Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension

doi:10.1001/jama.2019.21187

Arrhythmias & electrophysiologyRandomised controlled trial

Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension

JAMAPublished 21 Jan 2020

Randomised controlled trial
investigator-initiated
multicentre
single-blind
5 referral centres (Russian Federation, Poland, Germany)
No formal sham-control renal denervation procedure

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Authors' conclusion

Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months.

Study context

Population: Patients with paroxysmal AF and hypertension despite ≥1 antihypertensive medication, planned for ablation283 [93.7%] completed
Participants: 302 patients

Comparison: PVI plus renal denervation vs PVI alone
Isolation-onlyn = 148reference
Renal denervationn = 154
Primary endpoint: Freedom from AF, atrial flutter or atrial tachycardia
Follow-up: 12 months

Primary result

As reported in the abstract

Hazard ratio

0.57

95% CI 0.38–0.85

P = 0.006

Events by treatment group

PVI alone56.5%84 events

PVI plus renal denervation72.1%111 events

PVI plus renal denervation vs PVI alone

HR 0.57 (95% CI 0.38–0.85); P = 0.006

Secondary outcomes

Outcome	Isolation-only	Renal denervation	Lower with renal denervation ←→ Higher with renal denervation	between-group difference (mm Hg) (95% CI)	P value
Mean SBP, baseline to 12 months	mean 147 mm Hg	mean 135 mm Hg		−13 (−15 to −11)	P < 0.001
Baseline	151 mm Hg	150 mm Hg
			−20−10010Difference, mm Hg (linear scale)

Prespecified secondary end points

Of 5 prespecified secondary end points, 4 reported and 3 differed between groups

Safety

Procedural complications · within 30 days

Isolation-only4.7%

Renal denervation4.5%

Original publication

Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension. JAMA. Published 21 January 2020. doi:10.1001/jama.2019.21187

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Summarised from the published abstract; every number is checked against it