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.

Seven years of use of implantable cardioverter-defibrillator therapies: a nationwide population-based assessment of their effectiveness in real clinical settings.

BACKGROUND: The efficacy of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) therapy has already been established in clinical trials but their effectiveness in several clinical settings remains undetermined. This study aimed to assess the effectiveness of ICD and CRT-D therapies within the Brazilian National Health System (SUS). METHODS: All patients who underwent ICD or CRT-D implantation within the SUS from 2001 to 2007 were included in the study. We compared estimated Kaplan-Meier survival curves using the Peto's test. Prognostic factors were selected using Cox's models. RESULTS: There were included 3,295 patients in the ICD group and 681 patients in the CRT-D group. Cardiac causes accounted for 79% of all deaths in both groups and Chagas' heart disease accounted for 31% of these deaths. In the CRT-D group, survival significantly decreased around the fourth year of follow-up, with a decrease from 59.5% to 38.3% in 5.5 months. Transvenous implantation technique was used in 62% of CRT-D patients. In-hospital case-fatality rates were higher in those undergoing surgical implantation (5.3%) than those undergoing transvenous implantation (1.6%) (p = 0.02). CONCLUSIONS: The results show that short-term, medium-term and long-term effectiveness of ICD therapy appears to be similar to that evidenced in clinical trials. In the CRT-D group, in-hospital case-fatality and 30-day case-fatality were higher than those reported in other studies. Surgical epicardial implantation technique was performed in this group at a higher frequency than that reported in the literature and was associated with poorer short-term prognosis.

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.

Acurácia do relacionamento probabilístico na avaliação da alta complexidade em cardiologia / Accuracy of probabilistic record linkage in the assessment of high-complexity cardiology procedures / Precisión de la relación probabilística en la evaluación de la alta complejidad en cardiología

OBJETIVO: Avaliar a viabilidade de estratégia de relacionamento probabilístico de bases de dados na identificação de óbitos de pacientes submetidos a procedimentos de alta complexidade em cardiologia. MÉTODOS: O custo de processamento foi estimado com base em 1.672 registros de pacientes submetidos à cirurgia de revascularização do miocárdio, relacionados com todos os registros de óbito no Brasil em 2005. A acurácia do relacionamento baseou-se em linkage probabilístico entre 99 registros de autorização de internação hospitalar de pacientes submetidos a cirurgias cardíacas em instituto de referência em cardiologia, com status vital conhecido, e todos os registros de óbito do estado do Rio de Janeiro em 2005. O linkage foi realizado em quatro etapas: padronização das bases, blocagem, pareamento e classificação dos pares. Utilizou-se a blocagem em cinco passos, com chaves de blocagem com combinação de variáveis como soundex do primeiro e último nome, sexo e ano de nascimento. As variáveis utilizadas no pareamento foram "nome completo", com a utilização da distância de Levenshtein, e "data de nascimento". RESULTADOS: O segundo e o quinto passos de blocagem tiveram os maiores números de pares formados e os maiores tempos de processamento para o pareamento. O quarto passo demandou menor custo de processamento. No estudo de acurácia, após os cinco passos de blocagem, a sensibilidade do linkage foi de 90,6 por cento e a especificidade foi de 100 por cento. CONCLUSÕES: A estratégia de relacionamento probabilístico utilizada apresenta boa acurácia e poderá ser utilizada em estudos sobre a efetividade dos procedimentos de alta complexidade e alto custo em cardiologia.

OBJECTIVE: To evaluate the viability of a probabilistic record linkage strategy to identify patients who underwent complex cardiology procedures among the total deceased population. METHODS: The processing cost was estimated based on 1,672 records of patients undergoing coronary artery bypass grafting that were compared with all death records in Brazil in 2005. The accuracy of the linkage strategy was based on the probabilistic linkage of 99 hospital admissions records of patients, with known vital status, who underwent cardiac surgery at a single cardiology institute, with the death records of the state of Rio de Janeiro, Southeastern Brazil, in 2005. Linkage was conducted in four stages: standardizing the databases, blocking, matching, and rating peers. Blocking in five steps was used, with blocking keys formed by a combination of variables such as soundex codes for the first and last names, sex, and year of birth. The variables used for matching were "full name" with the use of Levenshtein distance and "birth date". RESULTS: The second and fifth blocking steps resulted in the largest number of formed pairs and the largest processing times for the matching. The fourth step required a lower processing cost. In the accuracy study, after five blocking steps, the sensitivity of the linkage was 90.6 percent, and the specificity was 100 percent. CONCLUSIONS: The probabilistic strategy used has high accuracy and can be used in studies of the effectiveness of high-complexity, high-cost cardiology procedures.

OBJETIVO: Evaluar la viabilidad de estrategia de relación probabilística en la identificación de pacientes sometidos a procedimientos de alta complejidad en cardiología. MÉTODOS: El costo de procesamiento fue calculado con base en 1.672 registros de pacientes sometidos a cirugía de revascularización del miocardio, relacionados con todos los registros de óbito en Brasil en 2005. La precisión de la relación se basó en linkage probabilística de 99 registros de autorización de internación hospitalaria de pacientes sometidos a cirugías cardíacas en instituto de referencia en cardiología, con status vital conocido, con todos los registros de óbito del estado de Rio de Janeiro en 2005. El linkage fue realizado en cuatro etapas: estandarización de las bases, blocaje, pareamiento y clasificación de los pares. Se utilizó blocaje en cinco pasos, con claves de blocaje con combinación de variables como soundex del primero y último nombre, sexo y año de nacimiento. Las variables utilizadas en el pareamiento fueron "nombre completo", con la utilización de la distancia de Levenshtein y "fecha de nacimiento". RESULTADOS: El segundo y el quinto pasos de blocaje tuvieron los mayores números de pares formados y los mayores tiempos de procesamiento para el pareamiento. El cuarto paso demandó menor costo de procesamiento. En el estudio de precisión, posterior a cinco pasos de blocaje, la sensibilidad del linkage fue de 90,6 por ciento y la especificidad fue de 100 por ciento. CONCLUSIONES: La estrategia de relación probabilística utilizada presenta buena precisión y podrá ser utilizada en estudios sobre la efectividad de los procedimientos de alta complejidad y alto costo en cardiología.

Accuracy of probabilistic record linkage in the assessment of high-complexity cardiology procedures.

OBJECTIVE: To evaluate the viability of a probabilistic record linkage strategy to identify patients who underwent complex cardiology procedures among the total deceased population. METHODS: The processing cost was estimated based on 1,672 records of patients undergoing coronary artery bypass grafting that were compared with all death records in Brazil in 2005. The accuracy of the linkage strategy was based on the probabilistic linkage of 99 hospital admissions records of patients, with known vital status, who underwent cardiac surgery at a single cardiology institute, with the death records of the state of Rio de Janeiro, Southeastern Brazil, in 2005. Linkage was conducted in four stages: standardizing the databases, blocking, matching, and rating peers. Blocking in five steps was used, with blocking keys formed by a combination of variables such as Soundex codes for the first and last names, sex, and year of birth. The variables used for matching were "full name" with the use of Levenshtein distance and "birth date". RESULTS: The second and fifth blocking steps resulted in the largest number of formed pairs and the largest processing times for the matching. The fourth step required a lower processing cost. In the accuracy study, after five blocking steps, the sensitivity of the linkage was 90.6%, and the specificity was 100%. CONCLUSIONS: The probabilistic strategy used has high accuracy and can be used in studies of the effectiveness of high-complexity, high-cost cardiology procedures.

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.