Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).

BACKGROUND: Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year. METHODS AND RESULTS: Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease. CONCLUSIONS: In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.

Effects of percutaneous transluminal angioplasty and endovascular brachytherapy on vascular remodeling of human femoropopliteal artery by noninvasive magnetic resonance imaging.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) of severely stenotic peripheral vascular lesions is hampered by a higher restenosis rate. The effects of PTA on vascular wall as well as the effects of the antirestenotic properties of endovascular brachytherapy (EVBT) remain unclear. MRI allows in vivo noninvasive assessment of the vascular effects of such treatment strategies. We sought to elucidate the vascular effect of PTA and PTA+EVBT by serial MRI. METHODS AND RESULTS: Twenty symptomatic patients with severe stenosis of the femoropopliteal artery were randomly assigned to PTA (n=10) or PTA+EVBT (n=10; 14 Gy by gamma-irradiation source) and imaged by high-resolution MRI before and 24 hours and 3 months after intervention. An independent observer blinded to the procedure analyzed the MRI data. At 24 hours, cross-sectional MRI revealed that lumen area (86% and 67%) and total vessel area (47% and 34%) increased similarly in the PTA and PTA+EVBT groups, respectively. All patients showed severe splitting of the atherosclerotic plaque, resulting in an irregularly shaped lumen. At 3 months, MRI revealed a significant difference in lumen area change between the PTA and PTA+EVBT groups (40% and 106%, respectively; P=0.026) and in the total vessel area (14% and 39%, respectively; P=0.018). At 3 months, plaque disruption was still present in 50% of the patients treated with PTA+EVBT. CONCLUSIONS: After PTA, there is deep disruption of the atherosclerotic plaques and an extensive remodeling process of the arterial wall. Luminal loss after PTA is partially due to inward vessel remodeling. Brachytherapy prevents inward remodeling and induces an increase in lumen area but partially prevents healing of disrupted vessel surface.

Late acute thrombotic occlusion after endovascular brachytherapy and stenting of femoropopliteal arteries.

OBJECTIVES: The aim of this article is to underline the importance of this complication after endovascular brachytherapy (EVBT) and intravascular stenting of the femoropopliteal arteries occurring in a running randomized trial. BACKGROUND: Endovascular brachytherapy has been proposed as a promising treatment modality to reduce restenosis after angioplasty. However, the phenomenon of late acute thrombotic occlusion (LATO) in patients receiving EVBT after stenting is of major concern. METHODS: In an ongoing prospective multicenter trial, patients were randomized to undergo EVBT (iridium 192; 14 Gy at a depth of the radius of the vessel +2 mm) after percutaneous recanalization of femoropopliteal obstructions. Of the 204 patients who completed the six months follow-up, 94 were randomized to EVBT. RESULTS: Late acute thrombotic occlusion occurred exclusively in 6 of 22 patients (27%) receiving EVBT after intravascular stenting and always in concomitance with reduction of antithrombotic drug prevention (clopidogrel). Conversely, none of the 13 patients with stents and without EVBT (0%; p < 0.05) and none of the 72 patients (0%; p < 0.01) undergoing EVBT after simple balloon angioplasty presented LATO. CONCLUSIONS: Late thrombotic occlusion occurs not only in patients undergoing EVBT after percutaneous coronary recanalization but also after stenting of the femoropopliteal arteries and may compromise the benefits of endovascular radiation. The fact that all our cases with LATO occurred concomitantly with stopping clopidogrel may indicate a possible rebound mechanism. An intensive and prolonged antithrombotic prevention is probably indicated in these patients.

[Raynaud's phenomenon and other circulatory disorders of the fingers]. / Das Raynaud-Phänomen und andere Durchblutungsstörungen der Finger.

Raynaud's phenomenon (RP) is defined as attacks of blanking, subsequent cyanosis and rubeosis of fingers due to vasospasms in response to cold or emotional stimuli. Primary RP has no known underlying cause and occurs mainly in young and otherwise healthy women. Secondary RP goes along with various causes such as connective tissue diseases, toxic substances, drugs, physical trauma or organic finger artery occlusions, and occurs at any age and in both genders. Related affections are acrocyanosis and finger artery occlusions either due to arteriosclerosis or vasculitis. Also spontaneous finger hematoma may provoke an episode of RP. Therapeutically strict cold protection and avoidance of possible noxa is recommended besides the treatment of underlying diseases. No standard vasoactive drug has proven ideal for RP due to side effects. In cases with rest pain or ulcerations the same principles are applied as in ischemic diseases with no possibility for revascularization.

Le phénomène de Raynaud(PR) est défini comme des attaques de blancheur suivie d'une cyanose et d'une rougeur des doigts dues à un vasospasme en réponse au froid ou à un stimulus émotionnel. Le PR primaire n'a pas de cause connue et atteint surtout des jeunes femmes qui sont par ailleurs en bonne santé. Le PR secondaire se rencontre avec des causes variées comme la sclérodermie, des substances toxiques, des médicaments, des traumatismes physiques ou des occlusions artérielles au niveau des doigts. Cette forme de PR peut survenir à tout âge, tant chez l'homme que chez la femme. Des affections relatées au PR sont l'acrocyanose et les occlusions des artères digitales dues à l'artériosclérose ou une vasculite. Enfin, un hématome spontané au niveau d'un doigt peut provoquer un PR. Une protection stricte contre le froid et l'évitement autant que possible des facteurs favorisants est recommandé, ceci en plus du traitement de la maladie sous-jacente. Il n'y a pas de médicament vasoactif standard idéal pour traiter le PR, particulièrement en raison de leurs effets secondaires. En cas de douleur au repos ou en présence d'ulcérations les mêmes principes de traitement sont appliqués que lors d'affections ischémiques, avec cependant l'impossibilité d'effectuer une revascularisation.

Falsely high ankle-brachial index predicts major amputation in critical limb ischemia.

Falsely high ankle-brachial index (ABI) values are associated with an adverse clinical outcome in diabetes mellitus. The aim of the present study was to verify whether such an association also exists in patients with chronic critical limb ischemia (CLI) with and without diabetes. A total of 229 patients (74 +/- 11 years, 136 males, 244 limbs with CLI) were followed for 262 +/- 136 days. Incompressibility of lower limb arteries (ABI > 1.3) was found in 45 patients, and was associated with diabetes mellitus (p = 0.01) and renal insufficiency (p = 0.035). Limbs with incompressible ankle arteries had a higher rate of major amputation (p = 0.002 by log-rank). This association was confirmed by multivariate Cox regression analysis (relative risk [RR] 2.67; 95% CI 1.27-5.64, p = 0.01). The relationship between ABI > 1.3 and amputation rate persisted after subjects with diabetes and renal insufficiency had been removed from the analysis (RR 3.85; 95% CI 1.25-11.79, p = 0.018). Dividing limbs with measurable ankle pressure according to tertiles of ABI, the group in the second tertile (0.323 < or = ABI < or = 0.469) had the lowest amputation rate (4/64, 6.2%), and a U-shaped association between the occurrence of major amputation and ABI was evident. No association was found between ABI and mortality. In conclusion, this study demonstrates that falsely high ABI is an independent predictor of major amputation in patients with CLI.

Below-the-knee angioplasty in patients with end-stage renal disease.

PURPOSE: To determine clinical efficacy of below-the-knee (BTK) angioplasty in patients with end-stage renal disease (ESRD). METHODS: Interrogation of a prospectively maintained database containing 2,659 patients treated at a tertiary referral hospital between February 1995 and June 2004 identified 29 ESRD patients (21 men; median age 69 years, IQR 10.12) who had 73 infrapopliteal atherosclerotic lesions treated in 38 ischemic limbs. The indication for treatment was intermittent claudication in 13 (34%) and critical limb ischemia in 25 (66%) limbs. BTK angioplasty was attempted either alone (n=18) or combined with an endovascular inflow procedure (n=20). Primary clinical success was defined as hemodynamic improvement (ABI increase >or=0.1) and/or symptomatic improvement (at least one clinical category). Cumulative rates were calculated according to the Kaplan-Meier estimate. RESULTS: Primary technical success reached 97%, whereas hemodynamic improvement was obtained in only 50% (19/38) of the limbs treated. The pedal arteries were severely diseased in all, and complete occlusion of the pedal arch was found in 58% (18/31) of limbs on completion angiography. Median follow-up was 5.9 months (IQR 11.5). Primary clinical success was 17%, 11%, 11%, and 11% in patients with BTK angioplasty alone and 53%, 45%, 45%, and 45% in patients with inflow procedures after 3, 6, 9, and 12 months, respectively (p=0.017). Limb salvage was 73% at 12 months. Subgroup analyses showed significantly better clinical results in men (p=0.003) and in patients on hemodialysis compared to peritoneal dialysis (p=0.037). CONCLUSIONS: Clinical efficacy of BTK angioplasty is limited in patients with ESRD because of the severely diseased pedal arteries. Further studies are warranted to define subgroups of patients likely to experience a more favorable outcome.

Endovascular brachytherapy after femoropopliteal balloon angioplasty fails to show robust clinical benefit over time.

PURPOSE: To determine if the short-term efficacy of adjunctive endovascular brachytherapy (EVBT) is maintained over time in patients undergoing balloon angioplasty (BA) of femoropopliteal atherosclerotic lesions. METHODS: To evaluate the long-term clinical and angiographic outcome of EVBT, 147 consecutive patients (82 men; mean age 70.8+/-8.5 years) with 147 treated limbs were randomized to BA with (n=72, 49%) or without (n=75, 51%) adjunctive EVBT (12 or 14-Gy from an (192)Ir source, no centering, a 5-mm reference depth). Sixty-eight (46%) limbs were treated for de novo and 79 (54%) for recurrent femoropopliteal lesions. Clinical follow-up at 1, 3, 6, and 12 months and annually thereafter included evaluation of symptoms, ankle-brachial index (ABI), and intra-arterial angiography for new/worsening symptoms or at follow-up between 2 and 5 years. Sustained clinical success was defined as improvement in ABI >or=0.1 and/or of symptoms without repeated target lesion revascularization. Angiographic restenosis was defined as >or=50% diameter reduction. Subgroup analysis was performed for de novo versus recurrent lesions. RESULTS: Mean clinical follow-up was 32.3+/-21.5 months. Angiographic follow-up was available in 83 (56%) patients (41 BA and 42 BA+EVBT) at a mean 31.8+/-20.7 months. Cumulative sustained clinical success rates at 1, 2, and 3 years, respectively, were 84.3%, 82.1%, and 76.4% after BA versus 82.4%, 69.8%, and 67.5% after BA+EVBT (p=0.26 by log-rank). Although the proportion of patients undergoing follow-up angiography was moderate, the freedom from angiographic restenosis at 1, 2, and 3 years was 70.7%, 63.1%, and 47.1% after BA versus 82.7%, 64.3%, and 64.3% after BA+EVBT (p=0.16 by log-rank). No differences were found between BA and BA+EVBT outcomes in patients with de novo versus recurrent femoropopliteal lesions. CONCLUSION: The seemingly beneficial short-term effects of BA+EVBT are not sustained in the longer term, with no robust clinical improvement after angioplasty of atherosclerotic de novo or recurrent femoropopliteal lesions at up to 5 years.

Adjunctive abciximab improves patency and functional outcome in endovascular treatment of femoropopliteal occlusions: initial experience.

PURPOSE: To prospectively evaluate the safety and effectiveness of adjunctive administration of abciximab observed within 30 days and at 6 months after randomization in patients undergoing endovascular revascularization of long-segment femoropopliteal occlusions. MATERIALS AND METHODS: The study was approved by the local ethical committee, and patients gave written informed consent. In a prospective, double-blind, placebo-controlled design, patients undergoing percutaneous treatment for long-segment (>5 cm) femoropopliteal occlusions were randomly assigned to receive abciximab or a placebo; all patients also received standard-dose heparin. Effectiveness and safety analyses were based on an intention-to-treat approach. Patency was calculated according to life-table analysis, and P values were derived from the log-rank statistic. The P values for dichotomous safety end points were calculated with the Fisher exact test. Odds ratios were calculated for subgroup analyses. Logistic regression modeling was used for analysis of the safety bleeding data. RESULTS: A total of 98 patients (103 limbs) were included: 47 patients received abciximab and 51 received a placebo. Patency with abciximab versus placebo was 95.7% versus 80.4% (relative risk, 0.21; 95% confidence interval: 0.05, 0.96; P = .02) at 30 days and was 61.7% versus 41.2% (relative risk, 0.57; 95% confidence interval: 0.32, 1.01; P = .03), coupled with a better clinical outcome according to the Rutherford score, at the end of follow-up (P = .03). Risk of major bleeding was not significantly increased, while access-site bleeding was significantly higher among patients receiving abciximab (odds ratio, 2.9; 95% confidence interval: 1.04, 8.2; P = .04). CONCLUSION: The data show that adjunctive administration of abciximab has a favorable effect on patency and clinical outcome in patients undergoing complex femoropopliteal catheter interventions not hampered by serious bleeding. Treatment effect of abciximab observed at 30 days was maintained at 6-month follow-up.

Endovascular treatment of an internal iliac artery aneurysm using a nitinol vascular occlusion plug.

PURPOSE: To report endovascular occlusion of an internal iliac artery (IIA) aneurysm with an Amplatz nitinol vascular occlusion plug. CASE REPORT: A 71-year-old asymptomatic man who had previously undergone open aortic aneurysm repair presented for annual follow-up. A bifurcated Dacron graft had been inserted 12 years ago from the infrarenal aorta to the left common femoral artery and the right common iliac artery. The left common iliac artery was ligated proximally, and the left external iliac artery (EIA) provided retrograde flow into the IIA. Magnetic resonance imaging (MRI) revealed a 7.4-cm aneurysm of the left IIA. After transfemoral calibrated catheter angiography was performed, the proximal EIA was occluded with an Amplatz nitinol vascular occlusion plug. In addition, microcoils were placed distal to the vascular plug to achieve complete thrombosis of the vessel. One day after treatment, the patient was discharged free of symptoms after MRI had shown complete obliteration of the IIA aneurysm. At 6 months, the patient was free from symptoms, and angiography confirmed exclusion of the IIA aneurysm. CONCLUSIONS: This case illustrates the technical feasibility and successful short-term follow-up of a novel embolization approach to IIA aneurysms in patients with an aortofemoral graft.

Balloon angioplasty in chronic critical limb ischemia: factors affecting clinical and angiographic outcome.

PURPOSE: To assess factors that affect clinical and angiographic outcome in chronic critical limb ischemia (CLI) 12 months after primary, technically successful balloon angioplasty (BA) in infrainguinal arteries. METHODS: Sixty consecutive patients (37 women; mean age 75 +/- 10 years, range 53-99) with technically successful BA in 66 limbs were followed for 12 months or until death, for major amputation, or repeat target lesion revascularization (TLR). Assessment at baseline and 1 day and 12 months after BA or at an endpoint event, if feasible, was performed with angiography or duplex ultrasound (above-knee revascularization only). Mortality, limb prognosis, and restenosis rate were correlated with cardiovascular risk factors, hemodynamic measures, and angiographic features. RESULTS: Mortality was 25% at 1 year; compared to survivors, nonsurvivors more often had coronary artery disease (93% versus 44% for survivors, p<0.001), bilateral CLI (60% versus 29%, p=0.033), and higher fibrinogen levels (5.1 g/L versus 4.3 g/L, p=0.049). CLI resolved in more than half (35, 53%) of the limbs without repeat TLR. The major amputation rate was 6%. Limb prognosis correlated with ankle pressures after BA. Restenosis rates were 65% at the femoropopliteal and 56% at the infrapopliteal level (NS); these correlated with the length of the treated arterial segment (8.7 cm with restenosis versus 4.0 cm without, p<0.001). CONCLUSIONS: High mortality in CLI was associated with an extensive, clinically manifest arteriosclerotic process and high fibrinogen levels. Limb prognosis and restenosis after BA were primarily influenced by local hemodynamic and technical factors. Despite considerable restenosis, more than 90% of survivors avoided major amputations.

Does deep femoral artery revascularization as an isolated procedure play a role in chronic critical limb ischemia?

PURPOSE: To prospectively evaluate the midterm outcome after balloon angioplasty or surgical profundaplasty of the deep femoral artery (DFA) as an isolated procedure in chronic critical limb ischemia (CLI). METHODS: Between 1995 and 2001, 21 limbs in 20 patients (mean age 77+/-8 years) were treated by revascularization of the deep femoral artery (DFA) as an isolated procedure for limb salvage. All patients had long-segment femoropopliteal occlusions unsuitable for revascularization and critical obstruction of the DFA. Clinical outcome was assessed at 1, 3, 6, and 12 months. Clinical treatment efficacy was defined as resolved CLI in surviving patients without major amputation after isolated DFA revascularization. Repeat target limb revascularization, major amputation, and death were solitary study endpoints; survival analyses were performed using the Kaplan-Meyer method. RESULTS: Angioplasty with or without stenting was performed in 14 (67%) limbs and surgical profundaplasty in 7 (33%) limbs, with a technical success rate of 100%. Clinical treatment efficacy was 25% at 12 months; the cumulative rates of repeat target limb revascularization, major amputation, and death were 49%, 36%, and 55%, respectively. Major amputation and persistent CLI dominated in patients with stage IV disease (89%), whereas rest pain resolved in the majority of patients with stage III disease (67%; p<0.05). CONCLUSIONS: Isolated DFA revascularization seems insufficient to support wound healing in CLI, but might be a treatment option in CLI patients with rest pain.

Endovascular brachytherapy for prevention of recurrent renal in-stent restenosis.

PURPOSE: To examine the ability of endovascular brachytherapy to prevent recurrent in-stent restenosis in patients at high risk for this complication. METHODS: Thirteen renal stent patients (8 women; mean age 66 +/- 8 years) with an initial (n=9) or recurrent (n=4) in-stent restenosis underwent redilation followed by high-dose-rate brachytherapy (12 Gy of gamma radiation delivered to the target site 5 mm from an iridium-192 source axis). RESULTS: The procedure was technically successful in 11 (85%) patients; in the other 2, the renal artery could not be accessed with the large sheaths required for brachytherapy. One patient with no clinical suspicion of restenosis died of an unrelated cause during the 1-year follow-up. Eight (80%) of 10 patients alive at 1 year had no in-stent restenosis apparent on duplex sonography or angiography. One of the postradiation recurrent restenoses was redilated, but the other patient was treated conservatively. CONCLUSIONS; Renal angioplasty followed by brachytherapy seems to be a feasible and efficient method to prevent recurrent in-stent restenosis in renal arteries at increased risk.

Thrombus aspiration as a bailout procedure during percutaneous renal angioplasty.

PURPOSE: To present a case in which thrombus aspiration, urokinase, and abciximab were used to recanalize a sudden acute thrombotic occlusion of the right renal artery during percutaneous renal angioplasty. CASE REPORT: A 72-year-old man with severe arterial hypertension, impaired renal function, and peripheral artery disease was referred for interventional renal revascularization of a proximal stenosis of the right renal artery. Predilation was unsuccessful, and stent placement was followed by immediate occlusion of the distal renal artery, probably due to dislocation of a mural thrombus. Since intra-arterial administration of urokinase (300,000 IU) was ineffective, thrombus aspiration was performed using the 7-F guiding catheter. After successful removal of the thrombus, abciximab was given intravenously. Control angiograms showed recanalization of the stented segment and patency of the distal renal arteries, an outcome confirmed 8 months later by duplex ultrasound. CONCLUSIONS: As demonstrated in our case, thromboembolic complications can be rapidly and successfully treated on the table by combined measures, such as catheter thrombus extraction and pharmacological strategies.

Endovascular brachytherapy after percutaneous transluminal angioplasty of recurrent femoropopliteal obstructions.

PURPOSE: To test the preventive effect of endovascular brachytherapy (EVBT) on restenosis following secondary angioplasty in patients with presumed neointimal restenosis in the femoropopliteal segment. METHODS: From March 1997 through May 2000, 100 patients (58 men; mean age 70 years, range 45-87) with postangioplasty femoropopliteal segment restenoses were enrolled and randomized to treatment with repeat angioplasty and EVBT (n=51) or to angioplasty alone (n=49) as control. The groups were similar with regard to demographics and lesion characteristics. High-dose-rate EVBT was performed with (192)Ir irradiation without a centering device (12 Gy for a reference vessel radius of 3 mm and a 2-mm reference depth). Primary endpoint in the 1-year follow-up was recurrent obstruction >50% documented by duplex ultrasound; the secondary endpoint was clinical improvement. RESULTS: Only 44 (86%) of 51 patients received adequate EVBT due to technical failure, so the 7 failures were included with the controls in the per-protocol adherence analysis. At 1 year, the patients receiving EVBT had a restenosis rate of 23% (10/44), which differed significantly (p<0.028) from the 42% (23/56) rate in controls. Clinical results tended to be better with EVBT, but differences did not achieve statistical significance. CONCLUSIONS: EVBT without a centering device reduced restenosis significantly in patients with recurrent stenosis after angioplasty, which confirms previous results in primary long-segment femoropopliteal obstructions.