One-Year Clinical Outcome of Inspiron Stent in All-Comers Population (Analysis from 790 Consecutive Patients)

Abstract

Aims. The goal of this study was to evaluate the performance of the InspironTM coronary stent (Scitech Medical™, Goiás, Brazil). The InspironTM sirolimus-eluting stent uses an ultrathin L-605 cobalt-chromium alloy with a 75 μm strut thickness platform coated with an abluminal biodegradable polymer. The polymer is eliminated from the body through the tricarboxylic acid cycle in 6–9 months, releasing 80% of the drug within 30 days after its deployment. Methods. It was a prospective, single-center registry. To represent clinical practice, all patients undergoing percutaneous coronary intervention were included in this registry. There were no exclusion criteria. Clinical follow-ups were performed at twelve months. The endpoints were the occurrence of all-cause death, definite stent thrombosis, and new revascularization. Results. Between November 2017 and May 2019, 790 patients were included (1067 lesions). The mean age was 60.42 ± 14.94 years, and 74.7% presented with acute coronary syndrome. Diabetes mellitus was present in 43.9% of patients, and previous myocardial infarction and previous percutaneous coronary intervention were present in 17.9% and 11.3%, respectively. Angiographic success was achieved in 99.1%. The incidence of all-cause death was 11.5% (6.2% in-hospital and 5.3% in the follow-up) and definitive stent thrombosis was 0.2%. New revascularization was performed in only 5.8% (target lesion revascularization: 2.2%; progression of disease in another lesion: 3.6%). Based on the multivariate regression analysis, only chronic renal failure was an independent predictor of adverse events (OR: 3.3; 95% CI: 1.22–8.92). Conclusion. The result of this single-center registry demonstrates the safety and excellent performance of the InspironTM stent in daily clinical practice with a low rate of adverse cardiac events.

A review on manufacturing processes of cobalt‐chromium alloy implants and its impact on corrosion resistance and biocompatibility

“…The L605 alloy is often used for making stents due to its excellent mechanical properties, radiopacity, and corrosion resistance 100 . Some examples of stents made from L605 are Inspiron™ coronary stent (Scitech Medical™, Goiás, Brazil) 101 and Bentley BeGrow™ stent system for newborns and infants 102 …”

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)

“…Registries of all-comers population demonstrated safety and excellent performance, with a low rate of adverse cardiac events. 1 , 2 In a randomized clinical trial comparing Inspiron® with Biomatrix Flex® biolimus-eluting stent, there was no difference in outcomes in patients undergoing elective or urgent percutaneous coronary intervention (PCI) after a five-year follow-up. Also, there was no stent thrombosis in patients treated with Inspiron® during the study period.…”

“…Os registros da população do tipo "all-comers" demonstraram segurança e excelente desempenho, com baixa taxa de eventos cardíacos adversos. 1,2 Em um ensaio clínico randomizado comparando Inspiron® com o stent eluidor de biolimus Biomatrix Flex®, não houve diferença nos resultados em pacientes submetidos à intervenção coronária percutânea (ICP) eletiva ou urgente após cinco anos de seguimento. Além disso, não houve trombose de stent em pacientes tratados com Inspiron® durante o período do estudo.…”