title: Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction.
abstract: OBJECTIVE
  TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction, showed no difference in the primary efficacy outcome but a significant increase in stroke. We sought to understand these findings.
  
  
  RESULTS
  A detailed analysis of stroke timing, stroke severity, and stroke subtype was performed. Strokes were adjudicated by neurologists blinded to treatment assignment. Stroke within 30 days, the primary safety outcome, was increased [33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.13-3.75]. The difference in stroke was apparent within 48 h [15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09-8.25]. There was an increase in strokes within 180 days with minor or no disability (Rankin 0-2) [18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI 0.68-2.82] and in strokes with major disability or fatal (Rankin 3-6) [35 (0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42-5.08]. Most of the absolute difference was due to an increase in ischaemic strokes within 180 days [37 (0.7%) vs. 21 (0.4%), HR 1.71; 95% CI 1.03-3.00], but there was also an increase in haemorrhagic strokes [10 (0.2%) vs. 2 (0.04%), HR 4.98; 95% CI 1.09-22.7]. Patients that had a stroke had a mortality of 30.8% within 180 days vs. 3.4% without a stroke (P < 0.001). A meta-analysis of randomized trials (N = 21 173) showed an increase in risk of stroke (odds ratio 1.59; 95% CI 1.11-2.27) but a trend towards reduction in mortality odds ratio (odds ratio 0.87; 95% CI 0.76-1.00).
  
  
  CONCLUSIONS
  Thrombectomy was associated with a significant increase in stroke. Based on these findings, future trials must carefully collect stroke to determine safety in addition to efficacy.
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada sanjit.jollly@phri.ca.
authors.forename: Sanjit S
authors.initials: SS
authors.lastname: Jolly
authors.affiliation: Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
authors.forename: John A
authors.initials: JA
authors.lastname: Cairns
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Brandi
authors.initials: B
authors.lastname: Meeks
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Peggy
authors.initials: P
authors.lastname: Gao
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hart
authors.affiliation: University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia.
authors.forename: Sasko
authors.initials: S
authors.lastname: Kedev
authors.affiliation: Clinical Center of Serbia, Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia.
authors.forename: Goran
authors.initials: G
authors.lastname: Stankovic
authors.affiliation: University Hospital La Paz, Madrid, Spain.
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.affiliation: Krajská Nemocnice Liberec, Liberec, Czech Republic.
authors.forename: David
authors.initials: D
authors.lastname: Horak
authors.affiliation: Rouge Valley Health System, Toronto, ON, Canada.
authors.forename: Saleem
authors.initials: S
authors.lastname: Kassam
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rokoss
authors.affiliation: CK Hui Heart Centre, Edmonton, AB, Canada.
authors.forename: Raymond C M
authors.initials: RC
authors.lastname: Leung
authors.affiliation: Central Manchester Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Magdi
authors.initials: M
authors.lastname: El-Omar
authors.affiliation: Heart Centre, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Hannu O
authors.initials: HO
authors.lastname: Romppanen
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Ashraf
authors.initials: A
authors.lastname: Alazzoni
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Aiman
authors.initials: A
authors.lastname: Alak
authors.affiliation: Division of Cardiology, Vancouver General Hospital/University of British Columbia, Vancouver, BC, Canada.
authors.forename: Anthony
authors.initials: A
authors.lastname: Fung
authors.affiliation: Patras University Hospital, Patras, Greece.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Alexopoulos
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: John D
authors.initials: JD
authors.lastname: Schwalm
authors.affiliation: The Population Health Research Institute, Hamilton Health Sciences, McMaster University, Rm. C3-118, DBCVSRI Building, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON, L8L 2X2, Canada.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Valettas
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Vladimír
authors.initials: V
authors.lastname: Džavík
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000401:mortality / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods* / Q000401:mortality; D011183:Postoperative Complications / Q000209:etiology*; D020521:Stroke / Q000209:etiology* / Q000401:mortality; D017131:Thrombectomy / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome
keywords: Meta-analysis; Randomized trial; STEMI; Stroke; Thrombectomy