Angioplastie fémoro-poplitée - Femoro popliteal angioplasty

1. Schillinger, M., S. Sabeti, et al. (2006). "Balloon angioplasty versus implantation of nitinol stents in the superficial femora artery". N Engl J Med 354(18): 1879-88.
2. Ansel, G. M., M. J. Silver,et al. (2006). "Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial." Catheter Cardiovasc Interv 67(2): 288-97.
   
3. Duda SH et al. (2005). "Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial." J Vasc Interv Radiol 16(3): 331-8
4. Adam DJ et al. (2005). "Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial." Lancet 366(9501): 1925-34
5. van der Zaag ES et al. (2004). "Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial." Eur J Vasc Endovasc Surg 28(2): 132-7
6. Fritz P et al. (2004). "External beam radiotherapy fails to prevent restenosis after iliac or femoropopliteal percutaneous transluminal angioplasty: results of a prospective randomized double-blind study." Int J Radiat Oncol Biol Phys 59(3): 815-21
7. Saxon RR et al. (2003). "Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial." J Vasc Interv Radiol 14(3): 303-11
8. Becquemin JP et al. (2003). "Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study." J Vasc Surg 37(3): 487-94
9. Bonvini R et al. (2003). "Late acute thrombotic occlusion after endovascular brachytherapy and stenting of femoropopliteal arteries." J Am Coll Cardiol 41(3): 409-12
10. Grimm J et al. (2001). "Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions." J Vasc Interv Radiol 12(8): 935-42
11. Cejna M et al. (2001). "PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study." J Vasc Interv Radiol 12(1): 23-31
12. Wolfram RM et al. (2001). "Endovascular brachytherapy for prophylaxis against restenosis after long-segment femoropopliteal placement of stents: initial results." Radiology 220(3): 724-9
13. Minar E et al. (2000). "Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: results of a prospective randomized study." Circulation 102(22): 2694-9
14. Zdanowski Z et al. (1999). "Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study." Int Angiol 18(4): 251-5
15. Whyman MR et al. (1997). "Is intermittent claudication improved by percutaneous transluminal angioplasty? A randomized controlled trial." J Vasc Surg 26(4): 551-7
16. Vroegindeweij D et al. (1997). "Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study." Cardiovasc Intervent Radiol 20(6): 420-5
17. Whyman MR et al. (1996). "Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication." Eur J Vasc Endovasc Surg 12(2): 167-72
18. Tielbeek AV et al. (1996). "Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial." J Vasc Interv Radiol 7(6): 837-44
19. Perkins JM et al. (1996). "Exercise training versus angioplasty for stable claudication. Long and medium term results of a prospective, randomised trial." Eur J Vasc Endovasc Surg 11(4): 409-13
20. Wolf GL et al. (1993). "Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199." J Vasc Interv Radiol 4(5): 639-48
21. Holm J et al. (1991). "Chronic lower limb ischaemia. A prospective randomised controlled study comparing the 1-year results of vascular surgery and percutaneous transluminal angioplasty (PTA)." Eur J Vasc Surg 5(5): 517-22
22. Belli AM et al. (1991). "Total peripheral artery occlusions: conventional versus laser thermal recanalization with a hybrid probe in percutaneous angioplasty--results of a randomized trial." Radiology 181(1): 57-60
23. Belli AM et al. (1991). "Follow-up of conventional angioplasty versus laser thermal angioplasty for total femoropopliteal artery occlusions: results of a randomized trial." J Vasc Interv Radiol 2(4): 485-8
24. Spies JB et al. (1990). "Comparison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropopliteal atherosclerotic disease: initial results of a prospective randomized trial. Work in progress." J Vasc Interv Radiol 1(1): 39-42

1. Schillinger, M., S. Sabeti, et al. (2006). "Balloon angioplasty versus implantation of nitinol stents in the superficial femora artery". N Engl J Med 354(18): 1879-88.
BACKGROUND: Because stent implantation for disease of the superficial femoral artery has
been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is
preferred for endovascular treatment, and stenting is recommended only in the event of
suboptimal technical results. We evaluated whether primary implantation of a self-expanding
nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded
by percutaneous transluminal angioplasty with optional secondary stenting. METHODS: We
randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to
stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51
patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and
12 months. RESULTS: The mean (+/-SD) length of the treated segment was 132+/-71 mm in the
stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in
17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal
result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in
the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on
duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the
stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those
in the angioplasty group. CONCLUSIONS: In the intermediate term, treatment of superficialfemoral-
artery disease by primary implantation of a self-expanding nitinol stent yielded results
that were superior to those with the currently recommended approach of balloon angioplasty
with optional secondary stenting.

2. Ansel, G. M., M. J. Silver,et al. (2006). "Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial." Catheter Cardiovasc Interv 67(2): 288-97.
OBJECTIVE: To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of
superficial femoral occlusive disease. BACKGROUND: Stent implantation in the superficial
femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors
have shown improved procedural results during coronary intervention. We evaluated abciximab
infusion during (Smart Stent) implantation in superficial femoral obstructions. METHODS: We
conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-
month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound
restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9
months. RESULTS: Twenty-seven patients were randomized to abciximab and 24 patients to
control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients
administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis
endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The
composite end point of 30-day mortality and 9-month revascularization occurred in 5.8%
abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and
Rutherford class were all significantly improved in both groups, but the abciximab group did not
appear to demonstrate any identifiable effect. CONCLUSION: (Smart Stent) nitinol stenting of
the superficial femoral artery was associated with favorable functional outcomes at 9 months.
Adjunctive abciximab did not appear to demonstrate any identifiable effect.

3. Duda, S. H., M. Bosiers, et al. (2005). "Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial." J Vasc Interv Radiol 16(3): 331-8.
PURPOSE: To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions. MATERIALS AND METHODS: This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography. RESULTS: Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P =.31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P =.20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P =.49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events. CONCLUSION: Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.

4. Adam, D. J., J. D. Beard, et al. (2005). "Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial." Lancet 366(9501): 1925-34.
BACKGROUND: The treatment of rest pain, ulceration, and gangrene of the leg (severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients. METHODS: We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first (n=228) or an angioplasty-first (n=224) strategy. The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register (NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889. FINDINGS: The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy. INTERPRETATION: In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty.

5. van der Zaag, E. S., D. A. Legemate, et al. (2004). "Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial." Eur J Vasc Endovasc Surg 28(2): 132-7.
AIM: To evaluate whether angioplasty or above-knee bypass is the best treatment for symptomatic superficial femoral artery occlusive lesions, we performed a multicentre randomised trial. PATIENTS AND METHODS: Between October 1995 and August 1998, 56 patients were enrolled, all with symptoms related to a 5-15 cm long occlusive lesion of the superficial femoral artery. Thirty-one patients were randomly assigned to percutaneous transluminal angioplasty (PTA); 25 patients to bypass surgery. All patients were followed at 1, 6 and 12 months after the procedure. The primary outcome of our study was re-occlusion of the femoral artery. RESULTS: Thirty patients underwent the allocated PTA and 24 patients underwent bypass surgery. Cumulative 1-year primary patency after PTA was 43 and 82% after bypass surgery. After PTA more than half of the patients had a re-occlusion with an absolute risk reduction of 31% (CI: 6-56%) in favour of bypass surgery. The hazard ratio for occlusion comparing PTA with bypass surgery is 2.24 (95% CI: 0.9-5.58). CONCLUSION: Despite 18 participating centres only 56 patients were randomised to PTA our bypass surgery. Based on our results, for every three patients treated with bypass surgery instead of PTA, one additional re-occlusion is prevented. Therefore, we conclude that with respect to patency, for long superficial femoral artery (SFA) stenoses or occlusions, surgery is better than PTA.

6. Fritz, P., U. Stein, et al. (2004). "External beam radiotherapy fails to prevent restenosis after iliac or femoropopliteal percutaneous transluminal angioplasty: results of a prospective randomized double-blind study." Int J Radiat Oncol Biol Phys 59(3): 815-21.
PURPOSE: Early restenosis is one of the major complications after successful percutaneous transluminal angioplasty (PTA), in main, as well as peripheral, arteries. The effectiveness of hypofractionated external beam radiotherapy (EBRT) as a prophylaxis for restenosis was examined in a prospective, randomized, double-blind, clinical trial. METHODS AND MATERIALS: Forty-eight patients underwent sham RT and 47 were treated with daily RT in 3-Gy fractions, to a total dose of 21 Gy. The follow-up lasted for 12 months, and the examinations included pressure measurements and calculations of the ankle-brachial index or duplex sonography ("peak velocity ratio"). If restenosis was suspected, additional angiography was performed. RESULTS: No statistically significant difference was found between the treatment groups: sham RT 16 failures (33.3%) and EBRT group 21 failures (45.7%; p = 0.292). EBRT also showed no substantial effects on subgroups classified by the specific length of the lesion or in diabetic patients. CONCLUSION: External beam radiotherapy does not prevent restenosis. A reduction in the failure rate >8% using fractionated EBRT with doses aimed at keloid prevention can be ruled out with a probability of 97.5%. Endovascular brachytherapy remains the preferred therapeutic method for achieving restenosis prophylaxis through RT.

7. Saxon, R. R., J. M. Coffman, et al. (2003). "Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial." J Vasc Interv Radiol 14(3): 303-11.
PURPOSE: To describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions. MATERIALS AND METHODS: Twenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months. RESULTS: Technical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87% of patients (13 of 15) in the endoprosthesis group versus 46% of patients (six of 13) in the PTA group. CONCLUSION: This single-center experience with placement of the Hemobahn endoprosthesis (W.L. Gore & Associates) in the SFA demonstrated a statistically significant improvement in both patency and clinical outcome compared with PTA alone.

8. Becquemin, J. P., J. P. Favre, et al. (2003). "Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study." J Vasc Surg 37(3): 487-94.
PURPOSE: Outcome with selective or systematic stenting with the Palmaz vascular stent was compared in patients with limb-threatening ischemia or persistent disabling claudication despite medical therapy, with less than 7 cm stenosis or occlusion of the superficial femoral artery. METHODS: This was a multicenter prospective randomized trial with centralized allocation of treatment and independent review of vascular events. The primary end point was presence of more than 50% stenosis at 1-year angiographic follow-up. Secondary end points were survival; occurrence of vascular events in the treated leg; and number of failed procedures, defined as more than 50% stenosis or death at 1 year. RESULTS: Two hundred twenty-seven patients were enrolled in the study, 112 in the selective stent group, and 115 in the systematic stent group. Seventeen patients (15%) in the selective stent group received a stent after suboptimal results of percutaneous transluminal angioplasty. Angiograms for 140 patients were available at 1-year follow-up and demonstrated no statistical difference between the two groups; more than 50% stenosis of the dilated site was noted in 21 of 65 patients (32,3%) in the selective stent group and 26 of 75 patients (34.7%) in the systematic stent group (P =.85, Fisher exact test). Survival in the percutaneous transluminal angioplasty and stent groups was, respectively, 92% and 96% at 1 year, 89% and 93% at 2 years, and 82% and 80% at 4 years (P =.40, log-rank test). Survival free of new vascular events in the treated limb was 77% and 65% at 1 year, 70% and 53% at 2 years, and 57% and 44% at 4 years (P =.017, log-rank test). Number of failed procedures at 1 year was 29 of 86 (33%) and 30 of 89 (34%) (P = 0.9). CONCLUSION: Systematic stenting of short stenosis or occlusion of the superficial femoral artery is not justified. Palmaz vascular stent placement should be reserved for use in patients with suboptimal results of balloon angioplasty.

9. Bonvini, R., I. Baumgartner, et al. (2003). "Late acute thrombotic occlusion after endovascular brachytherapy and stenting of femoropopliteal arteries." J Am Coll Cardiol 41(3): 409-12.
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.

10. Grimm, J., S. Muller-Hulsbeck, et al. (2001). "Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions." J Vasc Interv Radiol 12(8): 935-42.
PURPOSE: The purpose of this study was to evaluate whether percutaneous transluminal angioplasty (PTA) combined with Palmaz stent placement provides long-term advantages compared to PTA alone after 34 months of follow-up in the femoropopliteal region. MATERIALS AND METHODS: Thirty patients randomized to undergo PTA in combination with stent placement and 23 patients randomized to undergo PTA alone were evaluated. RESULTS: Mean follow-up (+/-SD) for the PTA group was 33.8 months (+/- 8.7) and for the Palmaz group 29.1 months (+/- 6.2), with a maximum follow-up period of 39 months for both groups. No significant differences in primary or secondary patency rates could be observed at 12 or 39 months. After 39 months, the primary patency rate for PTA alone was 68.4% and the secondary patency rate was 89.5%; the primary patency rate for PTA with stent placement was 62% and the secondary patency rate was 90%. CONCLUSIONS: The results of this study show that even after a long-term follow up of more than 3 years, PTA with stent placement in the femoropopliteal artery does not produce better results than PTA alone, although it does provide better initial luminal gain after the procedure.

11. Cejna, M., S. Thurnher, et al. (2001). "PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study." J Vasc Interv Radiol 12(1): 23-31.
PURPOSE: To evaluate if stent placement is superior to percutaneous transluminal angioplasty (PTA) in the treatment of chronic symptoms in short femoropopliteal arterial lesions. MATERIALS AND METHODS: One hundred fifty-four limbs in 141 patients who ranged in age from 39 to 87 years (mean age, 67 years) were randomized to PTA (n = 77) versus PTA followed by implantation of Palmaz stents (n = 77). Inclusion criteria were patients with intermittent claudication (n = 108, Society of Vascular Surgery/International Society of Cardiovascular Surgery [SVS-ISCVS] categories 1-3) or chronic critical limb ischemia (n = 46 with either ischemic rest pain [category 4] or minor tissue loss [category 5]), short stenosis or occlusion (lesion length < or = 5 cm), and at least one patent run-off vessel at angiography. Follow-up included clinical assessment, measurement of ankle/ brachial index (ABI), color duplex ultrasound, and/or angiography at 6 or 12 months. Angiographic follow-up between 12 and 36 months was available in 46 limbs (29.9%). RESULTS: In the PTA group, initial technical success was achieved in 65 of 77 limbs (84%) versus 76 of 77 (99%) limbs in the stent group (chi2 value = 0.009). Overall, major complications occurred in 3.9% (n = 6); n = 4 in the PTA group compared to n = 2 in the stent group. There was no difference between groups of treatment: hemodynamic/clinical success at 1 and 2 years in the PTA group was 72% and 65% versus 77% and 65% in the stent group (Gehan P value =.26). The cumulative 1- and 2-year angiographic primary patency rates were 63% and 53%, respectively, for both groups. The secondary 1- and 2-year angiographic patency rates were 86% and 74% in the PTA group versus 79% and 73% in the stent group (P =.5). CONCLUSION: After stent placement, the primary success rate was significantly higher than after PTA. However, 1-year angiographic and clinical/hemodynamic success was not improved.

12. Wolfram, R. M., B. Pokrajac, et al. (2001). "Endovascular brachytherapy for prophylaxis against restenosis after long-segment femoropopliteal placement of stents: initial results." Radiology 220(3): 724-9.
PURPOSE: To evaluate the feasibility, safety, and effectiveness of endovascular brachytherapy for the prevention of restenosis after long-segment femoropopliteal percutaneous transluminal angioplasty (PTA) and stent implantation. MATERIALS AND METHODS: Thirty-three patients (23 men, 10 women; mean age, 66 years) with femoropopliteal lesions (mean treated length, 17 cm; range, 4-30 cm) underwent PTA and stent implantation followed by brachytherapy with a centering catheter. A dose of 14 Gy was delivered to the adventitia by using an iridium 192 source. Long-term pharmacotherapy with acetylsalicylic acid was combined with clopidogrel for 1 month. Follow-up examinations included measurement of the ankle-brachial index, color-coded duplex ultrasonography, and angiography. RESULTS: The overall 6-month recurrence rate was 30% (10 of 33 arteries). Seven patients developed sudden late thrombotic occlusion of the segment with the stent 3.5-6 months after stent implantation. Considering the overall results after successful local thrombolysis in six of these seven patients, only four (12%) of 33 arteries with a stent had in-stent restenosis caused by neointimal hyperplasia. CONCLUSION: The study results are promising concerning the possibility of reducing in-stent restenosis by means of brachytherapy after long-segment femoropopliteal placement of stents. The high incidence of late thrombotic occlusion requires optimization of the antithrombotic regimen.

13. Minar, E., B. Pokrajac, et al. (2000). "Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: results of a prospective randomized study." Circulation 102(22): 2694-9.
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.

14. Zdanowski, Z., U. Albrechtsson, et al. (1999). "Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study." Int Angiol 18(4): 251-5.
BACKGROUND: To investigate the-one year outcome of PTA and stenting and PTA alone for femoropopliteal occlusions. DESIGN: Randomized prospective study METHODS: 32 patients with femoropopliteal occlusions were randomized into two treatment groups: PTA and Strecker-stent (n=15) and PTA alone (n=17). The median age of the patients was 71 years. All patients had chronic limb ischaemia, 66% had tissue loss, 19% had rest pain and 15% had disabling claudication. The median ABPI was 0.45. The occlusion was confined to the superficial femoral artery in 30 cases and to the popliteal artery in 2 cases. The median length of the occlusions was 7.3 cm. Aspirin (ASA), 160 mg daily, was administrated postoperatively but no anticoagulation was used. The follow-up included: clinical examination, measurement of ABPI and control angiography at 12 months or earlier when necessary (20 patients). RESULTS: There was no mortality or limb loss as a consequence of the treatment. There were six (16%) immediate major complications in five patients. In the PTA group, one patient had a myocardial infarction and three patients needed arteriography due to bleeding. In the stent group, one patient required arteriography and embolectomy. The one-year mortality was 6% and there were no amputations. Four patients (two in each group) were operated on with a femorodistal bypass. The rate of clinical improvement was 71% after PTA and stent and 60% after PTA alone (p=0.17). An increased ABPI (>0.10) was shown in 50% of the stent group and 61% in the PTA group (p=0.17). Angiographic re-occlusions were seen in 33% and 75% in the stent and PTA groups respectively (p=0.17), while the rate of restenosis was significantly higher in the stent group (50% vs 25%) (p=0.033). CONCLUSIONS: Stenting following PTA for femoropopliteal occlusions does not significantly improve neither the clinical state nor the clinical/angiographic patency. The results do not justify any routine placement of stent following PTA in the successfully recanalized femoropopliteal arteries. The low rate of acceptance of a follow-up angiography indicates that this kind of study should preferably use duplex scanning instead of angiography for follow-up.

15. Whyman, M. R., F. G. Fowkes, et al. (1997). "Is intermittent claudication improved by percutaneous transluminal angioplasty? A randomized controlled trial." J Vasc Surg 26(4): 551-7.
PURPOSE: Percutaneous transluminal angioplasty (PTA) is an increasingly popular invasive treatment for peripheral arterial disease, but there have been very few controlled trials to justify its use. This randomized controlled clinical trial was performed to determine in patients with mild and moderate intermittent claudication differences in outcome between PTA and conventional medical treatment after 2 years. METHODS: Six hundred patients with claudication were screened at the Peripheral Vascular Clinic, Royal Infirmary of Edinburgh. Sixty-two patients with short femoral artery stenoses or occlusions (47 patients) and iliac stenoses (15 patients) were randomized to either PTA plus medical treatment (PTA group, 30 patients) or to medical treatment alone (control group, 32 patients). Medical treatment consisted of daily low-dose aspirin and advice on smoking and exercise. Outcome measures studied were patient-reported maximum walking distance, exercise treadmill distance until onset of claudication, treadmill maximum walking distance, ankle-brachial pressure index (ABPI), quality of life (Nottingham Health Profile), and duplex ultrasound-measured extent of occlusive disease. RESULTS: At 2 years of follow-up, the PTA group and control subjects did not differ significantly in patient-reported maximum walking, treadmill onset to claudication, treadmill maximum walking distances, or ABPI (p > 0.05). However, the PTA group had significantly fewer occluded arteries (p = 0.003) and a lesser degree of stenosis (expressed in terms of the velocity ratio; p = 0.004) in patent arteries. Quality of life was not demonstrably different between the two groups (p > 0.05). CONCLUSIONS: Two years after PTA, patients had less extensive disease than medically treated patients, but this did not translate into a significant advantage in terms of improved walking or quality of life. There are important implications for patient management and future clinical research.

16. Vroegindeweij, D., L. D. Vos, et al. (1997). "Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study." Cardiovasc Intervent Radiol 20(6): 420-5.
PURPOSE: To evaluate whether balloon angioplasty combined with stenting (ST) of symptomatic femoropopliteal disease would provide better results compared with balloon angioplasty alone (BA). METHODS: Fifty-one patients were randomized between ST (24 patients) and BA (27 patients). Follow-up comprised clinical and hemodynamic assessment and color-flow duplex ultrasound examinations. RESULTS: Residual stenosis (> or = 30% diameter reduction) occurred in three BA patients, but not in the ST patients. By life-table analysis the cumulative rate of clinical and hemodynamic success after 1 year with ST was 74% (SE 9%) and for those with BA 85% (SE 7%) (p = 0.25). The primary patency at 1 year assessed by color-flow duplex ultrasound was 62% (SE 9%) for ST-treated patients and 74% (SE 8%) for BA patients (p = 0.22). Occlusion occurred in five ST patients (21%) compared with two BA patients (7%). CONCLUSION: ST does not improve clinical and hemodynamic outcome compared with BA. Moreover, the occlusion rate in ST-treated patients is higher.

17. Whyman, M. R., F. G. Fowkes, et al. (1996). "Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication." Eur J Vasc Endovasc Surg 12(2): 167-72.
OBJECTIVES: To determine differences between PTA and conventional medical treatment in treadmill distance until onset of claudication, treadmill maximum walking distance, patient reported maximum walking distance, ankle brachial pressure index (ABPI), quality of life (Nottingham Health Profile, NHP) and Duplex measured extent of occlusive disease. DESIGN: Randomised controlled clinical trial. METHODS: Six hundred claudicants were screened. Fifty-one men and 11 women with intermittent claudication due to short femoral stenoses or occlusions (n = 47) and iliac stenoses (n = 15) were randomised to either PTA plus medical treatment (PTA group, n = 30) or to medical treatment alone (control group, n = 32). Medical treatment consisted of daily low dose aspirin and advice on smoking and exercise. RESULTS: At 6 month follow up: In the PTA group more patients reported no claudication (p < or = 0.05) and were asymptomatic on the treadmill (p < or = 0.01) compared to the control group. The ABPI was significantly higher in the PTA group. More of the PTA group reported lower NHP pain scores (p < or = 0.05). In the control group there were more occluded arteries (p < or = 0.001), and the stenosis velocity ratio of patient arteries was significantly higher (p < or = 0.001). CONCLUSIONS: Only 10% of claudicants had discrete lesions suitable for PTA. Treatment of these patients with PTA produces a greater short-term improvement in walking and quality of life than medical treatment alone and is associated with less progression of disease.

18. Tielbeek, A. V., D. Vroegindeweij, et al. (1996). "Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial." J Vasc Interv Radiol 7(6): 837-44.
PURPOSE: This study involves a prospective randomized trial comparing clinical and angiographic results of balloon angioplasty (BA) and Simpson directional atherectomy (DA) in patients with short lesions in the femoropopliteal artery causing symptoms of intermittent claudication. MATERIALS AND METHODS: Thirty-five patients were treated with BA and 38 with DA. Procedural complications were seen in eight patients. Residual stenoses immediately after the procedure with between 30% and 50% diameter reduction (DR) were observed in three patients after BA and in five patients after DA. In all other patients, residual stenosis was less than 30% DR. Two study end-points during a 2-year follow-up were used: the angiographic occurrence of restenosis with a DR of 50% or greater or the recurrence of symptoms. RESULTS: Clinical success after 2 years, according to the criteria of the Society for Vascular Surgery/International Society for Cardiovascular Surgery, was seen in 79% of the BA patients and 56% of the DA patients (P =.07). The 2-year primary angiographic patency rates were 67% in patients treated with BA and 44% in patients treated with DA (P =.06). The secondary angiographically determined patency rates were 80% and 65%, respectively (P =.15). CONCLUSION: Simpson atherectomy is an interventional technique to treat arterial lesions in the femoropopliteal artery with an acceptably low complication rate. The clinical and angiographic results of DA and BA are comparable. DA should not be used to replace BA for routine treatment of short femoropopliteal lesions.

19. Perkins, J. M., J. Collin, et al. (1996). "Exercise training versus angioplasty for stable claudication. Long and medium term results of a prospective, randomised trial." Eur J Vasc Endovasc Surg 11(4): 409-13.
OBJECTIVES: To compare percutaneous transluminal angioplasty (PTA) against exercise training in the treatment of stable claudication. DESIGN: Prospective, randomised trial. MATERIALS: Fifty-six patients with unilateral, stable, lower limb claudication assessed prior to randomisation, at 3 monthly intervals for 15 months, and at approximately 6 years follow-up. Thirty-seven patients were available for long term review. OUTCOME MEASURES: Ankle/brachial pressure index (ABPI), treadmill claudication and maximum walking distances, percentage fall in ankle systolic pressure after exercise. RESULTS: Significant increases were seen in ABPI in the patients treated with PTA at all assessment to 15 months. However in terms of improved walking performance, the most significant changes in claudication and maximum walking distance were seen in the exercise training group. At long term follow-up, there was no significant difference between the groups. Subgroup analysis by angiographic site of disease showed greater functional improvement in those patients with disease confined to the superficial femoral artery treated by exercise training. The overall prognosis for the whole group of patients was benign, with only two (4%) undergoing amputation. CONCLUSIONS: Exercise training confers a greater improvement in claudication and maximum walking distance than PTA, especially in patients with disease confined to the superficial femoral artery.

20. Wolf, G. L., S. E. Wilson, et al. (1993). "Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199." J Vasc Interv Radiol 4(5): 639-48.
PURPOSE: Surgical revascularization and angioplasty (PTA) are effective therapies for patients with peripheral arterial disease, but there are no data on long-term survival, limb salvage, and hemodynamic status from a randomized study of such patients. A multicenter, prospective trial compared PTA with bypass surgery (BP) in 263 men who had iliac, femoral, or popliteal artery obstruction. PATIENTS AND METHODS: Lesions in the iliac versus the femoropopliteal artery and rest pain versus claudication were separately randomized to the two treatment interventions. One hundred twenty-six patients underwent BP, 129 patients underwent PTA, and eight patients were not treated for lower extremity ischemia. RESULTS: Three operative deaths occurred in the BP group and none in the PTA group. For the entire study, average annual mortality was higher in the BP group, but survival was not significantly different on life-table analysis (P =.08). Primary success favored BP, while limb salvage favored PTA, but differences were not statistically significant (P =.08 and.35, respectively). Patients with iliac disease or claudication fared better, but there was no statistical difference in response to PTA or BP. CONCLUSION: Patients in both treatment groups had prompt and sustained increases in hemodynamics and quality of life. This study of patients randomly assigned to BP or PTA shows no significant difference in outcomes during a median follow-up of 4 years.

21. Holm, J., B. Arfvidsson, et al. (1991). "Chronic lower limb ischaemia. A prospective randomised controlled study comparing the 1-year results of vascular surgery and percutaneous transluminal angioplasty (PTA)." Eur J Vasc Surg 5(5): 517-22.
In a prospective randomised study, performed over a 6-year period, 102 patients with severe lower limb ischaemia or claudication resistant to exercise training were randomised either to percutaneous transluminal angioplasty (PTA) or vascular surgery. Only patients who could be treated by both methods were included, constituting only 5% of the total number of patients treated during this period. The two groups were similar regarding age, severity of symptoms and diabetes. The immediate and 1-year results showed similar success and complication rates. There was, however, a significantly shorter hospital stay for patients treated with PTA. Due to early complications and initial failures PTA should, however, only be used in institutions where vascular surgical facilities are available since PTA demands access to such treatment.

22. Belli, A. M., D. C. Cumberland, et al. (1991). "Total peripheral artery occlusions: conventional versus laser thermal recanalization with a hybrid probe in percutaneous angioplasty--results of a randomized trial." Radiology 181(1): 57-60.
Increasing the primary success rate in recanalization of peripheral vascular occlusions is one aim of using laser techniques in the treatment of peripheral vascular disease. Although reports of lasers enabling recanalization after failure of guide wires have been numerous, direct comparisons of the success of the two techniques in a randomized trial have been few. The results of a randomized trial showed no statistical difference in recanalization of femoropopliteal occlusions between the conventional guide wire and hybrid laser probe. The number of patients with iliac occlusions was small and comparisons are difficult to make, but the findings suggest that the hybrid laser probe has little to offer. Immediate crossover to the alternative method allowed investigation of the relationship between the two methods in practice. Combining the two methods improved the primary success rate from 82% to 91% for femoropopliteal occlusions randomized to laser thermal recanalization and from 74% to 91% for those randomized to conventional recanalization.

23. Belli, A. M., D. C. Cumberland, et al. (1991). "Follow-up of conventional angioplasty versus laser thermal angioplasty for total femoropopliteal artery occlusions: results of a randomized trial." J Vasc Interv Radiol 2(4): 485-8.
Sixty-eight patients with 68 femoropopliteal occlusions were entered into a randomized trial of conventional guide-wire and catheter percutaneous angioplasty versus laser thermal angioplasty. Thirty-four occlusions were randomized to conventional angioplasty and 34 to laser thermal angioplasty. After successful recanalization and balloon dilation, the patients were followed up for 1 year. Follow-up consisted of obtaining measurements of the ankle-arm indexes at 1, 3, 6, and 12 months. The increase in the mean resting ankle-arm index 1 year after conventional angioplasty (0.26) was greater than that after laser angioplasty (0.12). At 1-year follow-up, the cumulative success rate was 47% for patients treated with conventional angioplasty versus 39% for those treated with laser angioplasty. Statistical analysis showed no significant difference in clinical success between the two treatment groups.

24. Spies, J. B., M. H. LeQuire, et al. (1990). "Comparison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropopliteal atherosclerotic disease: initial results of a prospective randomized trial. Work in progress." J Vasc Interv Radiol 1(1): 39-42.
The authors recently initiated a prospective randomized trial in which results of standard balloon angioplasty were compared with those of laser thermal angioplasty in the treatment of patients with symptoms of femoropopliteal occlusive disease. The data regarding their initial technical success are reported herein. Twenty-five patients with moderate to severe claudication have thus far undergone 27 procedures. The type of lesions treated varied from short focal stenoses to occlusions up to 10 cm in length; 12 stenoses and 15 occlusions were treated. Fourteen procedures were randomized to laser therapy and 13 to standard balloon angioplasty. If the primary randomized treatment failed, the alternative procedure was then attempted. Of the 14 laser procedures, five were initial failures; three of these failures were subsequently treated successfully with the balloon technique. Three of 13 balloon procedures were failures; none were subsequently successful with use of the laser. While these data are limited, initial experience indicates that technical success is directly related to the ability to pass an angiographic wire through the lesion and the length and type of lesions. It does not appear to depend on whether the laser or the balloon is used.