title: Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease.
abstract: OBJECTIVE
  This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease.
  
  
  BACKGROUND
  The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease.
  
  
  METHODS
  The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively.
  
  
  RESULTS
  In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries.
  
  
  CONCLUSIONS
  There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).
authors.affiliation: Division of Cardiothoracic Surgery, Baylor Healthcare System, The Heart Hospital, Plano, Texas 75075, USA. michaema@baylorhealth.edu
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Head
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Ståhle
authors.forename: Ted E
authors.initials: TE
authors.lastname: Feldman
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Felix
authors.initials: F
authors.lastname: Unger
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.forename: Robert
authors.initials: R
authors.lastname: Stoler
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Friedrich W
authors.initials: FW
authors.lastname: Mohr
authors.forename: A Pieter
authors.initials: AP
authors.lastname: Kappetein
mesh_terms: D000368:Aged; D016009:Chi-Square Distribution; D001026:Coronary Artery Bypass / Q000009:adverse effects* / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000401:mortality; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology* / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology