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5.
Praxis (Bern 1994) ; 103(5): 265-9, 2014 Feb 26.
Article in German | MEDLINE | ID: mdl-24568762

ABSTRACT

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.


Subject(s)
Fingers/blood supply , Ischemia/diagnosis , Raynaud Disease/diagnosis , Capillary Resistance/physiology , Diagnosis, Differential , Humans , Ischemia/etiology , Ischemia/therapy , Microscopy , Raynaud Disease/etiology , Raynaud Disease/therapy
7.
Circulation ; 116(3): 285-92, 2007 Jul 17.
Article in English | MEDLINE | ID: mdl-17592075

ABSTRACT

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.


Subject(s)
Alloys/administration & dosage , Angioplasty, Balloon , Blood Vessel Prosthesis Implantation , Femoral Artery/pathology , Stents , Aged , Angioplasty, Balloon/methods , Blood Vessel Prosthesis Implantation/methods , Female , Femoral Artery/diagnostic imaging , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/pathology , Graft Occlusion, Vascular/therapy , Humans , Ischemia/diagnostic imaging , Ischemia/pathology , Ischemia/therapy , Male , Middle Aged , Ultrasonography
8.
Vasc Med ; 11(2): 69-74, 2006 May.
Article in English | MEDLINE | ID: mdl-16886836

ABSTRACT

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.


Subject(s)
Amputation, Surgical , Ankle/blood supply , Blood Pressure , Brachial Artery/physiopathology , Ischemia/physiopathology , Leg/blood supply , Aged , Diabetes Complications/mortality , Diabetes Complications/physiopathology , Diabetes Complications/surgery , False Positive Reactions , Female , Humans , Ischemia/mortality , Ischemia/surgery , Leg/surgery , Limb Salvage , Male , Predictive Value of Tests , Prognosis , Renal Insufficiency/mortality , Renal Insufficiency/physiopathology , Renal Insufficiency/surgery , Research Design , Retrospective Studies , Survival Analysis
10.
J Endovasc Ther ; 12(6): 704-13, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16363900

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon , Arterial Occlusive Diseases/therapy , Kidney Failure, Chronic/complications , Leg/blood supply , Aged , Angiography, Digital Subtraction , Arterial Occlusive Diseases/diagnostic imaging , Arterial Occlusive Diseases/etiology , Female , Humans , Male , Popliteal Artery , Prospective Studies , Retrospective Studies , Statistics, Nonparametric , Treatment Outcome , Vascular Patency
11.
J Endovasc Ther ; 12(6): 723-30, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16363902

ABSTRACT

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.


Subject(s)
Arterial Occlusive Diseases/radiotherapy , Brachytherapy/methods , Peripheral Vascular Diseases/radiotherapy , Aged , Angiography , Angioplasty, Balloon , Arterial Occlusive Diseases/surgery , Combined Modality Therapy , Female , Femoral Artery , Follow-Up Studies , Humans , Male , Peripheral Vascular Diseases/surgery , Popliteal Artery , Proportional Hazards Models , Recurrence , Statistics, Nonparametric , Treatment Outcome , Vascular Patency
12.
Radiology ; 237(3): 1103-9, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16304122

ABSTRACT

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.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Arterial Occlusive Diseases/therapy , Immunoglobulin Fab Fragments/therapeutic use , Peripheral Vascular Diseases/therapy , Abciximab , Aged , Arterial Occlusive Diseases/drug therapy , Chi-Square Distribution , Combined Modality Therapy , Double-Blind Method , Female , Femoral Artery , Humans , Logistic Models , Male , Middle Aged , Peripheral Vascular Diseases/drug therapy , Popliteal Artery , Prospective Studies , Treatment Outcome , Vascular Patency/drug effects
14.
J Endovasc Ther ; 12(5): 616-9, 2005 Oct.
Article in English | MEDLINE | ID: mdl-16212464

ABSTRACT

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.


Subject(s)
Alloys/therapeutic use , Coated Materials, Biocompatible/therapeutic use , Iliac Aneurysm/therapy , Vascular Surgical Procedures , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/therapy , Embolization, Therapeutic , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/etiology , Magnetic Resonance Imaging , Male , Postoperative Complications/diagnostic imaging , Postoperative Complications/etiology , Postoperative Complications/therapy , Radiography , Reoperation
16.
J Endovasc Ther ; 11(6): 595-604, 2004 Dec.
Article in English | MEDLINE | ID: mdl-15615549

ABSTRACT

PURPOSE: To evaluate the effect of probucol and/or of endovascular brachytherapy (EVBT) on restenosis after percutaneous transluminal angioplasty (PTA) of femoropopliteal arteries. METHODS: A total of 335 patients (206 men; mean age 72+/-9 years) with intermittent claudication were randomized according to a 2x2 factorial design to 1 of the 4 groups: probucol, placebo, EVBT, and EVBT+probucol. Probucol (1 g/d) or placebo were given in double-blinded fashion 1 month before and for 6 months after PTA. Gamma irradiation (192Iridium, 14 Gy, 5-mm reference depth) was randomly applied in an unblinded manner from a noncentered endoluminal catheter. All patients received aspirin (100 mg/d). Primary endpoint was restenosis (>50% diameter reduction) detected by duplex ultrasound 6 months after PTA. Secondary endpoints included clinical and hemodynamic assessment. RESULTS: Restenosis in patients undergoing EVBT was 17% (23/133) versus 35% (50/142) in patients without EVBT (p<0.001); in patients treated with probucol versus placebo, the rates were 23% (31/135) and 30% (43/140, p<0.001). Three quarters (77%, 102/133) of patients were free of claudication after EVBT therapy versus 61% (87/142) without EVBT (p<0.05). Need for target vessel revascularization was 6% (8/133) with EVBT versus 14% (20/142) without EVBT (p<0.01). Late thrombotic occlusions occurred in 4% (6/133), exclusively in patients treated with EVBT after stent implantation. CONCLUSIONS: Endovascular brachytherapy significantly reduces restenosis, improves symptoms, and reduces reinterventions after PTA of femoropopliteal arteries. Probucol reduces restenosis but has no additive effect when combined with brachytherapy.


Subject(s)
Angioplasty, Balloon/adverse effects , Arterial Occlusive Diseases/therapy , Aspirin/therapeutic use , Brachytherapy , Probucol/therapeutic use , Aged , Aged, 80 and over , Analysis of Variance , Angioplasty, Balloon/methods , Arterial Occlusive Diseases/diagnosis , Female , Femoral Artery/drug effects , Femoral Artery/radiation effects , Follow-Up Studies , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/therapy , Male , Popliteal Artery/drug effects , Popliteal Artery/radiation effects , Probability , Recurrence , Reference Values , Risk Assessment , Single-Blind Method , Treatment Outcome , Vascular Patency/physiology
17.
Circulation ; 110(9): 1156-61, 2004 Aug 31.
Article in English | MEDLINE | ID: mdl-15326071

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon/adverse effects , Arteriosclerosis/radiotherapy , Arteriosclerosis/therapy , Brachytherapy/adverse effects , Femoral Artery/injuries , Intermittent Claudication/radiotherapy , Intermittent Claudication/therapy , Magnetic Resonance Angiography , Popliteal Artery/injuries , Radiation Injuries/physiopathology , Wound Healing/radiation effects , Aged , Arteriosclerosis/physiopathology , Brachytherapy/methods , Female , Femoral Artery/physiopathology , Femoral Artery/radiation effects , Humans , Intermittent Claudication/physiopathology , Male , Middle Aged , Popliteal Artery/physiopathology , Popliteal Artery/radiation effects , Secondary Prevention , Single-Blind Method , Tunica Intima/injuries , Tunica Intima/physiopathology , Tunica Media/injuries , Tunica Media/physiopathology
18.
J Endovasc Ther ; 11(4): 522-6, 2004 Aug.
Article in English | MEDLINE | ID: mdl-15298510

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon/adverse effects , Suction , Thrombectomy/methods , Thrombosis/etiology , Thrombosis/surgery , Aged , Humans , Male , Renal Artery Obstruction/surgery
19.
J Endovasc Ther ; 11(2): 119-24, 2004 Apr.
Article in English | MEDLINE | ID: mdl-15056030

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon , Femoral Artery , Ischemia/therapy , Aged , Aged, 80 and over , Chronic Disease , Female , Femoral Artery/diagnostic imaging , Humans , Ischemia/diagnostic imaging , Male , Radiography , Risk Factors , Stents
20.
J Endovasc Ther ; 10(2): 304-11, 2003 Apr.
Article in English | MEDLINE | ID: mdl-12877614

ABSTRACT

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.


Subject(s)
Angioplasty, Balloon , Arterial Occlusive Diseases/therapy , Brachytherapy , Femoral Artery/radiation effects , Peripheral Vascular Diseases/therapy , Popliteal Artery/radiation effects , Aged , Aged, 80 and over , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Prospective Studies , Retreatment , Secondary Prevention
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