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Status unknownNCT00114972SYNTAXUpdated Jun 23, 2010Results posted

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

A Phase 3 interventional study of Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent and Coronary Artery Bypass Surgery in Coronary Artery Disease, sponsored by Boston Scientific Corporation. Status unknown at 106 sites in 18 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2010-06-23.

Sponsored by Boston Scientific Corporation · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
1,800
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Three-vessel coronary artery disease
  • Left main coronary artery disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 1,800 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,800 participants (actual)

Study arms

  • Experimental
    PCI with DES

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

  • Active comparator
    CABG (coronary artery bypass graft)

    Coronary Artery Bypass Graft

    Procedure: Coronary Artery Bypass Surgery

Interventions

  • DevicePolymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent

    Drug Eluting Stent

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

  • ProcedureCoronary Artery Bypass Surgery

    Coronary Artery Bypass Surgery

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months post enrollment

  2. 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.

    Time frame: 12 months after enrollment

  3. Repeat Revascularization (PCI and/or CABG).

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

    Time frame: 12 Months post enrollment

Secondary outcomes

  1. 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.

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

  2. 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.

    Time frame: 1 month after procedure

  3. 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.

    Time frame: 6 months post allocation

  4. 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.

    Time frame: 1 year post allocation

  5. 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).

    Time frame: 1 year post allocation

  6. Freedom From MACCE and Its Components at 3 Years Post-allocation

    Time frame: 3 years post allocation

  7. Freedom From MACCE and Its Components at 5 Years Post-allocation

    Time frame: 5 years post allocation

  8. 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

  9. Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation

    Time frame: 1 year, 3 and 5 years post allocation

  10. 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

07

Results

Posted Jun 23, 2010

Participant flow

Participant flow — Overall Study
MilestoneCABGPCI With DES
Started897903
Completed849891
Not completed4812
Withdrew: Withdrawal by subject407
Withdrew: Lost to follow-up85

Outcome measures

PrimaryPrimary 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).

Time frame:
12 months post enrollment
Reported as:
Number · participants
Primary Clinical Endpoint of 12-Month Binary MACCE.
participantsCABGPCI With DES
Primary Clinical Endpoint of 12-Month Binary MACCE.105159
Primary12-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.

Time frame:
12 months after enrollment
Reported as:
Number · participants
12-month Composite Safety Endpoint.
participantsCABGPCI With DES
12-month Composite Safety Endpoint.6568
SecondaryOverall 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.

Time frame:
1 month after procedure and 6 months, 3 years, and 5 years post allocation
Reported as:
Number · participants
Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
participantsCABGPCI With DES
MACCE 1 month post procedure4554
MACCE 6 months post procedure85111
SecondaryIndividual 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.

Time frame:
1 month after procedure
Reported as:
Number · participants
Individual Components of MACCE at 1 Month Post-procedure.
participantsCABGPCI With DES
All cause death1020
Stroke92
Documented MI2131
Any repeat revascularization1531
SecondaryIndividual 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.

Time frame:
6 months post allocation
Reported as:
Number · Participants
Individual Components of MACCE at 6 Months Post-allocation.
ParticipantsCABGPCI With DES
All cause death2431
Stroke132
Documented MI2740
Any repeat revascularization3578
SecondaryIndividual 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.

Time frame:
1 year post allocation
Reported as:
Number · participants
Individual Components of MACCE at 1 Year Post-allocation.
participantsCABGPCI With DES
Death any cause3039
Stroke195
Documented MI2843
Any repeat revascularization50120
SecondaryFreedom 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).

Time frame:
1 year post allocation
Reported as:
Number · participants
Freedom From MACCE and Its Components at 1 Year Post-allocation.
participantsCABGPCI With DES
Freedom from any MACCE744732
Freedom from any cause death819852
Freedom from stroke830886
Freedom from documented MI821848
Freedom from any repeat revascularization799771
SecondaryFreedom From MACCE and Its Components at 3 Years Post-allocation
Time frame:
3 years post allocation
Reported as:
Number · participants

Results for this outcome have not been posted.

PrimaryRepeat Revascularization (PCI and/or CABG).

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

Time frame:
12 Months post enrollment
Reported as:
Number · Participants
Repeat Revascularization (PCI and/or CABG).
ParticipantsCABGPCI With DES
Repeat Revascularization (PCI and/or CABG).50120
SecondaryFreedom From MACCE and Its Components at 5 Years Post-allocation
Time frame:
5 years post allocation
Reported as:
Number · participants

Results for this outcome have not been posted.

SecondaryQuality 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

Results for this outcome have not been posted.

SecondaryCost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
Time frame:
1 year, 3 and 5 years post allocation

Results for this outcome have not been posted.

SecondaryThe 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 for this outcome have not been posted.

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CABG—391/897 (43.6%)509/897 (56.7%)
PCI With DES—357/903 (39.5%)405/903 (44.9%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventCABGPCI With DES
Arrhythmia, other rare cardiac disordersCardiac disorders51/89782/903
Angina PectorisCardiac disorders30/89774/903
Angina UnstableCardiac disorders30/89766/903
Vascular disordersVascular disorders45/89748/903
Atrial FibrillationCardiac disorders45/89710/903
Infection and abcessInfections and infestations44/89727/903
Injury and procedural complicationsInjury, poisoning and procedural complications33/89715/903
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders31/89720/903
Wound infectionInfections and infestations30/8971/903
Vascular graft occlusionInjury, poisoning and procedural complications28/8971/903
Most frequent other events
Most frequent other events
EventCABGPCI With DES
All other Adverse EventsGeneral disorders509/897405/903
Atrial fibrillationCardiac disorders123/89725/903
AnaemiaBlood and lymphatic system disorders104/89723/903
Angina pectorisCardiac disorders26/89761/903
Wound infectionInfections and infestations56/8972/903
Pleural effusionRespiratory, thoracic and mediastinal disorders54/8972/903
Incision site complicationInjury, poisoning and procedural complications47/8973/903

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CABGPCI With DESTotal
<=18 years000.0
Between 18 and 65 years400397797.0
>=65 years4975061003.0
Age Continuous
Age Continuous(years)CABGPCI With DESTotal
Mean64.96 ± 9.7965.23 ± 9.6665.09 ± 9.72
Sex: Female, Male
Sex: Female, Male(Participants)CABGPCI With DESTotal
Female189213402
Male7086901398
Region of Enrollment
Region of Enrollment(participants)CABGPCI With DESTotal
United States122123245.0
Portugal7613.0
Finland121224.0
Spain262753.0
Austria242852.0
United Kingdom132135267.0
Italy96101197.0
France105103208.0
Hungary394483.0
Czech Republic202040.0
Poland333366.0
Belgium474491.0
Denmark151732.0
Norway448.0
Latvia202040.0
Netherlands7474148.0
Germany9386179.0
Sweden282654.0
Angina
Angina(participants)CABGPCI With DESTotal
Participants with Stable Angina at Baseline5135141027.0
Participants with Unstable Angina at Baseline251261512.0
Participants with Silent Ischemia at Baseline7474148.0
Participants with No Angina at Baseline5954113.0
Bifurcation lesion (per participant)
Bifurcation lesion (per participant)(participants)CABGPCI With DESTotal
One or more Bifurcated Lesion(s)6526491301.0
No Bifurcated Lesions245254499.0
Blood pressure ≥130/85 mmHg
Blood pressure ≥130/85 mmHg(participants)CABGPCI With DESTotal
Blood Pressure >= 130/85 mmHG5746221196.0
Blood Pressure <130/85 mmHG323281604.0
Carotid artery disease
Carotid artery disease(participants)CABGPCI With DESTotal
Diagnosed Carotid Artery Disease at Baseline7573148.0
No Diagnosed Carotid Artery Disease at Baseline8228301652.0

19 further baseline measures are reported on the registry.

08

Study locations

106 sites
  • Mercy General Hospital
    Sacramento, California 95819, United States
  • Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Florida Cardiovascular Research
    Atlantis, Florida 33462, United States
  • Munroe Medical Center
    Ocala, Florida 34474, United States
  • Ocala Heart Institue
    Ocala, Florida 34474, United States
  • Florida Hospital
    Orlando, Florida 32803, United States
  • Evanston Hospital
    Evanston, Illinois 60201, United States
  • Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
    Rockford, Illinois 61108-2465, United States
  • University of Iowa Hospital and Clinics
    Iowa City, Iowa 52242, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • Tufts New England Medical Center
    Boston, Massachusetts 02111, United States
  • Cape Cod Hospital
    Hyannis, Massachusetts 02601, United States
  • Cape Cod Research Institute
    Hyannis, Massachusetts 02601, United States
  • Genesys Regional Medical Center
    Grand Blanc, Michigan 48439, United States
  • Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • Cardiac & Vascular Research Center of Northern Michigan
    Petoskey, Michigan 49770, United States
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • St. Mary's Hospital
    Rochester, Minnesota 55905, United States
  • SUNY - Stony Brook School of Medicine
    Stony Brook, New York 11794, United States
  • SJH Cardiology Associates
    Syracuse, New York 13203, United States
  • St. Joseph's Hospital Health Center
    Syracuse, New York 13203, United States
  • LeBauer Cardiovascular Research Foundation
    Greensboro, North Carolina 27401, United States
  • Cardiovascular and Thoracic Surgeons of Greensboro
    Greensboro, North Carolina 27405, United States
  • Wake Medical Center
    Raleigh, North Carolina 27610, United States
  • Forsyth Medical Center
    Winston-Salem, North Carolina 27103, United States
  • Oklahoma Foundation for Cardiovascular Research
    Oklahoma City, Oklahoma 73120, United States
  • St. Mary's Medical Center
    Langhorne, Pennsylvania 19047, United States
  • Medical City Dallas Hospital
    Dallas, Texas 75230, United States
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
  • San Antonio Endovascular Heart Institue
    San Antonio, Texas 78205, United States
  • Sentara Norfolk General Hospital 1st Fl
    Norfolk, Virginia 23507, United States
  • Univ. Klinik für Herzchirurgie Landeskliniken
    Salzburg, A-5020, Austria
  • Allgemeines Krankenhaus AKH
    Vienna, A-1090, Austria
  • Onze Lieve Vrouw Ziekenhuis
    Aalst, B-9300, Belgium
  • Academisch Ziekenhuis Middelheim
    Antwerpen, B-2020, Belgium
  • Universitair Ziekenhuis
    Gent, B-9000, Belgium
  • Centre Hôpital Universitaire Sart Tilman
    Liège, B-4000, Belgium
  • University Hospital Vinohrady
    Praha, CZ-100 34, Czech Republic
  • Interni Klinika VFN
    Praha, CZ-128 08, Czech Republic
  • Skejby Sygehus
    Aarhus, D-8200, Denmark
  • Helsinki University Central Hospital
    Helsinki, FIN-00290 HUS, Finland
  • University of Helsinki Meilahti Hospital
    Helsinki, FIN-00290 HUS, Finland
  • Clinique St Augustin
    Bordeaux, 33000, France
  • Institut Cardiovasculaire Paris Sud - Massy
    Massy, F-91349, France
  • Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
    Rouen Cedex, 76031, France
  • Clinique Saint-Hilaire Rouen
    Rouen, 76000, France
  • CHU Rangueil
    Toulouse Cedex 9, 31059, France
  • Clinique Pasteur
    Toulouse, 31076, France
  • Centre Hôpital Universitaire Rangueil
    Toulouse, 31403, France
  • Herz- und Diabeteszentrum Nordrhein-Westfalen
    Bad Oeynhausen, 32545, Germany
  • Universitatsklinik Charite Berlin, Campus Mitte
    Berlin, 10117, Germany
  • Campus Virchow Klinikum Herzkatheterlabor
    Berlin, 13353, Germany
  • Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
    Berlin, D-13353, Germany
  • Universitätsklinik Freiburg
    Freiburg, 79106, Germany
  • Universitatsklinikum Hamburg Eppendorf
    Hamburg, 20246, Germany
  • Universitätsklinikum Campus Kiel
    Kiel, 24105, Germany
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
    Kiel, 24105, Germany
  • Herzzentrum Universität Leipzig
    Leipzig, D-04289, Germany
  • Medizinische Universitaet Luebeck
    Lübeck, 23538, Germany
  • Klinikum Grosshadern
    München, D-81337, Germany
  • Krankenhaus der Barmherzigen Brüder
    Trier, D-54292, Germany
  • National Medical Center
    Budapest, 1134, Hungary
  • University of Debrecen, Medical and Health Science Center
    Debrecen, 4032, Hungary
  • Medical School of University PECS
    Pecs, 1135, Hungary
  • Ospedale Riuniti di Bergamo
    Bergamo, 24128, Italy
  • Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
    Massa, 54100, Italy
  • Ospedale San Raffaele
    Milan, 20132, Italy
  • Ospedale Civile di Mirano
    Mirano, 30035, Italy
  • IRCCS Policlinico S. Matteo
    Pavia, 27100, Italy
  • Policlinico San Matteo
    Pavia, 27100, Italy
  • Policlinico Agostino Gemelli
    Roma, 00161, Italy
  • Istituto Clinico Humanitas
    Rozzano, 20089, Italy
  • P. Stradins University Hospital
    Riga, LV-1002, Latvia
  • Amphia Ziekenhuis
    Breda, 4818 CK, Netherlands
  • Catharina Ziekenhuis
    Eindhoven, 5623 EJ, Netherlands
  • Academisch Ziekenhuis Groningen
    Groningen, 9713 GZ, Netherlands
  • St. Antonius Hospital
    Nieuwegein, 3435 CM, Netherlands
  • Erasmus MC - University Medical Center Rotterdam
    Rotterdam, 3000 CA, Netherlands
  • Isala Klinieken, De Weezenlanden
    Zwolle, 8011 JW, Netherlands
  • Rikshospitalet
    Oslo, 0027, Norway
  • Medical University of Silesia - Katowice
    Katowice, 40635, Poland
  • John Paul II Hospital
    Krakow, 31-202, Poland
  • Jagiellonian University of Cardiology
    Krakow, 31-501, Poland
  • National Institute of Cardiology
    Warsaw, 04-628, Poland
  • Hospital de Santa Marta
    Lisboa, 1169-024, Portugal
  • Hospital General de Alicante
    Alicante, 03010, Spain
  • Hospital General Universitario
    Alicante, 03010, Spain
  • Hospital Clinico Y Provincial
    Barcelona, ES-08036, Spain
  • Hospital Clinico San Carlos
    Madrid, ES-28040, Spain
  • Hospital Clinico Salamanca
    Salamanca, 37008, Spain
  • Sahlgrenska University Hospital
    Göteborg, 41345, Sweden
  • University Hospital of Lund
    Lund, SE-221 85, Sweden
  • Lund University Hospital
    Lund, SE-22181, Sweden
  • Karolinska Universitets Sjukhuset - Stockholm
    Stockholm, SE-171 76, Sweden
  • Akademiska sjukhuset
    Uppsala, SE-75185, Sweden
  • University Hospital Uppsala
    Uppsala, SE-75185, Sweden
  • Royal Sussex County Hospital
    Brighton, East Sussex BN2 1ES, United Kingdom
  • Western Infirmary
    Glasgow, G11 6NT, United Kingdom
  • Glenfield Hospital
    Leicester, LE3 9QP, United Kingdom

Showing the first 100 of 106 sites across 18 countries.

09

References and documents

Publications

  • 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. PubMed 35862109 ↗
  • 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. PubMed 35732441 ↗
  • 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. PubMed 35595676 ↗
  • 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. PubMed 35422242 ↗
  • 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. PubMed 34973904 ↗
  • 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. PubMed 34669586 ↗
  • 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. PubMed 34618017 ↗
  • 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. PubMed 34432113 ↗
  • 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. PubMed 34405875 ↗
  • 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. PubMed 34405232 ↗
  • 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. PubMed 34375706 ↗
  • 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. PubMed 34210411 ↗
  • 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. PubMed 34082905 ↗
  • 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. PubMed 34049676 ↗
  • 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. PubMed 34011163 ↗
  • 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. PubMed 33710385 ↗
  • 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. PubMed 33624046 ↗
  • 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. PubMed 33538250 ↗
  • 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. PubMed 33517534 ↗
  • 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. PubMed 33004127 ↗
  • 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. PubMed 32819461 ↗
  • 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. PubMed 30999989 ↗
  • 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. PubMed 28520861 ↗
  • 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. PubMed 28495897 ↗
  • 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. PubMed 28427580 ↗
  • 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. PubMed 27651390 ↗
  • 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. PubMed 27198680 ↗
  • 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. PubMed 26764065 ↗
  • 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. PubMed 26552756 ↗
  • 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. PubMed 26055439 ↗
  • 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. PubMed 25847979 ↗
  • 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. PubMed 25825008 ↗
  • 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. PubMed 25790882 ↗
  • 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. PubMed 25085960 ↗
  • 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. PubMed 25082573 ↗
  • 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. PubMed 24849105 ↗
  • 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. PubMed 24700706 ↗
  • 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. PubMed 24531331 ↗
  • 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. PubMed 23766350 ↗
  • 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. PubMed 23523456 ↗
  • 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. PubMed 23439103 ↗
  • 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. PubMed 23439102 ↗
  • 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. PubMed 22721656 ↗
  • 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. PubMed 22721655 ↗
  • 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. PubMed 22496114 ↗
  • 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. PubMed 21959312 ↗
  • 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. PubMed 21410370 ↗
  • 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. PubMed 21168023 ↗
  • 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. PubMed 20530001 ↗
  • 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. PubMed 20079596 ↗
  • 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. PubMed 19228612 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00114972
Lead sponsor
Boston Scientific Corporation
Collaborators
Cardialysis BV
First posted
Jun 21, 2005
Start date
Mar 2005
Primary completion
Apr 2008
Completion
May 2012 (estimated)
Results posted
Jun 23, 2010
Last update
Jun 23, 2010

Study contacts

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

Oversight

Data monitoring committee
Yes
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