Serruys 2000.

Methods	RCT, parallel design
Participants	Total number of randomized participants: 406 Inclusion criteria: stable or unstable angina pectoris who were scheduled to undergo elective directional coronary atherectomy of a single native primary coronary stenosis Exclusion criteria: contraindications to carvedilol (bradycardia < 50 bpm, 2nd‐ or 3rd‐degree atrioventricular block, obstructive airway disease, insulin‐dependent diabetes): contraindications to a discontinuation of existing beta‐blocker therapy; ineligibility for directional coronary atherectomy. Concomittant treatment with beta‐blockers, alpha‐blockers, anti‐arrhythmics, antioxidants, antiproliferative agents, drugs that influence the pharmacodynamics or kinetics of carvedilol, or anticoagulants was not allowed during the trial Type of surgery: elective directional coronary atherectomy Baseline characteristics (reported for 324 participants) Intervention group (carvedilol) Age, mean (SD): 57.9 (± 10.0) years Gender, M/F: 147/22 History of MI, %: 49.7 History of hypertension, %: 29.6 Preoperative use of beta‐blockers, %: 62.1 Control group (placebo) Age, mean (SD): 58.6 (± 9.7) years Gender, M/F: 137/18 History of MI, %: 36.1 History of hypertension, %: 27.7 Preoperative use of beta‐blockers, %: 62.6 Countries: Austria; Belgium; France; Germany; Netherlands; Portugal; Spain; Sweden Setting: hospitals; multicentre
Interventions	Intervention group (carvedilol) Randomized, n = 206; losses, n = 37 (withdrawn before intervention, MACE before intervention attempt, no intervention attempt, surgical techniques used other than planned intervention, failed attempt, complications during procedure); analysed, n = 169 Details: 25 mg carvedilol twice a day, starting at least 24 h before surgery and continued for 5 months Control group (placebo) Randomized, n = 200; losses, n = 45 (reasons same as the intervention group); analysed, n = 155 Details: placebo given, same as the intervention groups
Outcomes	Outcomes measured/reported by study authors: success of surgery; major adverse events (mortality, MI, need for CABG, repeat procedure. Measured at 7 months postoperatively); adverse events (bradycardia; hypotension ‐ not defined). Study follow‐up at 1, 5, 6, and 7 months Outcomes relevant to the review: mortality; MI; hypotension; bradycardia
Notes	Funding/declarations of interest: educational grant from Boehringer Mannheim, Germany Study dates: December 1994‐February 1997
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	Low risk	Described as double‐blinded study; we assumed that clinicians were not aware of group allocation
Blinding of outcome assessors (detection bias) All outcomes	Unclear risk	Not specified
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss of 20% participants. Reasons for losses were not reported by group, and it was not feasible to assess whether the reasons were balanced between groups
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