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.

Bioresorbable polymer Sirolimus-Eluting stent in native coronary artery stenosis: results of the prospective, multicenter inspirion and latitude trials

INTRODUCTION: Inspiron® (Scitech, Brazil) is a 3rd generation drug eluting stent designed to create a fast and homogeneous endothelialization, possibly improving clinical outcomes. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a sirolimus-eluting coronary stent, composed of a metallic chromium-cobalt platform with thin struts (75 µm), which releases sirolimus from a bioresorbable polymer applied only to the abluminal surface, in a real-world scenario, as a post-marketing clinical follow-up evaluation. METHODS: We pooled patient-level databases derived from the INSPIRION and LATITUDE prospective trials. Between June 2017 and January 2022, a total of 25 Brazilian centers included 2,803 patients that underwent percutaneous coronary intervention (PCI) in native coronary arteries lesions with Inspiron® (Scitech, Brazil) stent implantation. Exclusion criteria included target lesion located in saphenous vein or arterial graft, and use of coronary stent other than Inspiron® in the index procedure. The primary endpoint was a composite outcome of major adverse cardiovascular events (MACE) defined by the composite of cardiovascular death, myocardial infarction (MI) or target-lesion revascularization (TLR) at 12 months. The secondary outcomes included all-cause death, cardiovascular death, any MI, TLR, target-vessel revascularization (TVR), and probable and definite stent thrombosis at 12 months. RESULTS: The mean age was 62.0 ± 10.8 years, 36.5% had diabetes (12.7% on insulin), 17.6% had previous PCI and 54.9% presented with an acute coronary syndrome (ACS). At a median follow-up of 410 days, MACE occurred in 58 (2.1%) patients, all-cause death in 102 (3.6%), MI in 14 (0.5%), and target vessel revascularization in 2 (0.1%) patients. Definite or probable stent thrombosis occurred in 20 (0.7%) patients. CONCLUSIONS: The 1-year MACE rate, as well as the individual endpoint components, were low and consistent with previous results available for 3rd generation drug eluting stent. The result of this study demonstrates the safety and efficacy of this stent in a real-world population.

Emprego do stent farmacológico supralimus, com sirolimus e polímero absorvível, no tratamento de pacientes com síndrome coronária aguda submetidos a intervenção coronária percutânea / Use of Supralimus™ drug eluting stent with sirolimus and absorbable polymer in the treatment of acute coronary syndrome patients undergoing percutaneous coronary intervention

INTRODUÇÃO: Apesar da eficácia dos stents farmacológicos de primeira geração em reduzir a necessidade de novas intervenções, seu uso em cenários de maior complexidade, como as síndromes coronárias agudas, pode estar associado a maiores taxas de trombose. Estudos pré-clínicos têm atribuído papel central aos polímeros duráveis na gênese desses eventos adversos. O stent SupralimusTM combina uma plataforma de aço inoxidável com um polímero bioabsorvível com eluição de sirolimus. Esta análise teve por objetivo determinar a eficácia e a segurança clínica desse novo stent farmacológico no tratamento de pacientes não-selecionados com síndrome coronária aguda. MÉTODO: O Registro E-SERIES é um estudo multicêntrico e prospectivo, que inclui pacientes consecutivos tratados com SupralimusTM. Virtualmente todos os subtipos de pacientes e lesões encontram-se representados nesse registro. Toda informação pertinente ao procedimento e aos desfechos clínicos é coletada via internet, sendo os eventos adversos avaliados por comitê independente. RESULTADOS: Foram incluídos, no total, 1.263 pacientes, entre os quais 454 (35,9%) tiveram diagnóstico inicial de síndrome coronária aguda. A maioria era do sexo masculino (68,9%), com média de idade de 63 ± 11,4 anos. A incidência de diabetes melito nessa população foi elevada (36,8%). Em 6% dos casos havia trombo à angiografia pré-intervenção. Ao final do procedimento, fluxo TIMI 3 foi obtido em 96,8% dos procedimentos. A taxa de eventos cardíacos adversos na fase hospitalar foi de 1% (mortalidade de 0,4%). A taxa cumulativa de eventos cardíacos adversos maiores aos seis meses foi de 10%, com 0,4% de trombose do stent. CONCLUSÕES: Quando utilizado para tratar pacientes complexos portadores de síndrome coronária aguda, o stent farmacológico SupralimusTM demonstrou bom desempenho e segurança no seguimento de médio prazo, com baixas taxas de eventos adversos e trombose.

BACKGROUND: Despite the efficacy of first generation drug eluting stents in reducing the need of new interventions, its use in more complex conditions, such as acute coronary syndromes, may be associated to higher thrombosis rates. Pre-clinical analyses have attributed a major role to durable polymers in the genesis of these adverse events. The SupralimusTM stent combines a stainless steel platform with a bioabsorbable polymer loaded with sirolimus. This study was aimed at establishing the safety and clinical efficacy of this new drug eluting stent in non-selected acute coronary syndrome patients. METHOD: The E-SERIES Registry is a multicenter and prospective study, including consecutive patients treated with SupralimusTM stent. Virtually all subtypes of patients and lesions are represented in this registry. Information regarding the procedure and clinical outcomes is collected through the internet and adverse events are adjudicated by an independent committee. RESULTS: A total of 1,263 patients were included and 454 (35.9%) had an initial diagnosis of acute coronary syndrome. Most patients were male (68.9%) with mean age of 63 ± 11.4 years. Diabetes mellitus was highly prevalent in this subset (36.8%). Thrombus was visible at pre-intervention angiography in 6% of the cases. Final TIMI 3 flow was achieved in 96.8% of the patients. In-hospital major adverse cardiac events rate was 1% (mortality of 0.4%). Six-month cumulative major adverse cardiac events rate was 10% with 0.4% of stent thrombosis. CONCLUSIONS: The use of SupralimusTM drug eluting stent in the treatment of complex patients with acute coronary syndromes demonstrated excellent performance and safety profile in the midterm follow-up, with low adverse events and thrombosis rates.

Qual o erro da angiografia na definição de isquemia miocárdica durante intervenções coronarianas percutâneas? / What is the angiography error when defining myocardial ischemia during percutaneous coronary interventions?

FUNDAMENTO: A angiografia vem sendo utilizada como padrão de referência para definição de doença arterial coronariana (DAC), embora suas limitações sejam conhecidas. O valor da medida do fluxo fracionado de reserva do miocárdio (FFR) na avaliação da DAC está bem estabelecido. OBJETIVO: O objetivo deste estudo é avaliar a acurácia da angiografia em definir as lesões isquêmicas e sua correlação com o FFR. MÉTODOS: Duzentos e cinqüenta pacientes foram incluídos no estudo (471 vasos). Todas as estenoses > 50 por cento pela estimativa visual da angiografia (EVA) foram avaliadas medindo-se o FFR. Se o FFR <0,75 a lesão foi tratada, se o FFR >0,75 a lesão não foi tratada. As lesões foram divididas em moderadas (<70 por cento - 327) e graves (125) pela QCA. Foram determinados o coeficiente de correlação entre o grau de estenose ( por centoDE), o FFR e a acurácia da EVA em definir se uma lesão era ou não isquêmica. RESULTADOS: Foi possível obter o FFR em 96 por cento das lesões. por centoDE e FFR médios de 56±8 por cento e 0,74 e 76±6 por cento e 0,48 para as lesões moderadas e graves respectivamente. Notou-se pobre correlação entre o por centoDE e o FFR, especialmente nas lesões moderadas (Spearman rho = - 0.33, p<0,0001). A acurácia da EVA comparada com FFR foi de 57 por cento e 96 por cento nas lesões moderadas versus graves. CONCLUSÃO: A angiografia coronária não é adequada para avaliar a importância funcional das lesões coronarianas, sendo necessário associá-la a um método funcional capaz de fazê-lo, especialmente nas lesões moderadas.

BACKGROUND: The angiography has been used as a reference standard to define coronary artery disease (CAD), although its limitations are well-known. The significance of the myocardial fractional flow reserve (FFR) in the assessment of CAD is well established. OBJECTIVE: The aim of this study was to evaluate the accuracy of angiography when defining ischemic lesions and its correlation with FFR. METHODS: Two hundred and fifty consecutive patients (471 arteries) were included in this study. All stenoses > 50 percent at the angiography visual estimate (AVE) were assessed by FFR measurements. When FFR was < 0.75, stenting was performed; when FFR was > 0.75, no interventional treatment was carried out. Offline quantitative coronary angiography (QCA) was performed in all stenoses, which were divided in intermediate (< 70 percent - 327) and severe (125). The correlation coefficients between the diameter of the stenosis ( percentDS) and FFR and the accuracy of VA of the angiography when assessing ischemia were determined. RESULTS: FFR could be obtained in 452 lesions (96 percent). Mean percentDS and FFR were 56 ± 8 percent and 0.74 and 76 ± 6 percent and 0.48 for moderate and severe stenoses, respectively. Concordance between QCA and FFR was poor, especially in intermediate stenoses (Spearman's rho = - 0.33, p<0.0001). Visual assessment resulted in an accuracy of 57 percent and 96 percent in intermediate and severe lesions, respectively. CONCLUSION: Neither the visual assessment of an angiogram nor QCA can accurately predict the significance of most intermediate coronary stenoses, which emphasizes the importance of associating it to a functional evaluation of the coronary circulation, resulting in an adequate treatment of these stenoses.

Angiografia versus fluxo fracionado de reserva na avaliação do grau de importância das estenoses coronária / Angiography versus fractional flow reserve in the evaluation of coronary stenoses

Introdução: A decisão de realizar uma intervenção coronária percutânea (ICP) em pacientes com angina deve se basear em sinais objetivos de isquemia. A angiografia vem sendo utilizada como padrão-ouro para definição de doença arterial coronariana (DAC), embora suas limitações sejam conhecidas. Por outro lado, o valor da medida do fluxo fracionado de reserva do miocárdio (FFR) na avaliação da DAC esta bem estabelecido. Objetivo: Avaliar a acurácia da angiografia em definir as lesões culpadas e sua correlação com o FFR, em todos os pacientes admitidos para ICP eletiva em nossa institutição, durante determinado período. Método: Foram incluído no estudo 250 pacientes (471 vasos). Foram avaliadas todas as estenoses menor ou igual 0,75, a lesão foi tratada, se o FFR era maior ou igual 0,75, a lesão não foi tratada. Foi realizada QCA off-line de todas as lesões, divididas em moderada ( maior 70 por cento - 327) e graves (125). Foram determinados o coeficiente de correlação entre o grau de estenose (%DE) e o FFR para os dois grupos e a acurácia da estimativa visual da angiografia em definir se uma lesão era ou não isquêmica, tomando-se o FFR como padrão-ouro. Resultados: Foi possível obter o FFR em 96% das lesões (452). %DE e FFR médios de 56 ± 8% e 0,74 e 76 ± 6% e 0,48 para as lesões moderadas e graves. Notouse pobre correlação negativa entre o %DE e o FFR, principalmente nas lesões moderadas (Spearman rho = -0,33, p<0,0001). A acurácia da estimativa visual da angiografia comparada com o FFR foi de 57% e 96%, respectivamente, nas lesões moderadas e graves. Conclusões: A angiografia coronária não é um método capaz de prever adequadamente a importância funcional das lesões coronarianas, tornando clara a necessidade de associá-la a um método funcional capaz de orientar corretamente o tratamento dessas estenoses.

Introduction: In complex coronary artery disease, it is sometimes difficult to determine which lesions are associated with reversible ischemia. Despite this, the selection of lesions to be stented is often based on the subjectively interpreted angiogram alone. Fractional flow reserve (FFR) is an established objective methodology to indicate which lesions are ischemia-producing. Objective: The aim of this study, in patients admitted for elective percutaneous coronary intervention (PCI), was to evaluate the accuracy of angiography in defining culprit lesions, taking FFR as the gold standard, and also its correlation with FFR. Methods: Two hundred and fifty consecutive patients (471 arteries) scheduled for PCI were included in this study. All stenoses ≥ 50% by visual estimation, initially selected to be stented by 3 independent reviewers were assessed by measurement of the FFR. When the FFR was < 0.75, stenting was performed; when the FFR was ≥ 0.75, no interventional treatment was given. Offline quantitative coronary angiography (QCA) was performed for all stenoses, divided into intermediate (< 70% - 327) and severe (125). The correlation coefficient between the degree of stenosis (%DS) and FFR was determined as was the accuracy of the visual assessment of angiography in evaluating ischemia taking FFR as the gold standard. Results: Optimal FFR readings were obtained in 452 lesions (96%). %DS and FFR were 56 ± 8% and 0.74 for moderate and 76 ± 6% and 0.49 for severe stenosis. Concordance between QCA and FFR was poor especially in intermediate stenosis (Spearman's rho = -0.33, p<.0001). Visual assessment resulted in accuracies of 57% and 96% for intermediate and severe lesions, respectively. Conclusions: Thus, neither visual assessment of an angiogram nor QCA can accurately predict the significance of most intermediate coronary stenoses, stressing the importance of associating these to a functional evaluation of the coronary circulation which can correctly guide treatment of stenosis.