Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients

Danzi, Gian Battista; Piccolo, Raffaele; Chevalier, Bernard; Urban, Philip; Fath‐Ordoubadi, Farzin; Carrié, Didier; Wiemer, Marcus; Serra, Antonio; Wijns, William; Kala, Petr; Stabile, Amerigo; Ruigómez, Javier Goicolea; Sagić, Dragan; Laanmets, Peep; Strupp, Gerhard; West, Nick E.J.

doi:10.1136/heartjnl-2016-309283

Cited by 10 publications

(4 citation statements)

References 22 publications

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“…The prevention of incomplete endothelialisation and ongoing inflammatory response to permanent polymer might have brought better clinical outcomes 10–12. At present, the efficacy and safety of BP-BES are confirmed only for 5 years after the procedure and those beyond 5 years remain to be investigated 13. Moreover, limited data are available on the incidence and risk of bleeding in patients after BP-BES implantation, which has relatively low risk of ST.…”

Section: Introductionmentioning

confidence: 99%

Long-term (8–10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation

Ohya

Kubo

Kuwayama

et al. 2017

Heart

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Section: Introductionmentioning

confidence: 99%

Long-term (8–10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation

Ohya

Kubo

Kuwayama

et al. 2017

Heart

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“…Por outro lado, esses resultados favoráveis estão de acordo com vários outros ensaios clínicos com SF revestidos com polímeros biodegradáveis, nos quais as taxas de eventos combinados em cinco anos variaram entre 10,0% a 13,4%. [11][12][13][14] No estudo randomizado LEADERS, o grupo de pacientes tratados com um BES semelhante ao stent do DESTINY, apresentou uma taxa de eventos combinados, morte por todas Tabela 1. Características da população do estudo.…”

Section: Discussionunclassified

Comparative Clinical Performance of Two Types of Drug-Eluting Stents with Abluminal Biodegradable Polymer Coating: Five-Year Results of the DESTINY Randomized Trial

Dourado¹

2022

RCHSI

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Introduction and Objectives: The Stents Coated with the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the InspironTM sirolimus-eluting stent (SES) with the control BiomatrixTM Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. Methods: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. Results: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. Conclusions: The novel InspironTM stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation BiomatrixTM Flex biolimus-eluting stent.

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“…With long-term data available in 89.3% patients, the recently published 5-year data reported cumulative TLR and definite/probable ST rates of 5.3% and 1.1%, respectively. Between years 1 and 5 the TLR and VLST rates were 3.5% and 0.6%, respectively [41]. More recently, the COMPARE II [42] and NEXT [43] trials also showed non-inferiority of the Nobori stent at 5 years and 3 years in regard to safety and efficacy when compared to the Xience-V (Abbott Vascular, Redwood City, CA, USA) and Xience/Promus (Abbott Vascular) stents, respectively.…”

Section: Noborimentioning

confidence: 99%

Novel bioabsorbable polymer and polymer-free metallic drug-eluting stents

Nogic

McCormick

Francis

et al. 2018

Journal of Cardiology

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The introduction of drug-eluting stents (DES) significantly reduced angiographic restenosis and the clinical need for revascularization following percutaneous coronary intervention. However, concerns remain regarding the long-term safety and efficacy of DES. The use of durable polymers for drug elution that have limited biocompatibility is thought to contribute toward DES failure, by promoting an adverse local inflammatory response and vascular toxicity. Biodegradable polymer and polymer-free metallic stents represent two novel technological solutions to this challenging clinical problem. This review summarizes the available clinical evidence supporting the use of either biodegradable polymer or polymer-free DES platforms.

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Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients

Abstract: ISRCTN81649913; Results.

Cited by 10 publications

References 22 publications

Long-term (8–10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation

Long-term (8–10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation

Comparative Clinical Performance of Two Types of Drug-Eluting Stents with Abluminal Biodegradable Polymer Coating: Five-Year Results of the DESTINY Randomized Trial

Novel bioabsorbable polymer and polymer-free metallic drug-eluting stents

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