Kronika naukowa
HOT LINES Munich ESC 2008, Lisbone EACTS 2008

Interact CardioVasc Thorac Surg 2008; 7 (Suppl 3): S205-S254.



017 (1) THE SYNERGY BETWEEN PERCUTANEOUS CORONARY INTERVENTION AND CARDIAC SURGERY (SYNTAX) STUDY:
THE DESIGN AND RATIONALE
OF A COMPREHENSIVE STUDY COMPARING PERCUTANEOUS CORONARY INTERVENTION USING TAXUS DRUG-ELUTING STENT WITH CORONARY ARTERY BYPASS GRAFT TREATMENT IN PATIENTS REQUIRING REVASCULARISATION FOR DE NOVO THREE-VESSEL DISEASE
AND/OR LEFT MAIN DISEASE
P. Serruys1, M.-C. Morice2, A.P. Kappetein1, M. Mack3, E. Sta°hle4, J.L. Pomar5, K. Dawkins6, F.W. Mohr7
1Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands; 2L'Institut Cardiovasculaire Paris Sud, Paris, France; 3Medical City Hospital, Dallas, USA; 4University Hospital, Uppsala, Sweden; 5Hospital Clinico y Provincial, Barcelona, Spain;
6Boston Scientific, Natick, USA; 7Herzzentrum Universität Leipzig, Germany

Objectives: Percutaneous coronary intervention (PCI) with drug-eluting stents is challenging coronary artery bypass surgery (CABG) as the gold standard for treatment of three-vessel (3VD) and/or left main (LM) coronary disease. SYNTAX is a novel trial comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients. The design and rationale of SYNTAX will be described and final enrollment numbers will be reported.
Methods: In the SYNTAX trial, investigators at 85 sites
(62 European/23 U.S.) collected safety and outcomes data for patients with de novo 3VD and/or LM disease treated by PCI with TAXUS stents or CABG. A Heart Consultation Team (surgeon and interventionalist) determined the eligibility of all consecutive patients for each revascularisation treatment option. If suitable for both options, patients were randomised to TAXUS or CABG (stratified by LM disease and diabetes) and if suitable for only one treatment option, they were entered into a nested registry. A SYNTAX score was calculated to quantify the complexity of coronary artery disease by taking into account the number and location as well as the complexity of each lesion independently. For the primary randomised controlled trial endpoint of 12-month MACCE (major adverse cardiac and cerebral events), a non-inferiority comparison will be performed. Specifically, if the upper one-
-sided 95% confidence bound for the difference in 12-month MACCE rates (test minus control) is less than a delta of...


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