Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
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Randomized Controlled Trial Multicenter Study Comparative Study
Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial.
Purpose: To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). Materials and Methods: An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.6 years; 26 men) or uncoated balloon (n=41; mean age 67.6±10.2 years; 26 men) angioplasty (ClinicalTrials.gov identifier NCT01594684). Additionally, the protocol provided for an observational arm composed of patients from either randomized arm who experienced recurrent ISR ≥30 days after the index treatment. ⋯ At ~2 years after treatment, a remarkable number (14/27, 52%) of TLRs were recorded in the single-dose DCB group. Conclusion: Treatment with DCBs resulted in significantly less 6-month LLL and fewer TLRs up to 24 months than treatment with uncoated balloons. The double dose for treating recurrent ISR did not cause recognizable adverse events or require TLR up to 24 months.
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Randomized Controlled Trial Multicenter Study
A review of antithrombotic therapy and the rationale and design of the randomized edoxaban in patients with peripheral artery disease (ePAD) trial adding edoxaban or clopidogrel to aspirin after femoropopliteal endovascular intervention.
Compared with the coronary setting, knowledge about antithrombotic therapies after endovascular treatment (EVT) is inadequate in patients with peripheral artery disease (PAD). Based on a review of trials and guidelines, which is summarized in this article, there is scant evidence that antithrombotic drugs improve outcome after peripheral EVT. To address this knowledge gap, the randomized, open-label, multinational edoxaban in patients with Peripheral Artery Disease (ePAD) study (ClinicalTrials.gov identifier NCT01802775) was designed to explore the safety and efficacy of a combined regimen of antiplatelet therapy with clopidogrel and anticoagulation with edoxaban, a selective and direct factor Xa inhibitor, both combined with aspirin. ⋯ The primary safety endpoint is major or clinically relevant nonmajor bleeding; the primary efficacy endpoint is restenosis or reocclusion at the treated segment(s) measured at 1, 3, and 6 months using duplex ultrasound scanning. All outcomes will be assessed and adjudicated centrally in a masked fashion. The ePAD study is the first of its kind to investigate a combined regimen of antiplatelet therapy and anticoagulation through factor Xa inhibition with edoxaban.
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Randomized Controlled Trial Comparative Study
Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial.
To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). ⋯ PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
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Randomized Controlled Trial
Three-dimensional electromagnetic navigation vs. fluoroscopy for endovascular aneurysm repair: a prospective feasibility study in patients.
To evaluate the in vivo feasibility of a 3-dimensional (3D) electromagnetic (EM) navigation system with electromagnetically-tracked catheters in endovascular aneurysm repair (EVAR). ⋯ A 3D EM navigation system, used in conjunction with fluoroscopy and angiography, has the potential to provide more spatial information and reduce the use of radiation and contrast during endovascular interventions. This pilot study showed that 3D EM navigation is feasible in patients undergoing EVAR. However, a larger study must be performed to determine if 3D EM navigation is better than the existing practice for these patients.
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Randomized Controlled Trial
Cost-effectiveness analysis of protected carotid artery stent placement versus endarterectomy in high-risk patients.
To determine the cost-effectiveness of carotid angioplasty with stent placement (CAS) under emboli protection versus carotid endarterectomy (CEA) in patients with severe carotid stenosis considered to be at high surgical risk for CEA. ⋯ The proven non-inferiority of CAS versus CEA in high-surgical-risk patients with severe carotid stenosis might provide a marginal benefit that is offset by the higher cost associated with this procedure.