Ravinay Bhindi1, Olli A Kajander2, Sanjit S Jolly3, Saleem Kassam4, Shahar Lavi5, Kari Niemelä2, Anthony Fung6, Asim N Cheema7, Brandi Meeks3, Dimitrios Alexopoulos8, Viktor Kočka9, Warren J Cantor10, Timo P Kaivosoja2, Olga Shestakovska3, Peggy Gao3, Goran Stankovic11, Vladimír Džavík12, Tej Sheth13. 1. Royal North Shore Hospital, Sydney, and University of Sydney, Sydney, Australia. 2. Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland. 3. Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4. 4. Rouge Valley Health System Centenary, Cardiac Care Program, Toronto, ON, Canada. 5. Department of Cardiology, London Health Sciences Centre, London, ON, Canada. 6. Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada. 7. St. Michael's Hospital, Toronto, ON, Canada. 8. Cardiology Department, Patras University Hospital, Patras, Greece. 9. Medicine, Charles University in Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. 10. Southlake Regional Health Centre, University of Toronto, Newmarket, ON, Canada. 11. Department of Cardiology, Clinical Center of Serbia, and Medical Faculty, University of Belgrade, Belgrade, Serbia. 12. Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada. 13. Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4 shetht@mcmaster.ca.
Abstract
AIMS: Manual thrombectomy has been proposed as a strategy to reduce thrombus burden during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). However, the effectiveness of manual thrombectomy in reducing thrombus burden is uncertain. In this substudy of the TOTAL (ThrOmbecTomy versus PCI ALone) trial, we compared the thrombus burden at the culprit lesion using optical coherence tomography (OCT) in patients treated with thrombectomy vs. PCI-alone. METHODS AND RESULTS: The TOTAL trial (N = 10 732) was an international, multicentre, randomized trial of thrombectomy (using the Export catheter, Medtronic Cardiovascular, Santa Rosa, CA, USA) in STEMI patients treated with primary PCI. The OCT substudy prospectively enrolled 214 patients from 13 sites in 5 countries. Optical coherence tomography was performed immediately after thrombectomy or PCI-alone and then repeated after stent deployment. Thrombus quantification was performed by an independent core laboratory blinded to treatment assignment. The primary outcome of pre-stent thrombus burden as a percentage of segment analysed was 2.36% (95% CI: 1.73-3.22) in the thrombectomy group and 2.88% (95% CI: 2.12-3.90) in the PCI-alone group (P = 0.373). Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329). Other secondary outcomes of pre-stent quadrants of thrombus, post-stent atherothrombotic burden, and post-stent atherothrombotic volume were not different between groups. CONCLUSION: Manual thrombectomy did not reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone. Both strategies were associated with low thrombus burden at the lesion site after the initial intervention to restore flow. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Manual thrombectomy has been proposed as a strategy to reduce thrombus burden during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). However, the effectiveness of manual thrombectomy in reducing thrombus burden is uncertain. In this substudy of the TOTAL (ThrOmbecTomy versus PCI ALone) trial, we compared the thrombus burden at the culprit lesion using optical coherence tomography (OCT) in patients treated with thrombectomy vs. PCI-alone. METHODS AND RESULTS: The TOTAL trial (N = 10 732) was an international, multicentre, randomized trial of thrombectomy (using the Export catheter, Medtronic Cardiovascular, Santa Rosa, CA, USA) in STEMIpatients treated with primary PCI. The OCT substudy prospectively enrolled 214 patients from 13 sites in 5 countries. Optical coherence tomography was performed immediately after thrombectomy or PCI-alone and then repeated after stent deployment. Thrombus quantification was performed by an independent core laboratory blinded to treatment assignment. The primary outcome of pre-stent thrombus burden as a percentage of segment analysed was 2.36% (95% CI: 1.73-3.22) in the thrombectomy group and 2.88% (95% CI: 2.12-3.90) in the PCI-alone group (P = 0.373). Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329). Other secondary outcomes of pre-stent quadrants of thrombus, post-stent atherothrombotic burden, and post-stent atherothrombotic volume were not different between groups. CONCLUSION: Manual thrombectomy did not reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone. Both strategies were associated with low thrombus burden at the lesion site after the initial intervention to restore flow. Published on behalf of the European Society of Cardiology. All rights reserved.
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