Summary of RCTs and meta-analyses comparing catheter ablation of AF to medical therapy
| Study design | Study groups | n | Follow-up | AF freedom | Complications | Notes | |
|---|---|---|---|---|---|---|---|
| Oral 2006 12 | RCT comparing RFA with AAD for persistent AF | AAD
RFA | 69
77 | 12 months
12 months | 16%
66% | –
0% | 77% crossed over from AAD to RFA group. 3% in RFA group remained on AAD. |
| The A4 study,
Jais 2008 13 | RCT comparing RFA with AAD for paroxysmal AF (failed ≥1 AAD) | AAD
RFA | 59
53 | 12 months
12 months | 23%
89% | –
3% | 63% crossed over from AAD to RFA group. 9% in RFA were treated with AAD. |
| Calkins 2009 14 | Meta-analysis of studies performed 1990–2006 | AAD
RFA | 3481
3481 | 12 (1–48) months
14 (2–30) months | 52%
71% | –
5% | Efficacy for RFA is quoted for ≥1 procedure off AAD. |
| Wilber 2010 15 | RCT comparing RFA with AAD for paroxysmal AF (failed ≥1 AAD) | AAD
RFA | 61
106 | 9 months
9 months | 16%
66% | –
5% | – |
| Cappato 2010 10 | Real world international multi-centre survey | RFA | 16,309 | 10±8 months | 75% (paroxysmal AF)
65% (persistent AF) | 5% | – |
| Andrade 2011 16 | Systematic review of cryoballoon ablation for AF | Cryoballoon | 1308 | 12 months | 73% | 6%* | 93% patients had paroxysmal AF. 6% of patients had persistent PNP with 0.4% persisting beyond 1 year. |
| MANTRA-PAF, Nielsen 2012 17 | RCT comparing RFA with AAD for treatment naive paroxysmal AF | AAD
RFA | 148
146 | 24 months
24 months | 44%
53% | –
7% | 36% crossed over from AAD to RFA group. 9% in RFA remained on AAD after ablation. |
| STOP AF, Packer 2013 18 | RCT comparing cryoballoon ablation with AAD for paroxysmal AF (failed ≥1 AAD) | AAD
Cryoballoon | 82
163 | 12 months
12 months | 7%
70% | –
3%* | 78% patients had paroxysmal AF.
Persistent PNP occurred in 11% with 1.5% persisting beyond 1 year. |
| RAAFT-2, Morillo 2014 19 | RCT comparing RFA with AAD for treatment naive paroxysmal AF | AAD
RFA | 61
66 | 24 months
24 months | 52%
72% | –
9% | Significantly improved quality of life in RFA group compared with the AAD group. |
| SARA, Mont 2014 20 | RCT comparing RFA with AAD for persistent AF (<1 year duration) | AAD
RFA | 48
98 | 12 months
12 months | 44%
70% | –
6% | – |
AAD = antiarrhythmic drug; AF = atrial fibrillation; PNP-phrenic nerve palsy; RCT = randomised controlled trial; RFA = radiofrequency ablation. *procedure related complications excluding phrenic nerve palsy.