Cost-effectiveness analysis for surgical, angioplasty, or medical therapeutics for coronary artery disease: 5-year follow-up of medicine, angioplasty, or surgery study (MASS) II trial.

BACKGROUND: The Second Medicine, Angioplasty, or Surgery Study (MASS II) included patients with multivessel coronary artery disease and normal systolic ventricular function. Patients underwent coronary artery bypass graft surgery (CABG, n=203), percutaneous coronary intervention (PCI, n=205), or medical treatment alone (MT, n=203). This investigation compares the economic outcome at 5-year follow-up of the 3 therapeutic strategies. METHODS AND RESULTS: We analyzed cumulative costs during a 5-year follow-up period. To analyze the cost-effectiveness, adjustment was made on the cumulative costs for average event-free time and angina-free proportion. Respectively, for event-free survival and event plus angina-free survival, MT presented 3.79 quality-adjusted life-years and 2.07 quality-adjusted life-years; PCI presented 3.59 and 2.77 quality-adjusted life-years; and CABG demonstrated 4.4 and 2.81 quality-adjusted life-years. The event-free costs were $9071.00 for MT; $19,967.00 for PCI; and $18,263.00 for CABG. The paired comparison of the event-free costs showed that there was a significant difference favoring MT versus PCI (P<0.01) and versus CABG (P<0.01) and CABG versus PCI (P=0.01). The event-free plus angina-free costs were $16,553.00, $25,831.00, and $24,614.00, respectively. The paired comparison of the event-free plus angina-free costs showed that there was a significant difference favoring MT versus PCI (P=0.04), and versus CABG (P<0.001); there was no difference between CABG and PCI (P>0.05). CONCLUSIONS: In the long-term economic analysis, for the prevention of a composite primary end point, MT was more cost effective than CABG, and CABG was more cost-effective than PCI. CLINICAL TRIAL REGISTRATION INFORMATION: www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN66068876.

[Analysis of Brazilian Public Health System values for complete percutaneous myocardial revascularization in multi-arterial patients]. / Análise dos valores SUS para a revascularização miocárdica percutânea completa em multiarteriais.

BACKGROUND: The Brazilian Public Health System (SUS, acronym in Portuguese) establishes that coronary angioplasty with the double implant stent must not exceed 20% of the angioplasties, resulting in the need of assigning most of the procedures in patients with multiarterial disease. OBJECTIVE: The objective of the present study was to assess the paid values by the SUS in order to obtain the complete percutaneous myocardial revascularization in the SUS patients with the multiarterial disease, related to the number of necessary procedures and of implanted stents. METHODS: A total of 141 patients with multiarterial coronary disease, submitted to a successful complete revascularization, were included by the stent implant with coronariography in a 6-month period of post-implant. The complete revascularization was defined as the percutaneous treatment of all stenosis > 70% in vessels with diameter > 2 mm. For the costs analysis, the values from the Sistema de Informações Hospitalares (SIH) of the SUS table were considered as R$ 2,263.77, for the procedure; and R$ 2,034.23, per implanted stent. RESULTS: In the period from 7/2006 to 12/2007, 416 stents were implanted in 141 patients. The mean age was of 59.7 +/- 9.9 years old, prevailing the male sex (68.1%). The number of vessels was 356 and the lesions number corresponded to 416. In order to obtain the complete revascularization by the coronary stent implant, it was necessary to stagger in up to four procedures. The mean time between the 1st and 2nd, 2nd and 3rd and 3rd and 4th angioplasties was of 45.8 +/- 37.7; 55.4 +/- 55.3 and 33.5 +/- 19.1 days, respectively. CONCLUSION: The complete percutaneous revascularization in patients from the SUS with the multiarterial coronary disease, carried out in most of them staggered, causes considerable elevation of public expenses due to the increase of procedures' number.

Análise dos valores SUS para a revascularização miocárdica percutânea completa em multiarteriais / Analysis of Brazilian Public Health System values for complete percutaneous myocardial revascularization in multi-arterial patients

FUNDAMENTO: O Sistema Único de Saúde (SUS) estabelece que a angioplastia coronariana com o implante de duplo stent não deve exceder 20 por cento das angioplastias, resultando na necessidade de escalonar a maioria dos procedimentos nos pacientes com doença multiarterial. OBJETIVO: O objetivo do presente estudo foi avaliar os valores remunerados pelo SUS para a obtenção da revascularização miocárdica percutânea completa em pacientes do SUS com doença multiarterial relacionados ao número de procedimentos necessários e de stents implantados. MÉTODOS: Foram incluídos 141 pacientes com doença coronariana multiarterial, submetidos à revascularização completa com sucesso pelo implante de stent, com coronariografia aos 6 meses pós-implante. A revascularização completa foi definida como o tratamento percutâneo de todas as lesões com percentual de estenose > 70 por cento, em vasos com diâmetro > 2 mm. Para análise dos custos, foram considerados os valores da Tabela SIH/SUS de R$ 2.263,77 para o procedimento e R$ 2.034,23 por stent implantado. RESULTADOS: No período de 07/2006 a 12/2007 foram implantados 416 stents em 141 pacientes. A idade média foi de 59,7 ± 9,9 anos, com predomínio do sexo masculino (68,1 por cento). O número de vasos foi 356 e o número de lesões 416. Para a obtenção da revascularização completa pelo implante de stent coronáriano foi necessário o escalonamento em até 4 procedimentos. O tempo médio entre a 1ª e 2ª, 2ª e 3ª e 3ª e 4ª angioplastias foi de 45,8 ± 37,7, 55,4 ± 55,3 e 33,5 ± 19,1 dias, respectivamente. CONCLUSÃO: A revascularização percutânea completa em pacientes do SUS com doença coronariana multiarterial, realizada em sua grande maioria de forma escalonada, ocasiona considerável elevação de gastos públicos devido ao aumento do número de procedimentos.

BACKGROUND: The Brazilian Public Health System (SUS, acronym in Portuguese) establishes that coronary angioplasty with the double implant stent must not exceed 20 percent of the angioplasties, resulting in the need of assigning most of the procedures in patients with multiarterial disease. OBJECTIVE: The objective of the present study was to assess the paid values by the SUS in order to obtain the complete percutaneous myocardial revascularization in the SUS patients with the multiarterial disease, related to the number of necessary procedures and of implanted stents. METHODS: A total of 141 patients with multiarterial coronary disease, submitted to a successful complete revascularization, were included by the stent implant with coronariography in a 6-month period of post-implant. The complete revascularization was defined as the percutaneous treatment of all stenosis > 70 percent in vessels with diameter > 2 mm. For the costs analysis, the values from the Sistema de Informações Hospitalares (SIH) of the SUS table were considered as R$ 2,263.77, for the procedure; and R$ 2,034.23, per implanted stent. RESULTS: In the period from 7/2006 to 12/2007, 416 stents were implanted in 141 patients. The mean age was of 59.7 ± 9.9 years old, prevailing the male sex (68.1 percent). The number of vessels was 356 and the lesions number corresponded to 416. In order to obtain the complete revascularization by the coronary stent implant, it was necessary to stagger in up to four procedures. The mean time between the 1st and 2nd, 2nd and 3rd and 3rd and 4th angioplasties was of 45.8 ± 37.7; 55.4 ± 55.3 and 33.5 ± 19.1 days, respectively. CONCLUSION: The complete percutaneous revascularization in patients from the SUS with the multiarterial coronary disease, carried out in most of them staggered, causes considerable elevation of public expenses due to the increase of procedures' number.

Avaliação do custo do implante programado de múltiplos stents em mais de uma intervenção percutânea em pacientes com doença coronária multiarterial / Cost evaluation of scheduled multiple stents implantation in multivessel coronary disease patients

Fundamentos: O Sistema Único de Saúde estabelece que a angioplastia coronária com implante de dupla prótese intraluminal não deverá exceder o total de 20% das angioplastias realizadas, resultando na necessidade de escalonar a maioria dos procedimentos nos pacientes com doença coronária multiarterial. O objetivo deste estudo foi comparar os custos do escalonamento estabelecido pelo SUS para implante de stent ao planejamento de implante de stent considerado ideal pela equipe de cardiologia intervencionista, em pacientes com doença coronária multiarterial, com indicação de implante de mais um stent por procedimento. Método: Os custos foram comparados em uma série consecutiva de 100 pacientes com doença multiarterial com indicação de revascularização completa por intervenção coronária percutânea com o implante de dois ou mais stents por paciente. As coronariografias foram previamente avaliadas pela equipe de cardiologia intervencionista, que indicou o escalonamento considerado ideal para o tratamento das estenoses coronárias em cada paciente. Em seguida, foram realizados os procedimentos de acordo com os critérios do SUS e os custos das duas estratégias comparados. O valor do procedimento de implante de um stent pela tabela SUS é de R$4.298,00. Resultados: A idade média foi 61,5±10,7 anos, 66% eram do sexo masculino, 43% eram diabéticos e 67% tinham angina estável. Ocorreu concordância em relação ao escalonamento estabelecido pelo SUS em 44% e discordância em 56%. Foram realizados 58 procedimentos a mais do que o considerado ideal pela equipe de cardiologia intervencionista, gerando um custo adicional de R$131.298,00. Conclusões: O escalonamento estabelecido pelo SUS, com parado ao considerado ideal pela equipe de cardiologia intervencionista, ocasiona um aumento no número de procedimentos de implante de stent coronário e, consequentemente, uma elevação de gastos públicos.

Background: The Brazilian Public Health System (SUS)establishes that coronary ngioplasties with implantation of two stents must not exceed 20% of the total amount of angioplasties performed, resulting in the necessity of staged procedures in the majority of the patients with multivessel coronary disease. The objective of this study was to compare the costs of the staged stent implantation policy, imposed by SUS, with the stent implantation approach considered ideal by the interventional cardiology team, in patients with multivessel coronary disease. Methods: Costs were compared in a consecutive cohort of 100 patients with multivessel disease with indication of complete revascularization by percutaneous coronary intervention. Coronary angiographies had been previously evaluated by the interventional cardiology team that had individualized the approach considered ideal for the treatment of each patient. Procedures were then performed in accordance to SUS multistage policy and the costs of the two treatment strategies were compared. Of note, a single stent implantation procedure costs R$4,298.00 according to the SUS price list. Results: Mean age was 61.5±10.7 years, 66% were male, 43% diabetics and 67% had stable angina. Agreement in relation to the SUS staged procedures occurred in 44% and discordance in 56%. An excess of 58 procedures was detected, generating an additional cost of R$131,298.00. Conclusions: The multistaged approach imposed by SUS increases the number of procedures for coronary stent implantation in patients with multivessel disease and consequently increments the public expenses.

Relative cost comparison of treatments for coronary artery disease: the First Year Follow-Up of MASS II Study.

BACKGROUND: Prior comparisons of costs following CABG and PTCA have demonstrated higher initial costs after CABG but following PTCA, recurrent symptoms and repeat revascularization result in increased late costs and over time their costs equilibrate. The MASS II trial provides an opportunity to compare the costs of CABG and PTCA in addition to a strategy of medical therapy. METHODS: We studied the 611 patients of MASS II [Medical (203), Angioplasty (205), or Surgery (203) Study], a randomized study to compare treatments for multivessel CAD and preserved left ventricle function. The costs were: CABG 10,650.00 US dollars; PTCA 6400.00 US dollars; new AMI hospitalization AMI 2550 US dollars; angiography not followed-up of PTCA 1900.00 US dollars; and medication 1200.00 US dollars for medical, and 1000.00 US dollars for the other groups. We did adjustment for average event-free time, and angina-free proportion. The statistical analysis carried out was chi-square, t test, and analysis of variance. RESULTS: After 1 year, 49% Medical, 79% PTCA, and 88% CABG became angina-free; P<0.0001. There were 26 coronary angiograms (5 medical, 17 PTCA, and 4 CABG), 23 AMI (8 medical, 17 PTCA, and 6 CABG; P=0.03); PTCA was performed in 7 Medical, 17 PTCA, and 1 CABG, (P=0.0003), CABG was performed in 15 Medical, 8 PTCA, and zero CABG; P=0.002. The event-free and event and angina-free-costs in the first year were 2453.50 US dollars and 5006.32 US dollars for Medical; 10348,43 US dollars; and 13,099.31 US dollars for PTCA; and 12,404.21 US dollars and 14,095.09 US dollars for CABG group. An increase from expected costs of 317%, 77%, and 21%, respectively. CONCLUSIONS: PTCA effective costs were similar to CAGB costs, Medical treatment presented the lowest cost, and however, the greatest increment, and CABG presented the most stable costs.

Avaliação da reserva funcional miocárdica em portadores de aneurisma de ventrículo esquerdo por ventriculografia radioisotópica. Resposta ao exercício isotônico / Radionuclide Ventriculography Assessment of Myocardial Functional Reserve in Patients With Left Ventricular Aneurysm. Response to Isotonic Exercise

PURPOSE: To evaluate global and regional left ventricular (LV) ejection fractions (EF) by radionuclide ventriculography in patients with LV aneurysm at rest and during isotonic exercise. METHODS: Twenty patients were studied by radionuclide ventriculography at rest and during exercise. All patients had been submitted to cineangiography and showed LV aneurysm post myocardial infarction. RESULTS: Patients were divided according to LV EF in two groups: one with EF > or = 40 and the other with < 40 EF. Both groups showed normal response of global EF to exercise: mean rest EF was 40 +/- 14 and mean exercise EF was 45 +/- 14 (p < 0.01). When groups were considered separately, EF values showed the same behavior. Half of the patients showed normal response to exercise and the other half showed abnormal response. These changes were not associated with resting EF values, but were due to regional EF of lateral wall, that changed from 44 +/- 7 to 48 +/- 7 in the group of patients with normal LV EF response to stress and from 50 +/- 5 to 46 +/- 5 in those with abnormal response (p < 0.01). CONCLUSION: The evaluation of regional ventricular EF by radionuclide ventriculography during exercise better discriminates functional reserve in patients with LV aneurysm than resting global EF. These findings could help the decision making of the therapeutic approach in this specific group of patients.

Objetivo - Avaliar a fração de ejeção (FE) global e segmentar do ventrículo esquerdo (VE), em portadores de aneurisma ventricular pelo uso da ventriculografia radioisotópica no repouso e ao exercício isotônico. Métodos - Foram estudados 20 pacientes através da ventriculografia radioisotópica em repouso e na vigência de exercício isotônico. Os pacientes tinham dingnóstico de aneurisma de VE pós-infarto do miocárdio à cineangiografia contrastada. Resultados - Os pacientes foram divididos em 2 grupos segundo a FE global de VE no repouso: grupo com FE >40% e outro com FE <40%. Quando analisados os dois grupos em conjunto, a resposta da FE global ao esforço foi normal: média de FE no repouso 4014% e no esforço 4514% (p<0,01). Observou-se o mesmo comportamento das FE no esforço quando os 2 grupos foram analisados separadamente. Metade dos pacientes apresentou resposta normal da FE global de VE e na outra metade a resposta foi anormal. Este comportamento nao estava associado ao valor de repouso da FE global e deveu-se à resposta da FE regional da parede lateral ao exercício que passou de 447para 487% (p<0,01) no grupo com resposta normul e de 505 para 465% naqueles com resposta anormal (p<0,01). Conclusão - A avaliação da fração regional ventricular no esforço pela ventriculografia radioisotópica discrimina melhor a reserva funcional de portadores de aneurisma de VE do que a FE global de repouso e pode auxiliar na decisão terapêutica deste grupo de pacientes