• American heart journal · Mar 2014

    Randomized Controlled Trial Multicenter Study Comparative Study

    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, John Cairns, Salim Yusuf, Brandi Meeks, Olga Shestakovska, Lehana Thabane, Kari Niemelä, Philippe Gabriel Steg, Olivier F Bertrand, Sunil V Rao, Alvaro Avezum, Warren J Cantor, Samir B Pancholy, Raul Moreno, Anthony Gershlick, Ravinay Bhindi, Robert C Welsh, Asim N Cheema, Shahar Lavi, Michael Rokoss, and Vladimír Džavík.
    • McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: sanjit.jolly@phri.ca.
    • Am. Heart J. 2014 Mar 1;167(3):315-321.e1.

    BackgroundA 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.ObjectiveThe 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.DesignThis 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.SummaryThe TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

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