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

被引：93

作者：

Jolly, Sanjit S. ^{[1
,2
]}

Cairns, John ^{[3
]}

Yusuf, Salim ^{[1
,2
]}

Meeks, Brandi ^{[1
,2
]}

Shestakovska, Olga ^{[1
,2
]}

Thabane, Lehana ^{[1
,2
]}

Niemela, Kari ^{[4
,5
]}

Steg, Philippe Gabriel ^{[6
]}

Bertrand, Olivier F. ^{[7
]}

Rao, Sunil V. ^{[8
]}

Avezum, Alvaro ^{[9
]}

Cantor, Warren J. ^{[10
]}

Pancholy, Samir B. ^{[11
]}

Moreno, Raul ^{[12
]}

Gershlick, Anthony ^{[13
]}

Bhindi, Ravinay ^{[14
,15
]}

Welsh, Robert C. ^{[16
]}

Cheema, Asim N. ^{[17
]}

Lavi, Shahar ^{[18
]}

Rokoss, Michael ^{[1
,2
]}

Dzavik, Vladimir ^{[19
]}

机构：

[1] McMaster Univ, Hamilton, ON, Canada

[2] Hamilton Hlth Sci, Populat Hlth Res Inst, Hamilton, ON, Canada

[3] Univ British Columbia, Vancouver, BC V5Z 1M9, Canada

[4] Tampere Heart Ctr, Tampere, Finland

[5] Tampere Univ Hosp, Tampere, Finland

[6] Univ Paris Diderot, Paris, France

[7] Univ Laval, Quebec Heart Lung Inst, Quebec City, PQ, Canada

[8] Duke Univ, Duke Clin Res Inst, Durham, NC USA

[9] Dante Pazzanese Inst Cardiol, Sao Paulo, Brazil

[10] Univ Toronto, Southlake Reg Hlth Ctr, Newmarket, ON, Canada

[11] Commonwealth Med Coll, Scranton, PA USA

[12] Hosp La Paz, Madrid, Spain

[13] Glenfield Hosp, Univ Hosp Leicester, Univ Hosp Leicester Trust,Natl Inst Hlth Res, Leicester Cardiovasc Biomed Res Unit, Leicester, Leics, England

[14] Univ Sydney, Royal N Shore Hosp, Sydney, NSW, Australia

[15] Royal North Shore Private Hosp, Sydney, NSW, Australia

[16] Univ Alberta, Edmonton, AB, Canada

[17] Univ Toronto, St Michaels Hosp, Toronto, ON, Canada

[18] Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada

[19] Univ Toronto, Univ Hlth Network, Peter Munk Cardiac Ctr, Toronto, ON, Canada

来源：

AMERICAN HEART JOURNAL | 2014年 / 167卷 / 03期

基金：

加拿大健康研究院;

关键词：

THROMBUS ASPIRATION; ANGIOGRAPHIC ASSESSMENT; PRIMARY ANGIOPLASTY; REPERFUSION; THERAPY;

D O I：

10.1016/j.ahj.2013.12.002

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.

引用

页码：315 / +

页数：8

共 26 条

[1]

[Anonymous], 1988, LANCET, V2, P349

[2]

[Anonymous], 1989, NEW ENGL J MED, V320, P618

[3]

[Anonymous], JAMA

[4]

Intracoronary Optical Coherence Tomography: A Comprehensive Review Clinical and Research Applications [J].

Bezerra, Hiram G. ;

Costa, Marco A. ;

Guagliumi, Giulio ;

Rollins, Andrew M. ;

Simon, Daniel I. .

JACC-CARDIOVASCULAR INTERVENTIONS, 2009, 2 (11) :1035-1046

[5]

Comparison of primary coronary angioplasty versus thrombolysis in patients with ST-segment elevation acute myocardial infarction and grade II and grade III myocardial ischemia on the enrollment electrocardiogram [J].

Birnbaum, Y ;

Goodman, S ;

Barr, A ;

Gates, KB ;

Barbash, GI ;

Battler, A ;

Barbagelata, A ;

Clemmensen, P ;

Sgarbossa, EB ;

Granger, CB ;

Califf, RM ;

Wagner, GS .

AMERICAN JOURNAL OF CARDIOLOGY, 2001, 88 (08) :842-847

[6]

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 [J].

Buller, Christopher E. ;

Fu, Yuling ;

Mahaffey, Kenneth W. ;

Todaro, Thomas G. ;

Adams, Peter ;

Westerhout, Cynthia M. ;

White, Harvey D. ;

Hof, Arnoud W. J. Van 't ;

De Werf, Frans J. Van ;

Wagner, Galen S. ;

Granger, Christopher B. ;

Armstrong, Paul W. .

CIRCULATION, 2008, 118 (13) :1335-1346

[7]

The electrocardiographic window of opportunity to treat vs. the different evolving stages of ST-elevation myocardial infarction: correlation with therapeutic approach, coronary anatomy, and outcome in the DANAMI-2 trial [J].

Eskola, Markku J. ;

Holmvang, Lene ;

Nikus, Kjell C. ;

Sclarovsky, Samuel ;

Tilsted, Hans-Henrik ;

Huhtala, Heini ;

Niemela, Kari O. ;

Clemmensen, Peter .

EUROPEAN HEART JOURNAL, 2007, 28 (24) :2985-2991

[8]

Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction [J].

Frobert, Ole ;

Lagerqvist, Bo ;

Olivecrona, Goran K. ;

Omerovic, Elmir ;

Gudnason, Thorarinn ;

Maeng, Michael ;

Aasa, Mikael ;

Angeras, Oskar ;

Calais, Fredrik ;

Danielewicz, Mikael ;

Erlinge, David ;

Hellsten, Lars ;

Jensen, Ulf ;

Johansson, Agneta C. ;

Karegren, Amra ;

Nilsson, Johan ;

Robertson, Lotta ;

Sandhall, Lennart ;

Sjogren, Iwar ;

Ostlund, Ollie ;

Harnek, Jan ;

James, Stefan K. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (17) :1587-1597

[9]

Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale [J].

Frobert, Ole ;

Lagerqvist, Bo ;

Gudnason, Thorarinn ;

Thuesen, Leif ;

Svensson, Roger ;

Olivecrona, Goran K. ;

James, Stefan K. .

AMERICAN HEART JOURNAL, 2010, 160 (06) :1042-1048

[10]

Gibson CM, 2001, CIRCULATION, V103, P2550

← 1 2 3 →