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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.

We report our experience with the use of covered stents for the management of coarctation of the aorta. From December 2001 to March 2004, nine patients (seven males; median age, 31 years; mean weight, 65 +/- 15 kg) underwent implantation. Indications included critical or atretic native coarctation (n = 4), patients >50 years of age (n = 2), associated patent ductus arteriosus (n = 1) or adjacent aneurysm (n = 1), and the presence of a circumferential fracture within a previously implanted stent (n = 1). The covered balloon-expandable Cheatham-Platinum stent and the self-expandable stent graft Braile were employed. Adequate implantation was observed in all patients. Gradients were reduced from 54 +/- 14 to 3 +/- 8 mmHg and the coarctation site increased from 2.4 +/- 2.9 to 15.9 +/- 4.3 mm. The patent ductus arteriosus was immediately closed and the aneurysm excluded. Two patients >35 years with aneurysmal ascending aorta and metallic aortic prosthesis had aneurysm formation at follow-up, with one undergoing aneurysm exclusion using a Braile stent. Although covered stents are useful in the management of selected patients with coarctation, aneurysm formation may still occur in patients with markers of aortic wall weakness. Refinements in the deployment technique and/or the stent design are needed to eliminate this risk.

Background-Despite the proven superiority of sirolimus-eluting stents (SESs) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation. Methods and Results-The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; nϭ15] and fast release [FR; nϭ15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2-and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the total population (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group (0.41Ϯ0.49 mm) than the SR group (0.09Ϯ0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FRϭ9.1% and SRϭ5.7%). Conclusions-This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimuseluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation). Key Words: angiography Ⅲ restenosis Ⅲ stents D rug-eluting stent (DES) implantation is rapidly becoming the prime revascularization strategy for obstructive coronary artery disease because of reduced incidence of in-stent restenosis. 1-3 Despite much enthusiasm, only a few DES devices have proven clinical effectiveness, and longterm data are lacking.Most bioactive agents of DESs alter cell cycle division and have unpredictable long-term effects in the vessel wall. 4 These cellular effects, which may resemble the mechanism of action of radiation therapy, have raised concerns about the safety of the DES beyond the initial years after implantation. In addition, nonbiodegradable polymer coatings, as well as residual medication in some devices, remain on the stent surface in close contact with arterial wall structures and represent a potential source for late inflammation, restenosis, or other side effects. The present study provides a unique opportunity to evaluate clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with sirolimus-eluting stents (SESs) 4 years after implantation. MethodsThe study sample and study protocol have been described previously. 1 In brief, 30 consecutive patients were implanted with a single sirolimus-eluting Bx Velocity stent fro...

Intravascular ultrasound assessment late after the ASO revealed proximal eccentric intimal thickening in most of the studied vessels. This observation suggests the development of early atherosclerosis in the reimplanted coronary arteries, which may have a role in the genesis of late coronary events.

Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve Ͼ2.5 and a diameter stenosis Ͻ36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; Pϭ0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; Pϭ0.066). Conclusions-After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty. (Circulation.

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