The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design,
Andrew T L Ong1, Patrick W Serruys, Frederick W Mohr
1Thoraxcentre, Erasmus Medical Centre, Rotterdam, The Netherlands.
Insights
This study compares coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for left main and 3-vessel disease in all-comers. It aims to define the roles of CABG and PCI in contemporary treatment strategies.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Cardiac Surgery
Background:
- Major randomized trials for coronary artery disease treatments are outdated due to evolving surgical and percutaneous interventions.
- Previous trial criteria excluded many patients treated in daily practice.
- Coronary surgery remains the gold standard for left main and 3-vessel disease, but drug-eluting stents expand percutaneous coronary intervention (PCI) use.
Purpose of the Study:
- To compare the effectiveness of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in treating left main (LM) and 3-vessel coronary disease (3VD).
- To define the contemporary roles of CABG and PCI, utilizing drug-eluting stents, in managing LM and 3VD.
- To enroll an "all-comers" population, reflecting real-world patient demographics and treatment decisions.
Main Methods:
- The SYNTAX study is a prospective, multicenter, multinational trial enrolling 1500 "all-comers" with de novo 3VD and/or LM disease.
- Patients are allocated to a randomized cohort (if suitable for both PCI and CABG) or to nested registries (CABG-ineligible or PCI-ineligible).
- The primary endpoint is noninferiority of major adverse cardiac and cerebral events at 1 year between PCI and CABG groups. A run-in phase assessed site enrollment rates.
Main Results:
- The run-in phase results informed the steering committee for site eligibility and enrollment projections.
- Data from the randomized cohort and registries will provide insights into treatment outcomes.
Conclusions:
- This study replaces traditional inclusion/exclusion criteria with real-world Heart Team decisions to define CABG and PCI roles.
- It will establish the contemporary management strategies for left main and 3-vessel coronary disease using drug-eluting stents and CABG.
- The findings will guide clinical practice by clarifying the optimal revascularization approach for diverse patient populations.
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.
Study Design:
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.
Implications:
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.
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