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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To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). ⋯ There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.
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Multicenter Study
Association Between Extent of Stent-Graft Coverage and Thoracic Aortic Remodeling After Endovascular Repair of Type B Aortic Dissection.
Purpose: To examine the association between the extent of stent-graft coverage and thoracic aortic expansion after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection. Materials and Methods: A retrospective analysis was conducted of 201 patients (mean age 52.4±11.5 years; 178 men) with acute (135, 67.2%) or chronic (66, 32.8%) type B aortic dissection who underwent TEVAR at 4 medical centers. The mean stent-graft length was 157.1±33.3 mm. ⋯ Regression analysis showed no significant association between the risk of thoracic aortic expansion and the PSDA as a continuous variable (HR 0.97, 95% CI 0.91 to 1.03, p=0.288); however, analyzing the PSDA as a categorical variable indicated a significantly lower risk of thoracic aortic expansion for the PSDA >31.3% group (HR 0.46, 95% CI 0.22 to 0.95, p=0.036) after adjusting for a variety of demographic and anatomical characteristics. Conclusion: More extensive stent-graft coverage appears to improve thoracic aortic remodeling after TEVAR. However, the clinician should balance the benefit of extensive stent-graft coverage and its related risk of spinal cord ischemia.