The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase.
BACKGROUND
Changes in the treatment of coronary artery disease both surgically and percutaneously have rendered the major randomized trials historical. Furthermore, the restrictive criteria of previous trials excluded most patients treated in daily practice. Although coronary surgery is still considered the current, evidence-based, gold-standard treatment of left main (LM) and 3-vessel coronary disease, the added benefit of drug-eluting stents has further expanded the use of percutaneous coronary intervention (PCI) beyond less complex populations in daily practice.


METHODS
The 1500-patient, prospective, multicenter, multinational (European and North American), randomized SYNTAX study with nested registries will enroll "all-comers." Consecutive patients with de novo 3-vessel disease (3VD) and/or LM disease will be screened for eligibility by the Heart Team (composed of an interventionalist, a cardiac surgeon, and the study coordinator) at each site and then allocated to either (1) the randomized cohort, if comparable revascularization can be achieved by either PCI or coronary artery bypass surgery (CABG), or (2) to one of the nested registries for CABG-ineligible patients (PCI registry) or for PCI-ineligible patients (CABG registry). Randomized patients will be stratified based on LM disease and diabetes by site. The primary end point for the randomized comparison is noninferiority of major adverse cardiac and cerebral events between the 2 groups at 1 year. To adequately project the expected enrollment rate per site, a run-in phase was mandated for each site interested in participating in the trial. Both cardiothoracic and interventional cardiology departments within the same institution were asked to complete a questionnaire regarding their frequency of treatment of LM and 3VD over a retrospective 3-month period.


CONCLUSIONS
By replacing most traditional inclusion and exclusion criteria with the real-world decision between the cardiothoracic surgeon and the interventionalist, this study will define the roles of CABG and PCI using drug-eluting stents in the contemporary management of LM and 3VD. Results of the run-in phase were used by the steering committee to determine eligibility and to project enrollment for each site.
Ong
Andrew T L
AT
Thoraxcentre, Erasmus Medical Centre, Rotterdam, The Netherlands.
Serruys
Patrick W
PW
Mohr
Frederick W
FW
Morice
Marie-Claude
MC
Kappetein
A Pieter
AP
Holmes
David R
DR
Mack
Michael J
MJ
van den Brand
Marcel
M
Morel
Marie-Angele
MA
van Es
Gerrit-Anne
GA
Kleijne
Jeroen
J
Koglin
Joerg
J
Russell
Mary E
ME
D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000628:therapy*; D006801:Humans; D015337:Multicenter Studies as Topic; D017239:Paclitaxel / Q000627:therapeutic use*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D015607:Stents
D017239:Paclitaxel