ABC | Volume 115, Nº1, July 2020

Original Article Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazil’s Unified Public Health System (SUS) João Addison Pessoa, 1,2 Esmeralci Ferreira, 1 Denizar Viana Araújo, 1 Edirley Maia, 2 Felipe Souza Maia da Silva, 1 Maurício Salles de Oliveira, 1 Denilson Campos de Albuquerque 1 Universidade do Estado do Rio de Janeiro, 1 Rio de Janeiro, RJ - Brazil Hospital São Lucas, 2 Nova Friburgo, RJ - Brazil Mailing Address: João Addison Pessoa • Hospital Universitário Pedro Ernesto – Cardiologia – Av. 28 de Setembro, XXXXXX. Postal Code 20551-030, Rio de Janeiro, RJ – Brazil E-mail: joao.addson@uol.com.br Manuscript received March 16, 2020, revised manuscript June 14, 2019, acceoted July 31, 2019 DOI: https://doi.org/10.36660/abc.20180292 Abstract Background: The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective: To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single- vessel coronary artery disease. Methods: Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in- stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results: In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions: In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89) Keywords: Myocardial Infarction; Percutaneous Coronary Intervention; Drug-Eluting Stents; Coronary Reestenosis; Cost-Benefit Analysis; Unified Health System (SUS). Introduction Data extracted from the 2013 Brazilian National Health Interview Survey 1 estimated that 72.1% of the population would use the Unified Public Health System (SUS) for medical or dental treatment. According to the number of deaths per cause between 2004 and 2014 in Brazil, it was estimated that 1,069,653 (8.8%) individuals died from acute myocardial infarction (AMI) or other ischemic heart diseases. In this respect, it is important to develop sustainable measures for the prevention and treatment of these illnesses in the SUS. 2 In Brazil, the first drug-eluting stents (DESs) were restricted to the supplementary health system due to their high cost. Initial studies, conducted both in Brazil and abroad, have not demonstrated cost-effectiveness for DESs in all cases, suggesting their use in situations of greater risk for restenosis. 3-6 The limitations described above led to the development of new DESs, called second-generation DESs. With new antiproliferative drugs and improved platform with thinner metal struts (chromium-cobalt, platinum-cobalt alloys), they provided better stent apposition and less contact area for endothelialization. Biocompatible polymers reduced the local inflammatory process, reducing the occurrence of late thrombosis. 7,8 More than a decade after the beginning of their marketing, the use of DES in the SUS remained limited despite lower cost and more favorable results. In 2014, the Brazilian National Committee for Health Technology Incorporation (CONITEC) 9  recognized the cost-benefit of DES implantation in patients with diabetes, small vessels (<2.5 mm), and long lesions (>18 mm). Although the market price of DESs is higher than that of bare-metal stents (BMSs), the price suggested in the SUS (R$ 2,034.50 / code 070204061-4) 80