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).

Clinical Center of Serbia Department of Cardiology Medical Faculty University of Belgrade Belgrade Serbia

Department of Medicine Division of Cardiology McMaster University and Population Health Research Institute Hamilton Health Sciences Hamilton Ontario Canada

Department of Medicine Division of Cardiology Peter Munk Cardiac Centre University Health Network Toronto General Hospital Toronto Ontario Canada

Department of Medicine Division of Cardiology Southlake Regional Health Center University of Toronto Toronto Ontario Canada

Department of Medicine Division of Cardiology St Michael's Hospital University of Toronto Toronto Ontario Canada

Department of Medicine Division of Cardiology University Hospital La Paz Madrid Spain

Department of Medicine Division of Cardiology University Hospitals South Manchester Manchester Academic Health Science Centre Manchester United Kingdom

Department of Medicine Division of Cardiology University of British Columbia Vancouver British Columbia Canada

Department of Medicine Division of Cardiology Western University London Health Sciences Centre London Ontario Canada

Duke Clinical Research Institute Durham North Carolina

University Clinic of Cardiology Sts Cyril and Methodius University Skopje Macedonia

University Hospital and Faculty of Medicine Pilsen Pilsen Czech Republic

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$a Jolly, Sanjit S $u 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.

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$a Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial / $c SS. Jolly, JA. Cairns, S. Lavi, WJ. Cantor, I. Bernat, AN. Cheema, R. Moreno, S. Kedev, G. Stankovic, SV. Rao, B. Meeks, S. Chowdhary, P. Gao, M. Sibbald, JL. Velianou, SR. Mehta, M. Tsang, T. Sheth, V. Džavík, TOTAL Investigators,

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$a 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).

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$a Cairns, John A $u Department of Medicine, Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.

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$a Lavi, Shahar $u Department of Medicine, Division of Cardiology, Western University, London Health Sciences Centre, London, Ontario, Canada.

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$a Cantor, Warren J $u Department of Medicine, Division of Cardiology, Southlake Regional Health Center, University of Toronto, Toronto, Ontario, Canada.

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$a Bernat, Ivo $u University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.

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$a Cheema, Asim N $u Department of Medicine, Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

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$a Moreno, Raul $u Department of Medicine, Division of Cardiology, University Hospital La Paz, Madrid, Spain.

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$a Kedev, Sasko $u University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia.

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$a Stankovic, Goran $u Clinical Center of Serbia, Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia.

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$a Rao, Sunil V $u Duke Clinical Research Institute, Durham, North Carolina.

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$a Meeks, Brandi $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Chowdhary, Saqib $u Department of Medicine, Division of Cardiology, University Hospitals South Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.

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$a Gao, Peggy $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Sibbald, Matthew $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Velianou, James L $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Mehta, Shamir R $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Tsang, Michael $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Sheth, Tej $u Department of Medicine, Division of Cardiology, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Džavík, Vladimír $u Department of Medicine, Division of Cardiology, Peter Munk Cardiac Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.

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$a TOTAL Investigators

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