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the raaft-2 trial was a multicentre randomised clinical trial that was sponsored and co - ordinated by the population health research institute at mcmaster university and an unrestricted research grant from biosense webster .
it randomised 127 drug- & ablation - naive patients aged 1875 with paf to either first line catheter ablation ( n  =  66 ) , or medical therapy ( n  =  61 ) .
subjects were randomised in a 1:1 ratio to either treatment if they were symptomatic with recurrent paf , and had   4 episodes within the previous 6 months , one of which had to be documented by surface electrocardiography ( ecg ) .
all patients had normal systolic function and no history of heart failure or hypertension . at baseline
there were two significant differences between the study group characteristics ; previous electrical cardioversion ( 33.3% rfa group vs 52.5% aam group , p  =  0.03 ) and use of oral anticoagulation ( 53% rfa group vs 31.1% aam , p  =  0.01 ) .
after randomisation patients entered a 90-day blanking period during which medications were titrated or ablation was performed .
patients were followed up at 1 , 3 , 6 , 12 and 24 months .
the study also utilised transtelephonic monitoring ( ttm ) to assess the cardiac rhythm of patients biweekly and whenever subjects experienced symptoms of possible af .
patients randomised to the aam group had their medications selected according to investigator discretion , with doses being based on guidelines . 
 
patients in this group were able to undergo rfa after the 90-day treatment period if aam had failed .
this was demonstrated by either drug discontinuation due to intolerance , adverse events or inefficacy ( recurrence of paf or atrial tachyarrhythmia lasting > 30 seconds ) .
the primary efficacy outcome was time to first recurrence of symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds , as documented by ecg or ttm .
secondary outcomes included first documented recurrence of af - related atrial arrhythmia , repeated episodes of af - related atrial arrhythmia , and quality of life at the 1-year follow - up .
the study was powered to test the superiority of rfa over aad using cox regression analysis , stratified by clinical site .
the primary safety outcome was defined as the comparison of the proportion of patients with an occurrence of a cluster of serious complications in the rfa or aam arms .
primary outcome analysis demonstrated significantly lower recurrence of atrial tachyarrhythmia in the ablation group ( 54.5% ) than in the medically treated group ( 72.1% ) in the 2 years of follow - up ( hr , 0.56 ; 95% ci 0.35 - 0.90 , p  =  0.02 ) .
recurrence of symptomatic atrial tachyarrhythmia was also lower in the ablation group ( 40.9% vs. 57.4% ; hr 0.52 95% ci 0.300.89
quality of life , as assessed by the eq5d score , was significantly improved at 12 months in the rfa group ( p  =  0.03 ) but not in the aam group ( p  =  0.22 ) , although there was no statistically significant difference between the groups at 12 months ( p  =  0.25 ) .
flecainide was prescribed to 69% of patients at a mean dose of 175.8  mg / d and and 25% received propafenone at a mean dose of 487.7  mg / d . more than one type of drug was received by 16.4% of patients during the 90-day blanking period .
fifty - nine per cent of the aam group had to discontinue at least one aam , and 47.5% of patients underwent rfa during the 2-year follow up period . in the ablation group , complete pulmonary vein isolation ( pvi ; defined as entrance block ) was achieved in 87% of the cases .
in addition to pvi , sets of ablation in other regions of the left atrium were performed in at least 21.3% . during the 2-year follow up period
adverse events occurred in 9% of those in the rfa group ; 6% experiencing pericardial effusion with tamponade .
the results in the raaft-2 trial add to an increasing body of evidence showing potential benefits of ablation therapy as a primary treatment for paroxysmal atrial fibrillation in certain patients . 

 
the study demonstrated a significantly decreased rate of recurrent atrial tachyarrhythmias in patients treated with radiofrequency ablation .
however , the complication rate was unexpectedly high in the rfa group , given that the operators in the trial were highly skilled and the patient population was relatively healthy .
furthermore , although all patients were reported to have paf , a large proportion ( more than 21% ) of patients underwent sets of ablation beyond pulmonary vein isolation ; such ablation - sets are likely to have played a role , at least in part , in development of recurrent atrial tachyarrhythmias , and thereby potentially diluted the results of outcomes following ablation therapy .
the study 's strengths include the frequent assessments by ttm and the multi - institutional , international patient cohort .
limitations include the small sample size and its bias towards young , healthy patients . the baseline characteristics of the study groups were not identical ; there was a statistically significantly increased rate of electrical cardioversions in the aam group .
when removing ttm , the significance of ablation over aam disappeared , highlighting the importance of frequent ecg monitoring .
the authors highlighted the difficulty in estimating the burden of af , even with ttm .
studies such as raaft-2 remain limited without the use of implantable cardiac monitors to identify the incidence of asymptomatic af more accurately . 
 . in conclusion , according to this study , rfa appears to be modestly superior to aam , reducing recurrence of symptomatic and asymptomatic atrial tachyarrhythmia in patients with paf ; ablation therapy does however carry risks and patients require careful counselling before embarking on ablation as first - line therapy for paf .
radiofrequency ablation ( rfa ) for the treatment of paroxysmal atrial fibrillation ( paf ) has a class 1 indication in patients who have not tolerated or responded to antiarrhythmic medications . 
 antiarrhythmic medications ( aam ) are , however , limited not only by modest efficacy , but also by significant side effects . 
 discontinuation rates for aam range from 11 - 40% in trials . 
 the raaft-2 trial evaluates the use of rfa as a first line treatment for paf compared to optimal pharmacological management ( 1 ) .