Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial

Duda, Stephan H.; Bosiers, Marc; Lämmer, Johannes; Scheinert, Dierk; Zeller, Thomas; Tielbeek, Alexander V.; Anderson, John R.; Wiesinger, Benjamin; Tepe, Gunnar; Lansky, Alexandra J.; Mudde, Catharina; Tielemans, Hans; Beregi, Jean Paul

doi:10.1097/01.rvi.0000151260.74519.ca

Cited by 380 publications

(249 citation statements)

References 12 publications

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“…Animal studies have provided strong proof of concept and several multicentre, randomized, controlled trials have shown a discernible difference in respect to vessel restenosis with all three strategies compared with standard old balloon angioplasty as described later [7][8][9][10]63]. On the other hand, laser and directional atherectomy have no proven benefit compared with standard balloon angioplasty and stenting [64,65].…”

Section: Procedural Featuresmentioning

confidence: 99%

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Κατσάνος

Tepe

Tsetis

et al. 2014

Cardiovasc Intervent Radiol

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This is a Standards of Practice document endorsed by CIRSE. The authors performed a literature review and provide recommendations and quality improvement guidelines based on the most recent and highest level of evidence available to date on the field of Superficial Femoral and Popliteal Artery Angioplasty and Stenting. Standards for the use of basic and more advanced endovascular techniques in the femoropopliteal arteries are reported and relevant aspects of case selection, imaging, follow-up, and overall patient management are presented to guide endovascular practice in Europe.

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Section: Procedural Featuresmentioning

confidence: 99%

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Κατσάνος

Tepe

Tsetis

et al. 2014

Cardiovasc Intervent Radiol

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“…At 24 months, the restenosis rate was 22.9 and 21.1% in the sirolimus group and the control group, respectively (p > 0.05). In the SIROCCO II trial, 55 57 patients with chronic limb ischemia and FP occlusions or stenoses were randomized to the SMART control stent versus the SMART sirolimus-eluting stent. At 6 months, there was no restenosis seen in the sirolimuseluting stent group and 7.7% in the control group (p ¼ 0.49).…”

Section: Biological Factorsmentioning

confidence: 99%

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

Shammas¹

2013

Int J Angiol

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ReviewPeripheral arterial disease is highly prevalent in the general population affecting 12 to 14% of people and leading to claudication or threatened limb ischemia. 1 Endovascular lower extremity arterial interventions have increased exponentially over the past decade. 2 The femoropopliteal (FP) segment represents 40% of vessels treated and its treatment continues to be a challenge to the endovascular specialist. Despite a high rate of acute procedural success, target lesion revascularization (TLR) and target vessel revascularization remain elevated. 3,4 We have previously proposed a triad of optimal peripheral vascular revascularization strategy (►Fig. 1) 5 with an emphasis on three key principles: (1) Mechanical, improve vessel compliance to allow dilatation of a stenotic segment at low balloon inflation pressure and reduce dissection and recoil. Low balloon inflation pressure would theoretically preserve vessel integrity by minimizing barotrauma and bailout stenting. (2) Biological, inhibit smooth muscle cell (SMC) proliferation to improve patency rates and reduce repeat revascularization. (3) Procedural, preserve the outflow vessels by minimizing distal embolization (DE) and reduce procedural time and radiation exposure to both operator and patient.In this overview, we examine these principles to determine whether current data support their validity. We recognize the lack of uniform performance criteria and reporting standards in clinical trials in peripheral arterial disease. This unfortunately makes comparisons across studies difficult. Mechanical FactorsThe concept of improving vessel compliance as a prerequisite to a more definitive treatment of the FP artery has gained more attention over the past few years. Measurement of vessel compliance in vivo is difficult to obtain. One surrogate endpoint is the minimum balloon pressure (MBP) needed to fully stretch the artery to a lumen diameter equal to a normal reference segment with the use of a noncompliant balloon sized 1:1 to the reference vessel. The balloon is typically inflated to two atmospheres then the inflation pressure is increased by increment of one atmosphere at a time until full balloon expansion is achieved. 6,7 According to Laplace's law, tension (T) in the vessel wall is equal to (pressure (P) gradient across the arterial wall * radius (R) of artery)/wall thickening (M), or (T¼ [P * R]/M). In order for MBP change to reflect on compliance, the segments under comparison need to have similar radius and lesion Keywords AbstractTreatment of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Long-term patency is low with a high rate of target lesion revascularization. The true patency rate varies considerably between studies partly because there is a lack of uniform performance criteria and reporting standards in peripheral arterial interventions. Literature review supports three principles that emerge as important components of an optimal strategy in treating the FP artery: (1) improving vessel compliance and sub...

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“…6 Although the introduction of novel Nitinol stents decreased restenosis rates compared to plain balloon angioplasty (POBA), 7 restenosis still remains a significant problem in peripheral arteries. 6,8 In-stent restenosis occurs in up to 30% of the patients subsequent to bare metal Nitinol stent placement 6 and was reported to be associated with stent fractures 9,10 and arterial wall damage. 4,11 Stent failures are clearly associated with the forces exerted on the FPAS, which are caused by bending, torsion and axial motions during hip and knee flexion.…”

Section: Introductionmentioning

confidence: 99%

Quantification of Popliteal Artery Deformation During Leg Flexion in Subjects With Peripheral Artery Disease: A Pilot Study

Gökgöl

Diehm

Kara

et al. 2013

Journal of Endovascular Therapy

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Purpose: To quantify the in-vivo deformations of the popliteal arterial segment (PAS) during leg flexion in subjects with clinically relevant (Fontaine Stage IIb) peripheral arterial disease (PAD).Methods: Five patients with varying calcification levels of the PAS undergoing endovascular revascularization underwent 3D rotational angiography. Image acquisition was performed with the leg straight and with a flexion of 70°/20° in the knee/hip joint. The arterial centerline and the corresponding branches in both positions were segmented to create 3D reconstructions of the arterial trees. Axial deformation, twisting, and curvatures were quantified. Furthermore, the relationships between the calcification levels and the deformations were investigated. Results:We observed an average shortening of the PAS of 5.9% ± 2.5% and twist rate of 3.8 Conclusions:The PAS of patients with symptomatic PAD is exposed to significant deformations during flexion of the knee joint. The curvature is directly affected by the extent of arterial calcification. In contrast, the changes in arterial length and twisting angles are comparable to those of healthy arteries. These measurements have the potential to be used for realistic arterial modeling to improve stent designs.This study also showed the ability of rotational angiography to quantify the three-dimensional deformations of the PAS in patients with various levels of calcification, and that this technique can be used to collect data on larger groups of patients.

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Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial

Cited by 380 publications

References 12 publications

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

Standards of Practice for Superficial Femoral and Popliteal Artery Angioplasty and Stenting

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

Quantification of Popliteal Artery Deformation During Leg Flexion in Subjects With Peripheral Artery Disease: A Pilot Study

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