Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice

Abstract

implantation of Ն1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7Ϯ11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade Ͻ3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions-This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Desempenho do stent farmacológico firebird™ em diabéticos portadores de doença coronária multiarterial

“…Despite the low thrombosis rates of the Cypher ® stent, diabetes treated with insulin and the treatment of multiple lesions were independent predictors of one-year stent thrombosis, along with acute coronary syndrome, advanced age, post-procedure TIMI flow < 3, and very calcified or occluded lesions. 12 The very few studies that have evaluated the Firebird TM stent presented favourable clinical results in patients representing the daily clinical practice. The prospective and multicentre FIREMAN Registry included 1,029 consecutive patients with complex lesions, and evaluated their clinical evolution over one year.…”

Heavily Calcified Coronary Lesions Preclude Strut Apposition Despite High Pressure Balloon Dilatation and Rotational Atherectomy In-Vivo Demonstration With Optical Coherence Tomography

“…The importance of this is underscored by findings from the e-Cypher registry correlating HCL with future occurrence of stent thrombosis. 6 At times, stent expansion and apposition are often confused. Stent expansion is defined in relation to the lumen diameter of the proximal or distal vessel (reference diameter), whereas stent apposition is a description of the strut's attachment to the intima (plaque or vessel wall), regardless of whether it is properly expanded or not.…”

Coronary Artery Disease and Diabetes Mellitus

“…68 Delayed healing and impaired endothelialization (i.e., incomplete endothelial coverage of stent struts associated with persistence of fibrin deposits) is a common features of most cases of late and very late ST, which either alone or in combination with chronic inflammation and hypersensitivity reactions, and outward remodeling promote ST. 70 All of these pathologic processes are amplified in DM and it therefore not surprising that several studies demonstrated higher ST rates in diabetic patients, particularly in insulin-treated patients. 9,69,71,72 In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, insulin-requiring DM was a significant independent predictor of definite or probable ST occurring within 30 days (odds ratio, 2.35). 73 In the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38), patients with DM and acute coronary syndrome (n = 3146) had twice the rate of stent thrombosis than those without DM (2.8% versus 1.4%, P < 0.0001), with highest rates among subjects treated with insulin (3.7%, P <0.0001).…”

“…77 Finally, in the e-Cypher registry (n = 15157), insulin-dependent DM was an independent predictor of ST at 1-year (2.8-fold risk increase). 71 The increased risk of diabetic patients for ST might be related to the more diffuse nature of atherosclerosis, accompanied by longer lesion lengths, smaller vessel size, and greater plaque burden, which might impose less optimal procedural results. Additionally, the detrimental effects of DM on endothelial function 78 and platelet function 79 may also promote the development of ST.…”