Endovascular revascularization below the knee: 6-month results and predictive value of C-reactive protein level

PURPOSE: To determine the association between pre- and postintervention serum C-reactive protein (CRP) levels and 6-month restenosis after endovascular treatment of atherosclerotic lesions in arteries below the knee. MATERIALS AND METHODS: Eighty-nine patients with peripheral arterial disease underwent primary successful percutaneous transluminal angioplasty (PTA) of the distal popliteal, anterior tibial, posterior tibial, and fibular arteries. Six-month patency was evaluated with the ankle brachial index (ABI) and color-coded duplex ultrasonography (US). The association between restenosis and preintervention and 48-hour postintervention CRP levels was assessed with multiple logistic regression analysis. RESULTS: ABI improved from a preintervention median of 0.54 to a postintervention median of 0.75 (P <.001). The primary technical success rate was 94% (100 of 106). In 50 patients, a suboptimal technical result was achieved with 30%-40% residual stenosis at the dilated segment. The median ABI at 6 months was 0.65, and it was inversely correlated with preintervention (r = -0.27, P =.009) and 48-hour postintervention (r = -0.40, P <.001) CRP levels. With duplex US at 6 months, restenosis (> or =50%) occurred in 36 patients. Patients with a preintervention CRP level of 0.23-0.92 mg/dL (2.3-9.2 mg/L) had a 3.7-fold increased adjusted risk for restenosis (P =.05); patients with a preintervention CRP level greater than 0.92 mg/dL (9.2 mg/L) had a 4.7-fold increased adjusted risk (P =.03). Postintervention CRP values greater than 2.42 mg/dL (24.2 mg/L) were associated with a 10.7-fold adjusted risk for restenosis (P =.002). Suboptimal PTA result was the only other parameter associated with an increased risk for restenosis (odds ratio, 3.7; P =.03). CONCLUSION: Pre- and postintervention CRP levels were associated with restenosis after PTA of the distal popliteal and tibioperoneal arteries, which indicates that inflammation plays a crucial role in the pathophysiology of this process.     

Interleukin-6 promoter genotype and restenosis after femoropopliteal balloon angioplasty: initial observations

PURPOSE: To investigate whether there is an association between a functional polymorphism in the interleukin (IL)-6 gene promoter (-174)G/C and restenosis after percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery. MATERIALS AND METHODS: A total of 281 patients underwent PTA of the femoropopliteal artery during the study period; 23 (8%) patients had to be excluded due to missing genetic data. We studied 258 patients with intermittent claudication (n = 174) or critical limb ischemia (n = 84). The IL-6 promoter genotype was determined from venous blood samples before intervention by using a mutagenically separated polymerase chain reaction, and patients were followed up for 6 months with duplex ultrasonography for the occurrence of restenosis (> or =50%) after angioplasty. Multivariate Cox proportional hazards analysis was performed to assess the association between the IL-6 promoter genotype and restenosis, with adjustment for possible confounders such as atherosclerotic risk factors and angiographic covariates. RESULTS: The 6-month restenosis rate was 26% (23 of 90) in patients with the (-174)GG genotype, 28% (33 of 117) with the (-174)GC genotype, and 43% (22 of 51) with the (-174)CC genotype (P =.044). Homozygous carriers of the (-174)C allele ([-174]CC) exhibited a 2.42-fold increased adjusted risk for restenosis (95% CI: 1.28, 4.58; P =.007) compared with homozygous (-174)G allele carriers ([-174]GG). Heterozygous carriers ([-174]GC) had no significantly increased restenosis risk (hazard ratio, 1.37; 95% CI: 0.84, 2.22; P =.21). CONCLUSION: The IL-6 promoter polymorphism (-174)G/C seems to influence the occurrence of restenosis after PTA. Homozygous carriers of the (-174)C allele have an increased rate of intermediate-term restenosis.     

Endovascular brachytherapy: restenosis in de novo versus recurrent lesions of femoropopliteal artery--the Vienna experience

PURPOSE: To determine the effectiveness of endovascular brachytherapy in the prevention of restenosis in recurrent versus de novo femoropopliteal lesions. MATERIALS AND METHODS: Ethics committee approval and patient informed consent were obtained. After they had undergone femoropopliteal angioplasty, 199 patients (mean age, 71.9 years +/- 9.6; 115 men, 84 women) were treated with either percutaneous transluminal angioplasty (PTA) and brachytherapy (n = 100) or PTA alone (n = 99). The patients were part of prospective randomized trials, the Vienna 2 and 3 trials, and were evaluated according to the stratification criterion of de novo or recurrent disease. Sixty-six of 134 patients with a de novo lesion and 34 of 65 patients with a recurrent lesion were randomly assigned to the PTA and brachytherapy arm; the remaining patients were treated with PTA alone. Outcomes were compared between the groups. The Student t test or one-way analysis of variance was used to compare continuous variables, and the chi2 test or Fisher exact test was used to assess dichotomous variables. Kaplan-Meier curves were calculated, and the log-rank test was performed to determine freedom from recurrence at 12 months in both groups. A multivariate Cox proportional hazard regression analysis was performed to evaluate the multivariate predictors of recurrence at 12-month follow-up. RESULTS: For patients with de novo lesions, the frequency of recurrence at 12 months was not significantly different between those who underwent brachytherapy and PTA and those who underwent PTA alone (24 [36%] of 66 patients vs 30 [44%] of 68 patients, P = .32). For patients with recurrent lesions, however, the 12-month recurrence rate was significantly lower in those who received brachytherapy than in those who did not (nine [26%] of 34 patients vs 22 [71%] of 31 patients, P = .004). CONCLUSION: Endovascular brachytherapy with gamma radiation significantly reduces the restenosis rate after femoropopliteal angioplasty of recurrent but not de novo lesions.     

Effect of smoking on restenosis during the 1st year after lower-limb endovascular interventions

PURPOSE: To investigate whether smoking has an effect on recurrent lumen narrowing after percutaneous transluminal angioplasty (PTA) or stent placement in lower-limb arteries. MATERIALS AND METHODS: A total of 650 patients (median age, 70 years; 389 men) with peripheral artery disease who underwent iliac artery PTA (n = 95), iliac artery stent placement (n = 83), femoropopliteal PTA (n = 406), or femoropopliteal stent placement (n = 66) were selected from a prospective database. Patients were categorized according to their preintervention smoking habits as nonsmokers (n = 352), light smokers (one to nine cigarettes daily) (n = 54), habitual smokers (10-20 cigarettes daily) (n = 82), or heavy smokers (>20 cigarettes daily) (n = 162). Multivariate Cox proportional hazards analysis was used to determine whether there was an association between smoking habits and restenosis (> or =50%) in the treated vessel segment within 1 year after treatment. RESULTS: Cumulative restenosis rates at 6 and 12 months according to patients' smoking habits were 99 and 190 nonsmokers, 18 and 22 light smokers, 16 and 29 habitual smokers, and 26 and 47 heavy smokers, respectively (P <.001). Adjusted hazard ratios for restenosis in smokers compared with nonsmokers were 1.51 (95% CI: 0.92, 2.50) for light smokers, 0.49 (95% CI: 0.28, 0.87) for habitual smokers, and 0.46 (95% CI: 0.30, 0.71) for heavy smokers, indicating a reduced restenosis risk in patients who smoked 10 or more cigarettes daily. These patients had reduced restenosis rates after either iliac (P =.011) or femoropopliteal intervention (P =.009). However, endovascular treatment at a younger age, coronary artery disease, and history of myocardial or cerebrovascular infarction were more frequently found in smokers. CONCLUSION: Smoking 10 or more cigarettes daily is associated with a reduced rate of intermediate-term restenosis after lower-limb endovascular interventions.     

Endovascular gamma irradiation of femoropopliteal de novo stenoses immediately after PTA: interim results of prospective randomized controlled trial

PURPOSE: To report an interim analysis of whether centered endovascular irradiation with the iridium 192 ((192)Ir) source immediately after percutaneous transluminal angioplasty (PTA) of de novo femoropopliteal stenoses lowers the restenosis rate. MATERIALS AND METHODS: Thirty patients undergoing PTA to treat femoropopliteal stenoses were randomized for prophylaxis against restenosis with centered endovascular irradiation with a (192)Ir source (a dose of 14 Gy 2 mm deep to the vessel wall, irradiation group) or no irradiation (control group). Angiographic follow-up was available for 22 patients at 6 months (irradiation group, n = 10) and 12 patients at 12 months (irradiation group, n = 6). Duplex sonography, treadmill testing, and interviews were performed the day before and the day after PTA and after 1, 3, 6, 9, and 12 months. Results of angiography, duplex sonography, treadmill testing, and interviews were evaluated with a t test and multivariate analysis of variance (clinical characteristics, chi(2) test). RESULTS: Baseline characteristics were comparable in the two groups. Interim analysis of the 6-month follow-up data revealed a trend toward a significantly lower restenosis rate in the irradiation group. The change in the degree of stenosis compared with that after PTA was -14.7% +/- 20.8 (mean +/- SD) in the irradiation group versus 37.7% +/- 27.3 in the control group (P =.001) and became even more marked at 12 months (-9.5% +/- 34.5 vs 45.5% +/- 40.7 [P =.03], respectively). The follow-up results of treadmill testing and interviews showed a nonsignificant benefit for the irradiation group. One thromboembolic complication occurred during irradiation. No side effects were observed during follow-up. CONCLUSION: Endovascular irradiation with a centered (192)Ir source immediately after PTA of de novo femoropopliteal stenoses reduces the restenosis rate.     

Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: five-year follow-up--prospective randomized study

PURPOSE: To report the 5-year results from the prospective randomized Vienna-2 trial, which was designed to evaluate the safety and effectiveness of adjunctive endovascular brachytherapy (EBT) compared with no further treatment after successful revascularization in patients with long-segment femoropopliteal lesions. MATERIALS AND METHODS: Each patient gave written informed consent to participate in the study, which was approved by the hospital's ethics committee. One hundred two patients (men, 53.9%; mean age, 72.1 years +/- 8.7 [standard deviation]; lesion length, 8.1 cm +/- 4.9) underwent percutaneous transluminal angioplasty (PTA) without further stent implantation. Patients were then assigned to either receive EBT (n = 51) by using an iridium 192 source, with a prescribed dose of 12 Gy at 3 mm from the source axis, or no further treatment (n = 51). Radiation was delivered without a centering catheter. Data were analyzed by using a Student t test for continuous values and a chi(2) test to compare categorical values. A Cox proportional hazards regression analysis was performed to evaluate predictors of recurrence at follow-up. RESULTS: After 6 months, the restenosis rate for the 102 patients with completed 5-year follow-up was significantly reduced for the PTA plus EBT group versus the PTA alone group (29.4% vs 56.9%, P < .05). During follow-up we observed a late catch-up phenomenon, and after 5 years the recurrence rate was comparable in both groups (72.5% vs 72.5%, P > .99). Time to recurrence, however, was significantly delayed in the PTA plus EBT group (17.5 months +/- 14.7 vs 7.4 months +/- 6.8 for the PTA alone group, P < .05). CONCLUSION: At 5-year follow-up, PTA followed by gamma radiation EBT with a dose of 12 Gy resulted in a delay but not an inhibition of restenosis when compared with that of PTA alone.     

Treatment of restenosis after percutaneous transluminal angioplasty for internal carotid artery stenosis

The efficacy of repeated percutaneous transluminal angioplasty (PTA) and carotid endarterectomy (CEA) was examined in patients with restenosis after PTA for carotid stenosis. After percutaneous transluminal angioplasty (PTA) for 63 cases of internal carotid stenoses 13 cases of restenosis appeared. They were treated by PTA or carotid endarterectomy. The treatment was chosen by the patient after explanation of each treatment. We initially treated seven patients by repeat PTA and six by carotid endarterectomy. The degree of stenosis improved from 82 % to 30 % on average after repeated PTA. However, one patient in the PTA group had restenosis, and carotid endarterectomy was then performed. The other cases also had restenosis and were treated by PTA. The six cases treated by carotid endarterectomy were successfully treated without difficulty. The success rate of PTA was 5/7 (71 %) in the restenosis cases. Patients with a greater residual stenosis after initial PTA had significantly more frequent restenosis. Repeat PTA and CEA both appeared effective treatment for restenosis after initial PTA, although PTA had a restenosis rate similar to that of initial PTA. Received: 21 December 1998 Accepted: 21 July 1999     

A direct comparison of noninvasive coronary angiography by electron beam tomography and navigator-echo-based magnetic resonance imaging for the detection of restenosis following coronary angioplasty

RATIONALE AND OBJECTIVES: To compare electron beam tomography (EBT) with MR imaging (MRI) for detection of restenosis after coronary angioplasty (PTCA). METHODS: One hundred eighteen patients after PTCA were investigated. By EBT, 50 axial images were acquired (3-mm slice thickness, 120-160 mL radiographic contrast agent). MRI was performed using respiratory-gated sequences (24-48 cross-sections, 2-mm slice thickness, 20 mL Gd-DTPA). EBT and MRI images were evaluated concerning high-grade post-PTCA restenosis (> or = 70%) and validated against coronary angiography. RESULTS: In EBT, 28 patients and in MRI, 31 patients were not evaluable. In the remaining patients, sensitivity for restenosis detection was 90% in EBT (17/19) and 73% in MRI (11/15; P = 0.370). In EBT, specificity was significantly higher (66% vs. 49%, P = 0.043). Overall accuracy was 71% for EBT and 53% for MRI (P = 0.014). CONCLUSIONS: For the detection of high-grade restenosis after PTCA, EBT demonstrated significantly higher accuracy than MRI.     

Primary patency with cutting and conventional balloon angioplasty for different types of hemodialysis access stenosis

PURPOSE: To compare primary patency rates of cutting balloon percutaneous transluminal angioplasty (PTA) (hereafter, cutting PTA) and conventional balloon PTA (hereafter, conventional PTA) in the treatment of different types of hemodialysis access stenosis. MATERIALS AND METHODS: The institutional review board approved this study. Written informed consent was obtained for the prospective component of this study and waived for the retrospective component. Patients in whom treatment with cutting PTA alone or conventional PTA alone was clinically successful formed the two study groups. Primary patency for the lesion was defined as uninterrupted patency of the treated site after balloon PTA. A site was no longer considered patent when the patient underwent treatment for hemodialysis access failure due to restenosis of the treated site. Primary patency rates for lesions were calculated with the Kaplan-Meier method according to the type of stenosis. We compared the two groups by using the log-rank test to determine statistical significance. RESULTS: In the cutting PTA group, 62 patients with 77 stenoses (32 men, 30 women; mean age, 65.5 years +/- 10.1 [standard deviation]) achieved clinical success. In the conventional PTA group, 52 patients with 68 stenoses (23 men, 29 women; mean age, 61.9 years +/- 10.2) achieved clinical success. In patients with autogenous venous stenosis, no significant difference in the primary patency rate was noted between groups (P = .369). In patients with graft-to-vein anastomotic stenosis, the primary patency rate was significantly higher for cutting PTA than for conventional PTA (P = .39). In patients with intragraft stenosis, no significant difference in the primary patency rate was noted between groups (P = .379). In patients with in-stent restenosis, no significant difference in the primary patency rate was noted between groups (P = .923). CONCLUSION: Primary patency rates are significantly higher for cutting PTA in the treatment of graft-to-vein anastomotic stenosis; however, no significant differences in primary patency rates exist between these PTAs in the treatment of autogenous venous stenosis, intragraft stenosis, or in-stent restenosis.     

Insertion of Self-Expandable Nitinol Stents Without Previous Balloon Angioplasty Reduces Restenosis Compared with PTA Prior to Stenting

PURPOSE: To compare the development of intimal hyperplasia after deployment of a self-expanding nitinol stent with and without previous percutaneous transluminal balloon angioplasty (PTA), with the results after PTA alone. METHODS: In nine healthy pigs, the iliac arteries were divided into three groups: group 1 (n = 6 arteries) was treated with PTA; group 2 n = 6) with insertion of self-expanding stents after PTA; and group 3 (n = 6) with stent insertion without previous PTA. After 8 weeks the vessels were examined with intravascular ultrasonography, histologic examination and morphometric analysis. RESULTS: Although the injury index in group 1 (0.17 +/- 0.57) was lower (p <0.05) than in group 2 (0.26 +/- 0.06) and group 3 (0.26 +/- 0.08), PTA-treated arteries showed significantly (p <0.05) reduced mean luminal gain (0.53 +/- 2.84) compared with arteries treated with PTA prior to stenting (2.58 +/- 1.38) and compared with stenting alone (4.65 +/- 5.34). Stenting after PTA resulted in a higher (p <0.05) restenosis index (2.63 +/- 1.06) compared with stenting without PTA (1.35 +/- 0.59). Group 2 also had a significantly thicker intima p <0.05) and 83% and 74% higher intima/media ratio (p <0.05) compared with groups 1 and 3, respectively. CONCLUSION: Insertion of a self-expandable nitinol stent without previous PTA results in less intimal hyperplasia than if PTA is performed prior to stenting, suggesting that direct stenting can be used in angioplasty sessions with a favorable outcome.     

Vascular inflammation and percutaneous transluminal angioplasty of the femoropopliteal artery: association with restenosis

PURPOSE: To determine the association of pre- and postprocedural serum levels of C-reactive protein (CRP), serum amyloid A (SAA), and fibrinogen at 6-month evaluation of restenosis after percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery. MATERIALS AND METHODS: In a prospective cohort study, 172 consecutive patients with peripheral artery disease of Fontaine stage IIa, IIb, or III who underwent successful PTA of the superficial femoral and popliteal arteries were included. Patency at 6 months was evaluated by using oscillography, ankle-brachial index, and color-coded duplex ultrasonography. The association of restenosis and CRP, SAA, and fibrinogen levels at baseline, 24 hours, and 48 hours after intervention was assessed by means of multivariate analysis with adjustment for known risk factors for restenosis. RESULTS: Restenosis was found in 56 patients (33%) within 6 months. CRP values at baseline (adjusted odds ratio, 2.2; 95% CI: 1.1, 4.2) and 48 hours after intervention (adjusted odds ratio, 2.3; 95% CI: 1.6, 3.1) were independently associated with 6-month restenosis. SAA and fibrinogen values at any time interval were not significantly associated with patency in the multivariate models. CONCLUSION: The extent of vascular inflammation as measured by means of acute-phase reactants before and after PTA of the femoropopliteal artery is associated with 6-month restenosis. Baseline and 48-hour CRP levels were independent predictors of postangioplasty outcome.     

Percutaneous revascularization of femoropopliteal artery disease: PTA and PTA plus stent. Results after six years' follow-up

PURPOSE: To compare the long-term patency after the treatment of mild-to-moderate femoropopliteal artery disease by percutaneous transluminal angioplasty (PTA) alone (PTA group) and PTA plus stenting (STENT group) in a non-randomised retrospective study. MATERIALS AND METHODS: Eighty-six limbs in 64 patients (mean age 67+/-8 years, 47 males and 17 females) with femoropopliteal artery disease and symptomatic for mild-to-moderate intermittent claudication (Rutherford's category 1-2) were treated by percutaneous revascularization. None of the patients had critical lower limb ischaemia. Of the 86 lesions, 63 (40 stenoses and 23 occlusions) were treated by PTA alone and 23 (12 stenoses and 11 occlusions) by PTA plus stent implantation. The success was defined as a maximal = or < 30% residual stenosis of vessel lumen diameter, as defined by biplane angiography. The angiography findings were confirmed by colour-Doppler sonography of the treated segment. A peak systolic velocity = or < 150 cm/sec in the treated segment and an improvement of the ankle/brachial index by gs; 0.15 were considered indications of haemodynamic success. Restenosis at follow-up (mean 21 months, range 1-72 months) was defined by colour-Doppler sonography as a peak systolic velocity gs; 230 cm/sec or a peak systolic velocity ratio gs; 2.5 in the treated area and a gs; 0.15 decrease in ankle/brachial index compared with post-procedure measurements. RESULTS: Treatment by PTA plus stenting enabled correction of residual stenosis in 15/23 limbs, relief of PTA complications in 7/23 limbs and correction of restenosis after a PTA in 1/23. In the PTA group the treatment was successful in 59/86 limbs (68%) versus 21/23 (91%) in the STENT group (chi squared value= 0,04). As a whole, major complications occurred in 5.8% of cases (n=5), 3 in the PTA group and 2 in the STENT group. The primary patency rates at 6, 12, and 24 months were 70%, 66% and 58% in the PTA group versus 74%, 67% and 46% in the STENT group (Gehan p value=0.96). The secondary patency rates at 6, 12, 24 months were 75%, 73%, 65% in the PTA group versus 84%, 76%, 64% in the STENT group (Gehan p value=0,59). DISCUSSION AND CONCLUSIONS: In this study, stenting and PTA for the treatment of mild-to-moderate femoropopliteal peripheral artery disease improved the primary technical success of PTA by correcting residual stenosis, elastic recoil and occlusive intimal flaps. Moreover, stenting can prevent delayed constrictive remodelling. However, stenting did not improve long-term outcomes in comparison with PTA alone given that stent implantation increases the risk of restenosis due to myointimal hyperplasia. Our findings regarding the complication rates and long-term outcome agree with those published by other authors. Colour-Doppler US monitoring enabled early detection of restenosis in the treated area and its differentiation from the development of new lesions in other areas.     

Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone

PurposeTo assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA).Materials and MethodsThis prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality.ResultsLLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75).ConclusionsDespite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.     

De novo femoropopliteal stenoses: endovascular gamma irradiation following angioplasty--angiographic and clinical follow-up in a prospective randomized controlled trial

PURPOSE: To assess and report the follow-up results of a randomized controlled trial on centered endovascular gamma irradiation performed after percutaneous transluminal angioplasty (PTA) for de novo femoropopliteal stenoses. MATERIALS AND METHODS: Thirty patients who underwent PTA for de novo femoropopliteal stenoses were randomly assigned to undergo 14-Gy centered endovascular irradiation (irradiation group, n = 15) or no irradiation (control group, n = 15). Intraarterial angiography was performed 6, 12, and 24 months after treatment; duplex ultrasonography (US), the day before and after PTA and 1, 3, 6, 9, 12, 18, and 24 months later. Treadmill tests and interviews were performed the day before PTA and 1, 3, 6, 9, 12, 18, and 24 months later. Results of angiography, duplex US, treadmill tests, and interviews were evaluated with the nonpaired t or the Fisher exact test. RESULTS: Baseline characteristics did not differ significantly between the two groups. Mean absolute individual changes in degree of stenosis, compared with the degrees of stenosis shortly after PTA, in the irradiation group versus in the control group were -10.6% +/- 22.3 versus 39.6% +/- 24.6 (P <.001) at 6 months, -2.0% +/- 34.2 versus 40.6% +/- 32.6 (P =.002) at 12 months, and 7.4% +/- 43.2 versus 37.7% +/- 34.5 (P =.043) at 24 months. The rates of target lesion restenosis at 6 (P =.006) and 12 (P =.042) months were significantly lower in the irradiation group. The numbers of target lesion re-treatments were similar between the groups, but target vessel re-treatments were more frequent in the irradiation group. There were no significant differences in interview or treadmill test results between the two groups at t test analysis. CONCLUSION: The degree of stenosis was significantly reduced 6, 12, and 24 months after angioplasty of de novo femoropopliteal stenoses in the patients who underwent endovascular irradiation.     

Stent placement for renal arterial stenosis: where do we stand? A meta-analysis

PURPOSE: To perform a meta-analysis of renal arterial stent placement in comparison with renal percutaneous transluminal angioplasty (PTA) in patients with renal arterial stenosis. MATERIALS AND METHODS: Studies dealing with renal arterial stent placement (14 articles; 678 patients) and renal PTA (10 articles; 644 patients) published up to August 1998 were selected. A random-effects model was used to pool the data. RESULTS: Renal arterial stent placement proved highly successful, with an initial adequate performance in 98% and major complications in 11%. The overall cure rate for hypertension was 20%, whereas hypertension was improved in 49%. Renal function improved in 30% and stabilized in 38% of patients. The restenosis rate at follow-up of 6-29 months was 17%. Stent placement had a higher technical success rate and a lower restenosis rate than did renal PTA (98% vs 77% and 17% vs 26%, respectively; P <.001). The complication rate was not different between the two treatments. The cure rate for hypertension was higher and the improvement rate for renal function was lower after stent placement than after renal PTA (20% vs 10% and 30% vs 38%, respectively; P <.001). CONCLUSION: Renal arterial stent placement is technically superior and clinically comparable to renal PTA alone.     

Angioplasty with or without Stent Placement in the Brachiocephalic Artery: Feasible and Durable? A Retrospective Cohort Study

PURPOSE: To evaluate the results of percutaneous transluminal angioplasty (PTA) and stent placement in isolated brachiocephalic trunk lesions. MATERIALS AND METHODS: PTA, with or without stent placement, was used to treat 30 patients with isolated clinically significant stenoses (n = 25) or occlusions (n = 5) of the brachiocephalic artery. Initial clinical success was defined as a relief or substantial reduction of the preprocedural symptoms, and initial technical success was defined as a mean translesion pressure gradient of less than 5 mm Hg or a residual stenosis of less than 20%. Clinical evaluation and duplex Doppler ultrasonography of the lesion site were performed at follow-up. Clinical restenosis was defined as recurrent clinical symptoms and a lumen reduction of more than 50%, determining the primary clinical patency. Technical restenosis was defined as more than 50% lumen reduction with or without renewed clinical symptoms, determining the primary technical patency. RESULTS: The initial technical success rate was 83% (occlusions, 60%; stenoses, 88%), and the clinical success rate was 81%. Two patients had major complications, and four experienced minor complications. At a median follow-up of 24 months (4 weeks to 92 months), the primary clinical patency rate was 79% (95% confidence interval [CI]: 57%, 104%), with 83% (95% CI: 60%, 105%) for arteries with stents and 67% (95% CI: 13%, 120%) for those without stents (P = .11). The primary technical patency rate was 50% (95% CI: 24%, 76%). CONCLUSION: PTA with or without stent placement in a stenotic or occlusive brachiocephalic artery is a procedure of tolerable safety with a high initial success rate; however, only moderately rewarding results were obtained after 2 years. Selective stent placement probably improves long-term success. Primary PTA with selective stent placement in an atherosclerotic obstructive brachiocephalic artery should be considered the preferred treatment option.     

Ultrahigh-pressure versus High-pressure Angioplasty for Treatment of Venous Anastomotic Stenosis in Hemodialysis Grafts: Is There a Difference in Patency?

PURPOSE: Ultrahigh-pressure (UHP) balloon catheters were compared with high-pressure (HP) balloon catheters to determine if there was a difference in patency after percutaneous transluminal angioplasty (PTA) of venous anastomotic stenoses. MATERIALS AND METHODS: A retrospective study was conducted from January 2001 to September 2005 that included 22 patients with synthetic hemodialysis grafts who underwent 110 PTA procedures for venous anastomotic stenoses. Data collected included graft configuration and location, percent stenosis, balloon type used, residual stenosis, and total access blood flow before and after intervention. Patency from time of initial PTA to the next intervention was estimated with the Kaplan-Meier technique, with initial failures included in the analysis. RESULTS: A total of 55 PTAs were performed in each group. Technical success rate was 96% (n = 106) and clinical success rate was 100%. Median survival times were 4.6 months for the UHP cohort and 5.4 months for the HP group. When each event was considered independent, the difference was significant (P = .014). However, when each PTA event was considered dependent on earlier PTA events, no significant difference in patency was observed (P = .64). The mean increases in access blood flow rate by ultrasound dilution (available for 71 events) after PTA were 264 mL/min with UHP and 524 mL/min with HP (P = .14, Student t test). One minor complication (0.9%) of focal extravasation after PTA occurred and resolved with prolonged balloon inflation. CONCLUSION: Routine use of UHP for PTA of venous anastomotic stenoses in synthetic hemodialysis grafts was not associated with any significant change in patency compared with routine HP balloon angioplasty.     

Comparison of SMART stent placement for arteriovenous graft salvage versus successful graft PTA

PURPOSE: To compare the SMART (shape memory alloy recoverable technology) stent with percutaneous transluminal angioplasty (PTA) alone in hemodialysis access venous stenoses. MATERIALS AND METHODS: A prospective, nonrandomized study was undertaken in 60 patients with dysfunctional polytetrafluoroethylene dialysis grafts. Indications for stent placement were acute PTA failure, rapid restenosis, and vessel perforation. The primary endpoint was improved graft patency in patients treated with stents compared with that in patients whose disease responded to PTA alone. The secondary endpoints were lower postprocedural midgraft pressures and similar complication rates compared with PTA alone. RESULTS: The key venous stenosis was at the graft-to-vein anastomosis in all but two patients. Thirty-five patients showed a response to PTA alone. Sixteen patients received stents for stenoses greater than 30% after angioplasty, six for rapidly recurrent stenosis, and three for venous rupture. Nine patients received stents across the level of the elbow joint. Stenosis after intervention was significantly less frequent in the stent group (7% vs 16%; P = .001), but the midgraft systolic pressure ratios did not significantly differ. The clinical success rates were 100% after stent implantation and 97% after PTA alone. Except for venous rupture, there were no procedure-related complications, and, excluding early graft thrombosis, there were no complications at 30 days. A single stent fracture was found on follow-up. The mean primary graft patency times were 5.6 months after PTA and 8.2 months after stent treatment (P = .050). When stents were placed across the level of the elbow joint, the mean primary graft patency time was 8.9 months. CONCLUSION: Implantation of the SMART stent is safe and effective for the treatment of residual or rapidly recurrent dialysis access venous stenoses and is associated with better patency than PTA alone.     

Percutaneous transluminal angioplasty of peripheral bypass stenoses

Purpose: To assess the success of percutaneous transluminal angioplasty (PTA) in treating peripheral bypass stenoses. Methods: Patients who received a femoropopliteal or femorocrural bypass graft for limb ischemia were included in a duplex surveillance program. If duplex ultrasound revealed a short (<2 cm) severe (peak systolic velocity ratio ≥ 4.5) stenosis, patients were scheduled for arteriography and PTA. Fifty-eight peripheral bypass stenoses in 39 grafts in 37 patients were treated with PTA. The cumulative primary patency of treated stenoses was calculated. Results: During the first year after PTA 31 (53%) treated lesions remained patent, 15 (26%) lesions restenosed at a median interval of 5.0 (range 1–12) months and 4 (7%) bypasses occluded. The cumulative primary patency of 58 treated graft stenoses at 1 year was 60% [95% confidence interval (CI) 46%–74%] and 55% (95% CI 41%–70%) at 2 years. Graft body stenoses showed a better 2-year cumulative primary patency (86%; 95% CI 68%–100%) compared with juxta-anastomotic lesions (45%; 95% CI 29%–62%; p < 0.05). Conclusion: PTA is justifiable as the initial treatment of peripheral bypass stenoses. Nevertheless, the restenosis rate is rather high, especially in juxta-anastomotic lesions. Continuation of duplex surveillance after PTA and timely reintervention is recommended.     

Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

Purpose

To determine whether primary stenting reduces the rate of restenosis compared with balloon angioplasty alone in the endovascular treatment of long superficial femoral artery lesions; and to assess the effect of treatment on quality of life.

Methods

A total of 150 patients with superior femoral artery occlusion or severe stenosis of 5–22 cm length from 17 UK centers were randomized to either primary stenting with the SMART stent or balloon angioplasty (i.e., percutaneous transluminal angioplasty, PTA). Bailout stent placement was permitted in case of inadequate result from PTA. The primary end point was restenosis measured by duplex ultrasound at 1 year. Quality-of-life assessments were performed by the EuroQol (EQ)-5D questionnaire.

Results

Mean lesion length was 123.0 mm in the stent group and 116.8 mm in the PTA group. A total of 140 (93.3 %) of 150 had total occlusions. At 12 months’ follow-up, restenosis measured by Duplex ultrasound was not significantly different between the stent and PTA groups by intention-to-treat or as-treated analyses: 47.2 versus 43.5 % (p = 0.84) and 40.8 versus 46.7 % (p = 0.68), respectively. There were fewer target lesion revascularizations in patients randomized to stenting, but this did not reach statistical significance (12.5 vs. 20.8 %, p = 0.26). There was no difference in the rate of amputation. Patients in both groups reported improved quality of life.

Conclusion

Primary stenting of long lesions in predominantly occluded superficial femoral arteries does not reduce the rate of binary restenosis compared with balloon angioplasty and bailout stenting. Both treatment strategies conferred a meaningful and sustained improvement to the quality of life of patients with severe superficial femoral artery disease.