Multicenter Trial of the Wallstent in the Iliac and Femoral Arteries

Martin, Eric C.; Katzen, Barry T.; Benenati, James F.; Diethrich, Edward B.; Dorros, Gerald; Graor, Robert A.; Horton, Keith M.; Lannone, Liberato A.; Isner, Jeffrey M.; Ramee, Stephen R.; Schwarten, Donald E.; Tegtmeyer, Charles J.; Walker, Craig M.; Wholey, Mark H.

doi:10.1016/s1051-0443(95)71198-8

Cited by 184 publications

(68 citation statements)

References 15 publications

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“…The 1-and 2-year total patency rates of 79% and 72% compare favorably with the results of the United States Trial On Iliac and Femoral Artery Wallstents, which reported a total patency of rate of 84% and 72% at 1 and 2 years in opening occluded superficial femoral arteries (12). Vorwerk and Gunther had a primary patency rate 63% and a secondary patency rate of 83% at 1 year with use of Wallstents after angioplasty in occluded superficial femoral arteries (13).…”

Section: Discussionsupporting

confidence: 60%

“…The results of simple angioplasty of the superficial femoral artery have been improved by the addition of stents after angioplasty, as reported by The United States Trial on Iliac and Femoral Artery Wallstents (12), by Vorwerk et al (13) with use of Wallstents, by Richter et al (14) with use of Palmaz stents, and by Strecker et al (15) with use of Strecker stents.…”

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confidence: 87%

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Angioplasty and Stent Placement in Chronic Occlusion of the Superficial Femoral Artery: Technique and Results

Conroy

Gordon

Tobis

et al. 2000

Journal of Vascular and Interventional Radiology

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Abbreviations: ABI ϭ ankle/brachial index, OR ϭ odds ratio, UK ϭ urokinase PURPOSE: To improve the patency rate for angioplasty in chronic occlusion of the superficial femoral artery by deploying stents after angioplasty. MATERIALS AND METHODS:Angioplasty and stent placement were performed in 61 arteries in 48 male patients. The mean occlusion length was 13.5 cm and the mean stent length was 30 cm. Patency rates were analyzed at 6 months and at 1, 2, 3, and 4 years. The predictors of restenosis were analyzed by univariate and multiple logistic regression.RESULTS: Patency rates were 87% at 6 months, consisting of 74% primary, 6% primary assisted, and 7% secondary; 79% at 1 year, consisting of 47% primary, 19% primary assisted, and 13% secondary; 72% at 2 years, consisting of 36% primary, 26% primary assisted, and 10% secondary; 70% at 3 years, consisting of 26% primary, 22% primary assisted, and 22% secondary; and 63% at 4 years, consisting of 25% primary, 0% primary assisted, and 38% secondary. There was a 15% morbidity rate and one mortality as a result of retroperitoneal bleeding. Better patency rates were noted at all time intervals in diabetic limbs, 7-mm-diameter versus 10-mmdiameter stents, shorter obstructions and shorter stents, nonsmokers, in limbs in which urokinase was not necessary after stent deployment, and in limbs with an International Society of Cardiovascular Surgery (ISCVS) classification under 3. Patency rates were not affected by age, race, number of trifurcation vessels patent, experience in performing the procedures, and procedures requiring less time. By multivariate logistic analysis, the independent predictors of patency at 6 months were postprocedure ankle/brachial index (ABI) and shorter stent length; at 1 year, preprocedure ABI, shorter stent length, and the presence of diabetes; at 2 years, preprocedure ABI and the presence of diabetes; and at 3 years, the preprocedure ABI. CONCLUSIONS:The techniques used to reestablish antegrade flow in these superficial femoral arteries yielded a high success rate. In addition, the use of angioplasty with stents may improve patency rates over angioplasty without stents.A common cause of lower extremity claudication is arteriosclerotic occlusion of the superficial femoral artery. A recent analysis of leg arteriograms on 1,000 consecutive patients with lower extremity claudication from our medical center revealed that in patients with no previous surgical or radiologic intervention in the arteries of the

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Section: Discussionsupporting

confidence: 60%

mentioning

confidence: 87%

Angioplasty and Stent Placement in Chronic Occlusion of the Superficial Femoral Artery: Technique and Results

Conroy

Gordon

Tobis

et al. 2000

Journal of Vascular and Interventional Radiology

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“…Martin et al reported a 1-year patency rate of 61% with Wallstents for femoropopliteal occlusion, 2 and Henry et al used Palmaz stents in 126 patients, achieving patency rates for femoral and popliteal stents, respectively, of 81% and 50% at 1 year, 73% and 50% at 2 years and 65% and 50% at 4 years. Do-dai et al prospectively compared primary stenting and PTA in femoropopliteal occlusions in 52 patients and reported similar 1-year patency rates of 60% and 65%, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…1,2 More than 50% of all obstructive lesions are located in the femoropopliteal segment where they tend to be longer and have multiple coexisting atherosclerotic lesions at different levels. Surgical revascularization is the treatment of choice for these diffuse femoropopliteal stenoses and although percutaneous transluminal angioplasty (PTA) has a high risk of occlusion, it is the recommended primary treatment.…”

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confidence: 99%

Fracture of Popliteal Artery Stents

Babalık

Gülbaran

Gürmen

et al. 2003

Circ J

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tent implantation in the peripheral arteries is a safe and effective treatment not only for obstructive diseases, but also non-obstructive conditions such as aneurysm formation. 1,2 More than 50% of all obstructive lesions are located in the femoropopliteal segment where they tend to be longer and have multiple coexisting atherosclerotic lesions at different levels. Surgical revascularization is the treatment of choice for these diffuse femoropopliteal stenoses and although percutaneous transluminal angioplasty (PTA) has a high risk of occlusion, it is the recommended primary treatment. Stent implantation for femoropopliteal occlusions is not recommended because of poor patency rates, and should only be considered for major dissections after PTA because stenting has been associated with acute thrombosis, stent embolization or migration, distal embolization by plaque contents, vessel rupture or dissection. [3][4][5][6] In addition to these acute complications, late stent restenosis remains an unresolved clinical problem. Although stent fracture occurs rarely, it may contribute to or cause late stent failure when implanted in arteries near or at flexion points in the peripheral arteries. Stent fracture has occurred after iliac arterial stenting 7 and we describe a case of fracture in overlapping stents implanted in the left popliteal artery. Case ReportA 48-year-old man was referred for coronary and peripheral arteriography. He reported left calf claudication of 3 years' duration that had progressively worsened in the past few months. His complaints were pain and numbness with mild exercise. He had had non-insulin dependent diabetes mellitus for 1 year and had smoked 1 pack of cigarettes per day for 33 years. On physical examination, both his lower limbs were pale and cool. His left femoral pulse was present, but the left popliteal and left lower extremity pulses were absent. Right femoral and popliteal pulses were present, and the distal pulses in right lower extremity were also palpable. The ankle -brachial index was 0.32 for the left limb. There was not any ulcer formation related to occlusive arterial disease on either leg.The diagnostic coronary and peripheral arteriography revealed 2-vessel coronary artery disease: a severe stenosis in the proximal segment of the left popliteal artery and 50% narrowing of the right popliteal artery. There was late filling of the vasculature distal to the severely narrowed left popliteal artery (Fig 1). We used a standard angioplasty technique from an antegrade, ipsilateral puncture of the left common femoral artery with an 8F sheath. The lesion was crossed Circ J 2003; 67: 643 -645 (Received November 14, 2001; revised manuscript received January 21, 2002; accepted February 15, 2002

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“…Precise restenosis rates are lacking for the femoropopliteal region because of incomplete or absent angiographic follow-up in most studies. 19,20 Patency rates 12 months after the placement of Wallstents and Palmaz stents in mostly short SFA lesions have been reported to range from 22% to 61%. 1,14,15 Duplex ultrasound follow-up in a group of 55 patients, most of whom were treated with femoral Wallstents, showed a primary 6-month patency rate of only 47%.…”

Section: Discussionmentioning

confidence: 99%

Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease

et al. 2002

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Background-Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions. Methods and Results-Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85Ϯ57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (Pϭ0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; Pϭ0.047). No serious adverse events (death or prolonged hospitalization) were reported. Conclusions-The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

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Multicenter Trial of the Wallstent in the Iliac and Femoral Arteries

Cited by 184 publications

References 15 publications

Angioplasty and Stent Placement in Chronic Occlusion of the Superficial Femoral Artery: Technique and Results

Angioplasty and Stent Placement in Chronic Occlusion of the Superficial Femoral Artery: Technique and Results

Fracture of Popliteal Artery Stents

Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease

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