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Purpose: Endogenous and exogenous insulin is suggested to stimulate hypertrophic wound-healing responses and therefore may promote neointimal hyperplasia and restenosis after balloon angioplasty. The ratio of C-peptide to insulin reflects endogenous insulin secretion. In diabetic patients with insulin substitution, lower ratios display a higher proportion of exogenous insulin. The association and interaction of insulin and C-peptide with restenosis after percutaneous transluminal angioplasty (PTA) was investigated in type II diabetic and nondiabetic patients., Materials and Methods: The study group included 76 patients (median age, 68 years; interquartile range [IQR], 58-74 years; 55 men [72%]; 31 patients [41%] with type II diabetes) with intermittent claudication (n = 49; 64%) or critical limb ischemia (n = 27; 36%) who underwent primary successful femoral PTA. C-peptide and insulin levels were measured at baseline, and patients were followed to determine restenosis (> or =50%) at 12 months by color-coded duplex sonography., Results: Restenosis was found in 34 patients (45%) at 12 months. Patients with restenosis had higher insulin levels (median, 21.3 microU/mL IQR, 11.3-35.5 microU/mL) and a lower C-peptide/insulin ratio (median, 16; IQR, 10-21) compared with patients without restenosis (median insulin level, 11.6 microU/mL; IQR, 9.1-22.0 microU/mL [P = .008]; median ratio, 19 [IQR, 17-25], P = .039). In nondiabetic patients, insulin levels were significantly associated with restenosis (P = .046), whereas the ratio of C-peptide to insulin showed no association with restenosis. In patients with type II diabetes (n = 31; 41%), in contrast, the C-peptide/insulin ratio was associated with restenosis (P = .047), whereas insulin levels showed no significant association with restenosis (P = .14)., Conclusions: Insulin levels and the C-peptide/insulin ratio were associated with restenosis after femoral PTA. Exogenous and endogenous insulin may play a role in the pathogenesis of recurrent lumen loss after balloon angioplasty.

Objective: To analyse the clinical outcome of patients with ischaemic ulcers (Fontaine stage IV) undergoing percutaneous transluminal angioplasty (PTA)., Methods and Design: Retrospective cohort study of 40 patients (21 males) treated between January 1998 and December 1998. Cardiovascular risk factors, co-morbid, baseline laboratory, angiographic data and technical success were recorded. Patients were followed for a median of 20 (inter quartile range (IQR) 8-26) months., Results: Cumulative ulcer healing rates at 3, 6, 12, and 24 months were 15, 40, 54 and 81%, respectively. The median time to healing was 5 (IQR 2-7) months. Cumulative restenosis at 1, 3, 6 and 12 months was 3, 10, 29 and 52%, respectively. Nine patients (22%) suffered ulcer reappearance. Lipoprotein (a) serum levels > 30 mg/dl (HR 0.2, 95% CI 0.05-1.0, p = 0.05) and diabetes mellitus (HR 0.2, 95% CI 0.5-0.7, p = 0.01) were associated with delayed ulcer healing., Conclusion: PTA leads to ulcer healing in the majority of patients. Elevated lipoprotein (a) levels > 30 mg/dl and diabetes mellitus are independently associated with ulcer persistence.

Purpose: To assess immediate and long-term outcome after femoropopliteal implantation of a Dacron-covered stent-graft in patients with peripheral arterial disease., Materials and Methods: This prospective cohort study included 30 consecutive patients who underwent Dacron-covered stent-graft implantation because of recurrent stenosis after percutaneous transluminal angioplasty in the femoropopliteal segment. After interventional treatment, 100 mg of acetylsalicylic acid daily and oral anticoagulation therapy (therapeutic level, international normalized ratio, 2.0-3.0) were administered. Patients were followed up with ankle-brachial index measurement, color-coded duplex ultrasonography, and angiography. Primary and secondary patency rates and postintervention complications were documented as was initial technical success. Kaplan-Meier and life table analyses were used for calculation of patency rates., Results: Initial technical success was achieved in all 30 patients, with significant improvement of ankle-brachial index from a preintervention mean of 0.5 +/- 0.14 (SD) to a postintervention mean of 0.8 +/- 0.17 (P <.001). Postimplantation noninfectious fever and leukocyte and C-reactive protein level elevation occurred in 12 patients (40%), and 17 patients (57%) reported persistent pain at the site of implantation for a mean of 5 days (range, 2-28 days). Early recurrent occlusion within the first 24 hours was found in five patients (17%). Within the mean follow-up period of 60 months +/- 10, restenosis occurred in 25 patients (83%). At 6, 12, 36, and 72 months, respectively, primary patency rates were 27%, 23%, 17%, 17%, and secondary patency rates were 63%, 60%, 34%, 34%., Conclusion: Implantation of Dacron-covered stent-grafts for treatment of femoropopliteal lesions leads to high early and late restenosis rates, with a considerable rate of complications, such as fever and pain., (Copyright RSNA, 2002)

Background: Inasmuch as endovascular brachytherapy (BT) has gained recent interest because of its inhibitory effect on mechanisms leading to restenosis after percutaneous transluminal angioplasty (PTA), we performed this randomized study to determine its efficacy for prophylaxis of restenosis after femoropopliteal PTA., Methods and Results: One hundred thirteen patients (63 men, 50 women; mean age 71 years) with de novo or recurrent femoropopliteal lesions were included in this randomized trial comparing the restenosis rate after PTA plus BT (57 patients, PTA+BT group) versus PTA (56 patients, PTA group) without stent implantation. The mean treated length was 16.7 cm (PTA+BT group) versus 14.8 cm (PTA group). In patients randomized to PTA plus BT, a dose of 12 Gy was applied by an (192)Ir source 3 mm from the source axis. Follow-up examinations included measurement of the ankle-brachial index, color-flow duplex sonography, and angiography. The primary end point of the study was patency after 6 months. The overall recurrence rate after 6 months was 15 (28.3%) of 53 in the PTA+BT group versus 29 (53.7%) of 54 in the PTA group (chi(2) test, P<0.05). The cumulative patency rates at 12 months of follow-up were 63.6% in the PTA+BT group and 35.3% in the PTA group (log-rank test, P<0.005)., Conclusions: This is the first randomized study to demonstrate the efficacy of endovascular BT for prophylaxis of restenosis after femoropopliteal PTA. The value of this approach should now be improved by modification of the BT procedure and by combination with stent implantation.

Purpose: The aim of the Vienna-2-trial was to compare the restenosis rate of femoropopliteal arteries after percutaneous transluminal angioplasty (PTA) with or without intraarterial high-dose-rate (HDR) brachytherapy (BT) using an (192)Ir source., Materials and Methods: A prospective, randomized trial was conducted from 11/96 to 8/98. A total of 113 patients (63 men, 50 women), with a mean age of 71 years (range, 43-89 years) were included. Inclusion criteria were (1) claudication or critical limb ischemia, (2) de-novo stenosis of 5 cm or more, (3) restenosis after former PTA of any length, and (4) no stent implantation. Patients were randomized after successful PTA for BT vs. no further treatment. A well-balanced patient distribution was achieved for the criteria used for stratification, as there were "de-novo stenosis vs. restenosis after former PTA," "stenosis vs. occlusion," "claudication vs. critical limb ischemia" and above these for "diabetes vs. nondiabetes." PTA length was not well balanced between the treatment arms: a PTA length of 4-10 cm was seen in 19 patients in the PTA alone group and in 11 patients in the PTA+BT group, whereas a PTA length of greater than 10 cm was seen in 35 patients and 42 patients, respectively. A dose of 12 Gy was prescribed in 3-mm distance from the source axis. According to AAPM recommendations, the dose was 6.8 Gy in 5-mm distance (vessel radius + 2 mm). Primary endpoint of the study was femoropopliteal patency after 6 months., Results: PTA and additional BT were feasible and well tolerated by all 57 pts in this treatment arm. No acute, subacute, and late adverse side effects related to BT were seen after a mean follow up of 12 months (6-24 months) in 107 patients (PTA n = 54; PTA+ BT n = 53). Crude restenosis rate at 6 months was in the PTA arm 54% vs. 28% in the PTA + BT arm (chi(2) test; p < 0.013). Actuarial estimate of the patency rate was at 6 months 45% vs. 72% (p < 0.004). Comparison of restenosis rates for the different subgroups with risk factors (restenosis after former PTA, occlusion and PTA length >10 cm) showed significant decrease of the restenosis rate, if BT was added. Significant reduction was not achieved in diabetes patients., Conclusion: BT after femoropopliteal PTA is feasible and a safe therapeutic option. No BT related morbidity was observed. A significant reduction of the restenosis rate was obtained in the PTA+BT arm. Subgroup analysis showed significant decrease of restenosis rate in the subgroups with restenosis after former PTA, occlusion and PTA length of greater than 10 cm. With dose escalation and reduction of dose variation by a centering device a further significant decrease of restenosis rate can be expected.

Purpose: To evaluate in a pilot study the feasibility and efficacy of endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal percutaneous transluminal angioplasty (PTA) without stent implantation in a group of patients with a high risk of restenosis., Materials and Methods: Ten patients (six women, four men; mean age, 68 years) with long-segment (mean length, 16 cm; range, 9-22 cm) restenosis underwent PTA followed by endovascular irradiation with high-dose-rate afterloading of an iridium-192 rod. A dose of 12 Gy was targeted to the inner intimal layer of the vessel. Follow-up examinations until 12 months after PTA included measurement of the ankle-brachial index, color duplex ultrasonography (US) with calculation of the peak velocity ratio, and intraarterial angiography when recurrence was suspected., Results: Irradiation was technically feasible in all patients without complications. In six patients, the dilated and irradiated segment remained widely patent at color US, with corresponding excellent hemodynamic and clinical results after 12 months. In four patients, clinical and laboratory findings indicated recurrence and arteriography demonstrated restenosis with a diameter reduction of 60%, 70%, 80%, or 90%., Conclusion: Considering the negative selection of patients with a high risk of restenosis, the results of our pilot study are promising concerning the possibility of reduction of restenosis by means of endovascular brachytherapy after long-segment femoropopliteal PTA without stent implantation. The value of this approach should now be determined definitively in randomized trials.

Background: The following study was designed to evaluate the effectiveness and safety of ultrasound guided compression therapy (UGCT) of iatrogenic postcatheterization pseudo-aneurysms (PA) on the one hand and to justify the usefulness of the routine colour duplex control of the puncture site following transfemoral catheterization, on the other hand., Material and Methods: During the study period 142 patients with (PA) following transfemoral catheterization were identified by means of colour duplex examination Eighty of these 142 patients were identified during a routine colour duplex control of the puncture site the day after PTA/angiography because of peripheral arterial occlusive disease (PAOD) [group A]; the remaining 62 patients with symptomatic groins were referred from other departments [group B]., Results: In 8 patients of group B UGCT was considered to be contra-indicated, they were primarily treated by surgical repair of the PA. A total of 134 patients (group A 80 patients, group B 54 patients) underwent an UGCT. In total the success rate of UGCT was in group A 100% and in group B 78%. 12/54 patients (all group B) with failure of UGCT underwent a secondary surgical repair of the PA. Within group B there was a negative correlation between delay of diagnosis/UGCT and success (p < 0.04), whereas the size of the sheath did not influence the outcome of the UGCT (p = 0.3)., Conclusion: Our study confirms the effectiveness and safety of UGCT. Routine colour duplex control of the puncture site the day following the removal of the sheath after percutaneous catheterization and UGCT of PAs without delay can increase the success rate of UGCT and minimize the need for surgical repair of PAs.

It has been shown that the incidence of recurrent stenosis following successful percutaneous transluminal coronary angioplasty (PTCA) is correlated with serum Lipoprotein(a) [Lp(a)] levels. The aim of the present study was to examine the influence of Lp(a) on restenosis after primary successful femoropopliteal PTA. One hundred and thirty nine consecutive patients with peripheral arterial occlusive disease (PAOD) and successful femoropopliteal PTA were studied. Follow-up included clinical examination and non-invasive laboratory testing (pulse volume recordings, ankle-brachial arterial pressure measurement) in every patient before and after 1, 3, 6 and 12 months following intervention. Duplex sonography was performed 1 year after PTA. Suspicion of restenosis (> or = 50% diameter reduction) was verified by angiography. Lp(a) was determined using ELISA technique (mg/dl). Twelve months after successful PTA no restenosis was found in 82 patients (59%: group A). The one-year recurrence rate of 41% (group B) was due to significant restenosis in 35 patients (25%) and reocclusion in 22 patients (16%). The corresponding mean values +/- S.E.M. for Lp(a) were as follows: group A, 28 +/- 5.3; group B 59 +/- 11 (P < 0.01). Women showed a higher frequency of recurrences (55%) versus men (30%, P < 0.01) also corresponding with a high Lp(a) level (51.8 +/- 8 versus 32.7 +/- 5; P < 0.05). Furthermore Lp(a) aggravated the well known increased risk for recurrence in multiple stenoses or occlusions of > or = 5 cm in length. There were no significant differences between groups A and B with respect to age, diabetes, hyperlipidaemia, obesity and cigarette smoking. The results support the view that Lp(a) is an independent risk factor for recurrence after PTA in the femoropopliteal area. It might also be a causal basis for the higher incidence of recurrences in female PAOD patients.

Purpose: To evaluate color duplex ultrasonographic (US) guidance of percutaneous transluminal angioplasty (PTA) of femoropopliteal artery stenoses and occlusions., Materials and Methods: Twenty-four patients (11 women, 13 men; mean age, 65.0 years) with severe claudication, abnormal ankle-arm pressure indexes, and lesions in the superficial femoral or popliteal artery depicted at US underwent balloon PTA with US guidance. US findings were confirmed before and after PTA by means of intravenous digital subtraction angiography., Results: All of 22 segmental stenoses and three of four superficial femoral artery occlusions were successfully treated (in 23 patients). In three cases, a residual stenosis was detected after initial PTA, and PTA was repeated with a larger balloon catheter. Of the 21 patients followed up for 6 months, one had reocclusion and three had hemodynamically significant restenosis., Conclusion: Results of PTA with US guidance in short stenoses or occlusions of the femoral or popliteal artery are similar to those of PTA with fluoroscopic control.

Purpose: To investigate prospectively with color flow duplex (CFD) sonography the incidence of pseudoaneurysm or arteriovenous fistula (AVF) after transfemoral arterial catheterization with angiography, percutaneous transluminal angioplasty (PTA), or local lysis (LL)., Materials and Methods: CFD sonography was used to examine the puncture site in 565 consecutive patients who had undergone PTA, LL, or angiography (581 procedures)., Results: The incidence of pseudoaneurysm in the first 300 procedures in which standard compression was used was 14.0% overall, 27.0% after LL with antegrade-puncture PTA, 18.5% after antegrade-puncture PTA, 9.3% after retrograde-puncture PTA, and 1.2% after angiography. To decrease the high incidence, in the next 281 procedures manual compression was continued for at least 5 minutes after local bleeding had stopped. This significantly reduced the incidence to 1.1% overall, 8.0% after LL in combination with PTA, 0.9% after antegrade PTA alone, 0.9% after retrograde PTA, and 0% after angiography (P < .01)., Conclusion: The incidence of pseudoaneurysm after transfemoral arterial catheterization depends on the type of intervention. The main risk factor is too brief a period of manual compression.

Background: Long-term treatment with aspirin is recommended in patients with large-vessel peripheral arterial disease since these patients have a high risk of death from cardiovascular causes. Recent studies have demonstrated the prophylactic effect of low-dose aspirin in reducing the risk of cardiovascular events. Since aspirin is also recommended for prevention of late recurrence after peripheral angioplasty, the present study was undertaken to compare the effects of high-dose (1000 mg/d) and low-dose (100 mg/d) aspirin on long-term patency after femoropopliteal angioplasty., Methods and Results: Two hundred sixteen patients treated successfully by percutaneous transluminal angioplasty for femoropopliteal lesions were randomly allocated to therapy with either 1000 or 100 mg aspirin daily. The follow-up was 24 months. The long-term results were analyzed using the Kaplan-Meier method, and differences between curves of cumulative patency were determined with the Wilcoxon and log-rank statistics. Complete follow-up information (patency after 24 months, restenosis, and death) was obtained in 207 patients. During the 2-year follow-up period, 72 patients--36 in the high-dose and 36 in the low-dose aspirin group, respectively--developed angiographically verified reobstruction within the recanalized segment. By intention-to-treat analysis, the cumulative patency rates at 24 months were 62.5% in the high-dose and 62.6% in the low-dose aspirin group (Wilcoxon, P = .97; log-rank, P = .97). The cumulative survival at 24 months of follow-up was 86.6% in the high-dose and 87.7% in the low-dose aspirin group. The number of patients discontinuing therapy was 30 in the high-dose and 11 in the low-dose aspirin group (P < .01). Fewer patients receiving 100 mg of aspirin discontinued therapy because of gastrointestinal symptoms (4 versus 20)., Conclusions: The data indicate that 100 mg aspirin is no less effective in the prevention of restenosis after femoropopliteal PTA than a 1000-mg dose and has fewer side effects.