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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art_ESCANED_Rationale_and_design_of_the_SYNTAX_II_trial_2016.PDF (1.89 MB)
Citações na Scopus
24
Tipo de produção
article
Data de publicação
2016
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
EUROPA EDITION
Autores
ESCANED, Javier
BANNING, Adrian
FAROOQ, Vasim
ECHAVARRIA-PINTO, Mauro
ONUMA, Yoshinobu
RYAN, Nicola
CAVALCANTE, Rafael
STANETIC, Bojan M.
ISHIBASHI, Yuki
Citação
EUROINTERVENTION, v.12, n.2, p.E224-E234, 2016
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Aims: 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)
Palavras-chave
chronic total occlusion, coronary artery disease, coronary stent, fractional flow reserve, intravascular ultrasound, multivessel disease, percutaneous coronary intervention, physiology, SYNTAX score II
URI
https://observatorio.fm.usp.br/handle/OPI/20324
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Coleções
Artigos e Materiais de Revistas Científicas - HC/InCor
Artigos e Materiais de Revistas Científicas - ODS/03