Randomised controlled trial

Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial

LancetPublished

  • Randomised controlled trial
  • prospective
  • open-label
  • non-inferiority
  • multicentre (29 hospitals)

Authors' conclusion

In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation.

Study context

Population
Patients aged 18–85 years with STEMI or NSTE-ACS and multivessel CAD with a clearly identifiable culprit lesion, Belgium, Italy, the Netherlands and SpainITT population
Participants
764 vs 761
Comparison
Immediate vs staged complete revascularisation
  • Immediaten = 764
  • Stagedn = 761reference
Primary endpoint
Composite of:
  • All-cause mortality
  • MI
  • Any unplanned ischaemia-driven revascularisation
  • Cerebrovascular events
Follow-up
1 year after the index procedure

Primary result

As reported in the abstract

1 year

Hazard ratio

0.78

95% CI 0.55–1.11

P = 0.0011 for non-inferiority

Events by treatment group

Immediate vs Staged
HR 0.78 (95% CI 0.55–1.11); P for non-inferiority = 0.0011

Secondary outcomes

OutcomeImmediateStagedHR (95% CI)P value
All-cause death · 1 year1.9%1.2%1.56 (0.68–3.61)P = 0.30
MI · 1 year1.9%4.5%0.41 (0.22–0.76)P = 0.0045
Unplanned ischaemia-driven revascularisation · 1 year4.2%6.7%0.61 (0.39–0.95)P = 0.030

Original publication

Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial. Lancet. Published 5 March 2023. doi:10.1016/s0140-6736(23)00351-3

Summarised from the published abstract; every number is checked against it