Sirolimus-Eluting Versus Bare Stents for Bailout After Suboptimal Infrapopliteal Angioplasty for Critical Limb Ischemia: 6-Month Angiographic Results From a Nonrandomized Prospective Single-Center Study

Siablis, Dimitris; Kraniotis, Pantelis; Karnabatidis, Dimitris; Kagadis, George C.; Κατσάνος, Κωνσταντίνος; Tsolakis, John

doi:10.1583/05-1620mr.1

Cited by 108 publications

(105 citation statements)

References 35 publications

(49 reference statements)

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“…While this strategy appears to be both safe and feasible, trials comparing balloon angioplasty to bare-metal stents have not been done, and it remains to be proven that infrapopliteal stent placement improves clinical outcomes [12]. Recently, in an attempt to improve long-term patency, coronary drug-eluting stents have also been placed below the knee [13][14][15]. Because continued patency of infrapopliteal vessels correlates with improved clinical outcomes in patients undergoing peripheral bypass surgery [16] and coronary drug-eluting stents markedly reduce restenosis compared to bare metal stents [17][18][19], strategies that maximize stent patency would be expected to yield improved clinical outcomes.…”

Section: Discussionmentioning

confidence: 99%

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Grant

White

Collins

et al. 2007

Cathet Cardio Intervent

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Objective: We report our experience with the elective placement of below-knee, drugeluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3-year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug-eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug-eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n 5 1) or limb-threatening ischemia (n 5 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug-eluting stents were electively placed in 12 below-knee arteries in 10 patients, resulting in an average of 1.7 6 0.7 stents per patient. The mean lesion length was 24.8 6 10.9 mm, the mean total stent length was 38.3 6 19.1 mm, and the mean nominal stent diameter was 2.8 6 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 6 6.5 months of follow-up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug-eluting stent patency in each case. Conclusions: The use of below-knee drug-eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. '

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Section: Discussionmentioning

confidence: 99%

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Grant

White

Collins

et al. 2007

Cathet Cardio Intervent

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“…Most of current DES platforms slowly release cytostatic sirolimus or cytotoxic paclitaxel [9,43]. DCB are balloon catheters that are engineered for acute release of cytotoxic paclitaxel upon immediate contact with the vessel wall using an appropriate excipient, i.e., a drug carrier (contrast, urea, sorbitol) [7].…”

Section: Equipment Specificationsmentioning

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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“…Angiographic follow-up 6 months after index intervention revealed a binary in-stent restenosis of only 4.0% after Cypher stent implantation, while the rate was as high as 55.3% after BMS implantation (p < 0.001). 14 Siablis et al. also published their 1-year follow-up results showing 86.4% primary patency in patients with DES, whereas patients with BMS had primary patency of 40.5% (p < 0.001).…”

Section: Drug Eluting Balloon-expandable Stentsmentioning

confidence: 94%

Current status of infrapopliteal artery stenting in patients with critical limb ischemia

et al. 2008

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Due to the fear that early thrombosis and late luminal loss resulting from intimal hyperplasia might impede sustained patency of small-caliber arteries, such as those of the infrapopliteal bed, stent implantation in below-knee vessels remains controversial and is generally reserved for cases with a suboptimal outcome after percutaneous transluminal angioplasty (i.e. > 50% residual stenosis, flow-limiting dissection). Although evidence starts to build, favoring the use of stenting in the tibial area, results of well-conducted randomized controlled trials have to be awaited to change this strategy. Because of diameter similarities with coronary arteries, the first stents applied in the infrapopliteal vessels were all coronary devices. Once the feasibility of the stenting approach with these coronary products was shown, device manufacturers started to develop a dedicated infrapopliteal product range. To date, a broad spectrum of stent types has been used and investigated for the given indication. This article overviews the available literature and results of different balloon-expandable (bare metal, passive coated, drug eluting), self-expanding and absorbable stent types available for below-the-knee application and gives recommendations for future device technology advancements.Keywords: Stents, ischemia, arteriosclerosis. ResumoDevido ao receio de que a trombose precoce ou a estenose tardia por hiperplasia intimal possam impedir a manutenção da perviedade em vasos de pequeno calibre, o uso de stents pós-angioplastia no leito arterial infrapoplíteo permanece controverso e geralmente é reservado aos casos de resultado subótimo após angioplastia transluminal percutânea (isto é, estenose residual > 50% ou dissecção com limitação do fluxo). Apesar de evidências começarem a favorecer o uso de stents no segmento tibial, é necessário aguardar o resultado de ensaios controlados, randomizados e bem conduzidos para mudar esta estratégia. Sendo estes vasos infrapoplíteos de diâmetro similar às artérias coronárias, os primeiros stents usados neste segmento eram todos stents coronários. Uma vez que se mostrou exeqüível o uso destes stents, a indústria iniciou o desenvolvimento de uma linha de produtos específicos ao segmento infrapoplíteo. Atualmente uma gama de stents tem sido usada e investigada para este fim. Este artigo revê resultados disponíveis na literatura com diferentes stents expansíveis por balão (metal não-recoberto, revestimento passivo, eluição de fármacos), auto-expansíveis e absorvíveis disponíveis para o segmento infrapoplíteo e apresenta recomendações para os futuros avanços tecnológicos dos dispositivos.Palavras-chave: Stents, isquemia, arteriosclerose.

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Sirolimus-Eluting Versus Bare Stents for Bailout After Suboptimal Infrapopliteal Angioplasty for Critical Limb Ischemia: 6-Month Angiographic Results From a Nonrandomized Prospective Single-Center Study

Cited by 108 publications

References 35 publications

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Infrapopliteal drug‐eluting stents for chronic limb ischemia

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

Current status of infrapopliteal artery stenting in patients with critical limb ischemia

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