title: Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI.
abstract: BACKGROUND
  A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy.
  
  
  OBJECTIVE
  The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI.
  
  
  METHODS
  This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients.
  
  
  CONCLUSIONS
  The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: sanjit.jolly@phri.ca.
authors.forename: Sanjit S
authors.initials: SS
authors.lastname: Jolly
authors.affiliation: University of British Columbia, Vancouver, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Cairns
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Brandi
authors.initials: B
authors.lastname: Meeks
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Olga
authors.initials: O
authors.lastname: Shestakovska
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.affiliation: Tampere Heart Center and University Hospital, Tampere, Finland.
authors.forename: Kari
authors.initials: K
authors.lastname: Niemelä
authors.affiliation: Université Paris-Diderot, Paris, France.
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Quebec Heart-Lung Institute, Laval University, Quebec, Canada.
authors.forename: Olivier F
authors.initials: OF
authors.lastname: Bertrand
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, NC.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.
authors.forename: Alvaro
authors.initials: A
authors.lastname: Avezum
authors.affiliation: Southlake Regional Health Centre, University of Toronto, Newmarket, Canada.
authors.forename: Warren J
authors.initials: WJ
authors.lastname: Cantor
authors.affiliation: The Commonwealth Medical College, Scranton, PA.
authors.forename: Samir B
authors.initials: SB
authors.lastname: Pancholy
authors.affiliation: Hospital La Paz, Madrid, Spain.
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.affiliation: National Institute for Health Research, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, University Hospitals of Leicester, Glenfield Hospital, Leicester, United Kingdom.
authors.forename: Anthony
authors.initials: A
authors.lastname: Gershlick
authors.affiliation: Royal North Shore and North Shore Private Hospitals, Sydney, Australia.
authors.forename: Ravinay
authors.initials: R
authors.lastname: Bhindi
authors.affiliation: University of Alberta, Edmonton, Canada.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Welsh
authors.affiliation: St Michael's Hospital, University of Toronto, Toronto, Canada.
authors.forename: Asim N
authors.initials: AN
authors.lastname: Cheema
authors.affiliation: London Health Sciences Centre, Western University, London, Canada.
authors.forename: Shahar
authors.initials: S
authors.lastname: Lavi
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Rokoss
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Canada.
authors.forename: Vladimír
authors.initials: V
authors.lastname: Džavík
mesh_terms: D003131:Combined Modality Therapy; D006801:Humans; D008833:Microcirculation; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D013396:Suction / Q000379:methods; D017131:Thrombectomy / Q000379:methods*; D016896:Treatment Outcome