Abstract

The landmark Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial1-4 has aided in reducing the area of uncertainty in decision making between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery in patients with complex coronary artery disease.5-8 As part of the SYNTAX Trial, quantification of the coronary artery disease burden was undertaken with the anatomical SYNTAX Score (www.syntaxscore.com),9-11 and has since been implemented in international revascularisation guidelines.5-8 In addition, recognising the importance of quantifying coronary artery disease burden in decision-making between CABG and PCI, the US Food and Drugs Association mandates the SYNTAX Score as entry criteria in ongoing contemporary stent and structural heart disease trials. Namely, the EXCEL (Evaluation of XIENCE PRIME™ or XIENCE V® Everolimus Eluting Stent System Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) Trial (ClinicalTrials.gov identifier: NCT01205776), and SURTAVI (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) Trial (ClinicalTrials.gov identifier: NCT01586910). The SYNTAX Trial was conceived in an era when the potential benefits of drug eluting stents were first being realised between 2002-2006.12-19 After multiple prior attempts comparing CABG against PCI using older technologies – namely plain ‘old’ balloon angioplasty (POBA) and bare metal stents (BMS) – in over 20 randomised trials,20, 21 including the Bypass Angioplasty Revascularization Investigation (BARI)22 and Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI)23 trials, the time had once again come to rechallenge the cardiac surgeons in the management of complex coronary artery disease. Historically one of the major criticisms of randomised trial design comparing CABG against PCI was that the trials enrolled highly selected, “cherry-picked,” patients, with approximately 2-12% of screened subjects actually randomised in most trials, and thus being largely unrepresentative of conventional clinical practice.20, 24 At the time of the SYNTAX Trial design, one of the key requirements put forth by seven cardiac surgeons, dubbed the “magnificent seven,” and fully endorsed by the clinical and interventional cardiologists at the time, was the need for an ‘all-comers’ trial design, free from selection bias.

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P.W.J.C. Serruys (Patrick) , E.W. Steyerberg (Ewout)
Financial support for the publication of this thesis was generously provided by: Volcano, USA Boston Scientific, USA HeartFlow, USA Terumo, Japan Cardialysis BV, Rotterdam, The Netherlands Department of Public Health, ERASMUS MC, Rotterdam, The Netherlands Abbott, USA Financial support by the Dutch Heart Foundation for the publication of this thesis is gratefully acknowledged.
hdl.handle.net/1765/51110
Erasmus MC: University Medical Center Rotterdam

Farooq, V. (2014, April 11). Understanding the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial Implications for current and future clinical practice. Financial support for the publication of this thesis was generously provided by: Volcano, USA Boston Scientific, USA HeartFlow, USA Terumo, Japan Cardialysis BV, Rotterdam, The Netherlands Department of Public Health, ERASMUS MC, Rotterdam, The Netherlands Abbott, USA Financial support by the Dutch Heart Foundation for the publication of this thesis is gratefully acknowledged. Retrieved from http://hdl.handle.net/1765/51110