Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery

Abstract

G reater life expectancy and the increasing prevalence of diabetes mellitus in the developing world have led to a progressive rise in the number of patients with peripheral artery disease. Intermittent claudication and critical limb ischemia are the most common symptoms in patients with lowerextremity peripheral artery disease. 1-3 Editorial see p 2475 Clinical Perspective on p 2541Besides conservative therapy and bypass surgery, endovascular therapy has been established as a treatment option for femoropopliteal obstructive disease.2,3 During the past decade, randomized trials revealed that with increasing lesion length, nitinol stent (NS) placement frequently provides better patency, target-lesion revascularization (TLR) rates, and clinical improvement than percutaneous transluminal balloon angioplasty (PTA) alone after treatment of superficial femoral artery (SFA) lesions, including the proximal segment Background-Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery. Methods and Results-This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P=0.002). Targetlesion revascularization rates were 14.7% and 44.1%, respectively (P=0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class (P=0.31). Conclusions-Primary

Atheromatous Occlusive Lesions of the Popliteal Artery Treated with Stent Grafts: Predictive Factors of Midterm Patency

“…These last results seem in accordance with our series, in which 2 types of autoexpandable stents of the new generation, LifeStent and Misago Ò , were mostly used. The primary patency rates at 1 year reported by Rastan et al 17 (67%) and in our series (80%) seem however slightly lower than those obtained with Supera.…”

“…A primary patency rate of 80% at 12 months was observed in our series, which is comparable with that of the literature, varying from 68% to 88% (Table V). 14,15,17,24,25 However, the heterogeneous character of the series of the literature does not allow a comparison of the subgroups according to the type of lesions (stenosis versus occlusion), the symptoms (claudication versus critical ischemia), and the anatomic site (P1, P2, or P3).…”

“…17 Supera is a stent made up of a nitinol wire intermingled with a helicoid configuration, conferring to him at the same time flexibility and an important radial force; this explains the absence of fracture in the 2 series published 25,28 and a primary patency rate at 12 months between 79% and 88%. 25,28 In the study of Rastan et al, 17 the use of Lifestent Ò was associated with a 3.4% rate of fracture but without any correlation with restenosis or secondary thrombosis. These last results seem in accordance with our series, in which 2 types of autoexpandable stents of the new generation, LifeStent and Misago Ò , were mostly used.…”

Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes

“…Patients allocated to primary nitinol popliteal stenting showed a significantly higher primary patency rate at 1 year (67.4 %) compared to control balloon angioplasty (44.9 %) and significantly lower TLR rates of 14.9 % compared to 44.1 % in the balloon angioplasty arm [27]. The results from the nitinol stent arm of this RCT correlate very well with our popliteal TIGRIS experience (primary patency rate 69.5 % and TLR Variables identified by the Cox model as significant outcome predictors after adjustment for clinical presentation (CLI vs IC), hyperlipidemia, diabetes, renal status, smoking, initial lesion grade (stenosis or occlusion), run-off status, degree of calcification and median stented lesion length (CI 95 % confidence interval, significance set at 0.05 level)…”

Percutaneous endovascular treatment of peripheral arterial disease in Germany

“…With the introduction of new technology (hydrophilic guide-wires, stents, stent grafts) success rates up to 100% are reported in the literature [1][2][3][4]. Stent placement has been established in case of failure of primary angioplasty or early restenosis.…”