Article

The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II)

University of Wisconsin School of Medicine and Public Health, Madison, Wisc. Electronic address: .
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter (Impact Factor: 3.02). 05/2013; 58(1). DOI: 10.1016/j.jvs.2012.12.066
Source: PubMed

ABSTRACT

Objective:
Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery.

Methods:
Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing.

Results:
The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals.

Conclusions:
The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol Stent SYstem II) suggest that a new single stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year.

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    • "These data have led to US Food and Drug Administration (FDA) approval of a number of newer available stents that may provide greater flexibility, less stent fracture, and, possibly, more durable results. The Everflex Protégé (Covidien, Mansfield, MA, USA) nitinol self-expanding stent was evaluated in The United States Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By using the Protégé Everflex Nitinol Stent System (DURABILITY I and DURABILITY II) trials.30,31 Although these trials were nonrandomized, they enrolled a similar group of patients evaluated in previous randomized studies and treated long complex lesions (mean lesion lengths of 96.4±26.8 and 89±44.8, "
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    ABSTRACT: The endovascular management of obstructive disease of the superficial femoral artery (SFA) is challenging due to unique anatomical and biomechanical forces. Obstructive lesions of the SFA make up the largest proportion of lesions leading to symptomatic peripheral arterial disease. Accordingly, endovascular treatment of SFA disease is becoming increasingly common and, in many cases, is the preferred initial therapy. The use of self-expanding nitinol stents have proven superior to percutaneous transluminal balloon angioplasty in the treatment of intermediate length SFA stenosis. However, achieving durable results, as well as attaining adequate therapy for long occlusions typically seen in clinical practice, remains problematic. Newer technologies, such as paclitaxel eluting stents, seem promising in improving outcomes.
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    ABSTRACT: Background Despite initially encouraging technical success of femoropopliteal percutaneous transluminal angioplasty (PTA) restenosis still remains the major challenge. The main reason for restenosis is neointimal hyperplasia which can be suppressed with antiproliferative drugs. Drug-coated balloons (DCB) or drug-coated stents (DCS) are used for the inhibition of restenosis. Aim The present article gives an overview of the currently available DCB systems for femoropopliteal and infrapopliteal use and presents the completed, ongoing and planned trials and registries as well as the open questions for the use of DCBs in peripheral arterial occlusive disease. Material and methods A comprehensive search for infrainguinal use of DCBs from 2008 until July 2013 was performed in databases of medical journals, registered randomized controlled trials and published scientific session abstracts. Results The major advantages of DCBs are that no residual stent scaffold is left behind, immediate release of high drug concentrations with a single dose and efficacy in areas where DCSs are contraindicated. The clinical evidence of first generation paclitaxel drug-coated balloons (PTX-DCB) has been shown in several controlled randomized trials. Conclusions Depending on the type and location of the lesion, DCBs are suitable for treatment of in-stent restenoses, restenoses in the region of the popliteal artery or side branches of the profunda artery for which stent application is contraindicated.
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