A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI

NCT01149044 | Completed DMC

• 1 other identifier: TOTAL Trial
• Study Type: interventional
• Target: 10,732
• Locations: 19 countries
• Sites: 84

Brief Summary

This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Keywords

Acute Coronary Syndrome; PCI; Percutaneous Coronary Intervention; STEMI; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure

  up to 180 days

Secondary Outcomes (4)

• Stroke

  up to 30 days

• Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure

  up to 1 year

• Cardiovascular Mortality

  up to 180 days

• Key Secondary Efficacy Outcome: The first occurence of cardiovascular death, myocardial infarction, cardiogenic shock, new or worsening NYHA class IV heart failure, stent thrombosis and target vessel revascularization

  up to 180 days

Other Outcomes (11)

• Primary outcome at 30 days and 1 year

  up to 1 year

• Components of primary outcome and secondary outcomes

  up to 1 year

• All-cause mortality

  up to 1 year

Study Arms (2)

Upfront Thrombectomy followed by PCI

ACTIVE COMPARATOR

Upfront manual aspiration thrombectomy followed by PCI

Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

PCI Alone

ACTIVE COMPARATOR

PCI without upfront manual aspiration thrombectomy

Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Interventions

Percutaneous Coronary Intervention with or without manual aspiration thrombectomy PROCEDURE

PCI Alone; Upfront Thrombectomy followed by PCI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with:
• Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
• Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
• Referred for primary PCI
• Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
• Informed consent

You may not qualify if:

• Age ≤ 18 years
• Prior coronary artery bypass surgery (CABG)
• Life expectancy less than six months due to non-cardiac condition
• Treatment with fibrinolytic therapy for qualifying index STEMI event

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (87)

Central Cardiology medical Clinic

Bakersfield, California, 93308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Lindner Research Center at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

WPAHS - Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Northeast Clinical Trials Group

Scranton, Pennsylvania, 18510, United States

Location

Royal North Shore Hospital

Sydney, New South Wales, Australia

Location

St. George Public Hospital

Sydney, New South Wales, Australia

Location

Gold Coast Hospital

Southport, Queensland, Australia

Location

Medical University of Vienna

Vienna, Austria

Location

CHR de la Citadelle

Liège, Belgium

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Santa Isabel

Blumenau, Santa Catarina, Brazil

Location

Santa Casa de Marilia

Marília, São Paulo, Brazil

Location

Fundação Faculdade de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Location

Hospital Mae de Deus

Porto Elegre, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Victoria Heart Institute

Victoria, British Columbia, Canada

Location

Royal Columbian Hospital

Westminster, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences

Halifax, Nova Scotia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

York PCI Group - Southlake Regional

Newmarket, Ontario, Canada

Location

Scarborough Cardiology Research

Scarborough Village, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

CSSS de Chicoutimi

Chicoutimi, Quebec, Canada

Location

MUHC Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Quebec Heart Lung Insitute

Québec, Quebec, Canada

Location

Shanghai Gongli Hospital

Shanghai, China

Location

The First People's Hospital, Jiatong University

Shanghai, China

Location

The Tenth People's Hospital Tongji University

Shanghai, China

Location

Yueyang Hospital Shanghai University of TCM

Shanghai, China

Location

Krasjska Nemocnice Liberec

Liberec, Czechia

Location

University Hospital Pilsen

Pilsen, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, Czechia

Location

University Hospital Motol

Prague, Czechia

Location

Masaryk Hospital

Ústí nad Labem, Czechia

Location

Kuopio University Hospital

Kuopio, Finland

Location

Heart Center, Tampere University Hospital

Tampere, Finland

Location

Chu Jean Minjoz

Besançon, France

Location

CHU Albert Michallon

Grenoble, France

Location

Hopital Bichat

Paris, France

Location

Hopital Lariboisiere Ap-HP

Paris, France

Location

Centre Hospitalier de Pau

Pau, France

Location

Universitatsklinikum Bonn

Bonn, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, Germany

Location

Clinical Association Oberallgaeu-Kempten

Immenstadt im Allgäu, Germany

Location

Klinikum der Universitat Munchen

München, Germany

Location

Patras University Hospital

Pátrai, Greece

Location

Ahepa University Hospital

Thessaloniki, Greece

Location

Semmelweis University Heart and Vascular Center

Budapest, Hungary

Location

University of Szeged

Szeged, Hungary

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Waikato Hospital

Hamilton, New Zealand

Location

Medical University Skopje

Skopje, North Macedonia

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Kyung-Hee University Hospital

Seoul, South Korea

Location

Seoul Boramae Medical Center

Seoul, South Korea

Location

Hospital Universitari Germans Trias I Pujol

Baldona, Spain

Location

Complexo Hospitalario A Coruna

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

University Hospital La Paz

Madrid, Spain

Location

Hospital Son Espases

Palma de Mallorca, Spain

Location

Hospital Clinico Universitario de Vigo

Vigo, Spain

Location

Hampshire Hospitals NHS Fuondation Trust

Basingstoke, United Kingdom

Location

Barts and The London Heart and Chest Centre

Bethnal Green, United Kingdom

Location

Frimley Park Hospital, NHS Foundation Trust

Camberley, United Kingdom

Location

Hull and East Yorkshire Hospitals

Hull, United Kingdom

Location

Kettering General Hospital

Kettering, United Kingdom

Location

Glenfield General Hospital

Leicester, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

University Hospital South Manchester

Manchester, United Kingdom

Location

Queen Elizabeth the Queen Mother Hospital

Margate, United Kingdom

Location

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Musgrove Park Hospital

Taunton, United Kingdom

Location

Related Publications (9)

• Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemela K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Dzavik V. 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 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.

  PMID: 24576514 BACKGROUND

• Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

  PMID: 25853743 RESULT

• Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, Cantor WJ, Overgaard CB, Lavi S, Sharma V, Chowdhary S, Stankovic G, Kedev S, Bernat I, Bhindi R, Sheth T, Niemela K, Jolly SS, Dzavik V. Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011336. doi: 10.1161/CIRCINTERVENTIONS.121.011336. Epub 2022 May 17.

  PMID: 35580203 DERIVED

• Moxham R, Dzavik V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505.

  PMID: 33769510 DERIVED

• Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.

  PMID: 30261959 DERIVED

• Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemela K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414.

  PMID: 27056766 DERIVED

• Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.

  PMID: 26474811 DERIVED

• Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Dzavik V; TOTAL Investigators. 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 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29.

  PMID: 26129947 DERIVED

• Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14. No abstract available.

  PMID: 22000582 DERIVED

Related Links

• TOTAL - A Randomized Trial of Routine Aspiration Thrombectomy with Percutaneous Coronary Intervention (PCI) vs. PCI Alone in Patients with STEMI Undergoing Primary PCI (Population Health Research Institute)

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Sanjit S. Jolly, MD, MSc, FRCP

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Vladimir Džavík, MD, FRCPC

  Peter Munk Cardiac Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc, FRCP(C), Interventional Cardiologist, Assistant Professor

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

FI (2); AU (1); NL (1); NO (1); US (8); SE (1); CA (15); CZ (5); DE (4); KR (4); GB (12); NZ (1); ES (8); CN (4); FR (5); BR (7); BE (1); HU (2); GR (2)