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Objectives: The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis., Background: The optimal treatment strategy for femoropopliteal ISR is unclear., Methods: The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days., Results: Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%., Conclusions: The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low., (Copyright © 2012 Wiley Periodicals, Inc.)

Objective: To evaluate the procedural safety and filter efficiency of Lumen Biomedical FiberNet® embolic protection system in conjunction with primary stenting of ostial atherosclerotic renal artery lesions., Background: There is limited data regarding the utility of distal embolic protection devices in renal artery angioplasty and stenting., Methods: Patients with angiographically severe (≥70%) renal artery stenosis were prospectively enrolled if one or more inclusion criteria met: resistant hypertension, progressive chronic kidney disease, unexplained heart failure, or flash pulmonary edema. Patients underwent renal artery angioplasty and stenting with utilization of the Lumen Biomedical FiberNet® EPS. The protection devices and aspirate were analyzed for degree of atheromatous particles. Procedural safety and clinical outcomes were assessed through 6 months., Results: Twenty patients were prospectively enrolled at five centers; average age 73.8 (±9.5) years, mean baseline eGFR 60.8 cm(3) min(-1). Twenty-five renal artery stenting procedures were performed. Device and procedural success were achieved in 100% of cases. All patients tolerated the procedure without any adverse events. Embolic debris was captured in all cases. Debris analysis of the distal protection system displayed an average post procedure atheroma area of 51.31 mm(2). There was no clinical evidence of peripheral atheroembolization through 30-days follow-up. No subjects progressed to temporary or permanent renal replacement therapy. Favorable trends in blood pressure control were observed at 6 months., Conclusion: The Lumen Biomedical FiberNet® embolic protection system is a safe and feasible method to prevent atheroembolization associated with angioplasty and stenting of renal artery ostial lesions., (Copyright © 2011 Wiley Periodicals, Inc.)

Objective: The multicenter, single-arm RENAISSANCE trial evaluated outcomes in patients with progressive atherosclerotic renal artery stenosis (ARAS) treated with the Express Renal Premounted Stent System (Boston Scientific, Natick, MA)., Background: Renal artery stenting may prevent the morbidity and mortality of surgical revascularization and high restenosis rates of percutaneous renal angioplasty (PTRA). Renal artery duplex ultrasonography (DUS) offers an alternative to traditional invasive poststenting angiographic surveillance, though concordance with angiography for in-stent restenosis has yet to be validated independently., Methods: RENAISSANCE enrolled 100 patients (117 lesions) with de novo or restenotic ostial atherosclerotic lesions or=4.0 and or=70%. The primary endpoint, 9-month binary restenosis, was compared to an objective performance criterion (OPC) of 40% for published PTRA results. Follow-up was conducted through 3 years., Results: Technical and procedural success was both 99%. Follow-up angiography, triggered clinically or by ultrasonography, revealed 21.3% binary restenosis at 9 months, which was superior to the OPC (P < 0.0001). Concordance between ultrasonography and angiography for detection of binary restenosis at 9 months was 87%. Peak systolic velocity and renal-to-aortic ratio were both significantly improved compared to baseline at 9 months and 2 years. The major adverse event (defined as device- or procedure-related death, target lesion revascularization or significant embolic event) rate was 10.5% at 9 months and 20.9% at 3 years., Conclusions: RENAISSANCE demonstrates that renal artery stenting is superior to the prespecified OPC at 9 months, and also shows that DUS can accurately identify in-stent restenosis., ((c) 2008 Wiley-Liss, Inc.)

Objective: To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease., Background: Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions., Methods: We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months., Results: Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect., Conclusion: (Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect., (2006 Wiley-Liss, Inc.)

We investigated the clinical effectiveness and relative cost of two different infarct artery revascularization strategies in patients following systemic thrombolysis for acute myocardial infarction. The clinical efficacy and relative cost of stenting and angioplasty have not been investigated in patients requiring infarct artery revascularization after systemic thrombolysis for myocardial infarction. We prospectively enrolled 220 consecutive patients who received thrombolytic therapy for acute myocardial infarction and were subsequently treated with either angioplasty or primary stenting of the infarct artery. In-hospital and 1-year clinical outcomes, including death, myocardial infarction, and repeat revascularization, and total hospital costs over the 1-year study period were assessed. Compared to angioplasty, primary stenting resulted in lower in-hospital mortality (4% vs. 0%; P = 0.01) and reduced rates of repeat percutaneous or surgical revascularization (7% vs. 0%; P = 0.0009). At 1-year follow-up, stenting was associated with a lower death rate (6.25% vs. 0%; P = 0.002) and reduced repeat infarct artery revascularization (11% vs. 27%; P = 0. 001). Initial hospitalization costs were higher in the stent group ($11,818 +/- $3,377 vs. $9,723 +/- $8,661; P = 0.014) due primarily to catheterization laboratory-related expenditures ($7,346 +/- $2, 395 vs. $3,567 +/- $1,212; P = 0.0001). However, the cumulative 1-year medical cost difference between the two groups was not significant ($13,938 +/- $5,939 vs. $12,914 +/- $9,308; P = 0.33). Following thrombolytic therapy, primary infarct artery stenting reduced in-hospital and 1-year mortality and revascularization rates compared to angioplasty. Stenting was associated with higher initial hospital costs, which were off-set by lower revascularization rates, resulting in comparable total hospitalization costs after 1 year. These findings have important clinical and economic implications in an increasingly cost-conscious health care environment. Cathet. Cardiovasc. Intervent. 49:135-141, 2000., (Copyright 2000 Wiley-Liss, Inc.)

Despite a high procedural success rate, long-term blood pressure control after successful renal artery stenting of hypertensive patients has been inconsistent. This most likely reflects the absence of clinical guidelines for the selection of patients likely to benefit from renal revascularization. A cohort of 150 consecutive hypertensive patients (mean age, 66.7 years; 86 women) with 180 renal artery lesions (> or =75%) underwent primary Palmaz stent deployment. Mean arterial blood pressure (MAP), serum creatinine, and antihypertensive medication requirements were monitored prospectively. Specific definitions of blood pressure cure, improvement, or treatment failure were followed. Renal artery duplex Doppler or angiography was performed to assess stent patency at a mean 13 months (range, 7-15 months). Multivariate logistic regression analysis was used to select clinical variables that best related to a beneficial blood pressure control at follow-up. The procedural success rate was 97.3% (146 patients) and major in-laboratory complications were infrequent (1.3%). Late MAP values in 127 patients (91%) fell from 110 +/- 13.7 to 97.6 +/- 10.6 mm Hg (P < 0.001); antihypertensive medication requirements decreased from 2.9 +/- 1.2 to 1.9 +/- 1.1 (P < 0.01). The 13-month stent restenosis rate defined by duplex Doppler or angiography was 12%. Multivariate logistic regression analysis identified a preprocedure MAP of >110 mm Hg (odds ratio, 2.9; P = 0.003) and bilateral renal stenoses (odds ratio, 4.6; P = 0.009) as predictors of a beneficial blood pressure response at follow-up. This study provides general preprocedure guidelines for the selection of hypertensive patients with atherosclerotic renal lesions likely to benefit from primary Palmaz stenting and confirms a high procedural success and low stent restenosis rate.

A cost-containment strategy to reduce stent procedure-related resources utilizing an integrated system comprised of a Stablizer guide wire, a Brite-Tip guiding catheter, and a single Titan balloon catheter for both lesion predilatation and poststent deployment was compared to a conventional strategy utilizing a nonintegrated guide wire, guiding catheter, and balloon components. Both groups were comparable with respect to demographics, number of lesions stented, and stents deployed per lesion. No differences in lesion length or pre- and poststent minimal luminal diameter were observed. Balloon use was significantly reduced using the integrated strategy when compared to the conventional strategy (1.3 +/- 0.5 vs. 2.1 +/- 1.1; P < 0.01); overall nonstent-related resource utilization was significantly reduced ($747 +/- $401 vs. $1,093 +/- $467; P < 0.01). Procedural success rates were identical in both groups (100%), and no patient sustained subacute stent thrombosis or required target vessel revascularization at 1 mo follow-up. We conclude that the use of a single Titan balloon catheter as part of an integrated cost-containment strategy for both lesion predilatation and poststent deployment results in considerable cost savings while maintaining high procedural and clinical success rates.