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January 1, 2009Circulation Journal209 citationsOpen Access

Optimal Treatment Strategy for Patients With Paroxysmal Atrial Fibrillation J-RHYTHM Study

SOSatoshi OgawaTYTakeshi YamashitaTYTsutomu Yamazaki

Key Result

Rhythm control significantly reduced the primary composite endpoint compared to rate control in patients with paroxysmal atrial fibrillation (15.3% vs 22.0%, P=0.0128).

Study Design

Type

RCT (n=823)

Multicenter

Yes

Structured PICO

Does a rhythm control strategy reduce the composite of mortality, cardiovascular morbidity, and treatment crossover due to disability compared to a rate control strategy in patients with paroxysmal atrial fibrillation?

P
Population
823 Japanese patients with paroxysmal atrial fibrillation (PAF) expected to convert spontaneously to sinus rhythm within 48 hours, mean age 64.7, 69.3% male. Key exclusions: initial AF episodes, contraindication for anticoagulation, and AF occurring during the acute phase of myocardial infarction or cardiac surgery.
I
Intervention
Rhythm control strategy using antiarrhythmic drugs (predominantly class I drugs such as pilsicainide, cibenzoline, propafenone) selected according to Japanese guidelines, plus oral antithrombotic therapy (warfarin) based on stroke risk factors.
C
Comparator
Rate control strategy using beta-blockers, calcium-channel blockers, and digitalis, plus oral antithrombotic therapy (warfarin) based on stroke risk factors.
O
Outcome
Composite of total mortality, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for heart failure requiring intravenous administration of diuretics, and physical/psychological disability requiring alteration of the assigned treatment strategy.composite

In patients with paroxysmal atrial fibrillation, a rhythm control strategy reduced the primary composite endpoint compared to rate control, driven entirely by a reduction in physical/psychological disability requiring treatment crossover, with no difference in hard cardiovascular outcomes.

Main Result

Absolute Event Rate: 15.3% vs 22%

p-value: p=0.0128

Limitations

  • Therapeutic strategies were not blinded to physicians and patients, which could lead to biases in the occurrence of endpoints
  • Transtelephonic monitoring could not be used to evaluate drug effects on PAF
  • Most patients in the present study had no structural heart disease

Abstract

Background Although previous clinical trials demonstrated the non-inferiority of a rate control to rhythm control strategy for management of atrial fibrillation (AF), the optimal treatment strategy for paroxysmal AF (PAF) remains unclear. Methods and Results A randomized, multicenter comparison of rate control vs rhythm control in Japanese patients with PAF (the Japanese Rhythm Management Trial for Atrial Fibrillation (J-RHYTHM) study) was conducted. The primary endpoint was a composite of total mortality, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for heart failure, or physical/psychological disability requiring alteration of treatment strategy. In the study, 823 patients with PAF were followed for a mean period of 578 days. The primary endpoint occurred in 64 patients (15.3%) assigned to rhythm control and in 89 patients (22.0%) to rate control (P=0.0128). No significant differences between the treatment strategies were observed in the incidences of death, stroke, bleeding and heart failure. Meanwhile, significantly fewer patients requested changes of assigned treatment strategy in the rhythm control vs the rate control group, which was accompanied by improvement in AF-specific quality of life scores. Conclusion The J-RHYTHM study showed that rhythm control was associated with fewer primary endpoints than rate control. However, mortality and cardiovascular morbidity were not affected by the treatment strategy (umin-CTR No. C000000106).

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Cite This Study

Ogawa et al. (2009) conducted an RCT in Paroxysmal atrial fibrillation (n=823). Rhythm control vs. Rate control was evaluated on Composite of total mortality, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for heart failure, or physical/psychological disability requiring alteration of treatment strategy (p=0.0128). Rhythm control significantly reduced the primary composite endpoint compared to rate control in patients with paroxysmal atrial fibrillation (15.3% vs 22.0%, P=0.0128).

synapsesocial.com/papers/6a15933979ff98d0de4ed5cbhttps://doi.org/10.1253/circj.cj-08-0608
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