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.
OBJECTIVE
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.


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.
Hospital Clinico San Carlos/Faculty of Medicine Complutense University, Madrid, Spain.
Javier
J
Escaned
Adrian
A
Banning
Vasim
V
Farooq
Mauro
M
Echavarria-Pinto
Yoshinobu
Y
Onuma
Nicola
N
Ryan
Rafael
R
Cavalcante
Carlos M
CM
Campos
Bojan M
BM
Stanetic
Yuki
Y
Ishibashi
Pannipa
P
Suwannasom
Arie-Pieter
AP
Kappetein
David
D
Taggart
Marie-Angèle
MA
Morel
Gerrit-Anne
GA
van Es
Patrick W
PW
Serruys
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D001026:Coronary Artery Bypass / Q000379:methods; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects; D012720:Severity of Illness Index; D013995:Time; D013997:Time Factors; D016896:Treatment Outcome