SHAM-PVI
Trial question
What is the role of pulmonary vein isolation in patients with symptomatic AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 126
126 patients (37 female, 89 male).
Inclusion criteria: patients with symptomatic paroxysmal or persistent AF.
Key exclusion criteria: long-standing persistent AF; prior left atrium ablation; other arrhythmias requiring ablative therapy; left atrium ≥ 5.5 cm; ejection fraction < 35%.
Interventions
N=64 ablation (pulmonary vein isolation with cryoablation).
N=62 sham procedure (with phrenic nerve pacing).
Primary outcome
Improvement in atrial fibrillation burden at 6 months
60.31%
35%
60.3 %
45.2 %
30.2 %
15.1 %
0.0 %
Ablation
Sham
procedure
Significant
increase ▲
NNT = 3
Significantly greater improvement in AF burden at 6 months (60.31% vs. 35%; AD 25.31%, 95% CI 10.29 to 40.33).
Secondary outcomes
Significantly greater improvement in mean AF Effect on QoL scores at 6 months (77.4 points vs. 58.3 points; MD 18.39, 95% CI 11.48 to 25.3).
Significantly lower reduction in mean Mayo AF-Specific Symptom Inventory-severity scores at 6 months (5.2 points vs. 10.2 points; MD -4.84, 95% CI -6.43 to -3.26).
Significantly greater improvement in 36-Item Short Form Health Survey-general health scores at 6 months (58.3 points vs. 47.2 points; MD 9.27, 95% CI 3.78 to 14.76).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with symptomatic paroxysmal or persistent AF, ablation was superior to sham procedure with respect to improvement in AF burden at 6 months.
Reference
Rajdip Dulai, Neil Sulke, Nick Freemantle et al. Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial. JAMA. 2024 Sep 2:e2417921. Online ahead of print.
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