Primary Everolimus-Eluting Stenting Versus Balloon Angioplasty With Bailout Bare Metal Stenting of Long Infrapopliteal Lesions for Treatment of Critical Limb Ischemia

Karnabatidis, Dimitris; Spiliοpoulos, Stavros; Diamantopoulos, Athanasios; Κατσάνος, Κωνσταντίνος; Kagadis, George C.; Kakkos, Stavros K.; Siablis, Dimitris

doi:10.1583/10-3242.1

Cited by 66 publications

(61 citation statements)

References 35 publications

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“…Primary patency rate at 3-years of follow-up was reported by Karnabatidis et al [15] (29.7 % DES vs 20.6 % BMS; P<0.0001); the 1-year patency rate was between 75.0 % (ACHILLES [13]) and 86 % reported by Siablis et al [14] Target lesion revascularisation was between 8.7 % (DESTINY) and 13.8 % (YUKON) [9,10].…”

Section: Angiographic and Clinical Resultsmentioning

confidence: 60%

“…However, in long-term studies, limb salvage (YUKON: sirolimus-eluting stents 98.7 % vs BMSs 94.5 %, P=0.17; Siablis et al [14]: sirolimus-eluting stents 82.0 % vs BMSs 80.3 %, P=0.507 at 3 years; Karnabatidis et al [15] reported major amputation-free survival of 77.1 % vs 86.9 %, P=0.2) and mortality (YUKON: 26.3 % sirolimus-eluting stents vs 32.3 % BMSs, P=0.6; Siablis et al [14]: 32.0 % sirolimuseluting stents vs BMSs 29.3 %, P=0.2; Karnabatidis et al [15] reported survival of 82.2 % for DESs vs 65.7 % for BMSs, P= 0.9) did not differ as significantly different between DESs and BMSs at 3 years as that found in other studies [6]. …”

Section: Angiographic and Clinical Resultsmentioning

confidence: 99%

“…More data are available for DES, and level A (data derived from multiple randomised clinical trials or meta-analyses) and B (data derived from a single randomised controlled trial or large non-randomised studies) evidence supports the use of DES as a primary treatment for patients with critical limb ischaemia [5,[9][10][11][13][14][15]. However some issues are still present, such as long and small vessels, fracture rate and compromised future surgical intervention.…”

Section: Discussionmentioning

confidence: 99%

“…On the basis of these randomised controlled trials and other published studies [5,[9][10][11][12][13][14][15], features of DESs for below-theknee lesions may be summarised as follows:…”

Section: Drug-eluting Stent (Des)mentioning

confidence: 99%

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Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Fanelli

Cannavale

2014

Eur Radiol

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To analyse data comparing drug-eluting devices versus non-coated devices in the treatment of vascular disease in the infrapopliteal region. All data available in the literature (16 studies were included) comparing drug-eluting stents (DESs) and drug-eluting balloons (DEBs) versus bare-metal stents (BMSs) and conventional balloons were analysed. For each single study, primary and secondary endpoints were reported. As comparative studies between DEBs and DESs were not available, a technical evaluation of the advantages and disadvantages of both were also included. Besides the limitations of the published studies, all of them were reporting interesting results for the new generation devices (DEB and DES). DES: primary patency at 1 year comprised between 75.0 % and 86 %; target lesion revascularisation between 8.7 % and 13.8 %. DEB: primary patency comprised between 71 % and 84.6 % at 12 months; target lesion revascularisation between 15.3 % and 17.6 %. However, limb salvage rates were not always higher using a DEB rather than a standard percutaneous transluminal angioplasty (PTA); a clinical improvement for patients treated with DEB was demonstrated only in the Leipzig registry. On the basis of the results available, the drug-eluting devices produced better results. DEB can be considered the leading approach in below-the-knee disease. A comparative evaluation with DES is mandatory in the future. Key Points • We present data about advanced endovascular treatment of peripheral artery disease.• This provides an update on drug-eluting devices in infrapopliteal vascular disease.• Drug-eluting devices (DEB/DES) show promising results compared with traditional ones.Abbreviations BMS bare-metal stent DEB drug-eluting balloon DES drug-eluting stent PTA percutaneous transluminal angioplasty SFA superficial femoral artery

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Section: Angiographic and Clinical Resultsmentioning

confidence: 60%

Section: Angiographic and Clinical Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…On the basis of these randomised controlled trials and other published studies [5,[9][10][11][12][13][14][15], features of DESs for below-theknee lesions may be summarised as follows:…”

Section: Drug-eluting Stent (Des)mentioning

confidence: 99%

See 2 more Smart Citations

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Fanelli

Cannavale

2014

Eur Radiol

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“…[14,15,[25][26][27][28][29][30][31]. These devices are associated with significantly better primary patency, primaryassisted patency, and fewer secondary interventions at 3-year follow-up than balloon angioplasty.…”

Section: Infrapopliteal Stentingmentioning

confidence: 99%

SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use

Gray

Díaz‐Sandoval

Dieter

et al. 2014

Cathet Cardio Intervent

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Intervention to treat infrapopliteal arterial disease can be challenging because the patients' comorbidities, the anatomic variables, and the limitations of our techniques. Clinical scenarios based on anatomic and clinical variables are presented. Recommendations regarding intervention (appropriate care, may be appropriate care, rarely appropriate care) are made based on best evidence. V C 2014 Wiley Periodicals, Inc.Key words: peripheral intervention; appropriate use; peripheral arterial disease INTRODUCTION Infrapopliteal (IP) arterial disease or "below the knee" arterial disease is commonly seen in patients with long-standing diabetes mellitus, chronic kidney disease, or the elderly. The most concerning manifestation of peripheral arterial disease (PAD) in these high risk patients is the development of critical limb ischemia (CLI: ischemic rest pain or ischemic ulcers). This arterial bed consists of relatively small caliber vessels, which are often calcified and associated with diffuse, multilevel disease. Due to the complexity of this patient population, their co-morbidities, and severity of vascular disease, there is a paucity of scientific evidence for the generalizability of percutaneous revascularization.In general, non-ambulatory patients with a short life expectancy and extensive necrosis or gangrene should undergo primary amputation. Ambulatory patients who are acceptable surgical candidates, expected to survive more than two years with a patent IP artery that provides direct flow to the foot (considered to be a good distal target), and an adequate autologous venous conduit should be considered for surgical bypass. Patients with significant medical co-morbidities that limit life expectancy, those at increased risk for surgery, those without an adequate distal target for bypass, or with poor venous conduit should be considered for an endovascular-first approach.This document was developed to guide physicians in clinical decision-making in the modern practical application of endovascular intervention for patients with IP arterial disease. ANATOMIC CONSIDERATIONSPatients with CLI typically have disease involving multiple levels (i.e., aorto-iliac, femoropopliteal (FP) and IP), but less than 10% of patients with CLI have hemodynamically significant disease in all three levels [1][2][3] (Table I). Infrainguinal disease (FP and IP) can be further subdivided into those with predominantly isolated IP disease ( 33%) and those with both FP and IP disease ( 67%) [4][5][6][7].Additional Supporting Information may be found in the online version of this article. Catheterization and Cardiovascular Interventions 84:539-545 (2014) Isolated IP disease is mainly seen in the elderly (>80-years old), diabetic, or dialysis-dependent patients [5]. These patients are at higher risk for amputation and have a shorter amputation-free survival compared to those with FP and IP disease (median amputation-free survival: 17 months (95% CI ¼ 9-24 m) versus 37 months (95% CI ¼ 28-44 m), P ¼ 0.001) [6]. Clinical and non-invasive cr...

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Predictors of adverse clinical outcomes after successful infrapopliteal intervention

Kawarada

Fujihara

Higashimori

et al. 2012

Cathet Cardio Intervent

153

127

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Primary Everolimus-Eluting Stenting Versus Balloon Angioplasty With Bailout Bare Metal Stenting of Long Infrapopliteal Lesions for Treatment of Critical Limb Ischemia

Abstract: Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.

Cited by 66 publications

References 35 publications

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use

Predictors of adverse clinical outcomes after successful infrapopliteal intervention

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