ACC 2016: Two ablation techniques for atrial fibrillation show similar efficacy and safety

by Bruce Sylvester: For correction of atrial fibrillation, radiofrequency ablation and cryoballoon ablation show similar results for efficacy and safety, researchers reported on April 4, 2016 at the American College of Cardiology 2016 annual meeting.

“The FIRE AND ICE trial demonstrated that the cryoballoon, a newer, easier-to-use ablation catheter, worked as well as the established technology, which ultimately means that more patients can be treated for atrial fibrillation without having [to go to a] specialized cardiac center,” said lead investigator Karl-Heinz Kuck, M.D., Ph.D., head of cardiology at St. Georg Hospital in Hamburg, Germany. “In addition, there was, in general, a low risk of procedural complications in both groups, demonstrating that catheter ablation has become much safer over the years.”

As background, the authors noted that atrial even though medication and lifestyle adjustments can help  manage risk factors and symptoms associated with atrial fibrillation, about 30 percent of patients do not benefit from drug treatment medications or cannot tolerate side effects. Ablation is an option for these patients

In the multicenter, randomized trial, the primary efficacy end point was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the ablation procedure The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events.

The investigators enrolled and randomized 762 subjects, with 378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation. Mean follow-up was 1.5 years.

The primary efficacy endpoint occurred in 138 patients in the cryoballoon group and 143 in the radiofrequency group, which was statistically significant for the demonstration of the noninferiority of cryoballoom ablation (P<0.001 for noninferiority).

The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group, which was not a statistically significant difference (P=0.24).

The authors concluded, “In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety.”