SYNTAX Undersøgelse: TAXUS lægemiddeleluerende stent versus koronararterie-bypass-kirurgi til behandling af forsnævrede arterier (SYNTAX)
27. maj 2010 opdateret af: Boston Scientific Corporation
SYNTAX Undersøgelse: SYNergi mellem PCI med TAXUS og hjertekirurgi
SYNTAX-studiet er designet til at bestemme den bedste behandling for patienter med kompleks koronar sygdom (blokerede eller forsnævrede arterier i både højre og venstre side af hjertet) ved at randomisere patienter til at modtage enten perkutan koronar intervention (PCI) med polymerbaseret paclitaxel- eluerende TAXUS-stents eller til koronararterie-bypass-kirurgi (CABG).
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
På grund af introduktionen af lægemiddeleluerende stents (DES) og forbedringer i terapien for både perkutan koronar intervention (PCI) og koronararterie bypass-kirurgi (CABG) udfordrer PCI CABG som guldstandarden for behandling af tre kar (3VD) ) og venstre hoved (LM) koronarsygdom.
SYNTAX er et nyt, randomiseret forsøg med indlejrede registre, der sammenligner PCI med paclitaxel-eluerende TAXUS-stents med CABG til 3VD- og LM-patienter for at evaluere den bedste behandling for disse patienter med kompleks koronarsygdom.
Patienter på deltagende centre vil blive evalueret af både en kardiothoraxkirurg og af en interventionel kardiolog.
De patienter, der vurderes at være kvalificerede til behandling af både PCI og CABG, vil blive randomiseret til at modtage enten PCI med en polymerbaseret paclitaxel-eluerende TAXUS-stent eller CABG.
Patienter, der vurderes at være uegnede til behandling med PCI, vil blive behandlet af CABG og vil blive optaget i et CABG-register for at hjælpe med at definere patientpopulationen, hvor stenting fortsat er en uacceptabel behandlingsmulighed.
Tilsvarende vil patienter, som er fastslået at være uegnede til behandling med CABG, blive behandlet af PCI, ved hjælp af enhver interventionsteknik eller -anordning med eller uden brug af DES, og optaget i et PCI-register for at hjælpe med at definere de patienter, for hvem CABG anses for upassende. .
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1800
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aalst, Belgien, B-9300
- Onze Lieve Vrouw Ziekenhuis
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Antwerpen, Belgien, B-2020
- Academisch Ziekenhuis Middelheim
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Gent, Belgien, B-9000
- Universitair Ziekenhuis
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Liège, Belgien, B-4000
- Centre Hôpital Universitaire Sart Tilman
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Aarhus, Danmark, D-8200
- Skejby Sygehus
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Glasgow, Det Forenede Kongerige, G11 6NT
- Western Infirmary
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Leicester, Det Forenede Kongerige, LE3 9QP
- Glenfield Hospital
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Leicester, Det Forenede Kongerige, LE3 9QP
- University Hospitals of Leicester NHS Trust Glenfield Hospital
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London, Det Forenede Kongerige, E2 9JX
- London Chest Hospital
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London, Det Forenede Kongerige, SE1 7EH
- St Thomas Hospital
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London, Det Forenede Kongerige, SE5 9RS
- King's College Hospital London
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Oxford, Det Forenede Kongerige, OX3 9DU
- John Radcliffe Infirmary Oxford II
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Southampton, Det Forenede Kongerige, SO16 6YD
- Southampton University Hospital
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East Sussex
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Brighton, East Sussex, Det Forenede Kongerige, BN2 1ES
- Royal Sussex County Hospital
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Helsinki, Finland, FIN-00290 HUS
- Helsinki University Central Hospital
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Helsinki, Finland, FIN-00290 HUS
- University of Helsinki Meilahti Hospital
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Sacramento, California, Forenede Stater, 95819
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Washington, District of Columbia, Forenede Stater, 20010
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Florida
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Atlantis, Florida, Forenede Stater, 33462
- Florida Cardiovascular Research
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Ocala, Florida, Forenede Stater, 34474
- Munroe Medical Center
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Ocala, Florida, Forenede Stater, 34474
- Ocala Heart Institue
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Orlando, Florida, Forenede Stater, 32803
- Florida Hospital
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Illinois
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Evanston, Illinois, Forenede Stater, 60201
- Evanston Hospital
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Rockford, Illinois, Forenede Stater, 61108-2465
- Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospital and Clinics
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Maine
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Portland, Maine, Forenede Stater, 04102
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
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Hyannis, Massachusetts, Forenede Stater, 02601
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- Cape Cod Research Institute
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Michigan
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Grand Blanc, Michigan, Forenede Stater, 48439
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Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health
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Petoskey, Michigan, Forenede Stater, 49770
- Cardiac & Vascular Research Center of Northern Michigan
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott Northwestern Hospital
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Rochester, Minnesota, Forenede Stater, 55905
- St. Mary's Hospital
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New York
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Stony Brook, New York, Forenede Stater, 11794
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Syracuse, New York, Forenede Stater, 13203
- St. Joseph's Hospital Health Center
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Syracuse, New York, Forenede Stater, 13203
- SJH Cardiology Associates
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27401
- LeBauer Cardiovascular Research Foundation
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Greensboro, North Carolina, Forenede Stater, 27405
- Cardiovascular and Thoracic Surgeons of Greensboro
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Raleigh, North Carolina, Forenede Stater, 27610
- Wake Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Forsyth Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Oklahoma Foundation for Cardiovascular Research
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Pennsylvania
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Langhorne, Pennsylvania, Forenede Stater, 19047
- St. Mary's Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Forenede Stater, 75246
- Baylor University Medical Center
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San Antonio, Texas, Forenede Stater, 78205
- San Antonio Endovascular Heart Institue
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Virginia
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Norfolk, Virginia, Forenede Stater, 23507
- Sentara Norfolk General Hospital 1st Fl
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Bordeaux, Frankrig, 33000
- Clinique St Augustin
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Massy, Frankrig, F-91349
- Institut Cardiovasculaire Paris Sud - Massy
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Rouen, Frankrig, 76000
- Clinique Saint-Hilaire Rouen
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Rouen Cedex, Frankrig, 76031
- Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
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Toulouse, Frankrig, 31076
- Clinique Pasteur
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Toulouse, Frankrig, 31403
- Centre Hôpital Universitaire Rangueil
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Toulouse Cedex 9, Frankrig, 31059
- CHU Rangueil
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Breda, Holland, 4818 CK
- Amphia Ziekenhuis
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Eindhoven, Holland, 5623 EJ
- Catharina Ziekenhuis
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Groningen, Holland, 9713 GZ
- Academisch Ziekenhuis Groningen
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Nieuwegein, Holland, 3435 CM
- St. Antonius Hospital
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Rotterdam, Holland, 3000 CA
- Erasmus MC - University Medical Center Rotterdam
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Zwolle, Holland, 8011 JW
- Isala Klinieken, De Weezenlanden
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Bergamo, Italien, 24128
- Ospedale Riuniti Di Bergamo
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Massa, Italien, 54100
- Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
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Milan, Italien, 20132
- Ospedale San Raffaele
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Mirano, Italien, 30035
- Ospedale Civile Di Mirano
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Pavia, Italien, 27100
- Policlinico San Matteo
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Pavia, Italien, 27100
- IRCCS Policlinico S. Matteo
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Roma, Italien, 00161
- Policlinico Agostino Gemelli
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Rozzano, Italien, 20089
- Istituto Clinico Humanitas
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Riga, Letland, LV-1002
- P. Stradins University Hospital
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Oslo, Norge, 0027
- Rikshospitalet
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Katowice, Polen, 40635
- Medical University of Silesia - Katowice
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Krakow, Polen, 31-202
- John Paul II Hospital
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Krakow, Polen, 31-501
- Jagiellonian University of Cardiology
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Warsaw, Polen, 04-628
- National Institute of Cardiology
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Lisboa, Portugal, 1169-024
- Hospital de Santa Marta
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Alicante, Spanien, 03010
- Hospital General de Alicante
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Alicante, Spanien, 03010
- Hospital General Universitario
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Barcelona, Spanien, ES-08036
- Hospital Clinico Y Provincial
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Madrid, Spanien, ES-28040
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Salamanca, Spanien, 37008
- Hospital Clinico Salamanca
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Göteborg, Sverige, 41345
- Sahlgrenska University Hospital
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Lund, Sverige, SE-221 85
- University Hospital of Lund
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Lund, Sverige, SE-22181
- Lund University Hospital
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Stockholm, Sverige, SE-171 76
- Karolinska Universitets Sjukhuset - Stockholm
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Uppsala, Sverige, SE-75185
- Akademiska Sjukhuset
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Uppsala, Sverige, SE-75185
- University hospital Uppsala
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Praha, Tjekkiet, CZ-100 34
- University hospital Vinohrady
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Praha, Tjekkiet, CZ-128 08
- Interni klinika VFN
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Bad Oeynhausen, Tyskland, 32545
- Herz- und Diabeteszentrum Nordrhein-Westfalen
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Berlin, Tyskland, 10117
- Universitatsklinik Charite Berlin, Campus Mitte
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Berlin, Tyskland, 13353
- Campus Virchow Klinikum Herzkatheterlabor
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Berlin, Tyskland, D-13353
- Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
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Freiburg, Tyskland, 79106
- Universitätsklinik Freiburg
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Hamburg, Tyskland, 20246
- Universitatsklinikum Hamburg Eppendorf
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Kiel, Tyskland, 24105
- Universitätsklinikum Schleswig-Holstein Campus Kiel
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Kiel, Tyskland, 24105
- Universitätsklinikum Campus Kiel
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Leipzig, Tyskland, D-04289
- Herzzentrum Universität Leipzig
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Lübeck, Tyskland, 23538
- Medizinische Universitaet Luebeck
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München, Tyskland, D-81337
- Klinikum Großhadern
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Trier, Tyskland, D-54292
- Krankenhaus der Barmherzigen Brüder
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Budapest, Ungarn, 1134
- National Medical Center
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Debrecen, Ungarn, 4032
- University of Debrecen, Medical and Health Science Center
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Pecs, Ungarn, 1135
- Medical School of University PECS
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Salzburg, Østrig, A-5020
- Univ. Klinik für Herzchirurgie Landeskliniken
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Vienna, Østrig, A-1090
- Allgemeines Krankenhaus AKH
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Tre-kar sygdom, venstre hovedsygdom eller LM ækvivalent med eller uden 1, 2 eller 3VD (venstre anterior descendens [LAD], venstre circumflex [LCX], højre koronararterie [RCA] territorium)
- De novo læsioner med mindst 50 % stenose
- Myokardieiskæmi (stabil, ustabil, lydløs)
Ekskluderingskriterier:
- Tidligere PCI eller CABG
- Akut myokardieinfarkt (med kreatininkinase >2x øvre normalgrænse)
- Samtidig hjerteklapsygdom, der kræver kirurgisk behandling (rekonstruktion eller udskiftning)
- Deltagelse eller planlagt deltagelse i et andet kardiovaskulært klinisk studie inden 1 års opfølgning er afsluttet
- Manglende evne til at give informeret samtykke på grund af mental tilstand, mental retardering eller sprogbarriere
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: PCI med DES
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Lægemiddeleluerende stent
Andre navne:
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Aktiv komparator: CABG (koronararterie bypass graft)
Koronararterie Bypass-graft
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Koronararterie bypass kirurgi
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Primært klinisk slutpunkt for 12-måneders binær MACCE.
Tidsramme: 12 måneder efter tilmelding
|
Antal deltagere ved primært klinisk endepunkt på 12-måneders binær MACCE.
MACCE er defineret som: alle forårsager død, cerebrovaskulær hændelse (slagtilfælde), co-kumenteret myokardieinfarkt, gentagen revaskularisering (PCI og/eller CABG).
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12 måneder efter tilmelding
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12-måneders Composite Safety Endpoint.
Tidsramme: 12 måneder efter tilmelding
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Antal deltagere ved 12-måneders sammensat sikkerhedsendepunkt.
Sammensat sikkerhedsendepunkt kombinerer: alle forårsager død, cerebrovaskulær hændelse (slagtilfælde) og dokumenteret myokardieinfarkt.
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12 måneder efter tilmelding
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Gentag revaskularisering (PCI og/eller CABG).
Tidsramme: 12 måneder efter tilmelding
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Antal deltagere med gentagen revaskularisering (PCI og/eller CABG).
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12 måneder efter tilmelding
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet MACCE 1 måned efter proceduren og 6 måneder, 3 år og 5 år efter tildeling.
Tidsramme: 1 måned efter proceduren og 6 måneder, 3 år og 5 år efter tildeling
|
Antal deltagere med samlet MACCE 1 måned efter proceduren og 6 måneder, 3 år og 5 år efter tildeling.
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1 måned efter proceduren og 6 måneder, 3 år og 5 år efter tildeling
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Individuelle komponenter af MACCE 1 måned efter proceduren.
Tidsramme: 1 måned efter proceduren
|
Antal deltagere med individuelle komponenter af MACCE 1 måned efter proceduren.
De individuelle komponenter i MACCE er: alle forårsager død, slagtilfælde, dokumenteret myokardieinfarkt, gentagen revaskularisering.
|
1 måned efter proceduren
|
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Individuelle komponenter af MACCE 6 måneder efter tildeling.
Tidsramme: 6 måneder efter tildeling
|
Antal deltagere med individuelle komponenter af MACCE 6 måneder efter tildeling.
De individuelle komponenter i MACCE er: alle forårsager død, slagtilfælde, dokumenteret myokardieinfarkt, gentagen revaskularisering.
|
6 måneder efter tildeling
|
|
Individuelle komponenter af MACCE 1 år efter tildeling.
Tidsramme: 1 års eftertildeling
|
Antal deltagere med individuelle komponenter af MACCE 1 år efter tildeling.
De individuelle komponenter i MACCE er: alle forårsager død, slagtilfælde, dokumenteret myokardieinfarkt, gentagen revaskularisering.
|
1 års eftertildeling
|
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Frihed fra MACCE og dets komponenter 1 år efter tildeling.
Tidsramme: 1 års eftertildeling
|
Antal deltagere med frihed fra MACCE og dets komponenter 1 år efter tildeling.
Frihed fra MACCE er defineret som ingen MACCE eller nogen af de individuelle komponenter i MACCE (alle forårsager død, slagtilfælde, dokumenteret myokardieinfarkt, gentagen revaskularisering).
|
1 års eftertildeling
|
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Frihed fra MACCE og dets komponenter 3 år efter tildeling
Tidsramme: 3 år efter tildeling
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3 år efter tildeling
|
|
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Frihed fra MACCE og dets komponenter 5 år efter tildeling
Tidsramme: 5 år efter tildeling
|
5 år efter tildeling
|
|
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Livskvalitet 1 måned efter proceduren og 6 måneder, 1, 3 og 5 år efter tildeling
Tidsramme: 1 måned efter indgreb og 6 måneder, 1, 3 og 5 år efter tildeling
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1 måned efter indgreb og 6 måneder, 1, 3 og 5 år efter tildeling
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|
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Omkostninger og omkostningseffektivitet ved 1, 3 og 5 år efter tildeling
Tidsramme: 1 år, 3 og 5 år efter tildeling
|
1 år, 3 og 5 år efter tildeling
|
|
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Karakteristikaene (herunder komorbiditet og koronar vaskulær læsionskompleksitetsscoring kaldet SYNTAX-score) for følgende: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Invalidible), CABG Registry Cohort (PCI Inelible)
Tidsramme: 5 år
|
5 år
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Monika Hanisch, PhD, Boston Scientific Corporation
- Ledende efterforsker: Patrick W. Serruys, MD, PhD, Erasmus Medical Center
- Ledende efterforsker: Friedrich W Mohr, MD, Heart Center Leipzig - University Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2005
Primær færdiggørelse (Faktiske)
1. april 2008
Studieafslutning (Forventet)
1. maj 2012
Datoer for studieregistrering
Først indsendt
20. juni 2005
Først indsendt, der opfyldte QC-kriterier
20. juni 2005
Først opslået (Skøn)
21. juni 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. juni 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2010
Sidst verificeret
1. maj 2010
Mere information
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Yderligere relevante MeSH-vilkår
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronararteriesygdom
- Myokardieiskæmi
- Koronar sygdom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Paclitaxel
- Albumin-bundet Paclitaxel
Andre undersøgelses-id-numre
- S2024
- 90169394
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