Phase 4
N=54
Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter
Heart Rate and Rhythm Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01914926 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Percent of Patients Reaching Target HR<100bpm Within 30 Minutes — 46.4; 95.8 percentage of participants — p=.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metoprolol (Drug); Diltiazem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Antonios Likourezos
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Reaching Target HR<100bpm Within 30 Minutes |
46.4; 95.8 | .0001 sig |
Summary
Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia encountered in the emergency department (ED) and the most common dysrhythmia treated by emergency physicians. Atrial flutter is less common than atrial fibrillation but its management in the ED is very similar, and the majority of patients with atrial flutter also have atrial fibrillation. Symptomatic relief and ventricular rate control are generally the primary therapeutic objectives in the ED management of acute atrial fibrillation and flutter (AFF). The need for swift, appropriate action by the emergency physician is highlighted by the fact that up to 18% of patients with AFF develop potentially life-threatening complications such as congestive heart failure, hypotension, ventricular ectopy, respiratory failure, angina and myocardial infarction.
Both beta-blocking agents and calcium channel blockers are commonly used to treat AFF in the ED. Metoprolol is the most commonly used beta-blocker; and diltiazem is the most frequently used calcium channel antagonist.[8] Diltiazem was released by the FDA for treatment of AFF in 1992. Shreck et al. were the first to demonstrate both the efficacy of diltiazem in the ED management of AFF with rapid rate and its clear superiority over the previously most commonly used pharmacologic agent, digoxin.
To date, only one prospective, randomized trial has compared the effectiveness of a calcium channel blocker (diltiazem) with a beta-blocker (metoprolol) for rate control of AFF in the ED. Despite the relatively small sample size (n=20 in each group) the authors concluded that both pharmacologic agents were similarly effective. In order to test this finding, the investigators conducted a prospective comparison of metoprolol and diltiazem for the management of patients presenting to the ED with AFF with rapid ventricular rate.
Eligibility Criteria
Inclusion Criteria
Eligible patients had to have a 12-lead electrocardiogram (ECG) showing atrial fibrillation or atrial flutter with a ventricular rate of greater than or equal to 120 beats per minute and a systolic blood pressure of greater than or equal to 90 mmHg.
Exclusion Criteria
Patients were excluded if they had any of the following:
- a systolic blood pressure 0.100 seconds, 2nd or 3rd degree atrioventricular (AV) block,
- temperature >38.0 ˚C,
- acute ST elevation myocardial infarction,
- known history of New York Heart Association Class IV heart failure or
- active wheezing with a history of bronchial asthma or COPD.
In addition, patients were excluded if there was:
- prehospital administration of diltiazem or any other AV nodal blockading agent,
- a history of cocaine or methamphetamine use in the previous 24 hours prior to arrival,
- a history of allergic reaction to diltiazem or metoprolol,
- a history of sick sinus or pre-excitation syndromes,
- a history of anemia with hemoglobin <11.0 g/dl,
- pregnancy or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT01914926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.