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)

Clinical Outcomes and Cost-Effectiveness Analysis of FFR Compared with Angiography in Multivessel Disease Patient / Impacto Clínico e Custo-Efetividade da FFR em Comparação à Angiografia em Pacientes com Doenças Multiarteriais Submetidos à ICP

Abstract Background: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). Objectives: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. Methods: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. Results: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. Conclusion: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.

Resumo Fundamentos: Em pacientes multiarteriais e lesões moderadas, a reserva de fluxo fracionada (FFR) avalia cada lesão e direciona o tratamento, podendo ser útil no custo-efetividade (CE) de implante de stents não farmacológicos (SNF). Objetivos: Avaliar CE e impacto clínico da angioplastia + FFR versus angioplastia + angiografia (ANGIO), em multiarteriais, utilizando SNF. Métodos: pacientes com doença multiarteriais foram randomizados prospectivamente durante ±5 anos para FFR ou ANGIO, e acompanhados por até 12 meses. Foram avaliados eventos cardíacos maiores (ECAM), reestenose e CE. Resultados: foram incluídos 69 pacientes, 47(68,1%) homens, 34(49,2%) no FFR e 35(50,7%) no ANGIO, idade 62,0 ± 9,0 anos, com angina estável e Síndrome Coronariana Aguda estabilizada. No FFR, havia 26 com doença (76,5%) biarterial e 8 (23,5%) triarterial, e no grupo ANGIO, 24(68,6%) biarteriais e 11(31,4%) triarteriais. Ocorreram 12(17,3%) ECAM - 3(4,3%) óbitos: 2(5,8%) no FFR e 1(2,8%) no ANGIO, 9(13,0%) anginas, 4(11,7%) no FFR e 5(14,2%) no ANGIO, 6 reestenoses: 2(5,8%) no FFR e 4 (11,4%) no ANGIO. Angiografia detectou 87(53,0%) lesões no FFR, 39(23,7%) com ICP e 48(29,3%) com tratamento clínico; e 77(47,0%) lesões no ANGIO, todas submetidas à angioplastia. Quanto aos stents, registrou-se 39(33,3%) (0,45 ± 0,50 stents/lesão) no FFR e 78(66,6%) (1,05 ± 0,22 stents/lesão) no ANGIO (p = 0,0001); ANGIO utilizou 51,4% a mais que o FFR. Análise de CE revelou um custo de R$5045,97 e R$5.430,60 nos grupos ANGIO e FFR, respectivamente. A diferença de efetividade foi 1,82%. Conclusões: FFR diminuiu o número de lesões tratadas e de stents e necessidade de revascularização do vaso-alvo, com CE comparável ao da angiografia.

Clinical Outcomes and Cost-Effectiveness Analysis of FFR Compared with Angiography in Multivessel Disease Patient.

BACKGROUND: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). OBJECTIVES: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. METHODS: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. RESULTS: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. CONCLUSION: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.

Uso de escore de propensão na análise de custo-efetividade com utilização seletiva de stents farmacológicos e não-farmacológicos / Use of propensity score in cost-effectiveness analysisng using drug-eluting and bare metal stents

Introdução: Os estudos sobre a razão de custo-efetividade dos stents farmacológicos (SFs) são escassos. Nosso objetivo foi avaliar os resultados e comparar os custos (razão custo--efetividade incremental – RCEI) por reestenose evitada entre SFs e stents não-farmacológicos (SNFs) utilizando o escore de propensão. Métodos: Incluímos na análise 220 pacientes tratados consecutivamente, dos quais 111 com SFs e 109 com SNFs. O escore de propensão foi usado para ajustar o efeito da intervenção por meio de pareamento, estratificação e ponderação. Resultados: Predominaram pacientes do sexo masculino (67,7% vs. 66,9%; P = 0,53), com média de idade de 65,9 anos. Pacientes tratados com SFs apresentaram maior frequência de diabetes (54% vs. 17,4%; P < 0,001) e doença triarterial (18,9% vs. 10,1%; P = 0,029) e pior função ventricular(54,1% vs. 22%; P < 0,0001). O diâmetro dos stents foi de 2,76 ± 0,35 mm vs. 2,91 ± 0,47 mm (P = 0,006) e a soma do comprimento dos stents foi de 37,6 ± 23 mmvs. 24,8 ± 15,8 mm (P < 0,0001). Reestenose ocorreu em 6,3% vs. 12,8% dos pacientes (P = 0,099) e em 4,1% vs.9,8% das lesões (P = 0,048). Houve incremento de custo de R$ 9.590,00 e a RCEI foi de R$ 147.538,00 por reestenose evitada (acima do limiar da Organização Mundial da Saúde). Entretanto, utilizando o escore de propensão, as variáveis que melhor classificaram os pacientes para SFs e apresentam RCEI máxima de R$ 4.776,96 foram idade > 72 anos, diabetes e lesões com diâmetro < 3,2 mm e comprimento > 18 mm.Conclusões: Apesar de os SFs não terem sido custo-efetivos na população em geral, o escore de propensão demonstrou que em idosos, diabéticos e pacientes com lesões longas ou vasos de fino calibre o uso de SFs foi custo-efetivo.

Analysis of the cost-effectiveness of drug-eluting and bare-metal stents in coronary disease.

BACKGROUND: There is a scarcity of cost-effectiveness analyses in the national literature comparing drug-eluting stents (DES) with bare-metal stents (BMS), at late follow-up. OBJECTIVE: To estimate the Incremental Cost-Effectiveness Ratio (ICER) between DES and BMS in uniarterial coronariopathy. METHODS: 217 patients (130 DES and 87 BMS), with 48 months of follow-up (mean = 26 months) were assessed. PRIMARY OUTCOME: cost per prevented restenosis, with effectiveness being defined as the decrease in major events. The analytical model of decision was based on the study by Polanczyk et al. The direct costs were those used directly in the interventions. RESULTS: The sample was homogenous for age and sex. The DES was more used in diabetic patients: 59 (45.4%) vs 16 (18.4%)(p<0.0001) and with a history of coronary artery disease (CAD): 53 (40.7%) vs 13 (14.9%)(p<0.0001). The BMS was more used in simple lesions, but with worse ventricular function. The DES were implanted preferentially in proximal lesions: (p=0.0428) and the BMS in the mid-third (p=0.0001). Event-free survival: DES = 118 (90.8%) vs BMS=74 (85.0%) (p=0.19); Angina: DES=9 (6.9%) vs BMS=9 (10.3%) (NS): Clinical restenosis: DES=3 (2.3%) vs BMS=10 (10.3%) (p=0.0253). Cardiac deaths: 2 (1.5%) in DES and 3 (3.5%) in BMS (NS). COSTS: the tree of decision was modeled based on restenosis. The net benefit for the DES needed an increment of R$7,238.16. The ICER was R$131,647.84 per prevented restenosis (above the WHO threshold). CONCLUSIONS: The DES was used in more complex lesions. The clinical results were similar. The restenosis rate was higher in the BMS group. The DES was a non-cost-effective strategy.

Análise de custo-efetividade dos stents farmacológicos e não farmacológicos na doença coronariana / Analysis of the cost-effectiveness of drug-eluting and bare-metal stents in coronary disease

FUNDAMENTO: Na literatura nacional há escassez de análises de custo-efetividade, comparando stents farmacológicos (SF) versus não farmacológicos (SNF), no seguimento tardio. OBJETIVO: Estimar a Razão de Custo-Efetividade Incremental (RCEI) entre SF e SNF na coronariopatia uniarterial. MÉTODOS: 217 pacientes (130 SF e 87 SNF), com 48 meses de seguimento (média=26). Desfecho primário: custo por re-estenose evitada, sendo efetividade definida como redução de eventos maiores. O modelo analítico de decisão foi baseado no estudo de Polanczyk et al. Os custos diretos foram aqueles utilizados diretamente nas intervenções. RESULTADOS: A amostra foi homogênea para idade e sexo. O SF foi mais utilizado em diabéticos: 59 (45,4 por cento) vs 16 (18,4 por cento)(p<0,0001) e com história de DAC: 53 (40,7 por cento) vs 13 (14,9 por cento)(p<0,0001). O SNF foi utilizado em lesões mais simples, porém com pior função ventricular. Os SF foram implantados preferencialmente nas lesões proximais: (p=0,0428) e os SNF no 1/3 médio (p=0,0001). Sobrevida livre de eventos: SF=118 (90,8 por cento) vs SNF=74 (85,0 por cento) (p=0,19); Angina: SF=9 (6,9 por cento) vs SNF=9 (10,3 por cento) (NS): Reestenose clínica: SF=3 (2,3 por cento) vs SNF=10 (10,3 por cento) (p=0,0253). Óbitos cardíacos: 2 (1,5 por cento) no SF e 3 (3,5 por cento) no SNF (NS). Custos: a árvore de decisão foi modelada na reestenose. O benefício líquido para SF necessitou de incremento de R$7.238,16. A RCEI foi R$131.647,84 por reestenose evitada (acima do limiar da OMS). CONCLUSÕES: O SF abordou lesões mais complexas. Os resultados clínicos foram similares. A reestenose foi maior no SNF. O SF foi uma estratégia não custo-efetiva.

BACKGROUND: There is a scarcity of cost-effectiveness analyses in the national literature comparing drug-eluting stents (DES) with bare-metal stents (BMS), at late follow-up. OBJECTIVE: To estimate the Incremental Cost-Effectiveness Ratio (ICER) between DES and BMS in uniarterial coronariopathy. METHODS: 217 patients (130 DES and 87 BMS), with 48 months of follow-up (mean = 26 months) were assessed. Primary outcome: cost per prevented restenosis, with effectiveness being defined as the decrease in major events. The analytical model of decision was based on the study by Polanczyk et al. The direct costs were those used directly in the interventions. RESULTS: The sample was homogenous for age and sex. The DES was more used in diabetic patients: 59 (45.4 percent) vs 16 (18.4 percent)(p<0.0001) and with a history of coronary artery disease (CAD): 53 (40.7 percent) vs 13 (14.9 percent)(p<0.0001). The BMS was more used in simple lesions, but with worse ventricular function. The DES were implanted preferentially in proximal lesions: (p=0.0428) and the BMS in the mid-third (p=0.0001). Event-free survival: DES = 118 (90.8 percent) vs BMS=74 (85.0 percent) (p=0.19); Angina: DES=9 (6.9 percent) vs BMS=9 (10.3 percent) (NS): Clinical restenosis: DES=3 (2.3 percent) vs BMS=10 (10.3 percent) (p=0.0253). Cardiac deaths: 2 (1.5 percent) in DES and 3 (3.5 percent) in BMS (NS). Costs: the tree of decision was modeled based on restenosis. The net benefit for the DES needed an increment of R$7,238.16. The ICER was R$131,647.84 per prevented restenosis (above the WHO threshold). CONCLUSIONS: The DES was used in more complex lesions. The clinical results were similar. The restenosis rate was higher in the BMS group. The DES was a non-cost-effective strategy.

Avaliação do custo efetividade dos stents farmacológicos em comparação aos stents convencionais: resultados clínicos e de custos a médio e longo prazo / Assessing the cost effectiveness of drug eluting stents compared to bare metal stents: clinical results and costs in the medium and long term

Fundamentos: Os resultados tardios com os stents farmacológicos são melhores do que com stents convencionais, principalmente no que se refere à reestenose. Entretanto, no "mundo real", os stents farmacológicos são implantados em pacientes de maior complexidade, o que teoricamente já diminui a diferença dos resultados. Objetivos: Comparar resultados da utilização de stents com paclitaxel (Grupo I) em pacientes complexos com stents convencionais (Grupo II) implantados em pacientes menos graves. A partir dos resultados realizar análise para estimar a razão de custo-efetividade nos dois grupos. Métodos: Foram analisados 220 pacientes prospectivamente durante aproximadamente dois anos (média de 17 meses): 111 do Grupo 1 (GI) e 109 do Grupo II (GII). Foram avaliadas a sobrevida e a sobrevida livre de eventos através do método de Kaplan-Meier. Usando-se os critérios da Organização Mundial de Saúde, calculou-se a razão custo-efetividade incremental (RCEI) para cada reestenose evitada. O escore de propensão foi usado para reduzir diferenças entre os dois grupos. Resultados: Foi observado predomínio do sexo masculino nos dois grupos (n=174 66,8%), mas sem diferenças entre eles. Também não houve diferenças em relação à idade, que variou de 42 anos a 91 anos (65,9 anos). As diferenças que ocorreram, com maior incidência no GI foram: diabetes: GI=60 (50,4%) e GII=19 (17,4%), p=0,0001; história familiar para doença arterial coronariana (DAC): GI=43 (38,7%) e GII=24 (22,1%), p=0,007; infarto prévio: GI=54 (48,6%) e GII=31 (28,4%), p=0,002; cirurgia de revascularização prévia: GI=24 (21,7%) e GII=6 (5,5%), p=0,0005; angioplastia prévia: GI=28 (25,2%) e GII=17 (15,5%), p=0,077; síndromes coronarianas agudas: GI=48 (43,3%) e GII=35 (32,0%), p=0,088. Os pacientes triarteriais foram mais presentes no GI=21 (18,9%) do que no GII=11 (10,1%), p=0,029. No entanto, os pacientes do GII apresentaram mais frequentemente função normal do VE: GI=51 (45,9%) e GII=85 (77,9%), p=0,0001...

Background: Long term outcomes for drug eluting stents are better than those for bare metal stents, especially for restenosis. However, drug eluting stents are usually implanted in more complex patients, theoretically lessening the difference in the outcomes. Objetives: To compare the outcomes of paclitaxel stents (GI) in complex patients and bare metal stents (GII), in less complex patients. Methods: For some two years (mean: 17 months), 220 patients were analyzed prospectively: 111 in GI and 109 in GII. Their general survival and cardiovascular event-free survival rates were assessed through the Kaplan-Meier method. Using the criteria of the World Health Organization (WHO), the incremental cost-effectiveness ratio (ICER) was calculated for each restenosis avoided. Propensity scores was used to reduce selection bias by equating both groups based on these covariates. Results: Men predominated in both groups (n=174 66.8%), with no differences between them, including age, ranging from 42 to 91 years (65.9 years). The main differences, with higher rates in GI, were diabetes: GI=60 (50.4%) and GII=19 (17.4%), p=0.0001; family history: GI=43 (38.7%) and GII=24 (22.1%), p=0.007; previous acute myocardial infarction: GI=54 (48.6%) and GII=31 (28.4%), p=0.002; previous coronary artery bypass graft: GI=24 (21.7%) and GII=6 (5.5%), p=0.0005; previous angioplasty: GI=28 (25.2%) and GII=17 (15.5%), p=0.077; acute coronary syndrome: GI=48 (43.3%) and GII=35 (32.0%), p=0.088. Multivessel patients were more frequent in GI=21 (18.9%) than in GII=11 (10.1%), p=0.029. However, the GII patients presented normal left ventricle functions more frequently: GI=51 (45.9%) and GII=85 (77.9%), p=0.0001. There were no differences between the groups for the number of lesions treated and number of arteries per patient. The bare metal stent group presented simpler lesions: Type A GI=43 (25.6%); GII=65 (45.5%), p=0.0002; Type B: B1 GI=50 (29.7%) and GII=35 (24.5%), p=0.30...