Analysis of 1-Year Clinical Outcomes in the SIRIUS Trial

Abstract

Background-This study evaluated a large group of patients enrolled in a double-blind randomized trial of the sirolimus-eluting stent to document whether the initial clinical improvement seen in previous smaller series is maintained out to 12 months and to study the potential treatment effect in patient subsets known to be at increased risk of restenosis. Methods and Results-A total of 1058 patients with de novo native coronary stenosis undergoing clinically indicated percutaneous coronary intervention were randomly assigned to sirolimus-eluting stent (533) or control bare stent (525). Procedural success and in-hospital outcomes were excellent and did not differ between the 2 groups. At 9 months, clinical restenosis, defined as target-lesion revascularization, was 4.1% in the sirolimus limb versus 16.6% in the control limb (PϽ0.001). At 12 months, the absolute difference in target-lesion revascularization continued to increase and was 4.9% versus 20% (PϽ0.001). There were no differences in death or myocardial infarction rates. In high-risk patient subsets, defined by vessel size, lesion length, and presence of diabetes mellitus, there was a 70% to 80% reduction in clinical restenosis at 1 year. Conclusions-Placement of the sirolimus-eluting stent results in continued clinical improvement at 1 year after initial implantation, with significant reduction in clinical restenosis as defined by target-lesion revascularization. Between 9 and 12 months, the absolute reduction of clinical restenosis continues to increase. Even in high-risk subsets of patients, there is a 70% to 80% relative reduction in clinical restenosis at 12 months with this drug-eluting stent.

Resultados clínicos inmediatos y alejados del implante de stents metálicos no recubiertos: ¿Se justifica un reemplazo total por los stents liberadores de drogas?

“…Los stents liberadores de drogas (SLD) reducen la reestenosis angiográfica y clínica con relación a los stents metálicos no recubiertos (SMNR) 8,9 . En Chile, el uso de los SLD ha sido creciente, pero limitado por su mayor precio, necesidad de tratamiento antiplaquetario prolongado y el riesgo de trombosis tardía.…”

“…La superioridad clínica y angiográfica de los SLD ha quedado establecida 8,9 . Numerosos estudios con seguimiento angiográfico muestran una reducción marcada (62%-75%) de la RVT.…”

Brief review: Coronary drug-eluting stents and anesthesia

“…Clinical trials comparing DES with BMS have been conducted [12][13][14][15] (Table I). There is now an abundance of clinical trial data showing the superiority of DES over BMS for the prevention of in-stent restenosis.…”

“…Moreover, no test of platelet function is recommended to assess the antiplatelet effect of aspirin in an individual patient. 14,34 Hence, there is no established cut-off at present to distinguish between the presence or absence of aspirin resistance. 34 It has been proposed that the term clopidogrel resistance encompasses patients for whom the drug does not achieve its pharmacological effect, and failure of therapy reflects patients who have recurrent events on therapy.…”

Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core® pharmacokinetic study

“…Drug-eluting stents are widely used for the treatment of coronary artery disease (CAD) due to significant improvement in angiographic outcome, with reduced rates of restenosis and need for revascularisation compared with bare metal stents (BMS). [4][5][6] The Supralimus-Core ® SirolimusEluting Coronary Artery Stent System has proven its safety and efficacy in the first-in-man study. The Supralimus-Core ® is sirolimus-eluting stent (SES) with CE-approved Coronnium ® (L605 Co-Cr) bare metallic stent platform.…”