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
| Autor: | Warren J. Cantor, Philippe Gabriel Steg, Lehana Thabane, Salim Yusuf, Anthony H. Gershlick, Olga Shestakovska, Shahar Lavi, Asim N. Cheema, Raúl Moreno, Brandi Meeks, Sanjit S. Jolly, Vladimír Džavík, Sunil V. Rao, Samir Pancholy, Alvaro Avezum, Ravinay Bhindi, Michael Rokoss, Olivier F. Bertrand, John A. Cairns, Kari Niemelä, Robert C. Welsh |
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| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Myocardial Infarction Suction law.invention Percutaneous Coronary Intervention Randomized controlled trial law Internal medicine medicine Humans Prospective Studies Myocardial infarction Embolization Thrombectomy business.industry Microcirculation Cardiogenic shock Percutaneous coronary intervention medicine.disease Combined Modality Therapy Surgery Clinical trial Treatment Outcome Heart failure Conventional PCI Cardiology Cardiology and Cardiovascular Medicine business |
| Zdroj: | American Heart Journal. 167:315-321.e1 |
| ISSN: | 0002-8703 |
| DOI: | 10.1016/j.ahj.2013.12.002 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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