title: Adverse events following percutaneous and surgical coronary revascularisation: Analysis of non-MACE outcomes in the Stent or Surgery (SoS) Trial.
abstract: OBJECTIVE
  To analyse adverse events requiring or prolonging hospitalisation in the Stent or Surgery (SoS) trial.
  
  
  BACKGROUND
  Many adverse events following coronary revascularisation are non-major adverse cardiovascular events (non-MACE). Trials comparing percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) have reported rates of mortality and MACE only.
  
  
  METHODS
  Comparisons between PCI and CABG groups in the SOS trial were by intention to treat. For patients with non-fatal/non-MACE, number of events per 100 patient years follow-up and duration of hospital stay were assessed. Competing risk analysis was used to illustrate temporal pattern of adverse outcomes.
  
  
  RESULTS
  During 2 y median follow up, 1 one or more adverse event occurred in 47.3% (231) of the PCI group and 53% (265) of the CABG group (p=0.086). Non-fatal/non-MACE occurred in 11.9% of the PCI group and 38.6% of the CABG group (p<0.001). Non-fatal/non-MACE per 100 patient years follow-up was 17.49 (PCI) and 35.04 (CABG), rate ratio 2.0, 95% CI 1.7 to 2.4, p<0.001. Cumulative non-fatal/non-MACE associated hospital stays were 1387 and 3287 days in PCI and CABG groups respectively. Median duration of hospitalisation per non-fatal/non-MACE was 5 days (interquartile range 2 to 11.75 days) in the PCI group and 6 days (interquartile range 2 to 12 days) in the CABG group, p=0.245.
  
  
  CONCLUSIONS
  CABG had lower cumulative incidence of fatal or MACE outcomes, higher cumulative incidence of non-fatal/non-MACE outcomes, and longer cumulative hospitalisation periods compared to the PCI group.
authors.affiliation: University Hospitals of Leicester and Leicester NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester LE3 9QP, United Kingdom. Electronic address: elved.roberts@uhl-tr.nhs.uk.
authors.forename: Elved B
authors.initials: EB
authors.lastname: Roberts
authors.affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust, Thomas Drive, Liverpool L14 3PE, United Kingdom.
authors.forename: Raphael
authors.initials: R
authors.lastname: Perry
authors.affiliation: Clinical Trials and Evaluation Unit, Royal Brompton Hospital, Sydney Street, London SW3 6NP, United Kingdom.
authors.forename: Jean
authors.initials: J
authors.lastname: Booth
authors.affiliation: Cardiology Center, University Hospital of Geneva, 24 Rue Micheli du Crest, 1211 Geneva, Switzerland.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Sigwart
authors.affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust, Thomas Drive, Liverpool L14 3PE, United Kingdom.
authors.forename: Rod H
authors.initials: RH
authors.lastname: Stables
mesh_terms: D002423:Cause of Death / Q000639:trends; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery*; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D015994:Incidence; D007902:Length of Stay / Q000639:trends; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000379:methods; D011183:Postoperative Complications / Q000453:epidemiology*; D011379:Prognosis; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects*; D015996:Survival Rate / Q000639:trends; D013997:Time Factors
keywords: Adverse effects; Coronary artery bypass grafting; Percutaneous coronary intervention; Randomised controlled trial