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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.
Authors: Jolly, S. S.
Cairns, J.
Yusuf, S.
Meeks, B.
Shestakovska, O.
Thabane, L.
Niemelä, K.
Steg, P. G.
Bertrand, O. F.
Rao, S. V.
Avezum, A.
Cantor, W. J.
Pancholy, S. B.
Moreno, R.
Gershlick, Anthony
Bhindi, R.
Welsh, R. C.
Cheema, A. N.
Lavi, S.
Rokoss, M.
Džavík, V.
First Published: 14-Dec-2013
Publisher: Elsevier for Mosby
Citation: American Heart Journal, 2014, 167 (3), pp. 315-321.e1
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.
DOI Link: 10.1016/j.ahj.2013.12.002
ISSN: 0002-8703
eISSN: 1097-6744
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: © 2014 The Authors. Published Mosby Inc. Open access under CC BY-NC-ND license.
Description: Clinical trial registration: no. NCT01149044.
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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