Evaluation of Femoropopliteal In-Stent Restenosis Characteristics Stratified by Stent Design.

PURPOSE: To evaluate the potential differences in characteristics of femoropopliteal in-stent restenosis (ISR) stratified by stent design with a focus on the swirling flow-inducing BioMimics 3D helical centerline stent. METHODS: Patients with ISR of the superficial femoral and popliteal arteries undergoing reintervention were included in this study. The primary endpoint was the angiographic localization and extent of restenosis or reocclusion with the following five different stent systems: SMART Control stent, Supera peripheral stent, GORE® VIABAHN® endoprosthesis, BioMimics 3D stent, and Zilver® PTX® stent. RESULTS: 414 ISR lesions were analyzed, affecting 236 Supera stents, 67 BioMimics 3D stents, 48 Zilver® PTX® stents, 38 SMART Control stents, and 25 VIABAHN® endoprostheses. The mean stent diameter and length were 5.7 ± 0.77 mm and 121.4 ± 94.8 mm, respectively. ISR included 310 (74.9%) lesions with 1 stent, 89 (21.5%) lesions with 2 stents, 14 (3.4%) lesions with 3 stents, and 1 lesion (0.2%) with 4 stents. Most lesions presented as reocclusions (67.4%) rather than focal (13.3%) or diffuse restenoses (19.3%). No significant differences in ISR lesion morphology were found. By trend, BioMimics 3D stent lesion extension was more focal (16.4% versus 12.7%, p = 0.258), with the highest proportion of lesions in which only the proximal stent third was affected (9.0% versus 5.8%, p = 0.230), as compared to the average of the other four devices. The occlusion rate was the second lowest for the BioMimics 3D stent (64.2 vs. 68.0%, p = 0.316). Risk factors for restenosis or occlusion were active smoking, pre-interventional occlusion, and popliteal intervention. CONCLUSION: Our results suggest that the helical centerline stent design of the BioMimics 3D stent, which results in a swirling flow with increased wall shear stress, may offer protective properties over straight stent designs, including DES and endoprosthesis, regarding localization and extension of restenosis. Prospective, randomized studies are warranted.

Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.

BACKGROUND: This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure. METHODS: A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit. RESULTS: In the VIABAHN® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001). CONCLUSIONS: The treatment of femoropopliteal in-stent restenosis with a VIABAHN® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.

Renal artery stenosis: Up-date on diagnosis and treatment.

Significant renal artery stenosis (RAS) can cause or result in deterioration of arterial hypertension and may promote the development of renal insufficiency. The activation of the renin-angiotensin-aldosterone system results in structural heart disease and may impact patient survival. Technical improvements of diagnostic and interventional endovascular tools have led to a more widespread use of endoluminal renal artery revascularization and extension of the indications for this type of therapy during the past two decades. Whereas balloon angioplasty is still the method of choice for the treatment of fibromuscular dysplasia, stent implantation is indicated in ostial atherosclerotic RAS. However, none of the so far published or presented randomized controlled trials could prove a beneficial outcome of RAS revascularization compared to medical management. As a result of these negative trials including the largest published trial to date, the ASTRAL trial, referrals to endovascular renal artery revascularization have declined and, moreover, reimbursement of these procedures has become a matter of debate. Crucial for a clinical benefit following revascularization of RAS is proper patient selection, revascularization being only indicated after proof of hemodynamic relevance of RAS. This article summarizes the appropriate diagnostic work-up of patients with suspected RAS, discusses the limitations of the results published so far and their impact on the indication for RAS revascularization.

Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries.

BACKGROUND: Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates. The outcome might be improved in conjunction with drug-coated balloon angioplasty. METHODS: In this retrospective study, restenotic lesions of the femoropopliteal arteries were treated with directed atherectomy in 89 lesions of consecutive patients (58% male; mean age, 69 ± 11 years). All patients received adjunctive treatment with conventional balloon percutaneous angioplasty (PTA; n = 60) or drug-coated balloon angioplasty (DCB; n = 29). RESULTS: Lesion location was in the stent (DCB [n = 27] vs PTA [n = 36]) and in native restenotic vessels (DCB [n = 2] vs PTA [n = 25]). The 1-year Kaplan-Meier freedom from restenosis estimates (95% confidence intervals) in the DCB and PTA groups were 84.7% (70.9%-98.5%) and 43.8% (30.5%-57.1%), respectively. In a multivariable Cox model for restenosis, DCB treatment had a hazard ratio (95% confidence interval) of 0.28 (0.12-0.66; P = .0036) compared with the PTA group. In the multivariable model for procedural success, the effect of treatment did not differ between PTA and DCB (P = .134). CONCLUSIONS: The combination of directed atherectomy with adjunctive DCB is associated with a better event-free survival at 12 months of follow-up compared with PTA after directed atherectomy.

Elevated cardiac troponin T contributes to prediction of worse in-hospital outcomes after endovascular therapy for acute limb ischemia.

INTRODUCTION: The present study evaluated whether elevated cardiac troponin T (cTnT) was predictive of an increased risk for death or amputation in patients with acute lower limb ischemia (ALI). ALI is one of the most frequent causes of amputation, with mortality rates for ALI ranging from 15% to 20%. METHODS: This study included 254 consecutive ALI patients (155 men, 99 women; mean age, 71.6 ± 13.2 years) presenting with Rutherford categories I, IIA, or IIB according to the classification for ALI. RESULTS: ALI was caused by thromboembolism (29.5%), local arterial thrombosis (53.1%), or bypass graft occlusion (16.9%). Restoration of arterial blood flow was obtained by an endovascular approach, with a primary success rate of 98.4%. Rates were low for in-hospital mortality (3.9%) and amputation (5.1%). Patients who died or required amputation more frequently presented with elevated cTnT ≥0.01 ng/mL (52.2% vs 25.5%, P = .01) and impaired renal function (chronic kidney disease stage 3-5; 60.9% vs 38.1%; P = .04). After controlling for age, sex, C-reactive protein, renal function, presence or absence of coronary artery disease, and traditional vascular risk factors, as well as the interval between symptom onset and revascularization, the relationship between cTnT and a worse in-hospital outcome remained significant (hazard ratio, 3.4; 95% confidence interval, 1.3-8.5; P = .010). CONCLUSIONS: ALI patients frequently have elevated cTnT, which is associated with increased in-hospital mortality and amputation. Even small cTnT elevations predict a markedly increased risk of worse in-hospital outcome; however, the overall mortality and amputation rate in our study was low.

Histological diagnosis of atypical Takayasu arteritis using percutaneous transluminal atherectomy.

PURPOSE: To describe the use of percutaneous directional atherectomy to aid in the diagnosis of atypical Takayasu arteritis in the lower limb vessels. CASE REPORT: In a 24-year-old woman with severe peripheral artery disease (Rutherford-Becker category 5), imaging showed bilateral occlusion of the superficial femoral arteries (SFA), but no lesions of the proximal or supra-aortic vessels. The right SFA was treated first; after guidewire passage through the occlusion, 7 passes of the SilverHawk Peripheral Atherectomy Catheter debulked the lesion, followed by balloon angioplasty. Catheter biopsy showed inflammatory infiltrates consistent with Takayasu arteritis. CONCLUSION: Percutaneous transluminal atherectomy is not only an interventional device but also a diagnostic tool and can be used to distinguish between inflammatory and atherosclerotic lesions.