title: Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system.
abstract: The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents2, which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA). During this stage the interested company submits to the regulatory agency, results from clinical studies that demonstrate the efficacy and safety of the new device or pharmaceutical product. Frequently, in addition to clinical studies, approval records for clinical use from the regulatory agencies of other countries, mainly the United States of America and the European Community are also submitted. The successful completion of this stage means that the medication or device may be prescribed or used by the physicians in Brazil. The second stage in the incorporation of new healthcare technology involves the reimbursement or financing of the treatment that was approved in the previous stage based on its efficacy and safety. This stage can be more complex than the first one since the new technology, whether a substitution for established treatment methods or the introduction of a new treatment concept, are usually more expensive. The incorporation of new technology requires a cost-effectiveness analysis so that fund administrators can make decisions based on the universal scenario of limited resources to finance healthcare with treatments that are more and more burdensome. The difficulties of funding management are aggravated by medical and social ethical implications that arise when a treatment is approved based on its efficacy and safety but is not made available to patients who could benefit greatly from it. In Brazil, assessment methods for the incorporation of new technology based on reimbursement or financing have not been fully developed for either the private healthcare plans or the Brazilian Public Healthcare System (SUS). The implementation of new technology in both healthcare systems is a slow process and frequently the implementation is a result of the requirements of patients or the organizations that represent them and at times is the result of legal proceedings or political pressure imposed by physicians and their respective scientific societies. Our objective is to review the evolution of percutaneous coronary intervention (PCI) in Brazil and its current status in view of the advent of drug-eluting stents, the growing participation of drug-eluting stents in myocardial revascularization to treat patients with coronary heart disease, as well as, to compare the regulatory standards from Brazil and other countries regarding the incorporation and recommendations for the use of this new technology.
authors.affiliation: Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista, São Paulo, SP, Brazil. valterlima.dmed@epm.br
authors.forename: Valter C
authors.initials: VC
authors.lastname: Lima
authors.forename: Luiz Alberto P
authors.initials: LA
authors.lastname: Mattos
authors.forename: Paulo R A
authors.initials: PR
authors.lastname: Caramori
authors.forename: Marco A
authors.initials: MA
authors.lastname: Perin
authors.forename: José A
authors.initials: JA
authors.lastname: Mangione
authors.forename: Bruno M
authors.initials: BM
authors.lastname: Machado
authors.forename: Wilson M C
authors.initials: WM
authors.lastname: Coelho
authors.forename: Ronaldo R L
authors.initials: RR
authors.lastname: Bueno
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D001938:Brazil; D032921:Consensus; D003327:Coronary Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000517:prevention & control; D016503:Drug Delivery Systems; D006801:Humans; D012955:Societies, Medical; D015607:Stents / Q000191:economics