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. 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.
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.
RCT Entities:
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.
Authors: Ravinay Bhindi; Olli A Kajander; Sanjit S Jolly; Saleem Kassam; Shahar Lavi; Kari Niemelä; Anthony Fung; Asim N Cheema; Brandi Meeks; Dimitrios Alexopoulos; Viktor Kočka; Warren J Cantor; Timo P Kaivosoja; Olga Shestakovska; Peggy Gao; Goran Stankovic; Vladimír Džavík; Tej Sheth Journal: Eur Heart J Date: 2015-05-20 Impact factor: 29.983
Authors: Sanjit S Jolly; John A Cairns; Salim Yusuf; Michael J Rokoss; Peggy Gao; Brandi Meeks; Sasko Kedev; Goran Stankovic; Raul Moreno; Anthony Gershlick; Saqib Chowdhary; Shahar Lavi; Kari Niemela; Ivo Bernat; Warren J Cantor; Asim N Cheema; Philippe Gabriel Steg; Robert C Welsh; Tej Sheth; Olivier F Bertrand; Alvaro Avezum; Ravinay Bhindi; Madhu K Natarajan; David Horak; Raymond C M Leung; Saleem Kassam; Sunil V Rao; Magdi El-Omar; Shamir R Mehta; James L Velianou; Samir Pancholy; Vladimír Džavík Journal: Lancet Date: 2015-10-22 Impact factor: 79.321
Authors: Sanjit S Jolly; John A Cairns; Salim Yusuf; Brandi Meeks; Janice Pogue; Michael J Rokoss; Sasko Kedev; Lehana Thabane; Goran Stankovic; Raul Moreno; Anthony Gershlick; Saqib Chowdhary; Shahar Lavi; Kari Niemelä; Philippe Gabriel Steg; Ivo Bernat; Yawei Xu; Warren J Cantor; Christopher B Overgaard; Christoph K Naber; Asim N Cheema; Robert C Welsh; Olivier F Bertrand; Alvaro Avezum; Ravinay Bhindi; Samir Pancholy; Sunil V Rao; Madhu K Natarajan; Jurriën M ten Berg; Olga Shestakovska; Peggy Gao; Petr Widimsky; Vladimír Džavík Journal: N Engl J Med Date: 2015-03-16 Impact factor: 91.245
Authors: Diego Fernández-Rodríguez; Luis Alvarez-Contreras; Victoria Martín-Yuste; Salvatore Brugaletta; Ignacio Ferreira; Marta De Antonio; Montserrat Cardona; Vicens Martí; Juan García-Picart; Manel Sabaté Journal: World J Cardiol Date: 2014-09-26
Authors: Sanjit S Jolly; John A Cairns; Salim Yusuf; Brandi Meeks; Peggy Gao; Robert G Hart; Sasko Kedev; Goran Stankovic; Raul Moreno; David Horak; Saleem Kassam; Michael J Rokoss; Raymond C M Leung; Magdi El-Omar; Hannu O Romppanen; Ashraf Alazzoni; Aiman Alak; Anthony Fung; Dimitrios Alexopoulos; John D Schwalm; Nicholas Valettas; Vladimír Džavík Journal: Eur Heart J Date: 2015-06-29 Impact factor: 29.983