Europe and randomized to undergo pulmonary vein isolation followed by 0.5-mg colchicine twice daily for three months or placebo.

The patients were younger than 80 (with a mean age of 62.2), and 70% were men. They had no severe liver or kidney disease, since about 80% of the drug is metabolized in the liver and about 20% is excreted in the urine, Cleman said. Each patient had an average of 13.8 Holter recordings.

After a median of 15 months, 32 of 103 patients (31.1%) in the colchicine group vs 51 of 103 patients (49.5%) in the control group had AF recurrence (p=0.01), a 37% reduction in relative risk. These significant differences were seen even when the blanking period was not excluded. Most recurrences occurred within the first six months after ablation.

CRP and IL-6 levels were strongly associated with subsequent recurrences.

Diarrhea and nausea were the most frequently reported adverse events. Diarrhea was reported in 10 of 103 patients (9.7%) in the treatment group vs two of 103 patients (1.9%) in the control group. However, only five cases in the colchicine group and one case in the control group lasted more than one week. Nausea was reported by six patients taking colchicine (5.8%) vs three patients taking placebo (2.9%).

Physical- and psychological-health quality-of-life scores increased in both groups, but the improvements were greater in the patients who had received colchicine.

Potent, Safe, but Further Study Needed

"On the whole, [colchicine] has a potent anti-inflammatory effect, and, even more important, it is probably the only medication with anti-inflammatory action that can be used safely for a relatively long period of time in patients with cardiovascular disease, given the well-known and feared cardiovascular adverse effects of other anti-inflammatory classes, including corticosteroids and nonsteroidal anti-inflammatory drugs," the researchers write.

Before this use of colchicine might become part of clinical practice, funding is needed to conduct further studies to determine the optimal dose and length of treatmemt and to conduct a large-scale clinical trial that could lead to regulatory approval, Cleman said.


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