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.

Central Manchester Foundation Trust Manchester Academic Health Science Centre Manchester UK

CK Hui Heart Centre Edmonton AB Canada

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

Dante Pazzanese Institute of Cardiology University of Santo Amaro Sao Paulo Brazil

Department of Cardiovascular Sciences University of Leicester and NIHR Leicester Cardiovascular Biomedical Research Unit University Hospitals of Leicester NHS Trust Glenfield Hospital Leicester UK

Duke Clinical Research Institute Durham NC USA

Heart Center Tampere University Hospital Tampere Finland

Krajská Nemocnice Liberec Liberec Czech Republic

London Health Sciences Centre Department of Medicine London ON Canada

Mazankowski Alberta Heart Institute Department of Medicine Edmonton AB Canada

McMaster University and the Population Health Research Institute Hamilton Health Sciences Hamilton ON Canada

Northeast Clinical Trials Group Scranton PA USA

Peter Munk Cardiac Centre University Health Network Toronto ON Canada

Quebec Heart Lung Institute Laval University Quebec QC Canada

Rouge Valley Health System Toronto ON Canada

Royal North Shore Hospital Sydney Australia

Southlake Regional Health Centre Newmarket ON Canada

St Michael's Hospital Toronto ON Canada

Université Paris Diderot Sorbonne Paris Cité INSERM Unité 1148 Hôpital Bichat Assistance Publique Hôpitaux de Paris Paris France

University Clinic of Cardiology Sts Cyril and Methodius University Skopje Macedonia

University Hospital and Faculty of Medicine Pilsen Pilsen Czech Republic

University Hospital La Paz Madrid Spain

University Hospitals South Manchester Manchester Academic Health Science Centre Manchester UK

University of British Columbia Vancouver BC Canada

Lancet. 2016 Jan 9;387(10014):97-8. doi: 10.1016/S0140-6736(15)00460-2. PubMed

Zobrazit více v PubMed

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003;361:13–20. PubMed

Henriques JP, Zijlstra F, Ottervanger JP, et al. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002;23:1112–17. PubMed

Stone GW, Peterson MA, Lansky AJ, Dangas G, Mehran R, Leon MB. Impact of normalized myocardial perfusion after successful angioplasty in acute myocardial infarction. J Am Coll Cardiol. 2002;39:591–97. PubMed

Buller CE, Fu Y, Mahaffey KW, et al. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008;118:1335–46. PubMed

Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008;358:557–67. PubMed

Vlaar PJ, Svilaas T, van der Horst IC, et al. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008;371:1915–20. PubMed

Frobert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013;369:1587–97. PubMed

Lagerqvist B, Frobert O, Olivecrona GK, et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med. 2014;371:1111–20. PubMed

Jolly SS, Cairns JA, Yusuf S, et al. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015;372:1389–98. PubMed PMC

Jolly SS, Cairns J, Yusuf S, et al. 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. Am Heart J. 2014;167:315–21. PubMed

Bulum J, Ernst A, Strozzi M. The impact of successful manual thrombus aspiration on in-stent restenosis after primary PCI: angiographic and clinical follow-up. Coron Artery Dis. 2012;23:487–91. PubMed

Chao CL, Hung CS, Lin YH, et al. Time-dependent benefit of initial thrombosuction on myocardial reperfusion in primary percutaneous coronary intervention. Int J Clin Pract. 2008;62:555–61. PubMed

Ciszewski M, Pregowski J, Teresinska A, et al. Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv. 2011;78:523–31. PubMed

De Luca L, Sardella G, Davidson CJ, et al. Impact of intracoronary aspiration thrombectomy during primary angioplasty on left ventricular remodelling in patients with anterior ST elevation myocardial infarction. Heart. 2006;92:951–57. PubMed PMC

Silva-Orrego P, Colombo P, Bigi R, et al. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006;48:1552–59. PubMed

Sardella G, Mancone M, Canali E, et al. Impact of thrombectomy with Export catheter in infarct-related artery during primary percutaneous coronary intervention (EXPIRA Trial) on cardiac death. Am J Cardiol. 2010;106:624–29. PubMed

Stone GW, Witzenbichler B, Godlewski J, et al. Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the the INFUSE-AMI trial. Circ Cardiovasc Interv. 2012;6:527–34. PubMed

Liu C, Lin M, Chiu Y, et al. Additive benefit of glycoprotein IIb/IIIa inhibition and adjunctive thrombus aspiration during primary coronary intervention: results of the Initial Thrombosuction and Tirofiban Infusion (ITTI) trial. Int J Cardiol. 2012;156:174–79. PubMed

Kaltoft A, Bottcher M, Nielsen SS, et al. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation. 2006;114:40–47. PubMed

De Carlo M, Aquaro GD, Palmieri C, et al. A prospective randomized trial of thrombectomy versus no thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) Trial. JACC Cardiovasc Interv. 2012;5:1223–30. PubMed

Burzotta F, Trani C, Romagnoli E, et al. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005;46:371–76. PubMed

Onuma Y, Thuesen L, van Geuns RJ, et al. Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study-TROFI trial. Eur Heart J. 2013;34:1050–60. PubMed

Ikari Y, Sakurada M, Kozuma K, et al. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008;1:424–31. PubMed

Overgaard CB, Sharma V, Chan W, et al. Myocardial blush and microvascular reperfusion following manual thrombectomy during PCI for STEMI: insights from the TOTAL trial. EuroIntervention. 2015;2015 15-A-OP006. PubMed PMC

Bhindi R, Kajander OA, Jolly SS, et al. Culprit lesion thrombus burden after manual thrombectomy or percutaneous coronary intervention-alone in ST-segment elevation myocardial infarction: the optical coherence tomography sub-study of the TOTAL (ThrOmbecTomy versus PCI ALone) trial. Eur Heart J. 2015;36:1892–900. PubMed PMC

Stone GW, Maehara A, Witzenbichler B, et al. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012;307:1817–26. PubMed

Jolly SS, Cairns JA, Yusuf S, et al. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015;36:2364–72. PubMed PMC

Impact of SARS-CoV-2 positivity on clinical outcome among STEMI patients undergoing mechanical reperfusion: Insights from the ISACS STEMI COVID 19 registry

When the situation almost cannot be worse…

Zobrazit více v PubMed

ClinicalTrials.gov
NCT01149044