ABSTRACT
BACKGROUND: Clinical trial data show overall favorable outcomes of paclitaxel-eluting stents for treatment of femoro-popliteal (FP) occlusive disease. However, external validity of trial results may be restricted to less complex FP lesions, and limited data on outcomes of paclitaxel-eluting stents in real world practice have been published. METHODS: This is a retrospective analysis of data of all patients who received Zilver® PTX® for FP lesion from February 2013 to October 2014 at our center. The primary endpoint was primary patency, defined as peak systolic velocity ratio <2.0 by Doppler ultrasound, or angiographic diameter stenosis <50%, or freedom from clinically driven target lesion revascularization. RESULTS: Seventy-eight patients received Zilver® PTX® for FP lesions in the pre-specified time period. Of them, 63 had follow-up data and were included in this study. Mean patient age was 66.3±9.4years, and 57.1% of the patients were men. Participants had a high prevalence of diabetes (49.2%), hypertension (93.7%), hyperlipidemia (93.7%), previous coronary revascularization (52.4%), or previous peripheral arterial disease (77.8%). Critical limb ischemia was present in 25.4% of the patients, Trans-Atlantic Inter-Society Consensus (TASC) class C or D in 76.2%, in-stent restenosis (ISR) in 36.5%, and total occlusion in 69.8%. Mean lesion length was 218.9±128.3mm, mean number of stents was 2.02±1.0, and total stent length was 189.0±128.5mm. Mean follow-up was 270.4±190.3days. Primary patency rate at 1year was 66.7% by Kaplan-Meier survival curve. When compared with patients with primary patency at follow up, those with an adverse outcome had higher prevalence of TASC II class C or D lesions (100% vs. 68.8%, p=0.013), and were more likely to have ISR (66.7% vs. 27.1%, p=0.012), longer lesion (291.3±138.7 vs. 195.7±117.1, p=0.011), and incomplete coverage of the lesion (full coverage of lesions: 40% vs. 77.1%, p=0.011). CONCLUSION: Post marketing use of Zilver® PTX® for the treatment of FP lesions is associated with lower patency rates compared with clinical trial data. This may be related to the high prevalence of TASC II class C or D lesions and ISR in real world practice. Future studies should be more representative of contemporary clinical practice.
Subject(s)
Angioplasty, Balloon/instrumentation , Drug-Eluting Stents , Femoral Artery , Peripheral Arterial Disease/therapy , Aged , Angiography , Angioplasty, Balloon/adverse effects , Cardiovascular Agents/administration & dosage , Constriction, Pathologic , District of Columbia , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Paclitaxel/administration & dosage , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Ultrasonography, Doppler , Vascular PatencyABSTRACT
Currently, percutaneous endovascular intervention is considered a first line of therapy for treating patients with critical limb ischemia. As the result of remarkable development of techniques and technologies, percutaneous endovascular intervention has led to rates of limb salvage comparable to those achieved with bypass surgery, with fewer complications, even in the presence of lower rates of long-term patency. Currently, interventionalists have a multiplicity of access routes including smaller arteries, with both antegrade and retrograde approaches. Therefore, the choice of the optimal access site has become an integral part of the success of the percutaneous intervention. By understanding the technical aspects, as well as the advantages and limitations of each approach, the interventionalists can improve clinical outcomes in patients with severe peripheral arterial disease. This article reviews the access routes in critical limb ischemia, their advantages and disadvantages, and the clinical outcomes of each.
Subject(s)
Catheterization, Peripheral/methods , Endovascular Procedures/methods , Femoral Artery , Ischemia/therapy , Peripheral Vascular Diseases/therapy , Catheterization, Peripheral/adverse effects , Critical Illness , Endovascular Procedures/adverse effects , Femoral Artery/diagnostic imaging , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Limb Salvage , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/physiopathology , Punctures , Radiography, Interventional , Risk Factors , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
PURPOSE: To report a case of a thrombosed GORE® VIABAHN® endoprosthesis stent-graft in the femoral artery (SFA) and popliteal artery managed using the pulse-spray technique and complicated by compartment syndrome of the lower leg of the affected limb. CASE REPORT: A 61-year-old woman with three Viabahn stent grafts relining seven bare-metal stents in her right SFA and popliteal artery visited our hospital with complaint of recurrent lifestyle-limiting claudication of right leg. Angiography and intravascular ultrasound showed complete intra-stent obstruction by thrombus from the proximal right SFA to the proximal popliteal artery. Catheter-directed thrombolysis using pulse-spray technique followed by mechanical thrombectomy was performed. Despite successful recanalization, unfortunately, compartment syndrome developed on her right leg on the following day and fasciotomy was performed. CONCLUSION: The larger thrombus burden in Viabahn stent-grafts and its unique physicochemical properties increases the risk for distal embolic complications and potential poor clinical outcomes.
