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

Prado, Guy F.A.; Abizaid, Alexandre; Meireles, George César Ximenes; Sarmento‐Leite, Rogério; Prudente, Maurício; Cantarelli, Marcelo José de Carvalho; Dourado, Adriano; Mariani, José; Perin, Marco Antônio; Costantini, Costantino; Costa, Ricardo; Costa, J. Ribamar; Chamié, Daniel; Campos, Carlos M.; Ribeiro, Expedito E.; Lemos, Pedro A.

doi:10.1016/j.repc.2020.05.017

Cited by 5 publications

(6 citation statements)

References 11 publications

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“…According to the VSTENT study, the rate of pre-dilation balloon and post-dilation balloon dilation was 76.4% (95% CI: 70.1–82.0%; P<0.001) and 83.5% (95% CI: 77.8–88.2%; P<0.001), respectively. Similar results had been seen in other studies ( 4 , 12 , 20 ). During their hospital stay, all the subjects were completely recovered.…”

Section: Discussionsupporting

confidence: 92%

“…Other similar trials have shown a re-stenosis rate between 2.8% and 6.2% ( 11 , 12 , 14 , 20 ) ( Figure 10 ), but our study found only a 3.5% (95% CI: 1.4–7.1%; P<0.001) incidence, which was considered to be a low re-stenosis rate given the small sample size. As a result, one of the most essential objectives of our study, which was to reduce the rate of re-stenosis, was achieved.…”

Section: Discussioncontrasting

confidence: 82%

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Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary artery lesions: a prospective, cohort, multicenter study

Tran¹,

Vu²,

Nguyen³

et al. 2023

Cardiovasc Diagn Ther

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Background The drug-eluting stent was a significant stride forward in the development of enhanced therapeutic therapy for coronary intervention, with three generations of increased advancement. VSTENT is a newly developed stent manufactured in Vietnam that aims to provide coronary artery patients with a safe, effective, and cost-efficient option. The purpose of this trial was to determine the efficacy and safety of a new bioresorbable polymer sirolimus-eluting stent called VSTENT. Methods This is a prospective, cohort, multicenter research in 5 centers of Vietnam. A prespecified subgroup received intravascular ultrasound (IVUS) or optical coherence tomography (OCT) imaging. We determined procedure success and complications during index hospitalization. We monitored all participants for a year. Six-month and 12-month rates of major cardiovascular events were reported. All patients had coronary angiography after 6 months to detect late lumen loss (LLL). Prespecified patients also had IVUS or OCT performed. Results The rate of device success was 100% (95% CI: 98.3–100%; P<0.001). Major cardiovascular events were 4.7% (95% CI: 1.9–9.4%; P<0.001). The LLL over quantitative coronary angiography (QCA) was 0.08±0.19 mm (95% CI: 0.05–0.10; P<0.001) in the in-stent segment and 0.07±0.31 mm (95% CI: 0.03–0.11; P=0.002) in 5 mm within the two ends of the stent segment. The LLL recorded by IVUS and OCT at 6 months was 0.12±0.35 mm (95% CI: 0.01–0.22; P=0.028) and 0.15±0.24 mm (95% CI: 0.02–0.28; P=0.024), respectively. Conclusions This study’s device success rates were perfect. IVUS and OCT findings on LLL were favorable at 6-month follow-up. One-year follow-up showed low in-stent restenosis (ISR) and target lesion revascularization (TLR) rates, reflecting few significant cardiovascular events. VSTENT’s safety and efficacy make it a promising percutaneous intervention option in developing nations.

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Section: Discussionsupporting

confidence: 92%

Section: Discussioncontrasting

confidence: 82%

Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary artery lesions: a prospective, cohort, multicenter study

Tran¹,

Vu²,

Nguyen³

et al. 2023

Cardiovasc Diagn Ther

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“…Estudos avaliando o stent Inspiron® relataram propriedades promissoras de cicatrização dos vasos, com pouca hiperplasia neointimal por ultrassom intravascular (percentual de obstrução por hiperplasia neointimal de 4,9% ± 4,1%) e altas taxas de cobertura das hastes por tomografia de coerência óptica (99,49% ± 1,01%). 14 Embora o Inspiron® tenha demonstrado ser seguro em um ensaio clínico randomizado prévio com uma população “ all-comers ” com um longo acompanhamento, 3 o uso generalizado de dispositivos mais novos pode levar tempo, especialmente em pacientes e anatomias de risco elevados. Em nosso estudo, o risco basal da população Inspiron® foi claramente menor, e uma das hipóteses é que os operadores tendem a escolher dispositivos bem estabelecidos em casos mais complexos.…”

Section: Discussionunclassified

“…Studies evaluating Inspiron® stent have reported reassuring vessel healing properties, with very little neointimal hyperplasia either by intravascular ultrasound (percent of neointimal hyperplasia obstruction of 4.9% ± 4.1%) and high rates of strut coverage by optical coherence tomography (99.49% ± 1.01%). 14 Although Inspiron® was demonstrated safe in a previous randomized clinical trial with an all-comers population with a long follow-up, 3 widespread use of newer devices may take time, especially in higher risk patients and anatomy. In our study, baseline risk of the Inspiron® population was clearly lower, and one of the hypotheses is that operators tend to choose well established devices in more complex cases.…”

Section: Discussionmentioning

confidence: 99%

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Avaliação no Mundo Real de um Stent Eluidor de Sirolimus de Hastes Ultrafinas em Pacientes com Infarto do Miocárdio com Supradesnivelamento do Segmento ST Submetidos à Intervenção Coronária Percutânea Primária (Registro INSTEMI)

Araújo¹,

Machado²,

Moura³

et al. 2023

Arquivos Brasileiros De Cardiologia

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Resumo Fundamento O padrão-ouro atual dos stents farmacológicos (SF) coronários consiste em ligas metálicas com hastes mais finas e polímeros bioabsorvíveis. Objetivos Nosso objetivo foi comparar um stent eluidor de sirolimus de hastes ultrafinas (Inspiron®) com outras plataformas de SF de terceira geração em pacientes com infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST) submetidos à intervenção coronária percutânea (ICP) primária. Métodos Analisamos dados de um registro multicêntrico de IAMCSST de centros de referência da Região Sul do Brasil. Todos os pacientes foram submetidos à ICP primária, seja com Inspiron® ou outro SF de segunda ou terceira geração. Foi calculado pareamento por escore de propensão (PEP) para gerar grupos semelhantes (Inspiron® versus outros stents) em relação às características clínicas e do procedimento. Todos os testes de hipótese tiveram um nível de significância bilateral de 0,05. Resultados De janeiro de 2017 a janeiro de 2021, 1.711 pacientes foram submetidos à ICP primária, e 1.417 pacientes preencheram nossos critérios de inclusão (709 pacientes no grupo Inspiron® e 708 pacientes no grupo dos outros SF de segunda ou terceira geração). Após PEP, a amostra do estudo foi composta por 706 pacientes (353 pacientes no grupo Inspiron® e 353 pacientes no grupo dos demais SF de segunda ou terceira geração). As taxas de revascularização do vaso alvo ( odds ratio [OR] 0,52; intervalo de confiança [IC] 0,21 a 1,34; p = 0,173), trombose de stent (OR 1,00; IC 0,29 a 3,48;p = 1,000), mortalidade ( hazard ratio 0,724; IC 0,41 a 1,27; p = 0,257) e os desfechos cardiovasculares maiores (OR 1,170; IC 0,77 a 1,77; p = 0,526) foram semelhantes entre os grupos após um acompanhamento mediano de 17 meses. Conclusão Nossos achados mostram que o stent Inspiron® foi eficaz e seguro quando comparado a outros SF de segunda ou terceira geração em uma coorte contemporânea do mundo real de pacientes com IAMCSST submetidos à ICP primária.

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A multi-functional MgF2/polydopamine/hyaluronan-astaxanthin coating on the biodegradable ZE21B alloy with better corrosion resistance and biocompatibility for cardiovascular application

Hou

Zhang

et al. 2024

Journal of Magnesium and Alloys

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

Cited by 5 publications

References 11 publications

Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary artery lesions: a prospective, cohort, multicenter study

Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary artery lesions: a prospective, cohort, multicenter study

Avaliação no Mundo Real de um Stent Eluidor de Sirolimus de Hastes Ultrafinas em Pacientes com Infarto do Miocárdio com Supradesnivelamento do Segmento ST Submetidos à Intervenção Coronária Percutânea Primária (Registro INSTEMI)

A multi-functional MgF2/polydopamine/hyaluronan-astaxanthin coating on the biodegradable ZE21B alloy with better corrosion resistance and biocompatibility for cardiovascular application

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