Background-Stent fracture (SF) after drug-eluting stent implantation has recently become an important concern because of its potential association with in-stent restenosis and stent thrombosis. However, the incidence and clinical impact of SF after everolimus-eluting stent implantation remain unclear. Methods and Results-A total of 1035 patients with 1339 lesions undergoing everolimus-eluting stent implantation and follow-up angiography 6 to 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy or intravascular ultrasound during follow-up. We assessed the rates of SF and major adverse cardiac events, defined as cardiac death, myocardial infarction, stent thrombosis, and clinically driven target lesion revascularization within 9 months. SF was observed in 39 of 1339 lesions (2.9%) and in 39 of 1035 patients (3.8%). Ostial stent location and lesions with hinge motion, tortuosity, or calcification were independent predictors of SF. The rate of myocardial infarction and target lesion revascularization were significantly higher in the SF group than in the non-SF group (5.1% versus 0.4%; P=0.018 and 25.6% versus 2.0%; P<0.001, respectively). Stent thrombosis was more frequently observed in the SF group than in the non-SF group (5.1% versus 0.4%; P=0.018). Major adverse cardiac events within 9 months were significantly higher in the SF group than in the non-SF group (25.6% versus 2.3%; P<0.001). Conclusions-SF after everolimus-eluting stent implantation occurs in 2.9% of lesions and is associated with higher rate of major adverse cardiac events, driven by higher target lesion revascularization and stent thrombosis. (Circ Cardiovasc Interv. 2012;5:663-671.)

Background— Everolimus, an active immunosuppressive and antiproliferative agent of the same family as sirolimus (rapamycin), has demonstrated significant reduction of neointimal proliferation in animal studies. The First Use To Underscore restenosis Reduction with Everolimus (FUTURE) I trial was the first in-human experience to evaluate the safety and efficacy of everolimus-eluting stents (EES), coated with a bioabsorbable polymer, compared with bare metal stents (BMS). Methods and Results— FUTURE I was a prospective, single-blind, randomized trial that enrolled 42 patients with de novo coronary lesions (EES 27, BMS 15). Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low at 30 days and 6 months, without any early or late stent thrombosis for either group ( P =NS). Between 6 and 12 months, there were no additional reports of major adverse cardiac events. The 6-month angiographic in-stent restenosis rate was 0% versus 9.1% (1 patient) ( P =NS), with an associated late loss of 0.11 mm versus 0.85 mm ( P <0.001), and the in-segment restenosis rate was 4% (1 patient) and 9.1% (1 patient) ( P =NS) for EES and BMS, respectively. Intravascular ultrasound analysis revealed a significant reduction of percent neointimal volume in EES compared with BMS (2.9±1.9 mm 3 /mm versus 22.4±9.4 mm 3 /mm, P <0.001). There was no late stent malapposition in either group. The safety and efficacy of the EES appeared to be sustained at 12 months. Conclusions— In this initial clinical experience, EES with bioabsorbable polymer demonstrated a safe and efficacious method to reduce in-stent neointimal hyperplasia and restenosis.

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In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA. In addition, SES had a considerably lower optimal MSA threshold compared to BMS.

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Accumulating evidence has shown that seasonal variations can exist within metabolic syndrome parameters. The aim of this study was to examine the hypothesis that there are seasonal variations in the prevalence of metabolic syndrome in Japanese subjects. We investigated a total of 1202 male workers in our institution (44 ± 10 years) who underwent health checkups in both June (summer) and December (winter) 2008. In this study, metabolic syndrome was defined according to the criteria proposed by the National Cholesterol Education Program (NCEP), the International Diabetes Federation (IDF) and the Japanese Society of Internal Medicine (JSIM). Serum levels of high-density lipoprotein-cholesterol and fasting glucose, as well as blood pressure (BP), were significantly higher in winter than in summer, whereas waist circumference and serum levels of triglyceride exhibited little change. The prevalence rates of NCEP, IDF, and JSIM metabolic syndrome in this study were 3.8, 15.1 and 12.4% in winter and 3.2, 10.7 and 8.4% in summer, respectively. Of all metabolic syndrome components, an elevated BP was most significantly correlated with the seasonal variation of metabolic syndrome prevalence. This study demonstrated seasonal variations in metabolic syndrome prevalence in Japanese male workers. These results indicate that the season of health checkups may affect the clinical diagnosis and management of metabolic syndrome.