Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation

Abstract

Aims Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). Methods and results A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). Conclusions Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.

Catheter Ablation vs. Anti-Arrhythmic Drugs as First-Line Treatment in Symptomatic Paroxysmal Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

“…The main characteristics of the included RCTs are reported in Table 1. Ablation energy was RF in RAAFT-1 (10), MANTRA-PAF (11), and RAAFT-2 (12) while cryoenergy in EARLY-AF ( 14), STOP-AF (15), and Cryo-FIRST (16). Further, details regarding study inclusion/exclusion criteria and study-specific endpoints may be found in the Supplementary Tables 1, 2.…”

“…Median left atrial antero-posterior diameter was 40 mm (IQR 38-41 mm). Mean CHADS 2 score in MANTRA-PAF (11) and RAAFT-2 (12) was 0.6, while mean CHA 2 DS 2 -VASc score was 1.9 in EARLY-AF ( 14); 66% and 86% of the patients in STOP-AF (15) and in Cryo-FIRST (16), respectively, had a CHA 2 DS 2 -VASc score ≤2; and 58% (IQR 51-60%) of the patients were on beta-blocker therapy at the time of randomization.…”

“…All patients underwent PV isolation (PVI). In two RF studies, additional ablation lesion was also allowed at the physician's discretion [MANTRA-PAF (11) and RAAFT-2 (12)], while in Cryo-FIRST study, additional freeze applications were allowed in case of incomplete PVI isolation or focal trigger identification (16). AAD use in AFCA arm was only allowed during post-procedural blanking period in most of the studies.…”

“…The threshold defining an arrhythmic recurrence varied between 15 s in RAAFT-1 (10) and 60 s in MANTRA-PAF (11), with the four remaining studies used a 30-s threshold (12,(14)(15)(16).…”

“…In the last decade, three randomized clinical trials (RCTs) evaluating radiofrequency (RF) ablation compared with AADs as first-line treatment in rhythm control-naïve patients (10)(11)(12) had demonstrated lower recurrence rate by ablation, at the price of transiently exposing the patient to the rare, but not negligible, risk of periprocedural complications (13). More recently, three RCTs comparing cryoballoon ablation and AADs as first-line rhythm control therapy have been published (14)(15)(16).…”