Skip to main content
. 2019 Sep 23;2019(9):CD013435. doi: 10.1002/14651858.CD013435

Nyström 1993.

Methods RCT, parallel design
Participants Total number of randomized participants: 101
Inclusion criteria: scheduled for CABG surgery because of severe angina pectoris
Exclusion criteria: repeat CABG surgery, if preoperative rhythm was not sinus, or if HR < 45 bpm, known intolerance to beta‐blocking agents, significant pulmonary disease or uncompensated heart failure
Type of surgery: elective CABG
Baseline characteristics
Intervention group (sotalol)
  • Age, mean (range): 59 (33‐75) years

  • Gender, M/F: 45/5

  • History of MI, mean (SD): 1 (± 1.3)

  • Ejection fraction, mean (SD): 0.6 (± 0.1)

  • Preoperative use of beta‐blockers, n: 42


Control group (standard care)
  • Age, mean (range): 60 (43‐71) years

  • Gender, M/F: 43/8

  • History of MI, mean (SD): 1 (± 0.9)

  • Ejection fraction, mean (SD): 0.6 (± 0.2)

  • Preoperative use of beta‐blockers, n: 40


Country: Sweden
Setting: single centre; hospital
Interventions Intervention group (sotalol)
  • Randomized, n = 50; losses = 0; analysed, n = 50 (use of ITT analysis not reported)

  • Details: 160 mg sotalol, orally, on morning of surgery, continued once participant was able to resume oral medication usually the morning of 1st postoperative day, then given 160 mg twice a day for 6 days


Control group
  • Randomized, n = 51; losses = 0; analysed, n = 51

  • Details: participants who were already on beta‐blocking treatment had dose of beta‐blocker changed to half dose immediately after operation

Outcomes Outcomes measured/reported by study authors: AF, HR, bradycardia (not defined), hypotension (not defined), mortality, ventricular arrhythmias
Outcomes relevant to the review: AF, mortality, ventricular arrhythmias, bradycardia and hypotension (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • 11 participants in the sotalol group needed a reduction in dose due to bradycardia, and 2 participants needed a reduction in dose also due to hypotension. We did not include these data in analysis because we could not be certain whether these outcomes were recorded for the control group

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Unclear risk Not specified
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 Low risk Not detected