SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR StentProcedure: Coronary Artery Bypass Surgery
- Registration Number
- NCT00114972
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1800
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCI with DES Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent - CABG (coronary artery bypass graft) Coronary Artery Bypass Surgery Coronary Artery Bypass Graft
- Primary Outcome Measures
Name Time Method Primary Clinical Endpoint of 12-Month Binary MACCE. 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-month Composite Safety Endpoint. 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.
Repeat Revascularization (PCI and/or CABG). 12 Months post enrollment Number of participants with repeat revascularization (PCI and/or CABG).
- Secondary Outcome Measures
Name Time Method 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 Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.
Individual Components of MACCE at 1 Month Post-procedure. 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.
Individual Components of MACCE at 6 Months Post-allocation. 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.
Individual Components of MACCE at 1 Year Post-allocation. 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.
Freedom From MACCE and Its Components at 1 Year Post-allocation. 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).
Freedom From MACCE and Its Components at 3 Years Post-allocation 3 years post allocation Freedom From MACCE and Its Components at 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 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 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) 5 Years
Trial Locations
- Locations (106)
St. Joseph's Hospital Health Center
🇺🇸Syracuse, New York, United States
SUNY - Stony Brook School of Medicine
🇺🇸Stony Brook, New York, United States
SJH Cardiology Associates
🇺🇸Syracuse, New York, United States
Wake Medical Center
🇺🇸Raleigh, North Carolina, United States
Ospedale Riuniti di Bergamo
🇮🇹Bergamo, Italy
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Munroe Medical Center
🇺🇸Ocala, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Ocala Heart Institue
🇺🇸Ocala, Florida, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Florida Cardiovascular Research
🇺🇸Atlantis, Florida, United States
King's College Hospital London
🇬🇧London, United Kingdom
London Chest Hospital
🇬🇧London, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
John Radcliffe Infirmary Oxford II
🇬🇧Oxford, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom
Tufts New England Medical Center
🇺🇸Boston, Massachusetts, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
San Antonio Endovascular Heart Institue
🇺🇸San Antonio, Texas, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Allgemeines Krankenhaus AKH
🇦🇹Vienna, Austria
Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
🇺🇸Rockford, Illinois, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Cape Cod Research Institute
🇺🇸Hyannis, Massachusetts, United States
Cardiac & Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
St. Mary's Hospital
🇺🇸Rochester, Minnesota, United States
Cardiovascular and Thoracic Surgeons of Greensboro
🇺🇸Greensboro, North Carolina, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
St. Mary's Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Sentara Norfolk General Hospital 1st Fl
🇺🇸Norfolk, Virginia, United States
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
Academisch Ziekenhuis Middelheim
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis
🇧🇪Gent, Belgium
Univ. Klinik für Herzchirurgie Landeskliniken
🇦🇹Salzburg, Austria
Centre Hôpital Universitaire Sart Tilman
🇧🇪Liège, Belgium
Skejby Sygehus
🇩🇰Aarhus, Denmark
University Hospital Vinohrady
🇨🇿Praha, Czech Republic
Institut Cardiovasculaire Paris Sud - Massy
🇫🇷Massy, France
Interni Klinika VFN
🇨🇿Praha, Czech Republic
University of Helsinki Meilahti Hospital
🇫🇮Helsinki, Finland
Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
🇫🇷Rouen Cedex, France
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Clinique Pasteur
🇫🇷Toulouse, France
Clinique St Augustin
🇫🇷Bordeaux, France
Clinique Saint-Hilaire Rouen
🇫🇷Rouen, France
Herz- und Diabeteszentrum Nordrhein-Westfalen
🇩🇪Bad Oeynhausen, Germany
CHU Rangueil
🇫🇷Toulouse Cedex 9, France
Universitätsklinikum Campus Kiel
🇩🇪Kiel, Germany
Centre Hôpital Universitaire Rangueil
🇫🇷Toulouse, France
Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
🇩🇪Berlin, Germany
Universitatsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinik Freiburg
🇩🇪Freiburg, Germany
Campus Virchow Klinikum Herzkatheterlabor
🇩🇪Berlin, Germany
Universitatsklinik Charite Berlin, Campus Mitte
🇩🇪Berlin, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Herzzentrum Universität Leipzig
🇩🇪Leipzig, Germany
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Klinikum Grosshadern
🇩🇪München, Germany
Medizinische Universitaet Luebeck
🇩🇪Lübeck, Germany
National Medical Center
🇭🇺Budapest, Hungary
Ospedale San Raffaele
🇮🇹Milan, Italy
University of Debrecen, Medical and Health Science Center
🇭🇺Debrecen, Hungary
Medical School of University PECS
🇭🇺Pecs, Hungary
IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
🇮🇹Massa, Italy
Policlinico San Matteo
🇮🇹Pavia, Italy
Ospedale Civile di Mirano
🇮🇹Mirano, Italy
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
P. Stradins University Hospital
🇱🇻Riga, Latvia
Policlinico Agostino Gemelli
🇮🇹Roma, Italy
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
John Paul II Hospital
🇵🇱Krakow, Poland
Erasmus MC - University Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Isala Klinieken, De Weezenlanden
🇳🇱Zwolle, Netherlands
Rikshospitalet
🇳🇴Oslo, Norway
Jagiellonian University of Cardiology
🇵🇱Krakow, Poland
Medical University of Silesia - Katowice
🇵🇱Katowice, Poland
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
National Institute of Cardiology
🇵🇱Warsaw, Poland
Hospital Clinico Y Provincial
🇪🇸Barcelona, Spain
Hospital General Universitario
🇪🇸Alicante, Spain
Hospital de Santa Marta
🇵🇹Lisboa, Portugal
Hospital Clinico Salamanca
🇪🇸Salamanca, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
University Hospital of Lund
🇸🇪Lund, Sweden
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Karolinska Universitets Sjukhuset - Stockholm
🇸🇪Stockholm, Sweden
Lund University Hospital
🇸🇪Lund, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Western Infirmary
🇬🇧Glasgow, United Kingdom
University Hospital Uppsala
🇸🇪Uppsala, Sweden
Glenfield Hospital
🇬🇧Leicester, United Kingdom
University Hospitals of Leicester NHS Trust Glenfield Hospital
🇬🇧Leicester, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, East Sussex, United Kingdom
Mercy General Hospital
🇺🇸Sacramento, California, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States