NCT00114972

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Strong global presence with extensive site network
Enrollment
1,800

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
18 countries

106 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 23, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 23, 2010

Status Verified

May 1, 2010

Enrollment Period

3.1 years

First QC Date

June 20, 2005

Results QC Date

March 27, 2009

Last Update Submit

May 27, 2010

Conditions

Keywords

Three-vessel coronary artery diseaseLeft main coronary artery disease

Outcome Measures

Primary Outcomes (3)

  • 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 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.

    12 months after enrollment

  • Repeat Revascularization (PCI and/or CABG).

    Number of participants with repeat revascularization (PCI and/or CABG).

    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.

    1 month after procedure and 6 months, 3 years, and 5 years post allocation

  • Individual Components of MACCE at 1 Month Post-procedure.

    1 month after procedure

  • Individual Components of MACCE at 6 Months Post-allocation.

    6 months post allocation

  • Individual Components of MACCE at 1 Year Post-allocation.

    1 year post allocation

  • Freedom From MACCE and Its Components at 1 Year Post-allocation.

    1 year post allocation

  • +5 more secondary outcomes

Study Arms (2)

PCI with DES

EXPERIMENTAL
Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent

CABG (coronary artery bypass graft)

ACTIVE COMPARATOR

Coronary Artery Bypass Graft

Procedure: Coronary Artery Bypass Surgery

Interventions

Drug Eluting Stent

Also known as: Percutaneous coronary intervention, Paclitaxel eluting stent, 3 vessel disease, Left main stem
PCI with DES

Coronary Artery Bypass Surgery

Also known as: Coronary artery disease, Coronary artery bypass graft, Left Main coronary artery
CABG (coronary artery bypass graft)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (106)

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Cardiovascular Research

Atlantis, Florida, 33462, United States

Location

Munroe Medical Center

Ocala, Florida, 34474, United States

Location

Ocala Heart Institue

Ocala, Florida, 34474, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Rockford Cardiology Research Foundation (St. Anthony's Medical Center)

Rockford, Illinois, 61108-2465, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Cape Cod Research Institute

Hyannis, Massachusetts, 02601, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Mary's Hospital

Rochester, Minnesota, 55905, United States

Location

SUNY - Stony Brook School of Medicine

Stony Brook, New York, 11794, United States

Location

SJH Cardiology Associates

Syracuse, New York, 13203, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Cardiovascular and Thoracic Surgeons of Greensboro

Greensboro, North Carolina, 27405, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

St. Mary's Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

San Antonio Endovascular Heart Institue

San Antonio, Texas, 78205, United States

Location

Sentara Norfolk General Hospital 1st Fl

Norfolk, Virginia, 23507, United States

Location

Univ. Klinik fĂ¼r Herzchirurgie Landeskliniken

Salzburg, A-5020, Austria

Location

Allgemeines Krankenhaus AKH

Vienna, A-1090, Austria

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, B-9300, Belgium

Location

Academisch Ziekenhuis Middelheim

Antwerp, B-2020, Belgium

Location

Universitair Ziekenhuis

Ghent, B-9000, Belgium

Location

Centre HĂ´pital Universitaire Sart Tilman

Liège, B-4000, Belgium

Location

University Hospital Vinohrady

Prague, CZ-100 34, Czechia

Location

Interni Klinika VFN

Prague, CZ-128 08, Czechia

Location

Skejby Sygehus

Aarhus, D-8200, Denmark

Location

Helsinki University Central Hospital

Helsinki, FIN-00290 HUS, Finland

Location

University of Helsinki Meilahti Hospital

Helsinki, FIN-00290 HUS, Finland

Location

Clinique St Augustin

Bordeaux, 33000, France

Location

Institut Cardiovasculaire Paris Sud - Massy

Massy, F-91349, France

Location

Clinique Saint-Hilaire Rouen

Rouen, 76000, France

Location

Centre Hopital Universitaire Rouen - Hopital Charles Nicolle

Rouen, 76031, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Centre HĂ´pital Universitaire Rangueil

Toulouse, 31403, France

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, 32545, Germany

Location

Universitatsklinik Charite Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Campus Virchow Klinikum Herzkatheterlabor

Berlin, 13353, Germany

Location

Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitatsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Herzzentrum Universität Leipzig

Leipzig, D-04289, Germany

Location

Medizinische Universitaet Luebeck

LĂ¼beck, 23538, Germany

Location

Klinikum Grosshadern

MĂ¼nchen, D-81337, Germany

Location

Krankenhaus der Barmherzigen BrĂ¼der

Trier, D-54292, Germany

Location

National Medical Center

Budapest, 1134, Hungary

Location

University of Debrecen, Medical and Health Science Center

Debrecen, 4032, Hungary

Location

Medical School of University PECS

Pécs, 1135, Hungary

Location

Ospedale Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale

Massa, 54100, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Ospedale Civile di Mirano

Mirano, 30035, Italy

Location

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Policlinico San Matteo

Pavia, 27100, Italy

Location

Policlinico Agostino Gemelli

Roma, 00161, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

P. Stradins University Hospital

Riga, LV-1002, Latvia

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 GZ, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus MC - University Medical Center Rotterdam

Rotterdam, 3000 CA, Netherlands

Location

Isala Klinieken, De Weezenlanden

Zwolle, 8011 JW, Netherlands

Location

Rikshospitalet

Oslo, 0027, Norway

Location

Medical University of Silesia - Katowice

Katowice, 40635, Poland

Location

John Paul II Hospital

Krakow, 31-202, Poland

Location

Jagiellonian University of Cardiology

Krakow, 31-501, Poland

Location

National Institute of Cardiology

Warsaw, 04-628, Poland

Location

Hospital de Santa Marta

Lisbon, 1169-024, Portugal

Location

Hospital General de Alicante

Alicante, 03010, Spain

Location

Hospital General Universitario

Alicante, 03010, Spain

Location

Hospital Clinico Y Provincial

Barcelona, ES-08036, Spain

Location

Hospital Clinico San Carlos

Madrid, ES-28040, Spain

Location

Hospital Clinico Salamanca

Salamanca, 37008, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

University Hospital of Lund

Lund, SE-221 85, Sweden

Location

Lund University Hospital

Lund, SE-22181, Sweden

Location

Karolinska Universitets Sjukhuset - Stockholm

Stockholm, SE-171 76, Sweden

Location

Akademiska sjukhuset

Uppsala, SE-75185, Sweden

Location

University Hospital Uppsala

Uppsala, SE-75185, Sweden

Location

Royal Sussex County Hospital

Brighton, East Sussex, BN2 1ES, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

University Hospitals of Leicester NHS Trust Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

London Chest Hospital

London, E2 9JX, United Kingdom

Location

St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital London

London, SE5 9RS, United Kingdom

Location

John Radcliffe Infirmary Oxford II

Oxford, OX3 9DU, United Kingdom

Location

Southampton University Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (58)

  • 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.

  • Gaba 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.

  • Ninomiya 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.

  • Ninomiya 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.

  • Gaba 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.

  • Wang 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.

  • Ono 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.

  • Ono 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.

  • Ono 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.

  • Ninomiya 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.

  • Takahashi 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.

  • Kawashima 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.

  • Hara 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.

  • Thuijs 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.

  • Wang 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.

  • Davierwala PM, Gao C, Thuijs DJFM, Wang R, Hara H, Ono M, Noack T, Garg S, O'leary N, Milojevic M, Kappetein AP, Morice MC, Mack MJ, van Geuns RJ, Holmes DR, Gaudino M, Taggart DP, Onuma Y, Mohr FW, Serruys PW; SYNTAX Extended Survival Investigators. Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease. Eur Heart J. 2022 Mar 31;43(13):1334-1344. doi: 10.1093/eurheartj/ehab537.

  • Wang R, Serruys PW, Gao C, Hara H, Takahashi K, Ono M, Kawashima H, O'leary N, Holmes DR, Witkowski A, Curzen N, Burzotta F, James S, van Geuns RJ, Kappetein AP, Morel MA, Head SJ, Thuijs DJFM, Davierwala PM, O'Brien T, Fuster V, Garg S, Onuma Y. Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease. Eur Heart J. 2021 Dec 28;43(1):56-67. doi: 10.1093/eurheartj/ehab441.

  • Ono M, Kawashima H, Hara H, Mancone M, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Noack T, Mohr FW, Davierwala PM, Onuma Y, Serruys PW; SYNTAX Extended Survival Investigators. Impact of major infections on 10-year mortality after revascularization in patients with complex coronary artery disease. Int J Cardiol. 2021 Oct 15;341:9-12. doi: 10.1016/j.ijcard.2021.08.013. Epub 2021 Aug 8.

  • Kawashima H, Serruys PW, Ono M, Hara H, O'Leary N, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Sharif F, McEvoy JW, Onuma Y; SYNTAX Extended Survival Investigators. Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization. J Am Coll Cardiol. 2021 Jul 6;78(1):27-38. doi: 10.1016/j.jacc.2021.04.087.

  • Ono M, Serruys PW, Hara H, Kawashima H, Gao C, Wang R, Takahashi K, O'Leary N, Wykrzykowska JJ, Sharif F, Piek JJ, Garg S, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Davierwala PM, Mohr FW, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease. J Am Coll Cardiol. 2021 Jun 8;77(22):2761-2773. doi: 10.1016/j.jacc.2021.04.016.

  • Ono M, Kawashima H, Hara H, O'Leary N, Gao C, Wang R, Takahashi K, Wykrzykowska JJ, Piek JJ, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Friedrich MW, Davierwala PM, McEvoy JW, Onuma Y, Serruys PW. Impact of Body Composition Indices on Ten-year Mortality After Revascularization of Complex Coronary Artery Disease (From the Syntax Extended Survival Trial). Am J Cardiol. 2021 Jul 15;151:30-38. doi: 10.1016/j.amjcard.2021.04.008. Epub 2021 May 26.

  • Takahashi K, Serruys PW, Gao C, Ono M, Wang R, Thuijs DJFM, Mack MJ, Curzen N, Mohr FW, Davierwala P, Milojevic M, Wykrzykowska JJ, de Winter RJ, Sharif F, Onuma Y, Head SJ, Kappetein AP, Morice MC, Holmes DR Jr; SYNTAX Extended Survival Study Investigators. Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study. Circulation. 2021 Jul 13;144(2):96-109. doi: 10.1161/CIRCULATIONAHA.120.046289. Epub 2021 May 20.

  • Wang R, Tomaniak M, Takahashi K, Gao C, Kawashima H, Hara H, Ono M, van Klaveren D, van Geuns RJ, Morice MC, Davierwala PM, Mack MJ, Witkowski A, Curzen N, Berti S, Burzotta F, James S, Kappetein AP, Head SJ, Thuijs DJFM, Mohr FW, Holmes DR, Tao L, Onuma Y, Serruys PW. Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study. Clin Res Cardiol. 2021 Jul;110(7):1083-1095. doi: 10.1007/s00392-021-01833-y. Epub 2021 Mar 12.

  • Takahashi K, Thuijs DJFM, Gao C, Ono M, Holmes DR, Mack MJ, Morice MC, Mohr FW, Curzen N, Davierwala PM, Milojevic M, Dawkins KD, Wykrzykowska JJ, de Winter RJ, McEvoy JW, Onuma Y, Head SJ, Kappetein AP, Serruys PW; SYNTAX Extended Survival Study Investigators. Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization. Eur J Prev Cardiol. 2022 Mar 11;29(2):312-320. doi: 10.1093/eurjpc/zwaa089.

  • Kawashima H, Takahashi K, Ono M, Hara H, Wang R, Gao C, Sharif F, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Serruys PW, Onuma Y; SYNTAX Extended Survival Investigators. Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions. J Am Coll Cardiol. 2021 Feb 9;77(5):529-540. doi: 10.1016/j.jacc.2020.11.055.

  • Wang R, Takahashi K, Garg S, Thuijs DJFM, Kappetein AP, Mack MJ, Morice MC, Mohr FW, Curzen N, Davierwala P, Milojevic M, van Geuns RJ, Head SJ, Onuma Y, Holmes DR Jr, Serruys PW. Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study. Clin Res Cardiol. 2021 Oct;110(10):1543-1553. doi: 10.1007/s00392-020-01802-x. Epub 2021 Jan 30.

  • Hara H, Serruys PW, Takahashi K, Kawashima H, Ono M, Gao C, Wang R, Mohr FW, Holmes DR, Davierwala PM, Head SJ, Thuijs DJFM, Milojevic M, Kappetein AP, Garg S, Onuma Y, Mack MJ; SYNTAX Extended Survival Investigators. Impact of Peri-Procedural Myocardial Infarction on Outcomes After Revascularization. J Am Coll Cardiol. 2020 Oct 6;76(14):1622-1639. doi: 10.1016/j.jacc.2020.08.009.

  • Hara H, Takahashi K, van Klaveren D, Wang R, Garg S, Ono M, Kawashima H, Gao C, Mack M, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Onuma Y, Noack T, Mohr FW, Davierwala PM, Serruys PW; SYNTAX Extended Survival Investigators. Sex Differences in All-Cause Mortality in the Decade Following Complex Coronary Revascularization. J Am Coll Cardiol. 2020 Aug 25;76(8):889-899. doi: 10.1016/j.jacc.2020.06.066.

  • Modolo R, Chichareon P, Kogame N, Dressler O, Crowley A, Ben-Yehuda O, Puskas J, Banning A, Taggart DP, Kappetein AP, Sabik JA, Onuma Y, Stone GW, Serruys PW. Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease. J Am Coll Cardiol. 2019 Apr 23;73(15):1877-1886. doi: 10.1016/j.jacc.2018.12.090.

  • Milojevic M, Head SJ, Mack MJ, Mohr FW, Morice MC, Dawkins KD, Holmes DR Jr, Serruys PW, Kappetein AP. Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):445-453. doi: 10.1093/ejcts/ezx104.

  • Sotomi Y, Onuma Y, Cavalcante R, Ahn JM, Lee CW, van Klaveren D, de Winter RJ, Wykrzykowska JJ, Farooq V, Morice MC, Steyerberg EW, Park SJ, Serruys PW. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017 May;10(5):e005027. doi: 10.1161/CIRCINTERVENTIONS.117.005027.

  • Abdallah MS, Wang K, Magnuson EA, Osnabrugge RL, Kappetein AP, Morice MC, Mohr FA, Serruys PW, Cohen DJ; SYNTAX Trial Investigators. Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease. J Am Coll Cardiol. 2017 Apr 25;69(16):2039-2050. doi: 10.1016/j.jacc.2017.02.031.

  • Cavalcante R, Sotomi Y, Zeng Y, Lee CW, Ahn JM, Collet C, Tenekecioglu E, Suwannasom P, Onuma Y, Park SJ, Serruys PW. Coronary bypass surgery versus stenting in multivessel disease involving the proximal left anterior descending coronary artery. Heart. 2017 Mar;103(6):428-433. doi: 10.1136/heartjnl-2016-309720. Epub 2016 Sep 20.

  • Migliorini A, Valenti R, Parodi G, Vergara R, Buonamici P, Cerisano G, Carrabba N, Antoniucci D. Angiographic and Clinical Outcomes After Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity. JACC Cardiovasc Interv. 2016 May 23;9(10):1001-7. doi: 10.1016/j.jcin.2016.02.016.

  • Milojevic M, Head SJ, Parasca CA, Serruys PW, Mohr FW, Morice MC, Mack MJ, Stahle E, Feldman TE, Dawkins KD, Colombo A, Kappetein AP, Holmes DR Jr. Causes of Death Following PCI Versus CABG in Complex CAD: 5-Year Follow-Up of SYNTAX. J Am Coll Cardiol. 2016 Jan 5;67(1):42-55. doi: 10.1016/j.jacc.2015.10.043.

  • Osnabrugge RL, Magnuson EA, Serruys PW, Campos CM, Wang K, van Klaveren D, Farooq V, Abdallah MS, Li H, Vilain KA, Steyerberg EW, Morice MC, Dawkins KD, Mohr FW, Kappetein AP, Cohen DJ; SYNTAX trial investigators. Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective. Heart. 2015 Dec;101(24):1980-8. doi: 10.1136/heartjnl-2015-307578. Epub 2015 Nov 9.

  • Parasca CA, Head SJ, Mohr FW, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Colombo A, Dawkins KD, Serruys PW, Kappetein AP; SYNTAX Investigators. The impact of a second arterial graft on 5-year outcomes after coronary artery bypass grafting in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Trial and Registry. J Thorac Cardiovasc Surg. 2015 Sep;150(3):597-606.e2. doi: 10.1016/j.jtcvs.2015.05.010. Epub 2015 May 8.

  • 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.

  • Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

  • Zhang YJ, Iqbal J, van Klaveren D, Campos CM, Holmes DR, Kappetein AP, Morice MC, Banning AP, Grech ED, Bourantas CV, Onuma Y, Garcia-Garcia HM, Mack MJ, Colombo A, Mohr FW, Steyerberg EW, Serruys PW. Smoking is associated with adverse clinical outcomes in patients undergoing revascularization with PCI or CABG: the SYNTAX trial at 5-year follow-up. J Am Coll Cardiol. 2015 Mar 24;65(11):1107-15. doi: 10.1016/j.jacc.2015.01.014.

  • Cohen DJ, Osnabrugge RL, Magnuson EA, Wang K, Li H, Chinnakondepalli K, Pinto D, Abdallah MS, Vilain KA, Morice MC, Dawkins KD, Kappetein AP, Mohr FW, Serruys PW; SYNTAX Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2014 Sep 30;130(14):1146-57. doi: 10.1161/CIRCULATIONAHA.114.009985. Epub 2014 Aug 1.

  • Zhang YJ, Iqbal J, Campos CM, Klaveren DV, Bourantas CV, Dawkins KD, Banning AP, Escaned J, de Vries T, Morel MA, Farooq V, Onuma Y, Garcia-Garcia HM, Stone GW, Steyerberg EW, Mohr FW, Serruys PW. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. J Am Coll Cardiol. 2014 Aug 5;64(5):423-32. doi: 10.1016/j.jacc.2014.05.022.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary InterventionCoronary Artery BypassJCAD protein, mouse

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Results Point of Contact

Title
Nic Van Dyck / Senior Program Manager
Organization
Boston Scientific

Study Officials

  • Patrick W. Serruys, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR
  • Friedrich W Mohr, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR
  • Monika Hanisch, PhD

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 20, 2005

First Posted

June 21, 2005

Study Start

March 1, 2005

Primary Completion

April 1, 2008

Study Completion

May 1, 2012

Last Updated

June 23, 2010

Results First Posted

June 23, 2010

Record last verified: 2010-05

Locations