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. 2019 Sep 23;2019(9):CD013435. doi: 10.1002/14651858.CD013435

Evrard 2000.

Methods RCT, parallel design
Participants Total number of randomized participants: 206
Inclusion criteria: undergone CABG without cardiac concomitant procedures
Exclusion criteria: left ventricular ejection fraction < 35%, history of obstructive lung disease, known intolerance to beta‐blockers, history of recurrent or persistent SVT, ventricular tachycardia or fibrillation, postoperative aortic balloon pumping, renal failure, digoxin or other anti‐arrhythmic agents between surgery and randomization
Type of surgery: elective CABG
Baseline characteristics
Intervention group (sotalol)
  • Age, mean (SD): 61 (± 9) years

  • Gender, M/F: 92/11

  • History of MI, %: 38

  • Left ventricular ejection fraction, mean (SD), %: 61 (± 13)

  • Preoperative use of beta‐blockers, %: 67


Control group (standard care)
  • Age, mean (SD): 61 (± 9) years

  • Gender, M/F: 92/11

  • History of MI, %: 40

  • Left ventricular ejection fraction, mean (SD), %: 60 (± 12)

  • Preoperative use of beta‐blockers, %: 68


Country: Belgium
Setting: single centre; hospital
Interventions Intervention group (sotalol)
  • Randomized, n = 103; losses = 0; analysed, n = 103 (use of ITT analysis not reported)

  • Details: started at noon on 1st postoperative day, 80 mg sotalol. Then at 10 pm, twice a day. Discontinuation time point not specified


Control group (standard care)
  • Randomized, n = 103; losses = 0; analysed, n = 103

  • Details: standard care, no beta‐blocker treatment given

Outcomes Outcomes measured/reported by study authors: supraventricular and ventricular arrhythmias (to include 'runs of ventricular tachycardia'), length of hospital stay, mortality; MI; adverse events leading to discontinuation of treatment (to include asthma, mild heart failure, bradycardia, reduction in cardiac index, sinus tachycardia, moderate hypertension, ventricular extrasystoles)
Outcomes relevant to the review: AF; length of hospital stay (see notes below), mortality; MI
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • we did not include outcome data in analysis for bradycardia because we could not be certain whether data were measured in each group; study authors reported 1 participant had bradycardia in the intervention group

  • we did not include outcome data in analysis for length of hospital stay because data were not sufficiently reported. Study reported an 'average hospital stay' of 10 days in each group

  • we did not include 'runs of ventricular tachycardia' in analysis of ventricular arrhythmias because these were not sustained

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Blocked randomization in a prospective open manner"
Allocation concealment (selection bias) High risk Blocked randomization in an unblinded trial
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label trial
Blinding of outcome assessors (detection bias) 
 All outcomes High risk Open‐label trial
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent losses
Selective reporting (reporting bias) Unclear risk Study authors did not report prospective clinical trial registration or publication of a protocol. It was not feasible to effectively assess risk of reporting bias
Other bias High risk Quote: "In patients with sustained SVT, trial medication was stopped and patients were treated according to the physician in charge by amiodarone or digitalization, or both, beta‐blockers, sotalol, or an increased dose of sotalol"
Comment: in the control group, 15 participants were treated with beta‐blockers as rescue therapy for different reasons. This could influence outcome data