Lições dos ensaios clínicos FREEDOM e SYNTAX 5-anos: novas evidências ou evidências notadas somente agora?

Abstract

In recent weeks, the two most important and awaited scientific evidence in the treatment of multivessel coronary disease after eluting stents were released: the results from the FREEDOM study [1] and the 5-year analysis of the SYNTAX trial [2]. In a current scenario, in which the roles of intervention, surgery and medical treatment are increasingly discussed, and in which it is increasingly spread the need for therapeutic decision by multidisciplinary heart teams, the critical analysis of methodologically well-designed studies that bring a broader clinical applicability than previously published trials comparing angioplasty and coronary artery bypass surgery, becomes widely needed.However, if the main findings of both studies are not surprising, reasserting the role of revascularization surgery as preferred in patients with multivessel disease, a more detailed assessment of the body of evidence previously available will show that the information is already in the literature.The final analysis of 5-year follow-up of the SYNTAX trial, presented at the European Congress of Cardiothoracic Surgery in October, confirmed the strategy of revascularization, as more beneficial than the implantation of drug-eluting stents for patients with lesions of left main coronary artery or multivessel coronary heart disease and additionally separation was observed in the curves of some outcomes in relation to the previously published analyzes of 1 to 3 years of follow up. The rates of cardiovascular death and myocardial infarction, which previously did not reach statistical significance, were significantly higher in the PCI group (9.2% vs. 4.0% and 10.6% vs. 3.3%, respectively -P <0.001). Moreover, the rate of cerebral vascular accident (CVA), higher in the surgical previous analyzes, proved to be similar between groups after 5 years (3.0% vs. 3.4% -P = 0.66).Before this evidence, in April of this year, the record ASCERT [3] already signaled with similar results. Evaluating a robust sample of nearly 200,000 patients who underwent CABG (n = 86.244) or angioplasty with stents (n = 103.549), a study funded by the National Heart, Lung, and Blood Institute revealed on 4 years of follow up, mortality 20% lower in operated cases compared to cases intervened by catheter (16.4% vs. 20.8%, CR 0.79 -95% CI 0.76 to 0.82 -P = 0.002), which was effective similar evaluation of other variables, and in comparison between subgroups.Even more remotely, this information was already available in the publication of results from the registry of the Department of Health of the State of New York [4]. Evaluating all cases of coronary artery bypass grafting (n = 7437) and implantation of pharmacological stents (n = 9963) conducted in that state between 2003 and 2005,