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.

Influência da avaliação rotineira do fluxo fracionado de reserva durante intervenções coronárias percutâneas na estratégia terapêutica / Influence of routine assessment of fractional flow reserve on decision making coronary interventions

O objetivo desse estudo, em pacientes admitidos para angioplastia coronária eletiva, foi avaliar a percentagem de mudança na estratégia terapêutica se a decisão fosse baseada na medida do fluxo fracionado de reserva do miocárdio (FFR) ao invés de na angiografia somente.Duzentos e cinqüenta pacientes e 471 artérias com estenose ≥ 50 por cento pela estimativa visual, selecionadas para implante de stent foram avaliadas pela medida do FFR e a decisão sobre a intervenção foi baseada no mesmo. Se o FFR era < 0.75, a lesão era trata-da; se o FFR era ≥ 0.75, nenhuma intervenção era realizada.Em 68 por cento das estenoses a estratégia terapêutica inicial foi mantida e em 32 por cento houve alguma mudança com base nas medidas do FFR. Em 48 por cento dos pacientes do estudo existiu pelo menos uma lesão na qual houve mudança de tratamento após a medida do FFR / The aim of this study in patients admitted for elective percutaneous intervention was to evaluate the percentage of change in the therapeutic plan if decision is based on fractional flow reserve (FFR) measurement rather than on angiographic assessment.Two hundred and fifty patients and 471 arteries with a stenosis ≥ 50 per cent by visual estimation and initially selected to be stented were assessed by FFR measurements. Next, the decision to stent was based upon FFR measurement. If FFR was < 0.75, actual stenting was performed; if FFR was ≥ 0.75, no interventional treatment was given. In 68 per cent of the stenoses initial therapeutic strategy was followed and in 32 per cent there was a change in the approach based on FFR. In 48 per cent of the patients there was at least one lesion in which the treatment deci-sion was changed after FFR measurements...

[Diffuse atherosclerotic disease unmasked by invasive physiologic assessment of coronary flow]. / Doença aterosclerótica difusa desmascarada pela avaliação fisiológica invasiva da circulação coronária.

It is known that coronary atherosclerosis is a diffuse process, very little visible at angiography. This article describes a stable angina patient, three months after acute myocardial infarction (AMI), and a severe lesion in anterior descending artery (ADA), evinced by coronariography. Myocardial fractional flow reserve (FFR), obtained through intracoronary pressure measurements, was 0.37 during maximum hyperemia, clearly showing the presence of ischemia. A stent was implanted in ADA and, despite the excellent angiographic result, post-stent FFR was only 0.75, the minimum limit, below which there is ischemia. When the pressure wire (PW) was slowly drawn back from the distal portion of ADA to its proximal portion, a continuous and gradual increase in intracoronary pressure was noted, which clearly indicates diffuse atherosclerosis and not focal stenosis. A gradient was not observed at the stent place. The patient was kept under medical treatment and has been asymptomatic so far.

Doenca aterosclerótica difusa desmascarada pela avaliacão fisiológica invasiva da circulacão coronária / Diffuse atherosclerotic disease unmasked by invasive physiologic assessment of coronary flow

Sabe-se que a aterosclerose coronária é um processo difuso, pouco visível à angiografia. Este artigo descreve um paciente com angina estável, três meses após infarto agudo do miocárdio (IAM), e uma lesão severa na artéria descendente anterior (ADA), evidenciada pela cinecoronariografia. A reserva de fluxo fracionada do miocárdio (FFR), obtida através de medidas pressóricas intracoronárias, foi 0,37 durante a hiperemia máxima, demonstrando claramente a existência de isquemia. Um stent foi implantado na ADA e, a despeito do excelente resultado angiográfico, a FFR pós-stent foi apenas 0,75, o limite mínimo abaixo do qual existe isquemia. Quando a corda guia pressórica (pressure wire - PW) foi lentamente recuada da porcão distal da ADA para sua porcão proximal, notou-se um aumento contínuo e gradativo na pressão intracoronária, o que indica claramente aterosclerose difusa e não estenose focal. Não se notava gradiente no local do stent. O paciente foi mantido em tratamento médico e permanece assintomático até o momento.