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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Coronary Artery Bypass Surgery
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Three-vessel coronary artery disease, Left main coronary artery disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy General Hospital
  • Washington Hospital Center
  • Florida Cardiovascular Research
  • Munroe Medical Center
  • Ocala Heart Institue
  • Florida Hospital
  • Evanston Hospital
  • Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
  • University of Iowa Hospital and Clinics
  • Maine Medical Center
  • Tufts New England Medical Center
  • Cape Cod Hospital
  • Cape Cod Research Institute
  • Genesys Regional Medical Center
  • Spectrum Health
  • Cardiac & Vascular Research Center of Northern Michigan
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • St. Mary's Hospital
  • SUNY - Stony Brook School of Medicine
  • SJH Cardiology Associates
  • St. Joseph's Hospital Health Center
  • LeBauer Cardiovascular Research Foundation
  • Cardiovascular and Thoracic Surgeons of Greensboro
  • Wake Medical Center
  • Forsyth Medical Center
  • Oklahoma Foundation for Cardiovascular Research
  • St. Mary's Medical Center
  • Medical City Dallas Hospital
  • Baylor University Medical Center
  • San Antonio Endovascular Heart Institue
  • Sentara Norfolk General Hospital 1st Fl
  • Univ. Klinik für Herzchirurgie Landeskliniken
  • Allgemeines Krankenhaus AKH
  • Onze Lieve Vrouw Ziekenhuis
  • Academisch Ziekenhuis Middelheim
  • Universitair Ziekenhuis
  • Centre Hôpital Universitaire Sart Tilman
  • University Hospital Vinohrady
  • Interni Klinika VFN
  • Skejby Sygehus
  • Helsinki University Central Hospital
  • University of Helsinki Meilahti Hospital
  • Clinique St Augustin
  • Institut Cardiovasculaire Paris Sud - Massy
  • Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
  • Clinique Saint-Hilaire Rouen
  • CHU Rangueil
  • Clinique Pasteur
  • Centre Hôpital Universitaire Rangueil
  • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Universitatsklinik Charite Berlin, Campus Mitte
  • Campus Virchow Klinikum Herzkatheterlabor
  • Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
  • Universitätsklinik Freiburg
  • Universitatsklinikum Hamburg Eppendorf
  • Universitätsklinikum Campus Kiel
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Herzzentrum Universität Leipzig
  • Medizinische Universitaet Luebeck
  • Klinikum Grosshadern
  • Krankenhaus der Barmherzigen Brüder
  • National Medical Center
  • University of Debrecen, Medical and Health Science Center
  • Medical School of University PECS
  • Ospedale Riuniti di Bergamo
  • Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
  • Ospedale San Raffaele
  • Ospedale Civile di Mirano
  • IRCCS Policlinico S. Matteo
  • Policlinico San Matteo
  • Policlinico Agostino Gemelli
  • Istituto Clinico Humanitas
  • P. Stradins University Hospital
  • Amphia Ziekenhuis
  • Catharina Ziekenhuis
  • Academisch Ziekenhuis Groningen
  • St. Antonius Hospital
  • Erasmus MC - University Medical Center Rotterdam
  • Isala Klinieken, De Weezenlanden
  • Rikshospitalet
  • Medical University of Silesia - Katowice
  • John Paul II Hospital
  • Jagiellonian University of Cardiology
  • National Institute of Cardiology
  • Hospital de Santa Marta
  • Hospital General de Alicante
  • Hospital General Universitario
  • Hospital Clinico Y Provincial
  • Hospital Clinico San Carlos
  • Hospital Clinico Salamanca
  • Sahlgrenska University Hospital
  • University Hospital of Lund
  • Lund University Hospital
  • Karolinska Universitets Sjukhuset - Stockholm
  • Akademiska sjukhuset
  • University Hospital Uppsala
  • Royal Sussex County Hospital
  • Western Infirmary
  • Glenfield Hospital
  • University Hospitals of Leicester NHS Trust Glenfield Hospital
  • London Chest Hospital
  • St Thomas Hospital
  • King's College Hospital London
  • John Radcliffe Infirmary Oxford II
  • Southampton University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCI with DES

CABG (coronary artery bypass graft)

Arm Description

Coronary Artery Bypass Graft

Outcomes

Primary Outcome Measures

Primary Clinical Endpoint of 12-Month Binary MACCE.
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.
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).
Number of participants with repeat revascularization (PCI and/or CABG).

Secondary Outcome Measures

Overall MACCE at 1 Month Post-procedure and at 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.
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.
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.
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.
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
Freedom From MACCE and Its Components at 5 Years Post-allocation
Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
Cost and Cost-effectiveness at 1, 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)

Full Information

First Posted
June 20, 2005
Last Updated
May 27, 2010
Sponsor
Boston Scientific Corporation
Collaborators
Cardialysis BV
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1. Study Identification

Unique Protocol Identification Number
NCT00114972
Brief Title
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Acronym
SYNTAX
Official Title
SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation
Collaborators
Cardialysis BV

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Three-vessel coronary artery disease, Left main coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCI with DES
Arm Type
Experimental
Arm Title
CABG (coronary artery bypass graft)
Arm Type
Active Comparator
Arm Description
Coronary Artery Bypass Graft
Intervention Type
Device
Intervention Name(s)
Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Other Intervention Name(s)
Percutaneous coronary intervention, Paclitaxel eluting stent, 3 vessel disease, Left main stem
Intervention Description
Drug Eluting Stent
Intervention Type
Procedure
Intervention Name(s)
Coronary Artery Bypass Surgery
Other Intervention Name(s)
Coronary artery disease, Coronary artery bypass graft, Left Main coronary artery
Intervention Description
Coronary Artery Bypass Surgery
Primary Outcome Measure Information:
Title
Primary Clinical Endpoint of 12-Month Binary MACCE.
Description
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).
Time Frame
12 months post enrollment
Title
12-month Composite Safety Endpoint.
Description
Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
Time Frame
12 months after enrollment
Title
Repeat Revascularization (PCI and/or CABG).
Description
Number of participants with repeat revascularization (PCI and/or CABG).
Time Frame
12 Months post enrollment
Secondary Outcome Measure Information:
Title
Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
Description
Number of participants with 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
Title
Individual Components of MACCE at 1 Month Post-procedure.
Description
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.
Time Frame
1 month after procedure
Title
Individual Components of MACCE at 6 Months Post-allocation.
Description
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.
Time Frame
6 months post allocation
Title
Individual Components of MACCE at 1 Year Post-allocation.
Description
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.
Time Frame
1 year post allocation
Title
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Description
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).
Time Frame
1 year post allocation
Title
Freedom From MACCE and Its Components at 3 Years Post-allocation
Time Frame
3 years post allocation
Title
Freedom From MACCE and Its Components at 5 Years Post-allocation
Time Frame
5 years post allocation
Title
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
Title
Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
Time Frame
1 year, 3 and 5 years post allocation
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Citations:
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Citation
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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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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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Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, Feldman T, Morice MC, Stahle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys PW. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet. 2013 Feb 23;381(9867):639-50. doi: 10.1016/S0140-6736(13)60108-7.
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Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet. 2013 Feb 23;381(9867):629-38. doi: 10.1016/S0140-6736(13)60141-5.
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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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PubMed Identifier
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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. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
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SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

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