ABSTRACT
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.
ABSTRACT
Abstract Background The wide range of clinical presentations of acute coronary syndrome (ACS) makes it indispensible to use tools for risk stratification and for appropriate risks management; thus, the use of prognosis scores is recommended in the immediat clinical decision-making. Objective To validate the Global Registry of Acute Coronary Events (GRACE) score as a predictor of in-hospital and 6-month post-discharge mortality in a population diagnosed with ACS. Methods This is a prospective cohort study of consecutive patients diagnosed with ACS between May and December 2018. GRACE scores were calculated, as well as their predictive value for in-hospital and 6-month post-discharge mortality. The validity of the model was assessed by two techniques: discriminative power using the area under the receiver operating characteristic curve (AUC) and goodness-of-fit, using the Hosmer-Lemeshow (HL) test, at the 5% level of significance. Results A total of 160 patients were included, mean age 64 (±10.9) years; of which 60% were men. The risk model showed to have satisfactory ability to predict both in-hospital mortality, with an area under the curve (AUC) of 0.76 (95% confidence interval [CI], 0.57-0.95; p = 0.014), and 6-month post-discharge mortality, with AUC of 0.78 (95%CI, 0.62-0.94), p = 0.002. The HL test indicated good-fit for both models of the GRACE score. Conclusion In this study, the GRACE risk score for predicting mortality was appropriately validated in patients with ACS, with good discriminative power and goodness-of-fit. The results suggest that the GRACE score is appropriate for clinical use in our setting.
