Impact of stent diameter on clinical outcomes following percutaneous coronary intervention with thirdgeneration drug-eluting stents: results from inspirion and latitude trials

INTRODUCTION: In patients treated with bare metal stents and earlygeneration drug-eluting stents (DES) smaller stent diameter (SD) has been associated with worse long-term outcomes after percutaneous coronary intervention (PCI). Data on the impact of small SD on outcomes after PCI with third generation DES is scarce. OBJECTIVE: The aim of this study was to evaluate the impact of SD on clinical outcomes, using a third generation sirolimus-eluting coronary stent with thin struts and abluminal biodegradable polymer. METHODS: Consecutive patients treated with Inspiron® (Scitech, Brazil) in native coronary arteries lesions between June 2017 and January 2022 were included, in a total of 25 Brazilian centers. Patients were grouped according to SD: 3.50mm. One-year event rates were estimated using the Kaplan-Meier method and adjusted hazard ratios were generated using Cox regression analysis. The primary endpoint was a composite of major adverse cardiovascular events (MACE) defined by the composite of cardiovascular death, myocardial infarction (MI) or target-lesion revascularization (TLR) at 12 months. RESULTS: Of the 2,803 patients who underwent PCI with Inspiron®, 24,5% (n = 688) had SD ≤2.50 mm, 45.0% (n = 1,263) had SD 2.75-3.00mm and 30,4% (n = 852) had SD >3.50 mm. At 1 year, MACE rates were 3.1%, 2.1% and 1.3%, respectively, with increasing SD (p = 0.054). Death due to CV causes at 12 months rates decreased with increasing SD (2.9%, 1.8% and 0.8%, respectively [p < 0.009]) whereas rates of MI related study device at 12 months across SD groups were comparable (0.0%, 0.5%, and 0.1%, respectively [p = 0.086]). After multivariate stepwise Cox regression, smaller SD remained associated with higher rates of MACE (HR 0.46, 95%CI of 0.241-0.890; p=0.022). As seen in Figure 1, the risk of MACE is significantly increased in the first 30 days and remain higher up to 12 months among individuals with mean vessel diameter <2.50mm. CONCLUSIONS: In a large cohort of patients undergoing PCI with third generation DES MACE rates were low, but still higher among patients with smaller SD, mainly drive by higher CV deaths at 12 months. Further research into the optimal treatment strategy of small coronary arteries is still warranted.

Prognostic Assessment of Fractional Flow Reserve in Different Strata in Patients with Coronary Artery Disease. / Avaliação Prognóstica da Reserva de Fluxo Fracionada em Diferentes Estratos nos Pacientes com Doença Arterial Coronariana.

BACKGROUND: There are limited real-world data on the clinical course of untreated coronary lesions according to their functional severity. OBJECTIVE: To evaluate the 5-year clinical outcomes of patients with revascularized lesions with fractional flow reserve (FFR) ≤ 0.8 and patients with non-revascularized lesions with FFR > 0.8. METHODS: The FFR assessment was performed in 218 patients followed for up to 5 years. Participants were classified based on FFR into ischemia group (≤ 0.8, intervention group, n = 55), low-normal FFR group (> 0.8-0.9, n = 91), and high-normal FFR group (> 0.9, n = 72). The primary endpoint was major adverse cardiac events (MACEs), a composite of death, myocardial infarction, and need for repeat revascularization. The significance level was set at 0.05; therefore, results with a p-value < 0.05 were considered statistically significant. RESULTS: Most patients were male (62.8%) with a mean age of 64.1 years. Diabetes was present in 27%. On coronary angiography, the severity of stenosis was 62% in the ischemia group, 56.4% in the low-normal FFR group, and 54.3% in the high-normal FFR group (p<0.05). Mean follow-up was 3.5 years. The incidence of MACEs was 25.5%, 13.2%, and 11.1%, respectively (p=0.037). MACE incidence did not differ significantly between the low-normal and high-normal FFR groups. CONCLUSION: Patients with FFR indicative of ischemia had poorer outcomes than those in non-ischemia groups. There was no difference in the incidence of events between the low-normal and high-normal FFR groups. Long-term studies with a large sample size are needed to better assess cardiovascular outcomes in patients with moderate coronary stenosis with FFR values between 0.8 and 1.0.

FUNDAMENTO: Existem dados limitados sobre a evolução clínica de lesões coronarianas não tratadas de acordo com sua gravidade funcional no mundo real. OBJETIVO: Este estudo teve como objetivo avaliar os resultados clínicos de até 5 anos em pacientes com lesões revascularizadas com reserva de fluxo fracionada (FFR) ≤ 0,8 e em pacientes com lesões não revascularizadas com FFR > 0,8. MÉTODOS: A avaliação pelo FFR foi realizada em 218 pacientes seguidos por até 5 anos. Os participantes foram classificados com base na FFR no grupo isquêmico (≤ 0,8, grupo intervenção, n = 55), no grupo FFR normal-baixa (> 0,8-0,9, n = 91) e no grupo FFR normal-alta (> 0,9, n = 72). O desfecho primário foram eventos cardíacos adversos maiores (ECAMs), um composto de morte, infarto do miocárdio e necessidade de nova revascularização. O nível de significância adotado neste estudo foi alfa = 0,05; deste modo, resultados com valores de p < 0,05 foram considerados estatisticamente significativos. RESULTADOS: A maioria dos participantes era do sexo masculino (62,8%) com média de idade de 64,1 anos. Diabetes estava presente em 27%. À angiografia coronariana, a gravidade da estenose avaliada foi de 62%, 56,4% e 54,3% nos grupos isquêmico, FFR normal-baixa e FFR normal-alta, respectivamente (p < 0,05). O período médio de acompanhamento foi de 3,5 anos. A incidência ECAM foi de 25,5%, 13,2% e 11,1%, respectivamente (p = 0,037). Não houve diferença na incidência de ECAM entre os grupos FFR normal-baixa e FFR normal-alta (p = NS). CONCLUSÃO: Pacientes com FFR indicativa de isquemia apresentaram piores desfechos quando comparados aos dos grupos não isquêmicos. Entre os grupos que apresentaram valores de FFR considerados normal-baixo e normal-alto, não houve diferença na incidência de eventos. Há necessidade de estudos de longo prazo e com grande número de pacientes para melhor avaliar os desfechos cardiovasculares em pacientes portadores de estenose coronariana moderada com valores de FFR entre 0,8 e 1,0.

Avaliação Prognóstica da Reserva de Fluxo Fracionada em Diferentes Estratos nos Pacientes com Doença Arterial Coronariana / Prognostic Assessment of Fractional Flow Reserve in Different Strata in Patients with Coronary Artery Disease

Resumo Fundamento Existem dados limitados sobre a evolução clínica de lesões coronarianas não tratadas de acordo com sua gravidade funcional no mundo real. Objetivo Este estudo teve como objetivo avaliar os resultados clínicos de até 5 anos em pacientes com lesões revascularizadas com reserva de fluxo fracionada (FFR) ≤ 0,8 e em pacientes com lesões não revascularizadas com FFR > 0,8. Métodos A avaliação pelo FFR foi realizada em 218 pacientes seguidos por até 5 anos. Os participantes foram classificados com base na FFR no grupo isquêmico (≤ 0,8, grupo intervenção, n = 55), no grupo FFR normal-baixa (> 0,8-0,9, n = 91) e no grupo FFR normal-alta (> 0,9, n = 72). O desfecho primário foram eventos cardíacos adversos maiores (ECAMs), um composto de morte, infarto do miocárdio e necessidade de nova revascularização. O nível de significância adotado neste estudo foi alfa = 0,05; deste modo, resultados com valores de p < 0,05 foram considerados estatisticamente significativos. Resultados A maioria dos participantes era do sexo masculino (62,8%) com média de idade de 64,1 anos. Diabetes estava presente em 27%. À angiografia coronariana, a gravidade da estenose avaliada foi de 62%, 56,4% e 54,3% nos grupos isquêmico, FFR normal-baixa e FFR normal-alta, respectivamente (p < 0,05). O período médio de acompanhamento foi de 3,5 anos. A incidência ECAM foi de 25,5%, 13,2% e 11,1%, respectivamente (p = 0,037). Não houve diferença na incidência de ECAM entre os grupos FFR normal-baixa e FFR normal-alta (p = NS). Conclusão Pacientes com FFR indicativa de isquemia apresentaram piores desfechos quando comparados aos dos grupos não isquêmicos. Entre os grupos que apresentaram valores de FFR considerados normal-baixo e normal-alto, não houve diferença na incidência de eventos. Há necessidade de estudos de longo prazo e com grande número de pacientes para melhor avaliar os desfechos cardiovasculares em pacientes portadores de estenose coronariana moderada com valores de FFR entre 0,8 e 1,0.

Abstract Background There are limited real-world data on the clinical course of untreated coronary lesions according to their functional severity. Objective To evaluate the 5-year clinical outcomes of patients with revascularized lesions with fractional flow reserve (FFR) ≤ 0.8 and patients with non-revascularized lesions with FFR > 0.8. Methods The FFR assessment was performed in 218 patients followed for up to 5 years. Participants were classified based on FFR into ischemia group (≤ 0.8, intervention group, n = 55), low-normal FFR group (> 0.8-0.9, n = 91), and high-normal FFR group (> 0.9, n = 72). The primary endpoint was major adverse cardiac events (MACEs), a composite of death, myocardial infarction, and need for repeat revascularization. The significance level was set at 0.05; therefore, results with a p-value < 0.05 were considered statistically significant. Results Most patients were male (62.8%) with a mean age of 64.1 years. Diabetes was present in 27%. On coronary angiography, the severity of stenosis was 62% in the ischemia group, 56.4% in the low-normal FFR group, and 54.3% in the high-normal FFR group (p<0.05). Mean follow-up was 3.5 years. The incidence of MACEs was 25.5%, 13.2%, and 11.1%, respectively (p=0.037). MACE incidence did not differ significantly between the low-normal and high-normal FFR groups. Conclusion Patients with FFR indicative of ischemia had poorer outcomes than those in non-ischemia groups. There was no difference in the incidence of events between the low-normal and high-normal FFR groups. Long-term studies with a large sample size are needed to better assess cardiovascular outcomes in patients with moderate coronary stenosis with FFR values between 0.8 and 1.0.

Emergency Percutaneous Treatment of Saphenous Vein Graft Perforation After Cardiac Surgery.

Immediately post coronary artery bypass graft surgery, a 58-year-old woman developed excessive bleeding through the chest drains and hemodynamic instability, followed by total atrioventricular block requiring use of temporary pacemaker, which precluded electrocardiographic interpretation. She was referred for urgent diagnostic coronary angiography, which demonstrated important contrast leakage from the distal body of the saphenous vein graft to the first marginal branch. Acute saphenous vein graft perforation following coronary artery bypass graft surgery is rare. To the best of our knowledge, this is the first case report of acute saphenous vein graft perforation after coronary artery bypass graft surgery treated with a stent-graft.

Avaliação da relação do índice tornozelo-braquial com a gravidade da doença arterial coronáriana / Assessment of the relationship of ankle-brachial index with coronary artery disease severity

Fundamento: A Doença Arterial Periférica (DAP) está associada a eventos cardiovasculares, podendo ser diagnosticada e estimada através do Índice Tornozelo-Braquial (ITB). Está bem estabelecido que o ITB é fator agravante na estratificação de risco cardiovascular, mas sua contribuição para definir a gravidade do acometimento arterial coronariano não está bem estabelecida. Objetivos: Estudo testou o valor do ITB com a gravidade da doença aterosclerótica coronariana pelo Escore de Syntax (ES) em pacientes com Síndrome Coronariana Aguda (SCA). Métodos: Estudo prospectivo com medida do ITB de todos os pacientes internados com SCA no Hospital São Lucas da PUCRS, consecutivamente, de maio a setembro de 2016, e comparação de seu valor com o ES e tipos de SCA desses pacientes. As análises foram realizadas considerando-se o nível de confiança de 95% ( α = 5%). Resultados: 101 pacientes, com média de idade de 62,6±12,0 anos, 58 (57,4%) masculinos, 74 (82,2%) hipertensos, 33 (45,8%) diabéticos e 46 (45,5%) com infarto agudo do miocárdio com supradesnivelamento do ST (IAMCSST). A gravidade da DAP não teve relação com a gravidade anatômica da doença arterial coronariana (DAC). Encontramos uma associação significativa de ES intermediário com infarto agudo do miocárdio sem supradesnivelamento do ST (IAMSSST) e de ES baixo com angina instável (AI) [OR (IC95%): 1,11 (1,03-1,20); p = 0,004], que se manteve após análise multivariada, ajustada para idade, tabagismo, história familiar de DAC e DAC prévia [OR (IC95%): 1,13 (1,02-1,25); p = 0,019]. Conclusões: Analisando nossos resultados, encontramos que pacientes com ITB < 0,9 não apresentaram associação com maior complexidade determinada pelo ES em pacientes com SCA. Os pacientes com IAMSSST estiveram mais associados com ES intermediário

DOI: 10.5935/2359-4802.20170094 47 International Journal of Cardiovascular Sciences. 2018;31(1)47-55 ARTIGO ORIGINAL Correspondência: Andrea Mabilde Petracco Av. Ipiranga, 7464, sala 524. CEP: 91530-000, Jardim Botânico, Porto Alegre, RS ­ Brasil. E-mail: apetracco@terra.com.br; apetracco@cardiol.br Avaliação da Relação do Índice Tornozelo-Braquial com a Gravidade da Doença Arterial Coronária Assessment of the Relationship of Ankle-Brachial Index With Coronary Artery Disease Severity Andrea Mabilde Petracco, Luiz Carlos Bodanese, Gustavo Farias Porciúncula, Gabriel Santos Teixeira, Denise de Oliveira Pellegrini, Luiz Claudio Danzmann, Ricardo Medeiros Pianta, João Batista Petracco Hospital São Lucas, da Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS ­ Brasil Artigo recebido em 28/02/2017; revisado em 12/08/2017; aceito em 21/08/2017 Resumo Fundamento: A Doença Arterial Periférica (DAP) está associada a eventos cardiovasculares, podendo ser diagnosticada e estimada através do Índice Tornozelo-Braquial (ITB). Está bem estabelecido que o ITB é fator agravante na estratificação de risco cardiovascular, mas sua contribuição para definir a gravidade do acometimento arterial coronariano não está bem estabelecida. Objetivos: Estudo testou o valor do ITB com a gravidade da doença aterosclerótica coronariana pelo Escore de Syntax (ES) em pacientes com Síndrome Coronariana Aguda (SCA). Métodos: Estudo prospectivo com medida do ITB de todos os pacientes internados com SCA no Hospital São Lucas da PUCRS, consecutivamente, de maio a setembro de 2016, e comparação de seu valor com o ES e tipos de SCA desses pacientes. As análises foram realizadas considerando-se o nível de confiança de 95% ( α = 5%). Resultados: 101 pacientes, com média de idade de 62,6±12,0 anos, 58 (57,4%) masculinos, 74 (82,2%) hipertensos, 33 (45,8%) diabéticos e 46 (45,5%) com infarto agudo do miocárdio com supradesnivelamento do ST (IAMCSST). A gravidade da DAP não teve relação com a gravidade anatômica da doença arterial coronariana (DAC). Encontramos uma associação significativa de ES intermediário com infarto agudo do miocárdio sem supradesnivelamento do ST (IAMSSST) e de ES baixo com angina instável (AI) [OR (IC95%): 1,11 (1,03-1,20); p = 0,004], que se manteve após análise multivariada, ajustada para idade, tabagismo, história familiar de DAC e DAC prévia [OR (IC95%): 1,13 (1,02-1,25); p = 0,019]. Conclusões: Analisando nossos resultados, encontramos que pacientes com ITB < 0,9 não apresentaram associação com maior complexidade determinada pelo ES em pacientes com SCA. Os pacientes com IAMSSST estiveram mais associados com ES intermediário. (Int J Cardiovasc Sci. 2018;31(1)47-55) Palavras-chave: Índice Tornozelo-Braço, Síndrome Coronariana Aguda, Doença da Artéria Coronariana, Índice de Severidade da Doença, Aterosclerose, Doença Arterial Periférica. Abstract Background: Peripheral Artery Disease (PAD) is associated with cardiovascular events and can be diagnosed and estimated by use of the Ankle-Brachial Index (ABI). ABI is a worsening factor in the stratification of cardiovascular risk, but its contribution to define the severity of coronary artery disease has not been well established. Objectives: To compare the ABI value with the coronary atherosclerotic disease severity by use of the Syntax Score (SS) in patients with Acute Coronary Syndrome (ACS). Methods: This prospective study measured the ABI of all patients with ACS consecutively admitted to the São Lucas Hospital of PUCRS from May to September 2016, and compared the ABI values with the SS and ACS types of those patients. The analyzes were performed considering the 95%confidence interval ( α = 5%). Results: This study assessed 101 patients [mean age, 62.6 ± 12.0 years; 58 men (57.4%)], 74 (82.2%) were hypertensive, 33 (45.8%) had diabetes and 46 (45,5%) had ST-elevation acute myocardial infarction (STEMI). The PAD severity was not related to the anatomical severity of the coronary artery disease (CAD). We found a significant association of intermediate SS with non-ST-elevation acute myocardial infarction (NSTEMI), and of low SS with unstable angina (UA) [OR (95% CI): 1.11 (1.03-1.20) (p = 0.004)], which remained after multivariate analysis adjusted to age, smoking, family history of CAD and previous CAD [(OR 95%): 1.13 (1.02-1.25) (p = 0.019)]. Conclusions: Patients with ABI < 0.9 showed no association with higher disease complexity determined by the SS in patients with ACS. Patients with NSTEMI were more associated with an intermediate risk on the SS

Efficacy and Safety of Drug-Eluting Stents in the Real World: 8-Year Follow-Up / Eficácia e Segurança de Stents Eluidores de Drogas no Mundo Real: Acompanhamento de 8 Anos

Background: Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. Objective: To evaluate the efficacy and safety of drug-eluting stents in the real world. Methods: We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. Results: A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. Conclusion: These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the "real world" may benefit from drug-eluting stenting with excellent, long-term results. .

Fundamento: Stents eluidores de drogas têm sido utilizados na prática médica desde 2002, e apresentam grande eficácia na redução do risco de revascularização do vaso-alvo, e notável redução da taxa de reestenose de 50%-70%. No entanto, a ocorrência de trombose tardia pode comprometer os resultados a longo prazo, especialmente se o risco de trombose for mantido ao longo dos anos. Neste contexto, o registro da prática clínica assume grande importância. Objetivo: Avaliar a eficácia e segurança de stents eluidores de drogas no mundo real. Métodos: Relatamos os resultados de todos os pacientes que foram submetidos à intervenção coronária percutânea com stent eluidor de drogas no período entre janeiro de 2002 a abril de 2007, e que foram acompanhados por 8 anos. Os stents eluidores de drogas foram utilizados de acordo com as recomendações clínicas do cardiologista intervencionista e a disponibilidade do stent. Resultados: Um total de 611 pacientes foram avaliados, com acompanhamento clínico de 96,2% destes pacientes por até 8 anos. A mortalidade total foi de 8,7%. Infarto não-fatal ocorreu em 4,3% dos casos. A taxa de revascularização do vaso-alvo foi de 12,4% e a da lesão-alvo foi de 8,0%. A taxa de trombose de stent foi de 2,1%. Não houve novos episódios de trombose de stent após o quinto ano de acompanhamento. Uma subanálise comparativa indicou não haver diferenças nos desfechos clínicos apos a utilização dos stents Cypher, Taxus e Endeavor. Conclusão: Estes resultados indicam que stents eluidores de drogas são seguros e eficazes em acompanhamentos de longo prazo, e que pacientes no mundo real podem beneficiar destes stents, com excelentes resultados a longo prazo. .

Efficacy and safety of drug-eluting stents in the real world: 8-year follow-up.

BACKGROUND: Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. OBJECTIVE: To evaluate the efficacy and safety of drug-eluting stents in the real world. METHODS: We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. RESULTS: A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. CONCLUSION: These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the "real world" may benefit from drug-eluting stenting with excellent, long-term results.