PMID- 26474811
OWN - NLM
STAT- MEDLINE
DCOM- 20160307
LR  - 20230815
IS  - 1474-547X (Electronic)
IS  - 0140-6736 (Print)
IS  - 0140-6736 (Linking)
VI  - 387
IP  - 10014
DP  - 2016 Jan 9
TI  - Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year 
      follow-up of the prospective randomised TOTAL trial.
PG  - 127-35
LID - S0140-6736(15)00448-1 [pii]
LID - 10.1016/S0140-6736(15)00448-1 [doi]
AB  - BACKGROUND: Two large trials have reported contradictory results at 1 year after 
      thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year 
      follow-up of the largest randomised trial of thrombus aspiration, we aimed to 
      clarify the longer-term benefits, to help guide clinical practice. METHODS: The 
      trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients 
      with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of 
      routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone 
      in 10,732 patients with STEMI. Eligible adult patients (aged >/=18 years) from 87 
      hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h 
      of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. 
      Permuted block randomisation (with variable block size) was done by a 24 h 
      computerised central system, and was stratified by centre. Participants and 
      investigators were not masked to treatment assignment. The trial did not show a 
      difference at 180 days in the primary outcome of cardiovascular death, myocardial 
      infarction, cardiogenic shock, or heart failure. However, the results showed 
      improvements in the surrogate outcomes of ST segment resolution and distal 
      embolisation, but whether or not this finding would translate into a longer term 
      benefit remained unclear. In this longer-term follow-up of the TOTAL study, we 
      report the results on the primary outcome (cardiovascular death, myocardial 
      infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 
      year. Analyses of the primary outcome were by modified intention to treat and 
      only included patients who underwent index PCI. This trial is registered with 
      ClinicalTrials.gov, number NCT01149044. FINDINGS: Between Aug 5, 2010, and July 
      25, 2014, 10,732 eligible patients were enrolled and randomly assigned to 
      thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions 
      of patients who did not undergo PCI in each group (337 in the PCI and 
      thrombectomy group and 331 in the PCI alone group), the final study population 
      comprised 10,064 patients (5035 thrombectomy and 5029 PCI alone). The primary 
      outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group 
      compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1.00 
      [95% CI 0.87-1.15], p=0.99). Cardiovascular death within 1 year occurred in 179 
      (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 
      0.93 [95% CI 0.76-1.14], p=0.48). The key safety outcome, stroke within 1 year, 
      occurred in 60 patients (1.2%) in the thrombectomy group compared with 36 (0.7%) 
      in the PCI alone group (HR 1.66 [95% CI 1.10-2.51], p=0.015). INTERPRETATION: 
      Routine thrombus aspiration during PCI for STEMI did not reduce longer-term 
      clinical outcomes and might be associated with an increase in stroke. As a 
      result, thrombus aspiration can no longer be recommended as a routine strategy in 
      STEMI. FUNDING: Canadian Institutes of Health Research, Canadian Network and 
      Centre for Trials Internationally, and Medtronic Inc.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Jolly, Sanjit S
AU  - Jolly SS
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada. Electronic address: sanjit.jolly@phri.ca.
FAU - Cairns, John A
AU  - Cairns JA
AD  - University of British Columbia, Vancouver, BC, Canada.
FAU - Yusuf, Salim
AU  - Yusuf S
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Rokoss, Michael J
AU  - Rokoss MJ
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Gao, Peggy
AU  - Gao P
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Meeks, Brandi
AU  - Meeks B
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
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 and Department of Cardiology, Medical Faculty, 
      University of Belgrade, Belgrade, Serbia.
FAU - Moreno, Raul
AU  - Moreno R
AD  - University Hospital La Paz, Madrid, Spain.
FAU - Gershlick, Anthony
AU  - Gershlick A
AD  - Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester 
      Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS 
      Trust, Glenfield Hospital, Leicester, UK.
FAU - Chowdhary, Saqib
AU  - Chowdhary S
AD  - University Hospitals South Manchester, Manchester Academic Health Science Centre, 
      Manchester, UK.
FAU - Lavi, Shahar
AU  - Lavi S
AD  - London Health Sciences Centre, Department of Medicine, London, ON, Canada.
FAU - Niemela, Kari
AU  - Niemela K
AD  - Heart Center, Tampere University Hospital, Tampere, Finland.
FAU - Bernat, Ivo
AU  - Bernat I
AD  - University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.
FAU - Cantor, Warren J
AU  - Cantor WJ
AD  - Southlake Regional Health Centre, Newmarket, ON, Canada.
FAU - Cheema, Asim N
AU  - Cheema AN
AD  - St Michael's Hospital, Toronto, ON, Canada.
FAU - Steg, Philippe Gabriel
AU  - Steg PG
AD  - Universite Paris-Diderot, Sorbonne Paris-Cite, INSERM Unite 1148, Hopital Bichat, 
      Assistance Publique-Hopitaux de Paris, Paris, France.
FAU - Welsh, Robert C
AU  - Welsh RC
AD  - Mazankowski Alberta Heart Institute, Department of Medicine, Edmonton, AB, 
      Canada.
FAU - Sheth, Tej
AU  - Sheth T
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Bertrand, Olivier F
AU  - Bertrand OF
AD  - Quebec Heart-Lung Institute, Laval University, Quebec, QC, Canada.
FAU - Avezum, Alvaro
AU  - Avezum A
AD  - Dante Pazzanese Institute of Cardiology, University of Santo Amaro, Sao Paulo, 
      Brazil.
FAU - Bhindi, Ravinay
AU  - Bhindi R
AD  - Royal North Shore Hospital, Sydney, Australia.
FAU - Natarajan, Madhu K
AU  - Natarajan MK
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Horak, David
AU  - Horak D
AD  - Krajska Nemocnice Liberec, Liberec, Czech Republic.
FAU - Leung, Raymond C M
AU  - Leung RC
AD  - CK Hui Heart Centre, Edmonton, AB, Canada.
FAU - Kassam, Saleem
AU  - Kassam S
AD  - Rouge Valley Health System, Toronto, ON, Canada.
FAU - Rao, Sunil V
AU  - Rao SV
AD  - Duke Clinical Research Institute, Durham, NC, USA.
FAU - El-Omar, Magdi
AU  - El-Omar M
AD  - Central Manchester Foundation Trust, Manchester Academic Health Science Centre, 
      Manchester, UK.
FAU - Mehta, Shamir R
AU  - Mehta SR
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Velianou, James L
AU  - Velianou JL
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, Hamilton, ON, Canada.
FAU - Pancholy, Samir
AU  - Pancholy S
AD  - Northeast Clinical Trials Group, Scranton, PA, USA.
FAU - Dzavik, Vladimir
AU  - Dzavik V
AD  - Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.
CN  - TOTAL Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01149044
GR  - 119992-1/Canadian Institutes of Health Research/Canada
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151022
PL  - England
TA  - Lancet
JT  - Lancet (London, England)
JID - 2985213R
SB  - IM
CIN - Lancet. 2016 Jan 9;387(10014):97-8. PMID: 26474808
MH  - Aged
MH  - Cardiovascular Diseases/mortality
MH  - Combined Modality Therapy
MH  - Coronary Thrombosis/therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure/epidemiology
MH  - Humans
MH  - Male
MH  - Myocardial Infarction/*therapy
MH  - *Percutaneous Coronary Intervention
MH  - Prospective Studies
MH  - Shock/epidemiology
MH  - Stroke/*epidemiology
MH  - *Thrombectomy
PMC - PMC5007127
MID - CAMS5775
OID - NLM: CAMS5775
COIS- Declaration of interests SSJ has received grants from Medtronic during the 
      conduct of the study. JAC has received grants from the Canadian Institutes of 
      Health Research and Medtronic during the conduct of the study, and grants from 
      Medtronic outside the submitted work. RM has received personal fees from 
      Medtronic during the conduct of the study. AG has received personal fees and 
      advisory board fees from AstraZeneca, and grants, meeting support, and research 
      grants from Medronic, outside the submitted work. PGS has received personal fees 
      from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, 
      Daiichi-Sankyo, GlaxoSmithKline, Lilly, Merck-Sharpe-Dohme, Novartis, Otsuka, 
      Pfizer, Roche, Medtronic, Vivus, Janssen, Orexigen, and Regado; grants and 
      personal fees from Sanofi and Servier; and personal fees and non-financial 
      support from The Medicines Company, outside the submitted work. RCW has received 
      personal fees from Medtronic; grants from Abbott Vascular and Edwards 
      Lifesciences, grants and personal fees from AstraZeneca, Bayer, Boehringer 
      Ingelheim, Jansen and BMS/Pfizer, outside the submitted work. SVR has received 
      personal fees from Medtronic, outside the submitted work. SP has received 
      personal fees from Medtronic, outside the submitted work. VD has received an 
      institutional grant to conduct the trial from the TOTAL Coordinating Centre 
      during the conduct of the study. All other coauthors declare no competing 
      interests.
EDAT- 2015/10/18 06:00
MHDA- 2016/03/08 06:00
PMCR- 2016/08/31
CRDT- 2015/10/18 06:00
PHST- 2015/10/18 06:00 [entrez]
PHST- 2015/10/18 06:00 [pubmed]
PHST- 2016/03/08 06:00 [medline]
PHST- 2016/08/31 00:00 [pmc-release]
AID - S0140-6736(15)00448-1 [pii]
AID - 10.1016/S0140-6736(15)00448-1 [doi]
PST - ppublish
SO  - Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 
      2015 Oct 22.