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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Rastan 2005.

Study characteristics
Methods Randomised prospective study
Run‐in period: not specified
Received: 29 November 2004
Received in revised form: 27 February 2005
Accepted: 9 March 2005
Available online: 8 April 2005
Number of study centres and locations: single centre. Department of Cardiac Surgery, University of Leipzig, Heart Center Leipzig, Struempellstr. 39, 04289 Leipzig, Germany
Participants Forty participants were assigned to OPCAB or OnP‐BH surgery. One OPCAB participant crossed over to OnP‐BH.
Mean age: 64.15 years
Sex (female/male ratio): 20%
No high‐risk population
Inclusion criteria: elective, patients with normal EF and three‐vessel CAD (stenosis > 70%)
Exclusion criteria: patients > 75 years of age, combined cardiac procedures, cardiac reoperation, emergency surgery, left main stenosis > 70%, and EF < 50%
Interventions Intervention group: OPCAB surgery
Control group: on‐pump beating heart surgery
Outcomes Intraoperative myocardial ischaemia (pH, lactate, pO2) and oxidative stress (MDA) (CS blood) and myocardial necrosis (CK‐MB, cTnI), myocardial dysfunction (NT‐proBNP), and inflammation (CRP) (arterial blood) and clinical data
Arterial blood was analysed 4 hours, 12 hours, and 24 hours postoperatively.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear method of randomisation used. Authors state "Randomisation was performed by chance the day prior to surgery using randomisation envelops [sic]". Preoperative patient characteristics were similar in both groups.
Allocation concealment (selection bias) Unclear risk No clear method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No mention of blinding of participants and postoperative care. Because of the nature of the intervention, surgical team could not be blinded.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias)
All outcomes Unclear risk One OPCAB patient crossed over to OnP‐BH, and no further or unexpected events or conversions occurred. Two patients with evidence of perioperative MI required surgical re‐intervention and were excluded from the laboratory data analyses.
Selective reporting (reporting bias) Unclear risk All expected outcomes were reported properly.
Other bias Low risk No funding was disclosed.