Editorial II- EN.pmd

The SYNTAX trial, presented in the congresses of the European Society of Cardiology in Munich, Germany and the European Association of Cardiothoracic Surgery in Lisbon, Portugal in September 2008, is the first study to compare the clinical results of the best technology of percutaneous coronary interventions (PCI) using pharmacological stents (paclitaxel-eluding stent – Taxus, Boston Scientific Corp) with the best therapy currently provided by coronary artery bypass surgery (CABG) in patients with triple vessel coronary artery disease and/or lesions of the left coronary artery trunk. The study, carried out in 62 European and 23 American centers and financed by the Boston Scientific Corporation, the manufacturer of the Taxus stent, at a cost of approximately 50 millions US dollars, intended to demonstrate the hypothesis that the PCI-Taxus stent was not inferior to CABG in patients with triple vessel disease and/or lesions of the left coronary artery trunk. The primary objective of the study was to analyze the compound clinical outcome constituted of death by any cause, strokes, myocardial infarction, the necessity of repeated revascularization by PCI and/or CABG (defined as MACCE Major Cardiovascular or Cerebrovascular Events) at 12 months of follow up. Two types of study were formed, the first was randomized and the other was a register. The randomized study included patients that were eligible for both types of procedure (by consensus between the heart surgeon and the hemodynamicist). On the other hand, the register included patients that were considered only eligible for one of the two treatments. A total of 3075 patients were enrolled, with 1800 presenting with the inclusion criteria for the randomized study; 897 in the CABG Group and 903 in the PCI/Taxus Arm. The other 1275 patients formed the SYNTAX register, where the criterion was that only one treatment method was possible. Thus, 1077 patients were allocated to the Surgery Group and 198 to the PCI Group. The final result of the SYNTAX trial confirmed that CABG is better than PCIs with drug-eluting stents for this population of high-risk patients. In 12 months, 17.8% of the patients in the PCI/Taxus Group presented with the compound outcome versus 12.1% of the surgical patients with a statistically significantly difference (p = 0.0015). Thus, an analysis of the SYNTAX trial is important not only because of the result but also for the implications of the findings. Initially, as it was an “all comers” type study enabling the inclusion of patients with characteristics closer to the real world population, instead of being a classical controlled randomized study with many exclusion criteria, it reflected the current clinical practice.