Randomized Controlled Trial

. 2014 Mar;167(3):315-321.e1.

doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.

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

Sanjit S Jolly¹, John Cairns², Salim Yusuf³, Brandi Meeks³, Olga Shestakovska³, Lehana Thabane³, Kari Niemelä⁴, Philippe Gabriel Steg⁵, Olivier F Bertrand⁶, Sunil V Rao⁷, Alvaro Avezum⁸, Warren J Cantor⁹, Samir B Pancholy¹⁰, Raul Moreno¹¹, Anthony Gershlick¹², Ravinay Bhindi¹³, Robert C Welsh¹⁴, Asim N Cheema¹⁵, Shahar Lavi¹⁶, Michael Rokoss³, Vladimír Džavík¹⁷

Affiliations

¹ McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: sanjit.jolly@phri.ca.
² University of British Columbia, Vancouver, Canada.
³ McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
⁴ Tampere Heart Center and University Hospital, Tampere, Finland.
⁵ Université Paris-Diderot, Paris, France.
⁶ Quebec Heart-Lung Institute, Laval University, Quebec, Canada.
⁷ Duke Clinical Research Institute, Duke University, Durham, NC.
⁸ Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.
⁹ Southlake Regional Health Centre, University of Toronto, Newmarket, Canada.
¹⁰ The Commonwealth Medical College, Scranton, PA.
¹¹ Hospital La Paz, Madrid, Spain.
¹² National Institute for Health Research, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, University Hospitals of Leicester, Glenfield Hospital, Leicester, United Kingdom.
¹³ Royal North Shore and North Shore Private Hospitals, Sydney, Australia.
¹⁴ University of Alberta, Edmonton, Canada.
¹⁵ St Michael's Hospital, University of Toronto, Toronto, Canada.
¹⁶ London Health Sciences Centre, Western University, London, Canada.
¹⁷ Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Canada.

PMID: 24576514
DOI: 10.1016/j.ahj.2013.12.002

Free article

Randomized Controlled Trial

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

Sanjit S Jolly et al. Am Heart J. 2014 Mar.

Free article

. 2014 Mar;167(3):315-321.e1.

doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.

Authors

Affiliations

¹ McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: sanjit.jolly@phri.ca.
² University of British Columbia, Vancouver, Canada.
³ McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
⁴ Tampere Heart Center and University Hospital, Tampere, Finland.
⁵ Université Paris-Diderot, Paris, France.
⁶ Quebec Heart-Lung Institute, Laval University, Quebec, Canada.
⁷ Duke Clinical Research Institute, Duke University, Durham, NC.
⁸ Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.
⁹ Southlake Regional Health Centre, University of Toronto, Newmarket, Canada.
¹⁰ The Commonwealth Medical College, Scranton, PA.
¹¹ Hospital La Paz, Madrid, Spain.
¹² National Institute for Health Research, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, University Hospitals of Leicester, Glenfield Hospital, Leicester, United Kingdom.
¹³ Royal North Shore and North Shore Private Hospitals, Sydney, Australia.
¹⁴ University of Alberta, Edmonton, Canada.
¹⁵ St Michael's Hospital, University of Toronto, Toronto, Canada.
¹⁶ London Health Sciences Centre, Western University, London, Canada.
¹⁷ Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Canada.

PMID: 24576514
DOI: 10.1016/j.ahj.2013.12.002

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.

Design: 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.

Summary: The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.

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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

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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

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