Rationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorESCANED, Javier
dc.contributor.authorBANNING, Adrian
dc.contributor.authorFAROOQ, Vasim
dc.contributor.authorECHAVARRIA-PINTO, Mauro
dc.contributor.authorONUMA, Yoshinobu
dc.contributor.authorRYAN, Nicola
dc.contributor.authorCAVALCANTE, Rafael
dc.contributor.authorCAMPOS, Carlos M.
dc.contributor.authorSTANETIC, Bojan M.
dc.contributor.authorISHIBASHI, Yuki
dc.contributor.authorSUWANNASOM, Pannipa
dc.contributor.authorKAPPETEIN, Arie-Pieter
dc.contributor.authorTAGGART, David
dc.contributor.authorMOREL, Marie-Angele
dc.contributor.authorES, Gerrit-Anne van
dc.contributor.authorSERRUYS, Patrick W.
dc.contributor.groupauthorSyntax II Study Grp
dc.date.accessioned2017-06-09T15:39:41Z
dc.date.available2017-06-09T15:39:41Z
dc.date.issued2016
dc.description.abstractAims: The applicability of the results of the SYNTAX trial comparing percutaneous coronary intervention (PCI) using first-generation drug-eluting stents (DES) with coronary artery bypass graft (CABG) surgery for the treatment of patients with complex coronary artery disease (CAD) has been challenged by recent major technical and procedural developments in coronary revascularisation. Functional assessment of coronary lesions has contributed to marked improvements in both safety and efficacy of DES implantation. In addition, the recent development of the SYNTAX score II, a clinical tool based on anatomical and clinical factors, allows individualised objective decision making regarding the optimal revascularisation modality in patients with complex CAD. The ongoing SYNTAX II trial is currently evaluating the effectiveness of the clinical and technological advances in the treatment of patients with complex (de novo three-vessel) CAD. Methods and results: The SYNTAX II trial is a multicentre, all-comers, open-label, single-arm trial aiming to recruit 450 patients with de novo three-vessel CAD in approximately 25 European interventional cardiology centres. All patients will be selected and treated following the SYNTAX II strategy, which includes: a) establishing the appropriateness of revascularisation utilising the SYNTAX score II as a clinical tool to allow objective decision making by the Heart Team, b) ischaemia-driven revascularisation based on functional intracoronary assessment, c) implantation of the new-generation everolimus-eluting platinum chromium coronary stent with thin struts and abluminal bioabsorbable polymer coating to promote rapid vessel healing, d) intravascular ultrasound-guided DES implantation, and e) treatment at centres with expertise in CTO recanalisation. The primary endpoint is a composite of the major adverse cardiac and cerebral events (MACCE) rate at one-year follow-up compared to the historical PCI arm of the SYNTAX trial. An exploratory endpoint will be MACCE at five-year follow-up compared to the historical surgical arm of the SYNTAX trial. Conclusions: The SYNTAX II trial will provide valuable information on outcomes of state-of-the-art PCI for the contemporary management of complex (de novo three-vessel) CAD. SYNTAX II will be of critical value in the design of future trials in this arena. (ClinicalTrials.gov Identifier: NCT02015832)
dc.description.indexMEDLINE
dc.description.sponsorshipBoston Scientific
dc.description.sponsorshipVolcano Corporation
dc.description.sponsorshipNIHR Oxford Biomedical Research Unit
dc.identifier.citationEUROINTERVENTION, v.12, n.2, p.E224-E234, 2016
dc.identifier.doi10.4244/EIJV12I2A36
dc.identifier.eissn1969-6213
dc.identifier.issn1774-024X
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/20324
dc.language.isoeng
dc.publisherEUROPA EDITION
dc.relation.ispartofEurointervention
dc.rightsrestrictedAccess
dc.rights.holderCopyright EUROPA EDITION
dc.subjectchronic total occlusion
dc.subjectcoronary artery disease
dc.subjectcoronary stent
dc.subjectfractional flow reserve
dc.subjectintravascular ultrasound
dc.subjectmultivessel disease
dc.subjectpercutaneous coronary intervention
dc.subjectphysiology
dc.subjectSYNTAX score II
dc.subject.otherdrug-eluting stent
dc.subject.otherfractional flow reserve
dc.subject.othercardiac-surgery syntax
dc.subject.otherperiprocedural myocardial-infarction
dc.subject.otherrandomized controlled-trial
dc.subject.otherleft-ventricular function
dc.subject.otherwave-free ratio
dc.subject.otherscore ii
dc.subject.otherintravascular ultrasound
dc.subject.otherleft main
dc.subject.wosCardiac & Cardiovascular Systems
dc.titleRationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryBósnia e Herzegovina
hcfmusp.affiliation.countryHolanda
hcfmusp.affiliation.countryTailândia
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryisoes
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisonl
hcfmusp.affiliation.countryisoba
hcfmusp.affiliation.countryisoth
hcfmusp.author.externalESCANED, Javier:Univ Complutense Madrid, Fac Med, Hosp Clin San Carlos, Madrid, Spain
hcfmusp.author.externalBANNING, Adrian:John Radcliffe Hosp, Oxford, England
hcfmusp.author.externalFAROOQ, Vasim:Univ Manchester, Manchester Acad, Hlth Sci Ctr, Inst Cardiovasc Sci, Manchester, Lancs, England; Cent Manchester Univ Hosp NHS Trust, Manchester Royal Infirm, Manchester Heart Ctr, Manchester, Lancs, England
hcfmusp.author.externalECHAVARRIA-PINTO, Mauro:Univ Complutense Madrid, Fac Med, Hosp Clin San Carlos, Madrid, Spain
hcfmusp.author.externalONUMA, Yoshinobu:Cardialysis BV, Rotterdam, Netherlands
hcfmusp.author.externalRYAN, Nicola:Univ Complutense Madrid, Fac Med, Hosp Clin San Carlos, Madrid, Spain
hcfmusp.author.externalCAVALCANTE, Rafael:Erasmus Univ, Med Ctr, Thoraxctr, Rotterdam, Netherlands
hcfmusp.author.externalSTANETIC, Bojan M.:Erasmus Univ, Med Ctr, Thoraxctr, Rotterdam, Netherlands; Univ Hosp, Clin Ctr Banja Luka, Banja Luka, Bosnia & Herceg
hcfmusp.author.externalISHIBASHI, Yuki:Erasmus Univ, Med Ctr, Thoraxctr, Rotterdam, Netherlands
hcfmusp.author.externalSUWANNASOM, Pannipa:Erasmus Univ, Med Ctr, Thoraxctr, Rotterdam, Netherlands; Muharaj Nakorn Chiang Mai Hosp, Northern Reg Heart Ctr, Chiang Mai, Thailand
hcfmusp.author.externalKAPPETEIN, Arie-Pieter:Erasmus Univ, Med Ctr, Thoraxctr, Rotterdam, Netherlands
hcfmusp.author.externalTAGGART, David:John Radcliffe Hosp, Oxford, England
hcfmusp.author.externalMOREL, Marie-Angele:Cardialysis BV, Rotterdam, Netherlands
hcfmusp.author.externalES, Gerrit-Anne van:Cardialysis BV, Rotterdam, Netherlands
hcfmusp.author.externalSERRUYS, Patrick W.:Imperial Coll London, NHLI, Int Ctr Circulatory Hlth, London, England
hcfmusp.citation.scopus24
hcfmusp.contributor.author-fmusphcCARLOS AUGUSTO HOMEM DE MAGALHAES CAMPOS
hcfmusp.description.beginpageE224
hcfmusp.description.endpageE234
hcfmusp.description.issue2
hcfmusp.description.volume12
hcfmusp.origemWOS
hcfmusp.origem.pubmed27290681
hcfmusp.origem.scopus2-s2.0-84975852982
hcfmusp.origem.wosWOS:000400776100015
hcfmusp.publisher.cityTOULOUSE CEDEX 6
hcfmusp.publisher.countryFRANCE
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