Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial.

BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.

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.

Endovascular treatment for extensive aortoiliac artery reconstruction: a single-center experience based on 1712 interventions.

PURPOSE: To determine the clinical and technical outcomes following endovascular therapy for aortoiliac occlusive disease, including complex reconstruction of the aortic bifurcation. METHODS: A retrospective database search identified 1184 consecutive patients (864 men; mean age 64±10 years) who underwent 1712 procedures to treat target lesions in the distal aorta and iliac arteries from September 1996 to December 2006. The intended strategy was to open only one femoral access site primarily, so a second puncture was needed only for the kissing balloon technique at the aortic bifurcation. The primary endpoint was a 1-year duplex-based primary patency; secondary endpoints included acute technical success (residual stenosis <30%), secondary patency, and target lesion revascularization (TLR). Results were stratified by lesion morphology, which was classified according to the TransAtlantic Inter-Society Consensus (TASC II) document. RESULTS: Most of the interventions were done in the iliac arteries (n=1337); 292 cases involved the aortic bifurcation, and 83 cases were in the distal aorta/aortic bifurcation. The mean follow-up was 3.24 years (range 0-12.7). In the entire study cohort, the 12- and 24-month restenosis, TLR, and primary/secondary patency rates did not differ among TASC II A-D subgroups. The symptom-driven TLR in the entire cohort was 8% and 9% at the 12- and 24-month follow-up, leading to secondary patency rates of 96% and 91% in the entire cohort. Outcomes for complex interventions in the distal aorta or aortic bifurcation did not differ significantly compared to the total cohort. The overall survival without restenosis, amputation, or surgery in TASC II subgroups A+B was higher (69.6%±1.5%) compared to TASC II C+D lesions (62.8%±1.9%, p=0.001). CONCLUSION: The indication for percutaneous intervention in aortoiliac occlusive disease can be extended to complex TASC C and D lesions in experienced endovascular centers, even if complex reconstruction of the distal aorta or the aortic bifurcation is indicated.

Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.

OBJECTIVES: The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions. BACKGROUND: There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up. METHODS: The study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class. RESULTS: The trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was -2 (-3 to -1) in the SES group and -1 (-2 to 0) in the BMS group, respectively (p = 0.006). CONCLUSIONS: Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee-Randomised Double-Blind Study [YUKON-BTX]; NCT00664963).

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.

Endovascular treatment of common femoral artery disease: medium-term outcomes of 360 consecutive procedures.

OBJECTIVES: The purpose of this study was to evaluate the technical feasability, safety, and 1-year efficacy of the endovascular treatment of atherosclerotic common femoral artery (CFA) obstructions. BACKGROUND: Atherosclerotic CFA obstruction is a known cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice for this condition, little is known about the percutaneous options. METHODS: Using a prospectively maintained single-center database, we retrospectively analyzed the outcomes of 360 consecutive percutaneous interventions of the CFA for atherosclerotic disease and assessed procedural success, in-hospital complications, and 1-year patency and target lesion revascularization rates. RESULTS: Ninety-seven procedures (26.9%) were isolated CFA interventions, whereas 157 (43.6%) and 152 (42.2%) also involved inflow and outflow vessels, respectively. Bifurcation lesions were present in 140 cases (38.9%), and concomitant treatment of the profunda femoral artery was performed on 93 occasions (25.8%). Chronic total CFA occlusions were recanalized in 60 cases (16.7%). Balloon angioplasty was performed as the primary intervention in virtually all cases (98.6%), whereas stenting was needed for suboptimal angioplasty results in 133 procedures (36.9%). Failures-defined as a final angiographic result with a >30% residual stenosis-were observed on 26 occasions (7.2%). In-hospital major (i.e., requiring surgery) and minor (i.e., treated percutaneously or conservatively) complications occurred in 5 (1.4%) and 18 (5.0%) procedures, respectively. One-year follow-up data were available for 281 patients (87.5%). Restenosis >50% by duplex scanning and target lesion revascularization were observed in 74 of 268 (27.6%) and 64 of 322 (19.9%) procedures, respectively. CONCLUSIONS: This large series suggests that the percutaneous approach may be a valid alternative to surgery for CFA atherosclerotic obstructions.

One-year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus.

BACKGROUND: To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients. METHODS: A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5%) were compared with 92 nonDM (53.5%) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67% DM; 61% nonDM), popliteal (25% DM; 30% nonDM), and tibial (8% DM; 9% nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29% (DM) and 32% (nonDM), and 15% (DM) and 14% (nonDM) were restenotic. RESULTS: In the entire cohort, device success was 99% (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5% (n = 2 planned amputations) and 0% in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8% (11/80) and 25% (20/80) compared with 21.7% (20/92) and 31.5% (29/92) in nonDM, respectively. TLR rate through 12 months was 20% (16/80) in DM and 28% in nonDM (26/92). Overall, 1 year restenosis rate was 38.2% based on duplex. The ankle-brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months. CONCLUSION: Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups.

Endovenous laser ablation of varicose veins with the 1470-nm diode laser.

BACKGROUND: Endovenous laser ablation (EVLA) is one of the most accepted treatment options for varicose veins. In previous studies conducted with a laser at 810 to 1320 nm, paresthesia, pain, and ecchymosis were common adverse effects. We hypothesized that a lower linear endovenous energy density (LEED), as used with 1470-nm diode laser fibers, would lead to a reduction in adverse events. METHODS: We conducted a prospective, nonrandomized observational cohort study of 312 consecutively treated lower limbs legs in 286 patients. Of these, a bare laser fiber (ELVeS-plus kit) was used to treat 168 legs in 150 patients (group 1), and a radial fiber (ELVeS-radial kit) was used in 144 legs in 136 patients (group 2). Laser treatment was performed in the great saphenous vein. Follow-up for all patients was 3 months. The primary end point was the occurrence of ecchymosis and bruising. This was correlated to the reduced LEED needed with the 1470-nm diode laser. RESULTS: Laser fiber (odds ratio [OR], 22.3; 95% confidence interval [CI], 20.2-24.5) and body mass index (OR, 0.35; 95% CI, 0.15-0.55) were identified as independent parameters for LEED. In group 2 compared with group 1, LEED in the great saphenous vein could be reduced from 79.4 +/- 9.1 to 57.4 +/- 10 J/cm (P < .0001). LEED was an independent parameter for skin bleeding (OR, 1.04; 95% CI, 1.017-1.058). Ecchymosis and bruising were significantly less frequent in group 2 than in group 1 (P < .0001). The need for analgesia was low, with 103.08 +/- 15.34 mg diclofenac-sodium in group 1 vs 82.08 +/- 18.86 mg in group 2 (P < .04). Occlusion with elimination of reflux was achieved in 100% of group 1 and group 2 (P < 1). No recanalization occurred at follow-up. CONCLUSION: Endovenous laser treatment of varicose veins in the great saphenous vein with the 1470-nm diode laser is safe and highly effective. The lower energy level needed using the radial laser fiber significantly minimized adverse effects compared with the bare laser fiber.

Diffuse fibromuscular dysplasia successfully treated with scoring balloon angioplasty in a 3-year-old boy.

In children, up to 10% of the cases of arterial hypertension may be caused by a renovascular disease. The etiology of this renovascular disease is most of the time due to a fibromuscular dysplasia (FMD), which causes a noninflammatory intimal-medial fibroplasia leading to luminal compromise. Percutaneous transluminal angioplasty of FMD is a worldwide-accepted treatment modality for this serious arterial disease with, so far, good safety and long-term efficacy data. Once FMD involves several arterial compartments leading to symptoms the outcomes are poor. Herein we report the case of a 3(1/2)-year-old boy with severe arterial hypertension and abdominal angina due to a diffuse multivisceral FMD involvement, successfully managed by a percutaneous angioplasty approach using a new balloon catheter for plaque modulation.

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.

VIPER-2: a prospective, randomized single-center comparison of 2 different closure devices with a hemostatic wound dressing for closure of femoral artery access sites.

PURPOSE: To report the outcome of a prospective randomized safety and performance trial of 2 access site closure devices versus a wound dressing. METHODS: Between October 2005 and July 2006, 852 consecutive patients (605 men; mean age 67 years) undergoing diagnostic or interventional catheterization procedures thru a 5- or 6-F femoral sheath were randomized to one of the 3 closure methods: a collagen plug device (Angio-Seal), a clip (StarClose), or a wound dressing (D-Stat Dry). The efficacy of the devices was assessed, as well as the complications occurring at the puncture site during the hospital stay. The primary endpoint of the study was the cumulative incidence of access site pseudoaneurysm, major access site bleeding requiring transfusion, access site vascular surgery, or death from all causes. RESULTS: There were no significant differences in baseline characteristics between the 3 treatment groups. The primary endpoint was reached in 20 (7.1%) of 281 patients treated with D-Stat Dry and in 11 (1.9%) of 571 patients treated with the mechanical closure devices (p<0.0001). There was no significant difference among the mechanical closure devices concerning the incidence of the primary endpoint (Angio-Seal 1.1% versus StarClose 2.8%; p = 0.13). CONCLUSION: The collagen plug device had the lowest rates of major and minor access site-related complications after removal of 5- or 6-F femoral sheaths. The difference between the mechanical closure devices concerning the incidence of the primary endpoint did not reach statistical significance. The wound dressing showed significantly higher major and minor complication rates.

Treatment of reoccurring instent restenosis following reintervention after stent-supported renal artery angioplasty.

BACKGROUND: Reoccurrence of restenosis following angioplasty of renal instent restenosis is a considerable drawback of stent-supported angioplasty of renal artery stenosis especially in small vessel diameters. We therefore prospectively studied the long-term outcome of different techniques of endovascular treatment of reoccurrence of instent renal artery restenosis after primarily successful reangioplasty focusing on the impact of covered and drug eluting stents, respectively. PATIENTS AND METHODS: The study included 31 consecutive patients (33 lesions) presenting with their at least second instent restenosis following renal artery stenting who were included in a prospective follow-up program (mean follow-up 36+/-25 months, range 1-85). Primary endpoint of the study was the reoccurrence rate of instent stenosis after primarily successful treatment of instent restenosis determined by duplex ultrasound. RESULTS: Primary success rate was 100%, no major complication occurred. Seven lesions were treated with balloon angioplasty (21%, group 1), 7 lesions with stent-in-stent placement (21%, group 2), 6 lesions with placement of a covered stent (18%, group 3), 3 lesions with a cutting balloon (9%, group 4), and 10 lesions with placement of a drug eluting stent (31%, group 5). During follow-up, overall 12 lesions (36%) developed reoccurrence of instent restenosis: n=5 in group 1 (reoccurrence rate 71%), n=3 in group 2 (43%), n=1 in group3 (17%), 3 in group 4 (100%), and n=0 in group 5 (0%). Treatment with a cutting balloon was the only significant predictor of restenosis (hazard ratio 32.3 (95% CI, 3.3-315.0); P<0.001). CONCLUSION: Treatment of at least second renal artery instent restenosis is feasible and safe. Balloon angioplasty and the implantation of a bare metal stent, a covered stent, or a drug eluting stent seemed to offer favorable long-term patency, whereas cutting balloon angioplasty resulted in a very high rate of restenoses and should therefore be discouraged for this indication.

Endovascular therapy of chronic mesenteric ischaemia.

BACKGROUND: Chronic mesenteric ischaemia (CMI) is associated with a high morbidity and mortality. Most likely causes of CMI are atherosclerosis, external compression (Dunbar Syndrome) and vasculitis. We report on our experience with endovascular stent therapy. PATIENTS AND METHODS: Between Sept. 1998 and Dec. 2005 we treated 21 consecutive patients (52% male; mean age 64+/-15 years, range 18-81 years) due to symptomatic CMI. A total of 34 interventions with 41 treated lesions were performed. Aetiology of vessel obstruction was atherosclerosis in 14 patients (67%), Dunbar syndrome in 3 patients (14%), chronic type B aortic dissection in 2 patients (9%), Takayasu's arteritis in 1 patient (4.5%), external compression following abdominal surgery in 1 patient (4.5%). Target lesions were celiac trunk (n=16), superior mesenteric artery (n=24), and inferior mesenteric artery (n=1). Twenty-two percent (n=9) of the lesions were total occlusions. The patients underwent serial follow-up duplex examinations before discharge and every 6 months thereafter or in case of symptom recurrence. RESULTS: Thirty-one of the 34 (91%) interventions were technically successful (37/41 lesions; 90%). Two of these 4 lesions were treated successfully using another approach in a second intervention. Brachial access was used in 16/34 cases (47%). One or more stents were placed in 29/34 interventions (85%) and 35/41 lesions. In 3 cases, in-stent restenosis was treated with balloon angioplasty alone, and in two cases, 3 occlusions could not be reopened. During 6 interventions, drug eluting stents were placed. All patients treated successfully were free of symptoms immediately after the intervention with recurrence of symptoms in case of restenosis. After a mean follow-up of 31+/-26 (range 0-87) months restenosis was detected in 6 patients (29%). Two major complications occurred which were treated without permanent sequelae. CONCLUSION: Stenoses of mesenteric arteries resulting in symptomatic CMI can be treated successfully with stent-angioplasty; for anatomical reasons, the brachial approach should be considered. Recanalisation of total obstructions is feasible if a stump of the occluded artery is detectable. Restenosis is frequent and can easily be treated with balloon angioplasty or stent-in-stent placement.

Impact of carbon coating on the restenosis rate after stenting of atherosclerotic renal artery stenosis.

PURPOSE: To investigate the impact of carbofilm coating and low-profile rapid exchange stent devices on the restenosis rate after stent-angioplasty of atherosclerotic renal artery stenosis (RAS). METHODS: During a 2-year period (7/2002-7/2004), 143 consecutive patients with 179 primary ostial atherosclerotic RAS>or=70% diameter stenosis were treated with stents selected at the discretion of the operator. Eighteen patients (32 lesions) treated with 9 different types of stents were excluded from the analysis, leaving 125 patients (69 men; mean age 67 years, range 42 to 90) with 147 lesions who received either a Radix carbofilm-coated stent in 78 (53%) lesions (68 [54%] patients) or a Palmaz Genesis bare stainless steel stent in 69 (47%) lesions (57 [46%] patients). The target vessel diameter ranged from 5 to 7 mm. RESULTS: Baseline characteristics were similar in both groups except the mean stent diameter, which was larger in the bare stent cohort (6.4+/-0.7 versus 5.9+/-0.5 mm, p<0.001). Primary success was 100% in both groups; the initial mean diameter stenosis was reduced from 79%+/-14% and 80%+/-14% in the coated versus bare stent groups to 3+/-5% and 2+/-6%, respectively. After a mean follow-up of 22+/-5 months, the restenosis rate was 6.4% for the coated stent and 5.8% for the bare stent (p=0.87). For the entire cohort, restenosis rates varied significantly (p<0.05) according to stent diameter: 19% (5/26) for 5 mm, 4% (3/81) for 6 mm, and 2.5% (1/40) for 7 mm. In a binary logistic regression analysis including carbofilm coating, stent diameter, gender, diabetes, smoking status, and body mass index, stent diameter was the only independent predictor of restenosis (odds ratio 0.12, 95% CI 0.03 to 0.48 [p=0.003] for a 1-mm increase in vessel diameter). CONCLUSIONS: Using modern low-profile stent devices, carbofilm coating does not significantly reduce the restenosis rate compared to a bare metal stent. With contemporary stent devices, the restenosis rate has been decreasing compared to earlier reports in the literature.

Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience.

PURPOSE: To report the early and 6-month results after atherectomy of femoropopliteal lesions using a new atherectomy device compatible with a 7-F sheath. METHODS: Fifty-two patients (36 men; mean age 67+/-7 years) with stable, chronic lower limb occlusive disease were enrolled prospectively in a study of percutaneous directional atherectomy using the SilverHawk Atherectomy Catheter. The 71 femoropopliteal stenoses were grouped for analysis according to pathology: 30 (42%) primary stenoses, 27 (38%) native vessel restenoses, and 14 (20%) in-stent restenoses. The overall average stenosis length was 48+/-64 mm (range 10-300). There were more diabetics in the primary lesion cohort, whereas the lesion length of the in-stent restenoses was nearly twice as long as the other groups. RESULTS: After atherectomy alone, residual stenosis was < or =50% in 68 (96%) lesions and < or =30% in 54 (76%). Additional balloon angioplasty was used in 41 (58%) lesions, primarily to smooth the arterial contour; stents were implanted in 4 (6%) arteries. Acute results after atherectomy and additional therapy were identical for the 3 groups (mean residual stenosis 15% in primary lesions, 8% in restenoses, and 14% in in-stent lesions). At the beginning of the study, 5 cases of tissue embolism were successfully treated with aspiration (device modification solved this problem). Restenosis rates after 6 months were not significantly lower in primary lesions (27%) compared with the other groups (41% for restenoses and 36% for in-stent restenoses). Reintervention after 6 months was also lowest for primary lesions (20% versus 37% for restenoses and 29% for in-stent lesions; p=NS). The ankle-brachial index was significantly improved after 6 months in all groups. At the 6-month follow-up, >80% of all patients were symptom free or had no lifestyle-limiting claudication. CONCLUSIONS: Short and medium-length femoropopliteal lesions can be treated successfully and safely in most cases with this new atherectomy catheter. Technical and 6-month clinical outcomes seem to favor primary lesions compared with restenoses.