J-RHYTHM
Trial question
What is the role of rhythm control in patients with paroxysmal AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 823
823 patients (253 female, 570 male).
Inclusion criteria: patients with paroxysmal AF.
Key exclusion criteria: initial AF episodes; contraindication for anticoagulation; AF occurring during the acute phase of MI or cardiac surgery.
Interventions
N=419 rhythm control (antiarrhythmic drugs selected according to the Japanese Guideline for AF Management).
N=404 rate control (control of HR by β-blockers, calcium-channel blockers, and digitalis).
Primary outcome
Composite of death, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for heart failure, or physical/psychological disability requiring alteration of treatment strategy
15.3%
22%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Rhythm
control
Rate
control
Significant
decrease ▼
NNT = 14
Significant decrease in death, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for HF, or physical/psychological disability requiring alteration of treatment strategy (15.3% vs. 22%; RR 0.7, 95% CI 0.15 to 1.25).
Conclusion
In patients with paroxysmal AF, rhythm control was superior to rate control with respect to the composite of death, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for HF, or physical/psychological disability requiring alteration of treatment strategy.
Reference
Satoshi Ogawa, Takeshi Yamashita, Tsutomu Yamazaki et al. Optimal treatment strategy for patients with paroxysmal atrial fibrillation: J-RHYTHM Study. Circ J. 2009 Feb;73(2):242-8.
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