This study is still in progress and includes patients using SYNTAX II score based on functional invasive evaluation with iFR / FFR and performing angioplasty guided by IVUS using the biodegradable polymer everolimus eluting stent. The study seeks to prove superiority versus the first generation paclitaxel-eluting stent and non-inferiority versus surgery using historical data. We included patients with 3-vessel de novo lesion by angiography who were divided into 3 groups according to traditional SYNTAX score in low (0-22), medium (22-32) and high (> 33) and then apply the new score.
The iFR will be held in all the arteries to be treated. If this proves to be <0.86 the next step will be angioplasty. If it is > 0.93 the medical treatment will continue and if it results in an intermediate value is defined using FFR that will use 0.80 as cut. All angioplasties will be optimized with IVUS. The primary endpoint will be a composite of death, myocardial infarction, stroke and repeat revascularization annually. A random sample of 450 patients will be used to prove the superiority to first generation paclitaxel-eluting stent and non-inferiority versus surgery.
Patrick W. Serruys
2013-05-21
Original title: SINTAX II: A non-randomised trial to evaluate the effectiveness of the SYNERGY DES in patients with 3-vessel disease optimally diagnosed with iFR/FFR and IVUS guidance.
