Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazil's Unified Public Health System (SUS). / Custo-efetividade do Stent Farmacológico na Intervenção Coronariana Percutânea no SUS.

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).

Custo-efetividade do Stent Farmacológico na Intervenção Coronariana Percutânea no SUS / Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazils Unified Public Health System (SUS)

Resumo Fundamento O uso do stent farmacológico (SF) comparado ao stent não farmacológico (SNF) na intervenção coronariana percutânea (ICP) reduziu o percentual de reestenose, porém sem impacto na mortalidade, com aumento no custo. A literatura carece de estudos randomizados que comparem economicamente esses dois grupos de stents na realidade do Sistema Único de Saúde (SUS). Objetivo Estimar a razão custo-efetividade incremental (RCEI) entre SF e SNF na coronariopatia uniarterial em pacientes do SUS Métodos Pacientes com coronariopatia uniarterial sintomática foram randomizados em 3 anos para uso de SF ou SNF durante a ICP, na proporção de 1:2, com seguimento clínico de 12 meses. Foram avaliados reestenose intrastent (RIS), revascularização da lesão-alvo (RLA), eventos adversos maiores e custo-efetividade (CE) de cada grupo. Os valores de p < 0,05 foram considerados significativos. Resultados No grupo SF, dos 74 pacientes (96,1%) que completaram o acompanhamento, ocorreu RIS em 1(1,4%), RLA em 1 (1,4%), óbito em 1 (1,4%), sem trombose. No grupo SNF, dos 141 pacientes (91,5%),ocorreu RIS em 14 (10,1%), RLA em 10 (7,3%), óbito em 3 (2,1%) e trombose em 1 (0,74%). Na análise econômica, o custo do procedimento foi de R$ 5.722,21 no grupo SF e de R$4.085,21 no grupo SNF. A diferença de efetividade a favor do grupo SF por RIS e RLA foi 8,7% e 5,9%, respectivamente, com RCEI de R$ 18.816,09 e R$ 27.745,76. Conclusões No SUS, o SF foi custo-efetivo, em concordância com o limiar de CE preconizado pela Organização Mundial da Saúde. (Arq Bras Cardiol. 2020; 115(1):80-89)

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)

Validação de protocolo para obtenção de hemostasia com dispositivo de compressão radial TR band TM após intervenção coronária percutânea / Validation of a protocol to achieve hemostasis using the TR BandTM radial compression device after percutaneous coronary intervention

Introdução: A realização de procedimentos coronários invasivos pelo acesso radial tem sido crescente, graças à exibição de dados consistentes que corroboram sua segurança e eficácia. Embora seja uma complicação infrequente e, na maioria das vezes, assintomática, a oclusão da artéria radial, quando ocorre, impede a reutilização dessa via em procedimentos futuros. Métodos: Estudo prospectivo que avaliou pacientes submetidos a intervenção coronária percutânea (ICP) pelo acesso radial, utilizando o dispositivo de compressão radial TR BandTM como técnica para obtenção de hemostasia com manutenção de fluxo anterógrado, de acordo com novo protocolo proposto para o manuseio do dispositivo. Resultados: No período entre fevereiro e março de 2011, foram incluídos 30 pacientes submetidos a ICP com a utilização do dispositivo TR BandTM para obtenção de hemostasia após o procedimento. Entre os pacientes avaliados, 27 (90%) relataram conforto e ausência de dor na região do punho; a saturação arterial de oxigênio manteve-se > 90% em 29 (96,6%) pacientes; não se constatou episódio de oclusão arterial, mantendo-se o pulso presente após o término da compressão e na alta hospitalar em todos os casos; e a hemostasia foi obtida no intervalo e com a retirada do volume de ar predeterminado em 26 (86,7%) pacientes. Conclusões: Neste estudo, o dispositivo de compressão radial TR BandTM demonstrou ser técnica segura e eficaz de hemostasia, com manutenção de fluxo anterógrado após a ICP. A utilização do protocolo proposto neste estudo para o manejo do dispositivo mostrou ser factível e de fácil aplicação, sem a demanda por avaliações frequentes, que podem desestimular seu uso mais amplo.

Background: The use of the transradial approach has increased steadily, thanks to the availability of consistent data supporting their safety and effectiveness. Although radial artery occlusion is a rare and mostly asymptomatic complication, its occurrence prevents reuse of radial access in future procedures. Methods: Prospective study assessingconsecutive patients undergoing percutaneous coronary intervention (PCI) by radial access using the TR BandTM radial compression device to obtain hemostasis and maintainanterograde flow, according to the new protocol proposed to handle the device. Results: From February to March 2011, 30 patients undergoing PCI using the TR BandTM to obtain hemostasis after the procedure were included in the study. Twenty-seven (90%) patients reported comfort and no wrist pain; arterial oxygen saturation remained > 90%in 29 (96.6%) patients; there was no episode of arterial occlusion, and pulse was present after compression and atdischarge in all cases; and hemostasis was obtained within the interval and with the removal of pre-established volume of air in 26 (86.7%) patients. Conclusions: The TR BandTM radial compression device is a safe and effective strategy to achieve hemostasis, maintaining anterograde flow after PCI. The use of the protocol proposed for the management ofthe device proved to be feasible and easy to apply, without demanding frequent assessments that may discourage a more extensive use of this device.

Drug-eluting stents during ST-segment elevation acute myocardial infarction: a critical analysis.

Primary percutaneous coronary intervention is the preferred reperfusion therapy for ST-segment elevation acute myocardial infarction patients within 12 hours of symptom-onset. Routine stent implantation during the procedure significantly reduces the rate of target vessel revascularization, although restenosis still represents a current limitation of the technique. Drug-eluting stents were developed to treat and prevent coronary restenosis. Randomized trials, meta-analysis, and registries proved their efficacy and safety in different clinical situations, including acute myocardial infarction. However, the increased risk of late stent thrombosis associated with drug-eluting stents during primary percutaneous coronary interventions encourages a careful analysis to identify which patients most benefit from them, as well as those where a prolonged dual antiplatelet therapy does not represent a limiting factor.

Utilização do acesso radial elimina a ocorrência de sangramento grave relacionado ao sítio de punção após intervenção coronária percutânea primária / Transradial approach eliminates puncture site major bleeding after primary percutaneous coronary intervention

INTRODUÇÃO: O acesso radial associa-se a baixa ocorrência de complicações vasculares. Essa característica o torna vantajoso nas síndromes coronárias agudas, em que é frequênte o uso agressivo de terapias antiplaquetária e antitrombótica. O objetivo do estudo foi avaliar a eficácia e a segurança do acesso radial na realização de intervenção percutânea primária, em que atrasos na reperfusão advindos de maior dificuldade técnica representarian um fator limitante. Método: Registro envolvendo pacientes submetidos a intervenção percutânea primária pelo acesso radial. Os desfechos de eficácia constituíram-se em mortalidde hospitalar, tempo porta-balão, obtenção de fluxo final TIMI III e conclusão do procedimento sem troca de via de acesso. A segurança foi avaliada por meio de taxa de sangramento grave e ocorrência de complicações relacionadas ao sítio de punção. Resultados: Entre fevereiro de 2007 e novembro de 2009, 211 pacientes foram submetidos a intervenção percutânea primária, 201 por meio de acesso radial. A média de idade foi de 59 anos, sendo 27,4 por cento do sexo feminino e 22,4 por cento portadores de diabetes melito. Foram obtidos fluxo final TIMI III em 91,5 por cento dos pacientes e resolução do seguimento ST > 50 por cento em 88,5 por cento, com taxa de crossover de 1,5 por cento. A mortalidade hospitalar foi de 4,5 por cento e a taxa de sangramento grave foi de 1 por cento, sendo um...

BACKGROUND: Transradial approach is associated with a low incidence of vascular complications. This peculiarity makes it useful in acute coronary syndromes, where aggressive antiplatelet and antithrombotic therapy is frequently used. The aim of this study was to evaluate the efficacy and safety of transradial approach in primary percutaneous intervention, where delays in achieving reperfusion resulting from technical difficulties are unacceptable. METHOD: Registry including consecutive patients undergoing primary percutaneous intervention by transradial approach. The efficacy endpoints were in-hospital mortality, door-to-balloon time, final TIMI III flow and access site crossover. Safety was assessed by the rate of major bleeding and complications related to the puncture site. RESULTS: From February 2007 to November 2009, 211 patients underwent primary percutaneous intervention, 201 of them by transradial approach. Mean age was 59 years, 27.4% were female and 22.4% had diabetes mellitus. Final TIMI III flow was achieved in 91.5% of patients, ST segment resolution > 50% in 88.5%, with a crossover rate of 1.5%. In-hospital mortality was 4.5% and the rate of major bleeding was 1%, with one episode of upper gastrointestinal bleeding and a decrease in hemoglobin > 5 g/dl. Vascular complications related to the puncture site were limited to 3 cases of type II hematoma and 2 cases of type III hematoma, with no clinical impact and spontaneous resolution. CONCLUSION: The transradial approach, performed by operators familiarized with the technique, is a safe and effective alternative for primary percutaneous coronary intervention, with virtually no major vascular complications related to the puncture site.

Terapia farmacológica adjunta à intervenção coronária percutânea / Deputy drug therapy to percutaneous coronary intervention

O surgimento de novas técnicas e ampla difucão do método, fizeram da intervenção coronária percutânea ua realidade equiparável à cirurgia de revascularização miocárdica...