CABANA: Pilot study results encouraging for ablation therapy, leading to pivotal trial
Packer D. Presented at: 16th Annual Boston Atrial Fibrillation Symposium; Jan. 13-15, 2011; Boston.
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16th Annual Boston Atrial Fibrillation Symposium
Improvements in the prevention of recurrent symptomatic atrial fibrillation in ablation therapy when compared with drug therapy indicated by the CABANA pilot study have set the stage for a larger-scale trial that has already begun enrolling patients.
In his presentation, Douglas Packer, MD, professor of medicine at the Mayo Clinic in Rochester, Minn., president of the Heart Rhythm Society and a researcher on the study, said the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) pilot study was designed to examine patients with an underline risk for stroke or CAD and find out the freedom of recurrent AF in that population. “More importantly, we wanted to determine whether we could pull off a 3,000 patient study,” Packer said.
In the pilot study, 60 patients were examined who had paroxysmal (n=19), persistent (n=22) or long-standing persistent (n=19) AF. The patients (mean age, 61 ± 10 years) were treated with drug therapy (n=31) or ablation therapy (n=29) and followed for 12 months.
According to Packer, after a blanking period of 3 months, freedom from recurrence of symptomatic AF was significantly higher in the ablation arm (65% vs. 41%; HR=0.42; 95% CI, 0.19-0.95). Similar results were also reported regarding freedom from recurrence of any symptomatic AF, atrial flutter or atrial tachycardia (61% vs. 38%; HR=0.46; 95% CI, 0.21-0.99).
“We’re comfortable in saying that ablative intervention is more effective than drug therapy for preventing recurrent symptomatic AF,” Packer said. “The treatment success rates in this population, which include a significant percentage with persistent and long-standing persistent AF, were maybe a little bit lower than you would have expected and were actually good.”
Upcoming for CABANA, Packer said, is a full-scale clinical trial driven by the hypothesis that, for the purpose of eliminating AF, treatment strategy of percutaneous left atrial catheter ablation is superior to the current medical therapy with either rate control or rhythm control drugs for reducing mortality in patients with untreated or incompletely treated AF warranting therapy.
Currently, 164 sites have begun enrolling patients, 24 of which are outside North America. – by Brian Ellis
Disclosure: Dr. Packer has received financial support and or has been a consultant or on the advisory board for several companies, including Medtronic CryoCath LP, Boston Scientific, Sanofi-Aventis, Philips Healthcare and CardioFocus.
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