Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study.

OBJECTIVES: The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD). BACKGROUND: Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far. METHODS: The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months. RESULTS: From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred. CONCLUSIONS: Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).

Association of serum thyrotropin levels with coronary artery disease documented by quantitative coronary angiography: a transversal study.

OBJECTIVE: The association between coronary artery disease (CAD) and thyroid function remains controversial. We evaluated the thyroid function and graduated well-defined CAD as confirmed by quantitative coronary angiography (CA). SUBJECTS AND METHODS: We evaluated the serum TSH, free thyroxine, free triiodothyronine and thyroid antibody levels in 300 consecutive patients (age 61.6 ± 9.9 years and 54% were male) undergoing CAD diagnosis as confirmed by CA. Plaques with ≥ 50% stenosis being indicative of obstructive CAD, and patients were divided into groups according to main epicardial coronary arteries with plaques (0, 1, 2, 3). Lipid profiles and a homeostasis model assessment (HOMA-IR) were determined. RESULTS: Serum median (25% and 75% percentile) TSH levels in patients with group 2 and 3 (2.25; 1.66-3.12 mU/L and 4.99; 4.38-23.60 mU/L, respectively) had significantly higher TSH concentrations (p < 0.0001) than the group 0 (1.82; 1.35-2.51 mU/L). Furthermore, patients of group 3 had higher TSH concentration (p < 0.0001) than those of group 1 (1.60; 0.89-2.68 mU/L). Group 3 were older (64 ± 8.5 vs. 59 ± 9.5, p = 0.001), had more patients with dyslipidemia (84% versus 58%, p < 0.001), male (54% versus 44%, p = 0.01), hypertension (100% versus 86%, p < 0.001), and smoking (61% versus 33%, p < 0.001) than group 0. Multivariate stepwise logistic analysis showed TSH, age, HbA1c, and HOMA-IR were the CAD associated variables. CONCLUSIONS: In this cohort, elevated TSH levels in the high normal range or above are associated with the presence and severity of CAD besides may represent a weak CAD risk factor.

Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial.

We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Luminal recovery from six to twelve months after implantation of "thicker strut" coronary stents.

A group of 50 patients with 51 de novo lesions treated with thicker strut stents (strut thickness >100 microm) was angiographically evaluated at baseline, after stenting, and at 6 and 12 months. Minimal luminal diameter (MLD) significantly increased from 6 to 12 months (6 months: 1.72 +/- 0.50 mm vs 12 months: 1.81 +/- 0.47 mm; p <0.01). The binary restenosis (diameter stenosis >50%) rate was 17% at 6 months and 11% at 12 months (p = NS). At multivariate analysis, lumen loss at 6 months (p = 0.018) and deployment pressure (p = 0.041) independently predicted the changes in MLD between 6 and 12 months.

Association of serum thyrotropin levels with coronary artery disease documented by quantitative coronary angiography: a transversal study

ABSTRACT Objective: The association between coronary artery disease (CAD) and thyroid function remains controversial. We evaluated the thyroid function and graduated well-defined CAD as confirmed by quantitative coronary angiography (CA). Subjects and methods: We evaluated the serum TSH, free thyroxine, free triiodothyronine and thyroid antibody levels in 300 consecutive patients (age 61.6 ± 9.9 years and 54% were male) undergoing CAD diagnosis as confirmed by CA. Plaques with ≥ 50% stenosis being indicative of obstructive CAD, and patients were divided into groups according to main epicardial coronary arteries with plaques (0, 1, 2, 3). Lipid profiles and a homeostasis model assessment (HOMA-IR) were determined. Results: Serum median (25% and 75% percentile) TSH levels in patients with group 2 and 3 (2.25; 1.66-3.12 mU/L and 4.99; 4.38-23.60 mU/L, respectively) had significantly higher TSH concentrations (p < 0.0001) than the group 0 (1.82; 1.35-2.51 mU/L). Furthermore, patients of group 3 had higher TSH concentration (p < 0.0001) than those of group 1 (1.60; 0.89-2.68 mU/L). Group 3 were older (64 ± 8.5 vs. 59 ± 9.5, p = 0.001), had more patients with dyslipidemia (84% versus 58%, p < 0.001), male (54% versus 44%, p = 0.01), hypertension (100% versus 86%, p < 0.001), and smoking (61% versus 33%, p < 0.001) than group 0. Multivariate stepwise logistic analysis showed TSH, age, HbA1c, and HOMA-IR were the CAD associated variables. Conclusions: In this cohort, elevated TSH levels in the high normal range or above are associated with the presence and severity of CAD besides may represent a weak CAD risk factor.

Resultados clínicos tardios do stent farmacológico liberador de sirolimus firebird® no tratamento de pacientes com doença arterial coronária na prática diária: seguimento de 24 Meses do registro CLARIFIRE / Late clinical outcomes of firebird™ sirolimus-eluting stent for the treatment of coronary artery disease in daily practice – 24-month follow-up of the CLARIFIRE registry

Introdução: O stent farmacológico liberador de sirolimus Firebird® já demonstrou eficácia na inibição de hiperplasia neointimal em pacientes selecionados submetidos à intervenção coronária percutânea. Nosso objetivo foi avaliar o desempenho e o resultado clínico tardio do dispositivo Firebird® em pacientes submetidos à intervenção coronária percutânea na prática diária nacional. Métodos: O Registro CLARIFIRE foi um estudo prospectivo, não randomizado, multicêntrico, que incluiu 455 pacientes (536 lesões) em 14 centros no Brasil entre dezembro de 2008 e maio de 2011. O seguimento clínico foi realizado aos 1, 6, 12 e 24 meses, e os eventos adversos foram adjudicados por um Comitê de Eventos Clínicos independente. Resultados: A média das idades foi de 61,1 ± 10,4 anos, 30,8% eram do sexo feminino, 41,9% tinham diabetes e 58,2% apresentaram-se com angina estável. O vaso-alvo mais prevalente foi a artéria descendente anterior (46,5%), 29,9% eram lesões reestenóticas e 8% lesões em bifurcação. Foram implantados 613 stents e as médias de extensão e diâmetro nominal dos stents foram 22,0 ± 6,4 mm e 2,90 ± 0,40 mm, respectivamente. O sucesso do procedimento foi de 97,6%. A taxa cumulativa de eventos cardíacos adversos maiores aos 12 meses (desfecho primário) foi 8,1%. Considerando-se os eventos pós-hospitalização até 24 meses (409/455), observaram-se eventos cardíacos adversos maiores em 9,8%, morte cardíaca em 3,9% e revascularização do vaso-alvo em 7,6%. Já a trombose de stent (definitiva/provável) ocorreu em nove casos (2%) até 30 dias, sem ocorrências subsequentes. Conclusões: O stent farmacológico liberador de sirolimus Firebird ® demonstrou desempenho favorável, Além de segurança e eficácia sustentadas no tratamento de pacientes da prática diária, conforme evidenciado pela elevada taxa de sucesso do procedimento e pela ocorrência relativamente baixa de eventos adversos ao final de 2 anos...

Background: The Firebird™ sirolimus-eluting stent has proven to be effective in inhibiting neointimal hyperplasia in selected patients undergoing percutaneous coronary intervention. Our objective was to evaluate the performance and long-term outcomes of Firebird ™ in patients undergoing percutaneous coronary intervention in daily practice in Brazil. Methods: The CLARIFIRE Registry was a prospective, non-randomized, multicenter study enrolling 455 patients (536 lesions) in 14 Brazilian sites between December 2008 and May 2011. Clinical follow-up was performed at 1, 6, 12, and 24 months, and adverse events were adjudicated by the independent Clinical Events Committee. Results: Mean age was 61.1 ± 10.4 years, 30.8% were women, 41.9% had diabetes, and 58.2% had stable angina. The left anterior descending artery was the most prevalent target vessel (46.5%), 29.9% were restenotic lesions, and 8% were bifurcations. Six hundred and thirteen stents were implanted, and the mean nominal stent length and diameter were 22.0 ± 6.4 mm and 2.90 ± 0.40 mm, respectively. Procedural success was 97.6%. The cumulative major adverse cardiac events rate at 12 months (primary endpoint) was 8.1%. Considering post-discharge events up to 24 months (409/455), major adverse cardiac events were observed in 9.8%, cardiac death in 3.9%, and target vessel revascularization in 7.6% of the patients. Definite/probable stent thrombosis was observed in nine cases (2%) up to 30 days, and no further occurrences were found. Conclusions: The Firebird ™ sirolimus-eluting stent has demonstrated good performance and sustained safety and efficacy for patients treated in daily practice, as evidenced by the high procedural success rates and relatively low adverse event rates after 2 years...

Intervenção coronária percutânea pelas vias radial e femoral: comparação entre desconfortos relacionados ao procedimento e custos / Percutaneous coronary intervention using the radial and femoral approaches: comparison between procedure-related discomforts and costs

INTRODUÇÃO: Escassos são os estudos a respeito da Qualidade de Vida pós-intervenção coronária percutânea (ICP), pelas vias radial e femoral, e dos gastos comparando as duas vias de acesso. Comparamos os desconfortos relacionados ao procedimento e os custos da ICP pelos acessos radial e femoral na fase hospitalar. MÉTODOS: Registro prospectivo, unicêntrico, que incluiu pacientes submetidos à ICP eletiva. As queixas relacionadas ao procedimento foram avaliadas ao final do período de repouso no leito, por meio de um questionário específico. Foram computados os custos por unidade de todo o material utilizado na ICP. RESULTADOS: Os pacientes tratados por via radial eram mais jovens, do sexo masculino e a angina estável foi o quadro clínico mais frequentemente tratado nos dois grupos. O tempo de exame, o número de vasos tratados e stents por paciente foram semelhantes entre os grupos. Não ocorreram complicações vasculares maiores após a ICP. Observamos maior desconforto geral associado ao procedimento (60,3% vs. 81,0%; P = 0,01), dor nas costas (1,7% vs. 17,2%; P < 0,01), dificuldade para urinar (1,7% vs. 12,1%; P = 0,03) e dependência do paciente para desempenhar atividades básicas (70,7% vs. 98,3%; P < 0,01) durante o período de observação no grupo femoral. Na comparação dos gastos, não foram notadas diferenças significantes entre os grupos, com ou sem a inclusão dos custos dos stents. CONCLUSÕES: A ICP por via radial demonstrou trazer maior conforto para o paciente comparada à via femoral, durante a fase hospitalar. Os custos dos procedimentos pelas duas vias de acesso foram semelhantes.

BACKGROUND: There are few studies on quality of life and costs after percutaneous coronary intervention (PCI) using different vascular accesses. We have compared procedure-related discomforts and costs of PCI using the radial or femoral approaches during hospital stay. METHODS: Prospective, single center registry, including patients undergoing elective PCI. Procedure related complaints were assessed at the end of bed rest using a specific questionnaire. Costs per unit of all the materials used in PCI were taken into account. RESULTS: Patients treated by the radial approach were younger, male, and stable angina was the most common clinical presentation in both groups. Procedural duration, number of vessels treated and stents per patient were similar in both groups. There were no major vascular complications after PCI. We observed greater overall discomfort associated with the procedure (60.3% vs. 81.0%; P = 0.01), back pain (1.7% vs. 17.2%; P < 0.01), difficult urination (1.7% vs. 12.1%; P = 0.03) and patient's dependence to carry on basic activities (70.7% vs. 98.3%; P < 0.01) during the post-procedural observation period in the femoral group. No significant differences were observed between groups when costs were compared, with or without taking into account stent-related costs. CONCLUSIONS: PCI using the radial approach demonstrated to provide greater comfort for patients when compared to the femoral approach during hospitalization. Costs of the procedure using the two accesses were similar.

Origem anômala da artéria circunflexa e espasmo coronariano / Anomalous origin of the circumflex artery and coronary spasm

A 43 year-old female patient with angina pectoris and vasospasm demonstrated in the anomalous left circumflex (Cx) and right coronary (RCD) arteries by coronary angiograph. Origin of the left Cx from the RCD is the most common coronary anomaly and generally, is considered to be benign. Nevertheless, myocardial ischemia in patient with this anomaly has been described. To our knowledge, this is the first reported case of coronary vasospasm occurring simultaneously in the anomalous left Cx and RCD arteries. The diagnostic troubles and the potential danger of this association were emphasized.

Artéria coronária única e infarto agudo do miocárdio / Single coronary artery and acute myocardial infarction

We describe the rare angiographic finding of the right coronary artery arising from the middle portion of the left anterior descending coronary artery in a patient with atherosclerotic coronary artery disease and acute myocardial infarction. This anatomic variation has been previously described only four times in the modern literature.

Relatamos raro achado angiográfico da artéria coronária direita saindo do terço médio da artéria coronária descendente anterior em paciente com doença aterosclerótica coronariana e infarto agudo do miocárdio. Apenas 4 casos desta variação anatômica foram encontrados na literatura