Clinical trial NCT00114972: SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Official title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Three-vessel coronary artery disease
Left main coronary artery disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Cardialysis BV
First posted: 2005-06-21
Enrollment: 1800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Clinical Endpoint of 12-Month Binary MACCE.
timeFrame: 12 months post enrollment
measure: 12-month Composite Safety Endpoint.
timeFrame: 12 months after enrollment
measure: Repeat Revascularization (PCI and/or CABG).
timeFrame: 12 Months post enrollment
Secondary outcomes:
measure: Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
timeFrame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation
measure: Individual Components of MACCE at 1 Month Post-procedure.
timeFrame: 1 month after procedure
measure: Individual Components of MACCE at 6 Months Post-allocation.
timeFrame: 6 months post allocation
measure: Individual Components of MACCE at 1 Year Post-allocation.
timeFrame: 1 year post allocation
measure: Freedom From MACCE and Its Components at 1 Year Post-allocation.
timeFrame: 1 year post allocation
measure: Freedom From MACCE and Its Components at 3 Years Post-allocation
timeFrame: 3 years post allocation
measure: Freedom From MACCE and Its Components at 5 Years Post-allocation
timeFrame: 5 years post allocation
measure: Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
timeFrame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation
measure: Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
timeFrame: 1 year, 3 and 5 years post allocation
measure: 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)
timeFrame: 5 Years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: Florida Cardiovascular Research
state: Florida
city: Ocala
country: United States
facility: Munroe Medical Center
state: Florida
city: Ocala
country: United States
facility: Ocala Heart Institue
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Rockford
country: United States
facility: Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: St. Mary's Hospital
state: Minnesota
city: Stony Brook
country: United States
facility: SUNY - Stony Brook School of Medicine
state: New York
city: Syracuse
country: United States
facility: SJH Cardiology Associates
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Greensboro
country: United States
facility: Cardiovascular and Thoracic Surgeons of Greensboro
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Langhorne
country: United States
facility: St. Mary's Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Endovascular Heart Institue
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital 1st Fl
state: Virginia
city: Salzburg
country: Austria
facility: Univ. Klinik für Herzchirurgie Landeskliniken
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Antwerpen
country: Belgium
facility: Academisch Ziekenhuis Middelheim
city: Gent
country: Belgium
facility: Universitair Ziekenhuis
city: Liège
country: Belgium
facility: Centre Hôpital Universitaire Sart Tilman
city: Praha
country: Czech Republic
facility: University Hospital Vinohrady
city: Praha
country: Czech Republic
facility: Interni Klinika VFN
city: Aarhus
country: Denmark
facility: Skejby Sygehus
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Helsinki
country: Finland
facility: University of Helsinki Meilahti Hospital
city: Bordeaux
country: France
facility: Clinique St Augustin
city: Massy
country: France
facility: Institut Cardiovasculaire Paris Sud - Massy
city: Rouen Cedex
country: France
facility: Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
city: Rouen
country: France
facility: Clinique Saint-Hilaire Rouen
city: Toulouse Cedex 9
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueil
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Universitatsklinik Charite Berlin, Campus Mitte
city: Berlin
country: Germany
facility: Campus Virchow Klinikum Herzkatheterlabor
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Kiel
country: Germany
facility: Universitätsklinikum Campus Kiel
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Leipzig
country: Germany
facility: Herzzentrum Universität Leipzig
city: Lübeck
country: Germany
facility: Medizinische Universitaet Luebeck
city: München
country: Germany
facility: Klinikum Grosshadern
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Budapest
country: Hungary
facility: National Medical Center
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Science Center
city: Pecs
country: Hungary
facility: Medical School of University PECS
city: Bergamo
country: Italy
facility: Ospedale Riuniti di Bergamo
city: Massa
country: Italy
facility: Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Mirano
country: Italy
facility: Ospedale Civile di Mirano
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Riga
country: Latvia
facility: P. Stradins University Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC - University Medical Center Rotterdam
city: Zwolle
country: Netherlands
facility: Isala Klinieken, De Weezenlanden
city: Oslo
country: Norway
facility: Rikshospitalet
city: Katowice
country: Poland
facility: Medical University of Silesia - Katowice
city: Krakow
country: Poland
facility: John Paul II Hospital
city: Krakow
country: Poland
facility: Jagiellonian University of Cardiology
city: Warsaw
country: Poland
facility: National Institute of Cardiology
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Alicante
country: Spain
facility: Hospital General Universitario
city: Barcelona
country: Spain
facility: Hospital Clinico Y Provincial
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Salamanca
country: Spain
facility: Hospital Clinico Salamanca
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: University Hospital of Lund
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Universitets Sjukhuset - Stockholm
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Uppsala
country: Sweden
facility: University Hospital Uppsala
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: East Sussex
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust Glenfield Hospital
city: London
country: United Kingdom
facility: London Chest Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: King's College Hospital London
city: Oxford
country: United Kingdom
facility: John Radcliffe Infirmary Oxford II
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Patrick W. Serruys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Leipzig - University Hospital
name: Friedrich W Mohr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Monika Hanisch, PhD
role: STUDY_DIRECTOR
References:
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