Coronary Artery DiseasePhase 3SYNTAXNCT00114972
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
A Phase 3 study testing Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent and Coronary Artery Bypass Surgery in people with Coronary Artery Disease, run by Boston Scientific Corporation at 106 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent and Coronary Artery Bypass Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 106 sitesin 18 countries
- Study dates
- Mar 2005to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
106 sites in 18 countries.
106 sites in 18 countries
United States32 sites
Florida Cardiovascular Research
Atlantis, Florida, 33462
Tufts New England Medical Center
Boston, Massachusetts, 02111
Medical City Dallas Hospital
Dallas, Texas, 75230
Baylor University Medical Center
Dallas, Texas, 75246
Evanston Hospital
Evanston, Illinois, 60201
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Spectrum Health
Grand Rapids, Michigan, 49503
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Cardiovascular and Thoracic Surgeons of Greensboro
Greensboro, North Carolina, 27405
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Cape Cod Research Institute
Hyannis, Massachusetts, 02601
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
St. Mary's Medical Center
Langhorne, Pennsylvania, 19047
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Sentara Norfolk General Hospital 1st Fl
Norfolk, Virginia, 23507
Munroe Medical Center
Ocala, Florida, 34474
Ocala Heart Institue
Ocala, Florida, 34474
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
Florida Hospital
Orlando, Florida, 32803
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
Maine Medical Center
Portland, Maine, 04102
Wake Medical Center
Raleigh, North Carolina, 27610
Mayo Clinic
Rochester, Minnesota, 55905
St. Mary's Hospital
Rochester, Minnesota, 55905
Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
Rockford, Illinois, 61108-2465
Mercy General Hospital
Sacramento, California, 95819
San Antonio Endovascular Heart Institue
San Antonio, Texas, 78205
SUNY - Stony Brook School of Medicine
Stony Brook, New York, 11794
SJH Cardiology Associates
Syracuse, New York, 13203
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Germany12 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, 32545
Universitatsklinik Charite Berlin, Campus Mitte
Berlin, 10117
Campus Virchow Klinikum Herzkatheterlabor
Berlin, 13353
Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
Berlin, D-13353
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246
Universitätsklinikum Campus Kiel
Kiel, 24105
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Herzzentrum Universität Leipzig
Leipzig, D-04289
Medizinische Universitaet Luebeck
Lübeck, 23538
Klinikum Grosshadern
München, D-81337
Krankenhaus der Barmherzigen Brüder
Trier, D-54292
United Kingdom9 sites
Royal Sussex County Hospital
Brighton, East Sussex, BN2 1ES
Western Infirmary
Glasgow, G11 6NT
Glenfield Hospital
Leicester, LE3 9QP
University Hospitals of Leicester NHS Trust Glenfield Hospital
Leicester, LE3 9QP
London Chest Hospital
London, E2 9JX
St Thomas Hospital
London, SE1 7EH
King's College Hospital London
London, SE5 9RS
John Radcliffe Infirmary Oxford II
Oxford, OX3 9DU
Southampton University Hospital
Southampton, SO16 6YD
Italy8 sites
Ospedale Riuniti di Bergamo
Bergamo, 24128
Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
Massa, 54100
Ospedale San Raffaele
Milan, 20132
Ospedale Civile di Mirano
Mirano, 30035
IRCCS Policlinico S. Matteo
Pavia, 27100
Policlinico San Matteo
Pavia, 27100
Policlinico Agostino Gemelli
Roma, 00161
Istituto Clinico Humanitas
Rozzano, 20089
France7 sites
Clinique St Augustin
Bordeaux, 33000
Institut Cardiovasculaire Paris Sud - Massy
Massy, F-91349
Clinique Saint-Hilaire Rouen
Rouen, 76000
Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
Rouen, 76031
CHU Rangueil
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
Centre Hôpital Universitaire Rangueil
Toulouse, 31403
Netherlands6 sites
Amphia Ziekenhuis
Breda, 4818 CK
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Academisch Ziekenhuis Groningen
Groningen, 9713 GZ
St. Antonius Hospital
Nieuwegein, 3435 CM
Erasmus MC - University Medical Center Rotterdam
Rotterdam, 3000 CA
Isala Klinieken, De Weezenlanden
Zwolle, 8011 JW
Sweden6 sites
Sahlgrenska University Hospital
Gothenburg, 41345
University Hospital of Lund
Lund, SE-221 85
Lund University Hospital
Lund, SE-22181
Karolinska Universitets Sjukhuset - Stockholm
Stockholm, SE-171 76
Akademiska sjukhuset
Uppsala, SE-75185
University Hospital Uppsala
Uppsala, SE-75185
Spain5 sites
Hospital General de Alicante
Alicante, 03010
Hospital General Universitario
Alicante, 03010
Hospital Clinico Y Provincial
Barcelona, ES-08036
Hospital Clinico San Carlos
Madrid, ES-28040
Hospital Clinico Salamanca
Salamanca, 37008
Belgium4 sites
Onze Lieve Vrouw Ziekenhuis
Aalst, B-9300
Academisch Ziekenhuis Middelheim
Antwerp, B-2020
Universitair Ziekenhuis
Ghent, B-9000
Centre Hôpital Universitaire Sart Tilman
Liège, B-4000
Poland4 sites
Medical University of Silesia - Katowice
Katowice, 40635
John Paul II Hospital
Krakow, 31-202
Jagiellonian University of Cardiology
Krakow, 31-501
National Institute of Cardiology
Warsaw, 04-628
Hungary3 sites
National Medical Center
Budapest, 1134
University of Debrecen, Medical and Health Science Center
Debrecen, 4032
Medical School of University PECS
Pécs, 1135
Austria2 sites
Univ. Klinik für Herzchirurgie Landeskliniken
Salzburg, A-5020
Allgemeines Krankenhaus AKH
Vienna, A-1090
Czechia2 sites
University Hospital Vinohrady
Prague, CZ-100 34
Interni Klinika VFN
Prague, CZ-128 08
Finland2 sites
Helsinki University Central Hospital
Helsinki, FIN-00290 HUS
University of Helsinki Meilahti Hospital
Helsinki, FIN-00290 HUS
About this study
Official title: 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).
Read the 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
- Being tested
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent, Coronary Artery Bypass Surgery
- Keywords
- Three-vessel coronary artery disease, Left main coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer-based Paclitaxel-Eluting TAXUS Express2-SR StentDevice
Also called Percutaneous coronary intervention, Paclitaxel eluting stent, 3 vessel disease, Left main stem
Drug Eluting Stent
Coronary Artery Bypass SurgeryProcedure or surgery
Also called Coronary artery disease, Coronary artery bypass graft, Left Main coronary artery
Coronary Artery Bypass Surgery
| Study group | Role | What they receive |
|---|---|---|
| PCI with DES | Experimental | Not described Receives: Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent |
| CABG (coronary artery bypass graft) | Active comparator | Coronary Artery Bypass Graft Receives: Procedure: Coronary Artery Bypass Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post enrollment
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.
Measured: 12 months after enrollment
Repeat Revascularization (PCI and/or CABG).
Number of participants with repeat revascularization (PCI and/or CABG).
Measured: 12 Months post enrollment
Secondary outcomes (10)
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.
Measured: 1 month after procedure and 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.
Measured: 1 month after procedure
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.
Measured: 6 months post allocation
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.
Measured: 1 year post allocation
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).
Measured: 1 year post allocation
Freedom From MACCE and Its Components at 3 Years Post-allocation
Measured: 3 years post allocation
Freedom From MACCE and Its Components at 5 Years Post-allocation
Measured: 5 years post allocation
Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
Measured: 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
Measured: 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)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2005 (estimated)
- Study startMar 2005
- Primary completionApr 2008
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV
- Investigators
- Patrick W. Serruys, MD, PhD, Principal investigator, Erasmus Medical CenterFriedrich W Mohr, MD, Principal investigator, Heart Center Leipzig - University HospitalMonika Hanisch, PhD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114972
- Sponsor's protocol ID
- S2024
- Other IDs
- 90169394
- Acronym
- SYNTAX
- Status last verified
- May 2010
- First submitted
- 20 Jun 2005
- Last updated
- 23 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Serruys PW, Ninomiya K, Revaiah PC, Gao C, Garg S, van Klaveren D, Onuma Y, Kappetein AP, Davierwala P, Mack M, Thuijs DJFM, Taggart DP, Milojevic M. Ten-year survival benefit and appropriateness of surgical versus percutaneous revascularization in synergy between percutaneous coronary intervention with Taxus and cardiac surgery randomized trial. Eur J Cardiothorac Surg. 2024 Nov 4;66(5):ezae391. doi: 10.1093/ejcts/ezae391.
PubMed 39447048Gaba P, Sabik JF, Murphy SA, Bellavia A, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Christiansen EH, Holm NR, Nielsen PH, Sabatine MS, Stone GW, Bergmark BA. Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation. 2024 Apr 23;149(17):1328-1338. doi: 10.1161/CIRCULATIONAHA.123.065571. Epub 2024 Mar 11.
PubMed 38465592Ninomiya K, Kageyama S, Shiomi H, Kotoku N, Masuda S, Revaiah PC, Garg S, O'Leary N, van Klaveren D, Kimura T, Onuma Y, Serruys PW; SYNTAX Investigators. Can Machine Learning Aid the Selection of Percutaneous vs Surgical Revascularization? J Am Coll Cardiol. 2023 Nov 28;82(22):2113-2124. doi: 10.1016/j.jacc.2023.09.818.
PubMed 37993203Ninomiya K, Kageyama S, Garg S, Masuda S, Kotoku N, Revaiah PC, O'leary N, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Can machine learning unravel unsuspected, clinically important factors predictive of long-term mortality in complex coronary artery disease? A call for 'big data'. Eur Heart J Digit Health. 2023 Feb 28;4(3):275-278. doi: 10.1093/ehjdh/ztad014. eCollection 2023 May.
PubMed 37265868Gaba P, Christiansen EH, Nielsen PH, Murphy SA, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Stone GW, Sabik JF, Sabatine MS, Holm NR, Bergmark BA. Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials. JAMA Cardiol. 2023 Jul 1;8(7):631-639. doi: 10.1001/jamacardio.2023.1177.
PubMed 37256598Wang R, Lunardi M, Hara H, Gao C, Ono M, Davierwala PM, Holmes DR, Mohr FW, Curzen N, Burzotta F, van Geuns RJ, Kappetein AP, Head SJ, Thuijs DJFM, Tao L, Garg S, Onuma Y, Wijns W, Serruys PW. Impact of repeat revascularization within 5 years on 10-year mortality after percutaneous or surgical revascularization. Clin Res Cardiol. 2023 Sep;112(9):1302-1311. doi: 10.1007/s00392-023-02211-6. Epub 2023 May 8.
PubMed 37150783Ono M, Serruys PW, Kawashima H, Lunardi M, Wang R, Hara H, Gao C, Garg S, O'Leary N, Wykrzykowska JJ, Piek JJ, Holmes DR, Morice MC, Kappetein AP, Noack T, Davierwala PM, Spertus JA, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. Impact of residual angina on long-term clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft for complex coronary artery disease. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):490-501. doi: 10.1093/ehjqcco/qcac052.
PubMed 36001991Ono M, Serruys PW, Garg S, Kawashima H, Gao C, Hara H, Lunardi M, Wang R, O'Leary N, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Noack T, Mohr FW, Davierwala PM, Spertus JA, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. Effect of Patient-Reported Preprocedural Physical and Mental Health on 10-Year Mortality After Percutaneous or Surgical Coronary Revascularization. Circulation. 2022 Oct 25;146(17):1268-1280. doi: 10.1161/CIRCULATIONAHA.121.057021. Epub 2022 Jul 18.
PubMed 35862109Ono M, Hara H, Gao C, Kawashima H, Wang R, O'Leary N, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes D, Morice MC, Head S, Kappetein AP, Noack T, Davierwala PM, Mohr FW, Garg S, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Mortality after multivessel revascularisation involving the proximal left anterior descending artery. Heart. 2022 Oct 28;108(22):1784-1791. doi: 10.1136/heartjnl-2022-320934.
PubMed 35732441Ninomiya K, Serruys PW, Garg S, Gao C, Masuda S, Lunardi M, Lassen JF, Banning AP, Colombo A, Burzotta F, Morice MC, Mack MJ, Holmes DR, Davierwala PM, Thuijs DJFM, van Klaveren D, Onuma Y; SYNTAX Extended Survival Investigators. Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1231-1242. doi: 10.1016/j.jcin.2022.04.025. Epub 2022 May 17.
PubMed 35595676Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.
PubMed 35422242Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification. JACC Cardiovasc Interv. 2022 Jan 24;15(2):193-204. doi: 10.1016/j.jcin.2021.10.026. Epub 2021 Dec 29.
PubMed 34973904Hara H, Kawashima H, Ono M, Takahashi K, Mack MJ, Holmes DR Jr, Morice MC, Davierwala PM, Mohr FW, Thuijs DJFM, Kappetein AP, O'Leary N, van Klaveren D, Onuma Y, Serruys PW. Impact of preprocedural biological markers on 10-year mortality in the SYNTAXES trial. EuroIntervention. 2022 Apr 22;17(18):1477-1487. doi: 10.4244/EIJ-D-21-00415.
PubMed 34669586Thuijs DJFM, Davierwala P, Milojevic M, Deo SV, Noack T, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle LEGE, Verberkmoes NJ, Holmes DR, Head SJ; SYNTAX Extended Survival Investigators. Long-term survival after coronary bypass surgery with multiple versus single arterial grafts. Eur J Cardiothorac Surg. 2022 Mar 24;61(4):925-933. doi: 10.1093/ejcts/ezab392.
PubMed 34618017Wang R, Garg S, Gao C, Kawashima H, Ono M, Hara H, van Geuns RJ, Morice MC, Davierwala PM, Kappetein AP, Holmes DR, Wijns W, Tao L, Onuma Y, Serruys PW. Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease. Clin Res Cardiol. 2021 Oct;110(10):1680-1691. doi: 10.1007/s00392-021-01922-y. Epub 2021 Aug 25.
PubMed 34432113
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00114972
- Acronym / sponsor ID
- SYNTAX / S2024
- Conditions
- Coronary Artery Disease
- Keywords
- Three-vessel coronary artery disease, Left main coronary artery disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV
- Study start
- Mar 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 21 Jun 2005 (estimated)
- Results
- Posted 23 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI with DES | Experimental | Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent |
| CABG (coronary artery bypass graft) | Active comparator | Procedure: Coronary Artery Bypass SurgeryCoronary Artery Bypass Graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymer-based Paclitaxel-Eluting TAXUS Express2-SR StentAlso: Percutaneous coronary intervention, Paclitaxel eluting stent, 3 vessel disease, Left main stemDrug Eluting Stent | Device | PCI with DES |
| Coronary Artery Bypass SurgeryAlso: Coronary artery disease, Coronary artery bypass graft, Left Main coronary arteryCoronary Artery Bypass Surgery | Procedure or surgery | CABG (coronary artery bypass graft) |
Primary outcome
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-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.
Repeat Revascularization (PCI and/or CABG).
Time frame: 12 Months post enrollment
Number of participants with repeat revascularization (PCI and/or CABG).
10 secondary outcomes
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
Individual Components of MACCE at 1 Month Post-procedure.
Time frame: 1 month after procedure
Individual Components of MACCE at 6 Months Post-allocation.
Time frame: 6 months post allocation
Individual Components of MACCE at 1 Year Post-allocation.
Time frame: 1 year post allocation
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Time frame: 1 year post allocation
Freedom From MACCE and Its Components at 3 Years Post-allocation
Time frame: 3 years post allocation
Freedom From MACCE and Its Components at 5 Years Post-allocation
Time frame: 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
Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39447048Serruys PW, Ninomiya K, Revaiah PC, Gao C, Garg S, van Klaveren D, Onuma Y, Kappetein AP, Davierwala P, Mack M, Thuijs DJFM, Taggart DP, Milojevic M. Ten-year survival benefit and appropriateness of surgical versus percutaneous revascularization in synergy between percutaneous coronary intervention with Taxus and cardiac surgery randomized trial. Eur J Cardiothorac Surg. 2024 Nov 4;66(5):ezae391. doi: 10.1093/ejcts/ezae391.
- Derived from this study: PubMed 38465592Gaba P, Sabik JF, Murphy SA, Bellavia A, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Christiansen EH, Holm NR, Nielsen PH, Sabatine MS, Stone GW, Bergmark BA. Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation. 2024 Apr 23;149(17):1328-1338. doi: 10.1161/CIRCULATIONAHA.123.065571. Epub 2024 Mar 11.
- Derived from this study: PubMed 37993203Ninomiya K, Kageyama S, Shiomi H, Kotoku N, Masuda S, Revaiah PC, Garg S, O'Leary N, van Klaveren D, Kimura T, Onuma Y, Serruys PW; SYNTAX Investigators. Can Machine Learning Aid the Selection of Percutaneous vs Surgical Revascularization? J Am Coll Cardiol. 2023 Nov 28;82(22):2113-2124. doi: 10.1016/j.jacc.2023.09.818.
- Derived from this study: PubMed 37265868Ninomiya K, Kageyama S, Garg S, Masuda S, Kotoku N, Revaiah PC, O'leary N, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Can machine learning unravel unsuspected, clinically important factors predictive of long-term mortality in complex coronary artery disease? A call for 'big data'. Eur Heart J Digit Health. 2023 Feb 28;4(3):275-278. doi: 10.1093/ehjdh/ztad014. eCollection 2023 May.
- Derived from this study: PubMed 37256598Gaba P, Christiansen EH, Nielsen PH, Murphy SA, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Stone GW, Sabik JF, Sabatine MS, Holm NR, Bergmark BA. Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials. JAMA Cardiol. 2023 Jul 1;8(7):631-639. doi: 10.1001/jamacardio.2023.1177.
- Derived from this study: PubMed 37150783Wang R, Lunardi M, Hara H, Gao C, Ono M, Davierwala PM, Holmes DR, Mohr FW, Curzen N, Burzotta F, van Geuns RJ, Kappetein AP, Head SJ, Thuijs DJFM, Tao L, Garg S, Onuma Y, Wijns W, Serruys PW. Impact of repeat revascularization within 5 years on 10-year mortality after percutaneous or surgical revascularization. Clin Res Cardiol. 2023 Sep;112(9):1302-1311. doi: 10.1007/s00392-023-02211-6. Epub 2023 May 8.
- Derived from this study: PubMed 36001991Ono M, Serruys PW, Kawashima H, Lunardi M, Wang R, Hara H, Gao C, Garg S, O'Leary N, Wykrzykowska JJ, Piek JJ, Holmes DR, Morice MC, Kappetein AP, Noack T, Davierwala PM, Spertus JA, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. Impact of residual angina on long-term clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft for complex coronary artery disease. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):490-501. doi: 10.1093/ehjqcco/qcac052.
- Derived from this study: PubMed 35862109Ono M, Serruys PW, Garg S, Kawashima H, Gao C, Hara H, Lunardi M, Wang R, O'Leary N, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Noack T, Mohr FW, Davierwala PM, Spertus JA, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. Effect of Patient-Reported Preprocedural Physical and Mental Health on 10-Year Mortality After Percutaneous or Surgical Coronary Revascularization. Circulation. 2022 Oct 25;146(17):1268-1280. doi: 10.1161/CIRCULATIONAHA.121.057021. Epub 2022 Jul 18.
- Derived from this study: PubMed 35732441Ono M, Hara H, Gao C, Kawashima H, Wang R, O'Leary N, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes D, Morice MC, Head S, Kappetein AP, Noack T, Davierwala PM, Mohr FW, Garg S, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Mortality after multivessel revascularisation involving the proximal left anterior descending artery. Heart. 2022 Oct 28;108(22):1784-1791. doi: 10.1136/heartjnl-2022-320934.
- Derived from this study: PubMed 35595676Ninomiya K, Serruys PW, Garg S, Gao C, Masuda S, Lunardi M, Lassen JF, Banning AP, Colombo A, Burzotta F, Morice MC, Mack MJ, Holmes DR, Davierwala PM, Thuijs DJFM, van Klaveren D, Onuma Y; SYNTAX Extended Survival Investigators. Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1231-1242. doi: 10.1016/j.jcin.2022.04.025. Epub 2022 May 17.
- Derived from this study: PubMed 35422242Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.
- Derived from this study: PubMed 34973904Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification. JACC Cardiovasc Interv. 2022 Jan 24;15(2):193-204. doi: 10.1016/j.jcin.2021.10.026. Epub 2021 Dec 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick W. Serruys, MD, PhD principal investigator
Erasmus Medical Center
Friedrich W Mohr, MD principal investigator
Heart Center Leipzig - University Hospital
Monika Hanisch, PhD study director
Boston Scientific Corporation
106 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent and Coronary Artery Bypass Surgery in people with Coronary Artery Disease, run by Boston Scientific Corporation at 106 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Germany, United Kingdom, Italy, France and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Clinical Endpoint of 12-Month Binary MACCE. (time frame: 12 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114972, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2010.