PMID- 30261959 OWN - NLM STAT- MEDLINE DCOM- 20190910 LR - 20190910 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 72 IP - 14 DP - 2018 Oct 2 TI - Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. PG - 1589-1596 LID - S0735-1097(18)35751-6 [pii] LID - 10.1016/j.jacc.2018.07.047 [doi] AB - BACKGROUND: Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. OBJECTIVES: The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. METHODS: TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade >/=3) was a pre-specified subgroup. RESULTS: The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). CONCLUSIONS: In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044). CI - Copyright (c) 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Jolly, Sanjit S AU - Jolly SS AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: sanjit.jolly@phri.ca. FAU - Cairns, John A AU - Cairns JA AD - Department of Medicine, Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. FAU - Lavi, Shahar AU - Lavi S AD - Department of Medicine, Division of Cardiology, Western University, London Health Sciences Centre, London, Ontario, Canada. FAU - Cantor, Warren J AU - Cantor WJ AD - Department of Medicine, Division of Cardiology, Southlake Regional Health Center, University of Toronto, Toronto, Ontario, Canada. FAU - Bernat, Ivo AU - Bernat I AD - University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic. FAU - Cheema, Asim N AU - Cheema AN AD - Department of Medicine, Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. FAU - Moreno, Raul AU - Moreno R AD - Department of Medicine, Division of Cardiology, University Hospital La Paz, Madrid, Spain. FAU - Kedev, Sasko AU - Kedev S AD - University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia. FAU - Stankovic, Goran AU - Stankovic G AD - Clinical Center of Serbia, Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia. FAU - Rao, Sunil V AU - Rao SV AD - Duke Clinical Research Institute, Durham, North Carolina. FAU - Meeks, Brandi AU - Meeks B AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Chowdhary, Saqib AU - Chowdhary S AD - Department of Medicine, Division of Cardiology, University Hospitals South Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom. FAU - Gao, Peggy AU - Gao P AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Sibbald, Matthew AU - Sibbald M AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Velianou, James L AU - Velianou JL AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Mehta, Shamir R AU - Mehta SR AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Tsang, Michael AU - Tsang M AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Sheth, Tej AU - Sheth T AD - Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Dzavik, Vladimir AU - Dzavik V AD - Department of Medicine, Division of Cardiology, Peter Munk Cardiac Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada. CN - TOTAL Investigators LA - eng SI - ClinicalTrials.gov/NCT01149044 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 SB - IM CIN - J Am Coll Cardiol. 2018 Oct 2;72(14):1597-1599. PMID: 30261960 CIN - J Am Coll Cardiol. 2019 Feb 5;73(4):530-531. PMID: 30704588 CIN - J Am Coll Cardiol. 2019 Feb 5;73(4):532. PMID: 30704590 MH - Coronary Thrombosis/epidemiology/*therapy MH - Female MH - Heart Failure/epidemiology MH - Humans MH - Male MH - Middle Aged MH - *Percutaneous Coronary Intervention MH - Recurrence MH - ST Elevation Myocardial Infarction/epidemiology/*therapy MH - Shock, Cardiogenic/epidemiology MH - Stroke/epidemiology MH - *Thrombectomy OTO - NOTNLM OT - PCI OT - STEMI OT - thrombectomy EDAT- 2018/09/29 06:00 MHDA- 2019/09/11 06:00 CRDT- 2018/09/29 06:00 PHST- 2018/04/16 00:00 [received] PHST- 2018/06/29 00:00 [revised] PHST- 2018/07/02 00:00 [accepted] PHST- 2018/09/29 06:00 [entrez] PHST- 2018/09/29 06:00 [pubmed] PHST- 2019/09/11 06:00 [medline] AID - S0735-1097(18)35751-6 [pii] AID - 10.1016/j.jacc.2018.07.047 [doi] PST - ppublish SO - J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.