RACE 7 ACWAS

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Pluymaekers NAHA. "Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation". NEJM. 2019. 380(16):1499-1508.
PubMedClinicalTrials.gov

Clinical Question

In hemodynamically stable patients who present with new-onset atrial fibrillation within 36 hours, is delayed cardioversion at 48 hours non-inferior to early cardioversion for normal sinus rhythm at 4 weeks.

Bottom Line

Major Points

Guidelines

As of June 2018, no guidelines have been published that reflect the results of this trial.

Design

  • Multicenter, randomized, open-label, non-inferiority trial
  • N=427
    • Delayed-cardioversion (n=212)
    • Early-cardioversion (n=215)
  • Setting: Netherlands
  • Enrollment:
  • Mean follow-up:
  • Analysis: non-inferiority proven if the lower limit of the 95% CI difference in the primary outcome in percent was more than −10
  • Primary Outcome: Presence of normal sinus rhythm at 4 weeks

Population

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

BLANK Group displayed

  • Demographics:
  • Physiologic parameters:
  • Anthropomorphics: Weight
  • Labs:
  • Site of infection

Interventions

  • Delayed cardioverion
    • Rate control of heart rate <110 bpm with beta-blockers, non-dihydropyridine calcium channel blockers, or digoxin
    • Discharge with follow-up ~48h from onset
  • Early cardioversion: pharmacological (flecainide) unless contraindicated then electrical was secondary

Outcomes

Comparisons are BLANK therapy vs. BLANK therapy.

Primary Outcomes

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

  • Follow-up at 48 hours as an outpatient may be challenging in some settings

Funding

  • Netherlands Organization for Health Research and Development–Health Care Efficiency Research Program greatn 837002524
  • Maastricht University Medical Center
  • Boehringer Ingelheim provided some of the remote monitoring devices.

Further Reading

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