on behalf of the Zilver PTX Investigators Background-Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Methods and Results-Patients were randomly assigned to primary DES implantation (nϭ236) or PTA (nϭ238).Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65Ϯ40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (nϭ61) or BMS (nϭ59
Inherent risks of stenting include restenosis and thrombosis. Recently, stent fractures have been recognized as a complication that may result in thrombosis, perforation, restenosis, and migration of the stent resulting in morbidity and mortality. Stent fractures were originally seen in the superficial femoral arteries but have since then been reported in almost all vascular sites including the coronary, renal, carotid, iliac, and femoropopliteal arteries. Fractures are the result of the complex interplay between stent manufacturing, the stented segment, pulsatile and nonpulsatile biomechanical forces, and plaque morphology at a particular vascular site. The presentation of a patient with a fracture is highly variable, ranging from asymptomatic in nature, detected on routine screening without any sequelae, to sudden cardiac death related to a thrombosed coronary artery. Despite being recognized as an important complication, consensus on routine surveillance and diagnostic methods to detect fractures continues to be lacking. Fortunately, most cases are relatively benign and can be managed conservatively if detected. In the setting of recurrent symptoms, further intervention is usually sought. In review of the literature most cases are managed with placement of a stent over the fractured area, the stent-in-stent technique, but several other alternatives may be available. As the knowledge of the variables that make stents prone to fracture are identified, better technologies and techniques can be employed to minimize the risk of this complication. This article reviews the available literature on stent fractures and complications using data found on PubMed, MEDLINE, the Manufacturer and User Facility Device Experience (MAUDE) database, and the Cochrane databases.
Background-Preservation of renal function is an important objective of renal artery stent procedures. Although atheroembolization can cause renal dysfunction during renal stent procedures, whether adjunctive use of embolic protection devices or glycoprotein IIb/IIIa inhibitors improves renal function is unknown. Methods and Results-One hundred patients undergoing renal artery stenting at 7 centers were randomly assigned to an open-label embolic protection device, Angioguard, or double-blind use of a platelet glycoprotein IIb/IIIa inhibitor, abciximab, in a 2ϫ2 factorial design. The main effects of treatments and their interaction were assessed on percentage change in Modification in Diet in Renal Disease-derived glomerular filtration rate from baseline to 1 month using centrally analyzed creatinine. Filter devices were analyzed for the presence of platelet-rich thrombus. With stenting alone, stenting and embolic protection, and stenting with abciximab alone, glomerular filtration rate declined (PϽ0.05), but with combination therapy, it did not decline and was superior to the other allocations in the 2ϫ2 design (PϽ0.01). The main effects of treatment demonstrated no overall improvement in glomerular filtration rate; although abciximab was superior to placebo (0Ϯ27% versus Ϫ10Ϯ20%; PϽ0.05), embolic protection was not (Ϫ1Ϯ28% versus Ϫ10Ϯ20%; Pϭ0.08). An interaction was observed between abciximab and embolic protection (PϽ0.05), favoring combination treatment. Abciximab reduced the occurrence of platelet-rich emboli in the filters from 42% to 7% (PϽ0.01). Conclusions-Renal artery stenting alone, stenting with embolic protection, and stenting with abciximab were associated with a decline in glomerular filtration rate. An unanticipated interaction between Angioguard and abciximab was seen, with combination therapy better than no treatment or either treatment alone. (Circulation. 2008;117:2752-2760.)
Radiation therapy is a cause of cardiovascular morbidity and mortality. This is due to the significant degree of atherosclerosis seen in the vessels in the vicinity of the area being irradiated. Radiation-induced peripheral arterial disease is increasingly being recognized as large populations of cancer patients survive longer, yet it is a problem that is often under reported. Although it has most commonly been associated with carotid artery disease, all vascular beds are prone to this form of injury. The injury is accelerated by usual risk factors for atherosclerosis. Developing a healthy lifestyle, dietary prudence and the aggressive treatment of hypertension, diabetes mellitus, and dyslipidemia should all be encouraged in this patient population. When revascularization strategies are warranted, the percutaneous approach may be superior to open surgery as technical difficulties may arise in the fibrotic, scarred tissue. Stenting with distal embolic protection devices should be considered as the treatment of choice for patients with radiation-induced carotid artery disease. Several reports also suggest good results with balloon angioplasty with or without stenting in the case of radiation-induced renal, iliac, and femoral artery disease. Lifelong antiplatelet therapy may be appropriate.
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