SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

NCT ID: NCT00114972

Last Updated: 2010-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2012-05-31

Brief Summary

The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).

Detailed Description

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI with DES

Group Type: EXPERIMENTAL

Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent

Intervention Type: DEVICE

Drug Eluting Stent

CABG (coronary artery bypass graft)

Coronary Artery Bypass Graft

Group Type: ACTIVE_COMPARATOR

Coronary Artery Bypass Surgery

Intervention Type: PROCEDURE

Coronary Artery Bypass Surgery

Interventions

Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent

Drug Eluting Stent

Intervention Type: DEVICE

Coronary Artery Bypass Surgery

Coronary Artery Bypass Surgery

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous coronary intervention; Paclitaxel eluting stent; 3 vessel disease; Left main stem; Coronary artery disease; Coronary artery bypass graft; Left Main coronary artery

Eligibility Criteria

Inclusion Criteria

• Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
• De novo lesions with at least 50% stenosis
• Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria

• Prior PCI or CABG
• Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)
• Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
• Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
• Inability to give informed consent due to mental condition, mental retardation, or language barrier

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardialysis BV

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Boston Scientific

Principal Investigators

Patrick W. Serruys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Friedrich W Mohr, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Monika Hanisch, PhD

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Mercy General Hospital

Sacramento, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Florida Cardiovascular Research

Atlantis, Florida, United States

Munroe Medical Center

Ocala, Florida, United States

Ocala Heart Institue

Ocala, Florida, United States

Florida Hospital

Orlando, Florida, United States

Evanston Hospital

Evanston, Illinois, United States

Rockford Cardiology Research Foundation (St. Anthony's Medical Center)

Rockford, Illinois, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Maine Medical Center

Portland, Maine, United States

Tufts New England Medical Center

Boston, Massachusetts, United States

Cape Cod Hospital

Hyannis, Massachusetts, United States

Cape Cod Research Institute

Hyannis, Massachusetts, United States

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Mary's Hospital

Rochester, Minnesota, United States

SUNY - Stony Brook School of Medicine

Stony Brook, New York, United States

SJH Cardiology Associates

Syracuse, New York, United States

St. Joseph's Hospital Health Center

Syracuse, New York, United States

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Cardiovascular and Thoracic Surgeons of Greensboro

Greensboro, North Carolina, United States

Wake Medical Center

Raleigh, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

St. Mary's Medical Center

Langhorne, Pennsylvania, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

San Antonio Endovascular Heart Institue

San Antonio, Texas, United States

Sentara Norfolk General Hospital 1st Fl

Norfolk, Virginia, United States

Univ. Klinik für Herzchirurgie Landeskliniken

Salzburg, , Austria

Allgemeines Krankenhaus AKH

Vienna, , Austria

Onze Lieve Vrouw Ziekenhuis

Aalst, , Belgium

Academisch Ziekenhuis Middelheim

Antwerp, , Belgium

Universitair Ziekenhuis

Ghent, , Belgium

Centre Hôpital Universitaire Sart Tilman

Liège, , Belgium

University Hospital Vinohrady

Prague, , Czechia

Interni Klinika VFN

Prague, , Czechia

Skejby Sygehus

Aarhus, , Denmark

Helsinki University Central Hospital

Helsinki, , Finland

University of Helsinki Meilahti Hospital

Helsinki, , Finland

Clinique St Augustin

Bordeaux, , France

Institut Cardiovasculaire Paris Sud - Massy

Massy, , France

Clinique Saint-Hilaire Rouen

Rouen, , France

Centre Hopital Universitaire Rouen - Hopital Charles Nicolle

Rouen, , France

CHU Rangueil

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Centre Hôpital Universitaire Rangueil

Toulouse, , France

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, , Germany

Universitatsklinik Charite Berlin, Campus Mitte

Berlin, , Germany

Campus Virchow Klinikum Herzkatheterlabor

Berlin, , Germany

Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum

Berlin, , Germany

Universitätsklinik Freiburg

Freiburg im Breisgau, , Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, , Germany

Universitätsklinikum Campus Kiel

Kiel, , Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, , Germany

Herzzentrum Universität Leipzig

Leipzig, , Germany

Medizinische Universitaet Luebeck

Lübeck, , Germany

Klinikum Grosshadern

München, , Germany

Krankenhaus der Barmherzigen Brüder

Trier, , Germany

National Medical Center

Budapest, , Hungary

University of Debrecen, Medical and Health Science Center

Debrecen, , Hungary

Medical School of University PECS

Pécs, , Hungary

Ospedale Riuniti di Bergamo

Bergamo, , Italy

Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale

Massa, , Italy

Ospedale San Raffaele

Milan, , Italy

Ospedale Civile di Mirano

Mirano, , Italy

IRCCS Policlinico S. Matteo

Pavia, , Italy

Policlinico San Matteo

Pavia, , Italy

Policlinico Agostino Gemelli

Roma, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

P. Stradins University Hospital

Riga, , Latvia

Amphia Ziekenhuis

Breda, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

St. Antonius Hospital

Nieuwegein, , Netherlands

Erasmus MC - University Medical Center Rotterdam

Rotterdam, , Netherlands

Isala Klinieken, De Weezenlanden

Zwolle, , Netherlands

Rikshospitalet

Oslo, , Norway

Medical University of Silesia - Katowice

Katowice, , Poland

John Paul II Hospital

Krakow, , Poland

Jagiellonian University of Cardiology

Krakow, , Poland

National Institute of Cardiology

Warsaw, , Poland

Hospital de Santa Marta

Lisbon, , Portugal

Hospital General de Alicante

Alicante, , Spain

Hospital General Universitario

Alicante, , Spain

Hospital Clinico Y Provincial

Barcelona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Clinico Salamanca

Salamanca, , Spain

Sahlgrenska University Hospital

Gothenburg, , Sweden

University Hospital of Lund

Lund, , Sweden

Lund University Hospital

Lund, , Sweden

Karolinska Universitets Sjukhuset - Stockholm

Stockholm, , Sweden

Akademiska sjukhuset

Uppsala, , Sweden

University Hospital Uppsala

Uppsala, , Sweden

Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom

Western Infirmary

Glasgow, , United Kingdom

Glenfield Hospital

Leicester, , United Kingdom

University Hospitals of Leicester NHS Trust Glenfield Hospital

Leicester, , United Kingdom

London Chest Hospital

London, , United Kingdom

St Thomas Hospital

London, , United Kingdom

King's College Hospital London

London, , United Kingdom

John Radcliffe Infirmary Oxford II

Oxford, , United Kingdom

Southampton University Hospital

Southampton, , United Kingdom

Countries

United States; Austria; Belgium; Czechia; Denmark; Finland; France; Germany; Hungary; Italy; Latvia; Netherlands; Norway; Poland; Portugal; Spain; Sweden; United Kingdom

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Milojevic M, Head SJ, Mack MJ, Mohr FW, Morice MC, Dawkins KD, Holmes DR Jr, Serruys PW, Kappetein AP. Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):445-453. doi: 10.1093/ejcts/ezx104.

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Abdallah MS, Wang K, Magnuson EA, Osnabrugge RL, Kappetein AP, Morice MC, Mohr FA, Serruys PW, Cohen DJ; SYNTAX Trial Investigators. Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease. J Am Coll Cardiol. 2017 Apr 25;69(16):2039-2050. doi: 10.1016/j.jacc.2017.02.031.

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Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of Death Following PCI Versus CABG in Complex CAD: 5-Year Follow-Up of SYNTAX. J Am Coll Cardiol. 2016 Jan 5;67(1):42-55. doi: 10.1016/j.jacc.2015.10.043.

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Osnabrugge RL, Magnuson EA, Serruys PW, Campos CM, Wang K, van Klaveren D, Farooq V, Abdallah MS, Li H, Vilain KA, Steyerberg EW, Morice MC, Dawkins KD, Mohr FW, Kappetein AP, Cohen DJ; SYNTAX trial investigators. Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective. Heart. 2015 Dec;101(24):1980-8. doi: 10.1136/heartjnl-2015-307578. Epub 2015 Nov 9.

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Parasca CA, Head SJ, Mohr FW, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Colombo A, Dawkins KD, Serruys PW, Kappetein AP; SYNTAX Investigators. The impact of a second arterial graft on 5-year outcomes after coronary artery bypass grafting in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Trial and Registry. J Thorac Cardiovasc Surg. 2015 Sep;150(3):597-606.e2. doi: 10.1016/j.jtcvs.2015.05.010. Epub 2015 May 8.

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Iqbal J, Zhang YJ, Holmes DR, Morice MC, Mack MJ, Kappetein AP, Feldman T, Stahle E, Escaned J, Banning AP, Gunn JP, Colombo A, Steyerberg EW, Mohr FW, Serruys PW. Optimal medical therapy improves clinical outcomes in patients undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting: insights from the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial at the 5-year follow-up. Circulation. 2015 Apr 7;131(14):1269-77. doi: 10.1161/CIRCULATIONAHA.114.013042. Epub 2015 Feb 24.

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Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

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Zhang YJ, Iqbal J, van Klaveren D, Campos CM, Holmes DR, Kappetein AP, Morice MC, Banning AP, Grech ED, Bourantas CV, Onuma Y, Garcia-Garcia HM, Mack MJ, Colombo A, Mohr FW, Steyerberg EW, Serruys PW. Smoking is associated with adverse clinical outcomes in patients undergoing revascularization with PCI or CABG: the SYNTAX trial at 5-year follow-up. J Am Coll Cardiol. 2015 Mar 24;65(11):1107-15. doi: 10.1016/j.jacc.2015.01.014.

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Cohen DJ, Osnabrugge RL, Magnuson EA, Wang K, Li H, Chinnakondepalli K, Pinto D, Abdallah MS, Vilain KA, Morice MC, Dawkins KD, Kappetein AP, Mohr FW, Serruys PW; SYNTAX Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2014 Sep 30;130(14):1146-57. doi: 10.1161/CIRCULATIONAHA.114.009985. Epub 2014 Aug 1.

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Head SJ, Davierwala PM, Serruys PW, Redwood SR, Colombo A, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Stahle E, Underwood P, Dawkins KD, Kappetein AP, Mohr FW. Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. Eur Heart J. 2014 Oct 21;35(40):2821-30. doi: 10.1093/eurheartj/ehu213. Epub 2014 May 21.

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Morice MC, Serruys PW, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR, Choi JW, Ruzyllo W, Religa G, Huang J, Roy K, Dawkins KD, Mohr F. Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial. Circulation. 2014 Jun 10;129(23):2388-94. doi: 10.1161/CIRCULATIONAHA.113.006689. Epub 2014 Apr 3.

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Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Juni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.

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Farooq V, Serruys PW, Bourantas CV, Zhang Y, Muramatsu T, Feldman T, Holmes DR, Mack M, Morice MC, Stahle E, Colombo A, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW. Quantification of incomplete revascularization and its association with five-year mortality in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial validation of the residual SYNTAX score. Circulation. 2013 Jul 9;128(2):141-51. doi: 10.1161/CIRCULATIONAHA.113.001803. Epub 2013 Jun 13.

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Mack MJ, Head SJ, Holmes DR Jr, Stahle E, Feldman TE, Colombo A, Morice MC, Unger F, Erglis A, Stoler R, Dawkins KD, Serruys PW, Mohr FW, Kappetein AP. Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease. JACC Cardiovasc Interv. 2013 Apr;6(4):344-54. doi: 10.1016/j.jcin.2012.11.010. Epub 2013 Mar 20.

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Head SJ, Holmes DR Jr, Mack MJ, Serruys PW, Mohr FW, Morice MC, Colombo A, Kappetein AP; SYNTAX Investigators. Risk profile and 3-year outcomes from the SYNTAX percutaneous coronary intervention and coronary artery bypass grafting nested registries. JACC Cardiovasc Interv. 2012 Jun;5(6):618-25. doi: 10.1016/j.jcin.2012.02.013.

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Serruys PW, Farooq V, Vranckx P, Girasis C, Brugaletta S, Garcia-Garcia HM, Holmes DR Jr, Kappetein AP, Mack MJ, Feldman T, Morice MC, Stahle E, James S, Colombo A, Pereda P, Huang J, Morel MA, Van Es GA, Dawkins KD, Mohr FW, Steyerberg EW. A global risk approach to identify patients with left main or 3-vessel disease who could safely and efficaciously be treated with percutaneous coronary intervention: the SYNTAX Trial at 3 years. JACC Cardiovasc Interv. 2012 Jun;5(6):606-17. doi: 10.1016/j.jcin.2012.03.016.

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Arnold SV, Magnuson EA, Wang K, Serruys PW, Kappetein AP, Mohr FW, Cohen DJ; SYNTAX Investigators. Do differences in repeat revascularization explain the antianginal benefits of bypass surgery versus percutaneous coronary intervention?: implications for future treatment comparisons. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):267-75. doi: 10.1161/CIRCOUTCOMES.111.964585. Epub 2012 Apr 10.

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Morice MC, Feldman TE, Mack MJ, Stahle E, Holmes DR, Colombo A, Morel MA, van den Brand M, Serruys PW, Mohr F, Carrie D, Fournial G, James S, Leadley K, Dawkins KD, Kappetein AP. Angiographic outcomes following stenting or coronary artery bypass surgery of the left main coronary artery: fifteen-month outcomes from the synergy between PCI with TAXUS express and cardiac surgery left main angiographic substudy (SYNTAX-LE MANS). EuroIntervention. 2011 Oct 30;7(6):670-9. doi: 10.4244/EIJV7I6A109.

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Cohen DJ, Van Hout B, Serruys PW, Mohr FW, Macaya C, den Heijer P, Vrakking MM, Wang K, Mahoney EM, Audi S, Leadley K, Dawkins KD, Kappetein AP; Synergy between PCI with Taxus and Cardiac Surgery Investigators. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011 Mar 17;364(11):1016-26. doi: 10.1056/NEJMoa1001508.

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Mohr FW, Rastan AJ, Serruys PW, Kappetein AP, Holmes DR, Pomar JL, Westaby S, Leadley K, Dawkins KD, Mack MJ. Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years. J Thorac Cardiovasc Surg. 2011 Jan;141(1):130-40. doi: 10.1016/j.jtcvs.2010.07.094.

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Morice MC, Serruys PW, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR, Torracca L, van Es GA, Leadley K, Dawkins KD, Mohr F. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2010 Jun 22;121(24):2645-53. doi: 10.1161/CIRCULATIONAHA.109.899211. Epub 2010 Jun 7.

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Banning AP, Westaby S, Morice MC, Kappetein AP, Mohr FW, Berti S, Glauber M, Kellett MA, Kramer RS, Leadley K, Dawkins KD, Serruys PW. Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents. J Am Coll Cardiol. 2010 Mar 16;55(11):1067-75. doi: 10.1016/j.jacc.2009.09.057. Epub 2010 Jan 14.

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Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.

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Other Identifiers

90169394

Identifier Type: -

Identifier Source: secondary_id

S2024

Identifier Type: -

Identifier Source: org_study_id