Long-term performance of the second-generation cobalt-chromium sirolimus-eluting stents in real-world clinical practice: 3-year clinical outcomes from the prospective multicenter FOCUS registry.

BACKGROUND: The short- and mid-term outcomes of the second-generation cobalt-chromium sirolimus-eluting stent (CoCr-SES) in real-world patients had been reported previously, but the long-term performance remained unclear. The objective of this analysis was to evaluate the long-term safety and efficacy of the second-generation CoCr-SES from the FOCUS registry. METHODS: The FOCUS registry (ClinicalTrials.gov Identifier: NCT00868829) enrolled all-comers eligible to receive Firebird-2 CoCr-SES. Follow-up was continued to 3 years to evaluate long-term safety and effectiveness of the second-generation CoCr-SES in real-world practice. Results of the extended-use group and standard-use group are compared to explore performance of CoCr-SES in more severe patients with more complex lesions. RESULTS: The rate of 3-year MACE was 7.37%, consisting of 84 cases (1.78%) of cardiac death, 166 cases (3.52%) of MI and 98 cases (2.08%) of TVR. ARC definite/probable stent thrombosis happened in 34 (0.72%) patients, only 3 new cases (<0.1%) of very late stent thrombosis was reported in the third year. Meanwhile, the difference of MACE (7.77% vs. 6.06%; P=0.058), TLF (4.71% vs. 3.49%; P=0.085) and ARC definite/probable stent thrombosis (0.83% vs. 0.37%; P=0.116) between extended-use group and standard-use group showed no significance. CONCLUSIONS: The second-generation CoCr-SES was associated with continued low rates of 3-year MACE, TLF and stent thrombosis in a broad spectrum of patients.

Clinical performance of a novel ultrathin strut, low-dose, sirolimus-eluting stent with abluminal-only biodegradable polymeric coating for patients undergoing percutaneous coronary intervention in the daily practice.

BACKGROUND: The present study aimed to evaluate the clinical performance, in the daily practice of a busy catheterization laboratory, of a novel drug-eluting stent (DES) built with an ultra-thin-strut metallic platform, eluting sirolimus at low doses, abluminal coated with biodegradable polymers, and mounted in a low-compliant delivery system. METHODS: Prospective, single-arm study, comprising all consecutive patients undergoing percutaneous coronary intervention (PCI) with the Inspiron™ sirolimus-eluting stent (SES) (Scitech, Aparecida de Goiania, Brazil). The primary endpoint was the occurrence of major adverse cardiac events (MACE) [cardiac death, non-PCI related myocardial infarction (MI), or target vessel revascularization (TVR)]. RESULTS: A total of 470 patients were included, from which 51.3% were diabetics, 33.8% had triple-vessel disease, 15.3% had heart failure, 38.9% had at least one bifurcation treated, 19.8% were treated for a bare metal stent restenosis, and 61.9% had at least one type C lesion; one or more of these features were found in 96.0%. At 300 days, the rate target lesion revascularization was 5.4% and the rate of MACE was 8.1%. The incidence of definite or probable stent thrombosis was 0.4%, with no cases between 30 and 300 days. CONCLUSIONS: The novel stent is associated with excellent short and mid-term clinical outcomes in patients treated with PCI in the daily practice.

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial.

BACKGROUND: The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391). METHODS: A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years. RESULTS: Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11). The rate of death/MI was similar between the groups, but there was a significant decrease in the risk of repeat revascularization in the Inspiron group compared to the control arm TLR (0.0% vs. 23.5% respectively, P=0.02). There were no stent thromboses in the study population. CONCLUSIONS: The novel Inspiron™ SES showed a sustained safe and effective clinical profile after 4-year of follow-up, with very low adverse events and null stent thrombosis (ST) occurrence.