MEDICAL PROFESSIONALS

Therapy Outcomes

Randomized, controlled clinical studies demonstrate the benefits of catheter ablation over more traditional therapies

A long-standing concern of the medical community regarding catheter ablation is that no large randomized controlled trials (RCTs) have been performed that clearly demonstrate its benefits. This is now changing, with the results of several randomized clinical trials recently being published. In fact, a total of four randomized clinical studies have emerged, all of which indicate that in selected patients catheter ablation is favourable compared to current pharmacological therapies.

In the first RCT, 70 patients were randomized to either radiofrequency ablation or to antiarrhythmic drugs as first-line therapy for symptomatic Afib (ref. 21). After 1-year, 63% patients receiving AADs had at least 1 recurrence of symptomatic Afib compared to 13% in the ablation group. Hospitalization during 1-year follow-up occurred in 19 (54%) of 35 patients in the AAD group compared to 3 (9%) of 32 in the ablation group. At 6-months, the improvement in the quality of life of patients in the ablation group was significantly higher than that in the AAD group.

In a second RCT in drug-refractory Afib, patients were randomized to ablation and AAD therapy or to AAD therapy alone (ref. 22). After one year, 91% of patients treated with AADs alone had at least one recurrence of Afib, while 44% in the ablation and AAD group experienced recurrence of arrhythmia.

In another study, Oral and colleagues randomized 147 patients with chronic Afib to either pulmonary vein ablation (with amiodarone for 3 months and had sinus rhythm restored) or a control group that was not ablated. After one year, sinus rhythm was maintained in 74% of patients with chronic Afib in the ablation group (ref. 23).

Lastly, Pappone et al. have recently presented the early results of an RCT comparing circumferential pulmonary vein ablation to AADs in 198 patients (ref. 24). After nine months, 84% of the patients in the ablation group remained free of Afib, compared to only 24% of those treated with AADs.

Controlled, randomized trials involving catheter ablation

Figure: Month-by-month percentages of patients in SR in ablation and control groups (Oral 2006)