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

May 27, 2010 updated by: Boston Scientific Corporation

SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, A-5020
        • Univ. Klinik für Herzchirurgie Landeskliniken
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus AKH
  • Belgium
      • Aalst, Belgium, B-9300
        • Onze Lieve Vrouw Ziekenhuis
      • Antwerpen, Belgium, B-2020
        • Academisch Ziekenhuis Middelheim
      • Gent, Belgium, B-9000
        • Universitair Ziekenhuis
      • Liège, Belgium, B-4000
        • Centre Hôpital Universitaire Sart Tilman
  • Czech Republic
      • Praha, Czech Republic, CZ-100 34
        • University hospital Vinohrady
      • Praha, Czech Republic, CZ-128 08
        • Interni klinika VFN
  • Denmark
      • Aarhus, Denmark, D-8200
        • Skejby Sygehus
  • Finland
      • Helsinki, Finland, FIN-00290 HUS
        • Helsinki University Central Hospital
      • Helsinki, Finland, FIN-00290 HUS
        • University of Helsinki Meilahti Hospital
  • France
      • Bordeaux, France, 33000
        • Clinique St Augustin
      • Massy, France, F-91349
        • Institut Cardiovasculaire Paris Sud - Massy
      • Rouen, France, 76000
        • Clinique Saint-Hilaire Rouen
      • Rouen Cedex, France, 76031
        • Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Toulouse, France, 31403
        • Centre Hôpital Universitaire Rangueil
      • Toulouse Cedex 9, France, 31059
        • CHU Rangueil
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum Nordrhein-Westfalen
      • Berlin, Germany, 10117
        • Universitatsklinik Charite Berlin, Campus Mitte
      • Berlin, Germany, 13353
        • Campus Virchow Klinikum Herzkatheterlabor
      • Berlin, Germany, D-13353
        • Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
      • Freiburg, Germany, 79106
        • Universitätsklinik Freiburg
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Kiel, Germany, 24105
        • Universitätsklinikum Campus Kiel
      • Leipzig, Germany, D-04289
        • Herzzentrum Universität Leipzig
      • Lübeck, Germany, 23538
        • Medizinische Universitaet Luebeck
      • München, Germany, D-81337
        • Klinikum Großhadern
      • Trier, Germany, D-54292
        • Krankenhaus der Barmherzigen Brüder
  • Hungary
      • Budapest, Hungary, 1134
        • National Medical Center
      • Debrecen, Hungary, 4032
        • University of Debrecen, Medical and Health Science Center
      • Pecs, Hungary, 1135
        • Medical School of University PECS
  • Italy
      • Bergamo, Italy, 24128
        • Ospedale Riuniti Di Bergamo
      • Massa, Italy, 54100
        • Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Mirano, Italy, 30035
        • Ospedale Civile Di Mirano
      • Pavia, Italy, 27100
        • Policlinico San Matteo
      • Pavia, Italy, 27100
        • IRCCS Policlinico S. Matteo
      • Roma, Italy, 00161
        • Policlinico Agostino Gemelli
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
  • Latvia
      • Riga, Latvia, LV-1002
        • P. Stradins University Hospital
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Amphia ziekenhuis
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • Academisch Ziekenhuis Groningen
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Hospital
      • Rotterdam, Netherlands, 3000 CA
        • Erasmus MC - University Medical Center Rotterdam
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken, De Weezenlanden
  • Norway
      • Oslo, Norway, 0027
        • Rikshospitalet
  • Poland
      • Katowice, Poland, 40635
        • Medical University of Silesia - Katowice
      • Krakow, Poland, 31-202
        • John Paul II Hospital
      • Krakow, Poland, 31-501
        • Jagiellonian University of Cardiology
      • Warsaw, Poland, 04-628
        • National Institute of Cardiology
  • Portugal
      • Lisboa, Portugal, 1169-024
        • Hospital de Santa Marta
  • Spain
      • Alicante, Spain, 03010
        • Hospital general de Alicante
      • Alicante, Spain, 03010
        • Hospital General Universitario
      • Barcelona, Spain, ES-08036
        • Hospital Clinico Y Provincial
      • Madrid, Spain, ES-28040
        • Hospital Clinico San Carlos
      • Salamanca, Spain, 37008
        • Hospital Clinico Salamanca
  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrenska University Hospital
      • Lund, Sweden, SE-221 85
        • University Hospital of Lund
      • Lund, Sweden, SE-22181
        • Lund University Hospital
      • Stockholm, Sweden, SE-171 76
        • Karolinska Universitets Sjukhuset - Stockholm
      • Uppsala, Sweden, SE-75185
        • Akademiska sjukhuset
      • Uppsala, Sweden, SE-75185
        • University hospital Uppsala
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Western Infirmary
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • Leicester, United Kingdom, LE3 9QP
        • University Hospitals of Leicester NHS Trust Glenfield Hospital
      • London, United Kingdom, E2 9JX
        • London Chest Hospital
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital London
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Infirmary Oxford II
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospital
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 1ES
        • Royal Sussex County Hospital
  • United States
    • California
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • Florida Cardiovascular Research
      • Ocala, Florida, United States, 34474
        • Munroe Medical Center
      • Ocala, Florida, United States, 34474
        • Ocala Heart Institue
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital
      • Rockford, Illinois, United States, 61108-2465
        • Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts New England Medical Center
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Hospital
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Research Institute
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Petoskey, Michigan, United States, 49770
        • Cardiac & Vascular Research Center of Northern Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55905
        • St. Mary's Hospital
    • New York
      • Stony Brook, New York, United States, 11794
        • Suny - Stony Brook School Of Medicine
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Center
      • Syracuse, New York, United States, 13203
        • SJH Cardiology Associates
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research Foundation
      • Greensboro, North Carolina, United States, 27405
        • Cardiovascular and Thoracic Surgeons of Greensboro
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary's Medical Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • San Antonio, Texas, United States, 78205
        • San Antonio Endovascular Heart Institue
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital 1st Fl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCI with DES
Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Drug Eluting Stent
Other Names:
  • Percutaneous coronary intervention
  • Paclitaxel eluting stent
  • 3 vessel disease
  • Left main stem
Active Comparator: CABG (coronary artery bypass graft)
Coronary Artery Bypass Graft
Procedure: Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery
Other Names:
  • Coronary artery disease
  • Coronary artery bypass graft
  • Left Main coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Clinical Endpoint of 12-Month Binary MACCE.
Time Frame: 12 months post enrollment
Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).
12 months post enrollment
12-month Composite Safety Endpoint.
Time Frame: 12 months after enrollment
Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
12 months after enrollment
Repeat Revascularization (PCI and/or CABG).
Time Frame: 12 Months post enrollment
Number of participants with repeat revascularization (PCI and/or CABG).
12 Months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
Time Frame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation
Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.
1 month after procedure and 6 months, 3 years, and 5 years post allocation
Individual Components of MACCE at 1 Month Post-procedure.
Time Frame: 1 month after procedure
Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
1 month after procedure
Individual Components of MACCE at 6 Months Post-allocation.
Time Frame: 6 months post allocation
Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
6 months post allocation
Individual Components of MACCE at 1 Year Post-allocation.
Time Frame: 1 year post allocation
Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
1 year post allocation
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Time Frame: 1 year post allocation
Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).
1 year post allocation
Freedom From MACCE and Its Components at 3 Years Post-allocation
Time Frame: 3 years post allocation
3 years post allocation
Freedom From MACCE and Its Components at 5 Years Post-allocation
Time Frame: 5 years post allocation
5 years post allocation
Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
Time Frame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation
1 month after procedure and 6 months, 1, 3 and 5 years post allocation
Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
Time Frame: 1 year, 3 and 5 years post allocation
1 year, 3 and 5 years post allocation
The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Cardialysis BV

Investigators

  • Study Director: Monika Hanisch, PhD, Boston Scientific Corporation
  • Principal Investigator: Patrick W. Serruys, MD, PhD, Erasmus Medical Center
  • Principal Investigator: Friedrich W Mohr, MD, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria

June 20, 2005

First Posted (Estimate)

June 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2024
  • 90169394

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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