Evidence map›Paper›PMID 25853743›Full record

Trial reportThe New England journal of medicine2015

Randomized trial of primary PCI with or without routine manual thrombectomy.

Sanjit S Jolly, John A Cairns, Salim Yusuf, Brandi Meeks, Janice Pogue, Michael J Rokoss, Sasko Kedev, Lehana Thabane, Goran Stankovic, Raul Moreno and 24 more

6 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 226 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
226citing papers in PubMed, 5 pooled it
86.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01149044 nacompletednot on this map

TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

TypeinterventionalSponsorPopulation Health Research InstituteRan2010 to 2015Enrolled10,732ConditionsAcute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary InterventionArmsPercutaneous Coronary Intervention with or without manual aspiration thrombectomy
NCT03087175 nacompletednot on this mapstarted 2016, after this paper: background citation

Impact of Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) on Coronary Microcirculation's Lesions in Patients With ST or Non ST-segment Elevation Myocardial Infarction (STE and NSTE-ACS): Assessment by Index of Microcirculatory Resistance (IMR)

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2016 to 2019Enrolled52ConditionsCoronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Cardiovascular DiseasesArmsMGuard stent, Drug eluting stent and bare metal stent
NCT03160547 nacompletednot on this mapstarted 2017, after this paper: background citation

The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial

TypeinterventionalSponsorClinical Evaluation Research Unit at Kingston General HospitalRan2017 to 2021Enrolled1,329ConditionsCritical Illness, MalnutritionArmsUsual Protein/Amino Acid Group, Higher Protein/Amino Acid Group
NCT03950310 naterminatednot on this mapstarted 2018, after this paper: background citation

Evaluation of Myocardial Salvage by Scintigraphy After Excimer Laser Coronary Angioplasty and Percutaneous Coronary Intervention With Biodegradable-polymer Platinum Chromium Everolimus-eluting Stent in the Patients With Anterior ST Elevation Myocardial Infarction

TypeinterventionalSponsorTokai UniversityRan2018 to 2021Enrolled142ConditionsSTEMI - ST Elevation Myocardial InfarctionArmsExcimer laser catheter
NCT04212494 narecruitingnot on this mapstarted 2020, after this paper: background citation

Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden

TypeinterventionalSponsorGuangdong Provincial People's HospitalRan2020 to 2026Enrolled3,838ConditionsST-segment Elevation Myocardial Infarction (STEMI)ArmsThrombus aspiration, PCI Alone
NCT04242966 phase3withdrawnnot on this mapstarted 2020, after this paper: background citation

The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial: The EFFORT Ultrasound a Sub-study

TypeinterventionalSponsorClinical Evaluation Research Unit at Kingston General HospitalRan2020 to 2022Enrolled0ConditionsCritical Illness, MalnutritionArmsUsual Care, Higher Protein/Amino Acid Group, Ultrasound measure
3 · Its place in the literature

Who cites it

226 citing papers in PubMed, 5 syntheses or guidelines pooled it, 632 citations in OpenAlex.

  1. Upstream anticoagulation in patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
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  6. No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
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  16. Efficacy and Safety of Thrombectomy Combined with Intracoronary Administration of Tirofiban in ST-segment Elevation Myocardial Infarction (STEMI).Medical science monitor : international medical journal of experimental and clinical research · 2016
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166 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors at 20 institutions in 14 countries.

Sanjit S JollyFrom the Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.S.J., S.Y., B.M., J.P., M.J.R., L.T., M.K.N., O.S., P.G.), University of British Columbia, Vancouver (J.A.C.), London Health Sciences Centre, Department of Medicine, London, ON (S.L.), Southlake Regional Health Centre, Newmarket, ON (W.J.C.), Peter Munk Cardiac Centre, University Health Network (C.B.O., V.D.), and St. Michael's Hospital (A.N.C.), Toronto, Mazankowski Alberta Heart Institute, Department of Medicine, Edmonton (R.C.W.), and Quebec Heart-Lung Institute, Laval University, Quebec, QC (O.F.B.) - all in Canada; University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia (S.K.); Clinical Center of Serbia and Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia (G.S.); University Hospital La Paz, Madrid (R.M.); University Hospitals of Leicester, Department of Cardiovascular Sciences, Leicester (A.G.), and University Hospitals South Manchester, Manchester Academic Health Science Centre, Manchester (S.C.) - both in the United Kingdom; Heart Center, Tampere University Hospital, Tampere, Finland (K.N.); Université Paris-Diderot, Sorbonne Paris-Cité, INSERM Unité 1148, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris (P.G.S.); University Hospital and Faculty of Medicine Pilsen, Pilsen (I.B.), and the Third Faculty of Medicine, Charles University Prague, University Hospital Kralovske Vinohrady, Prague (P.W.) - both in the Czech Republic; the Tenth People's Hospital, Tongji University, Shanghai, China (Y.X.); Department of Cardiology and Angiology, Contilla Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany (C.K.N.); Dante Pazzanese Institute of Cardiology, São Paulo (A.A.); Royal North Shore Hospital, Sydney (R.B.); Northeast Clinical Trials Group, Scranton, PA (S.P.); Duke Clinical Research Institute, Durham, NC (S.V.R.); and Department
John A Cairns
Salim Yusuf
Brandi Meeks
Janice Pogue
Michael J Rokoss
Sasko Kedev
Lehana Thabane
Goran Stankovic
Raul Moreno
Anthony Gershlick
Saqib Chowdhary
Shahar Lavi
Kari Niemelä
Philippe Gabriel Steg
Ivo Bernat
Yawei Xu
Warren J Cantor
Christopher B Overgaard
Christoph K Naber
Asim N Cheema
Robert C Welsh
Olivier F Bertrand
Alvaro Avezum
Ravinay Bhindi
Samir Pancholy
Sunil V Rao
Madhu K Natarajan
Jurriën M ten Berg
Olga Shestakovska
Peggy Gao
Petr Widimsky
Vladimír Džavík
TOTAL Investigators
Hamilton Health Sciences · CAMcMaster University · CAPopulation Health Research Institute · CAUniversity Health Network · CAClinical Research Institute · USElisabeth-Krankenhaus Essen · DEHôpital Bichat-Claude-Bernard · FRHospital Universitario La Paz · ESInstituto Dante Pazzanese de Cardiologia · BRLondon Health Sciences Centre · CALung Institute · USManchester Academic Health Science Centre · GBNorthEast Regional Epilepsy Group · USRoyal North Shore Hospital · AUSouthlake Regional Health Center · CASs. Cyril and Methodius University in Skopje · MKSt. Antonius Ziekenhuis · NLTampere University · FITongji University · CNUniversity Hospital Kralovske Vinohrady · CZ

Funding

CIHR 119992-1
6 · The paper itself

Abstract

backgroundDuring primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results.

methodsWe randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.

resultsThe primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02).

conclusionsIn patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

Indexed as

Percutaneous Coronary InterventionThrombectomyAgedCardiovascular DiseasesCombined Modality TherapyCoronary ThrombosisElectrocardiographyFemaleHeart FailureHumansKaplan-Meier EstimateMaleMicrovesselsMiddle AgedMyocardial InfarctionStroke

Identifiers

PMID25853743
PMCPMC4995102
OpenAlexW2096429890

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.