Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in “Real-World” Practice

Han, Yaling; Jing, Quanmin; Xu, Bo; Yang, Lixia; Liu, Huiliang; Shang, Xiaoming; Jiang, Tieming; Li, Zhanquan; Zhang, Hua; Li, Hui; Qiu, Jian; Lei, Yingfeng; Li, Yang; Chen, Xuezhi; Gao, Runlin; Investigators, Create

doi:10.1016/j.jcin.2008.12.013

Cited by 79 publications

(41 citation statements)

References 36 publications

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“…The stents' clinical effectiveness and safety was initially demonstrated in the 100-patient SERIES I (Study on the Supralimus ® Sirolimus-Eluting Stent in the Treatment of Patients With Real World Coronary Artery Lesions) First-in-Man study, which reported a rate of in-stent angiographic restenosis of 0.0% and a late loss of 0.09 ± 0.37 mm at 6-months of follow-up. At 30 months, the rate of target vessel revascularisation (TVR) was 4%, with no reported definite ST [27]. Similar clinical effectiveness and safety have been reported at 6-months of follow-up in the larger e-SERIES multicenter registry, which included over 1,100 patients [28].…”

Section: Discussionmentioning

confidence: 58%

Experience with Biodegradable Polymer Coated Sirolimus-Eluting Coronary Stent System in “Real-Life” Percutaneous Coronary Intervention: 24-Month Data from the Manipal-S Registry

Shetty¹,

Vivek²,

Thakkar³

et al. 2013

JCDR

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Introduction: Despite the undeniable clinical efficacy of drugeluting stents with durable polymers, concerns regarding their long-term safety have been raised, especially in more complex subsets. The Manipal-S Registry was designed to evaluate the safety and effectiveness of the biodegradable polymer coated Supralimus ® Sirolimus-Eluting Coronary Stent for the treatment of coronary artery disease, across a wide range of patients who are treated in real-life clinical practice.Methods: All the consecutive 116 patients who underwent singlevessel or multiple vessel percutaneous coronary interventions with the use of Supralimus ® sirolimus-eluting stents between September 2009 and December 2010, were included in this study. Patients were clinically followed-up at 1, 9, 12 and 24 months post-procedure. All clinical, procedural, and follow-up information were collected and analysed. Results:In total 116 patients, 126 lesions were implanted with 144 stents which had an average stent length of 25.8±8.0 mm. The incidences of any major adverse cardiac and cerebral events at 1, 9, 12 and 24 months were 0, 5 (4.3%), 8 (6.9%), and 10 (8.6%) respectively. Conclusion:These 24-month results clearly provide evidence for safety and effectiveness of the Supralimus ® Sirolimus-eluting coronary stent system with the biodegradable polymer in real-life patients, even in those with acute myocardial infarctions.

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Section: Discussionmentioning

confidence: 58%

Experience with Biodegradable Polymer Coated Sirolimus-Eluting Coronary Stent System in “Real-Life” Percutaneous Coronary Intervention: 24-Month Data from the Manipal-S Registry

Shetty¹,

Vivek²,

Thakkar³

et al. 2013

JCDR

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“…The Excel stent is a sirolimus-eluting stent (SES) coated with a biodegradable polylactic acid (PLA) polymer and its feature has been described elsewhere [12]. The PLA polymer resorption is complete in the porcine model by 6 to 9 months, thus leaving only the bare-metal platform in perpetuity.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and safety of a biodegradable polymer sirolimus-eluting stent in primary percutaneous coronary intervention: a randomized controlled trial

Li¹,

Tong²,

Wang³

et al. 2013

aoms

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IntroductionWith long-term follow-up, whether biodegradable polymer drug-eluting stents (DES) is efficient and safe in primary percutaneous coronary intervention (PCI) remains a controversial issue. This study aims to assess the long-term efficacy and safety of DES in PCI for ST-segment elevation myocardial infarction (STEMI).Material and methodsA prospective, randomized single-blind study with 3-year follow-up was performed to compare biodegradable polymer DES with durable polymer DES in 332 STEMI patients treated with primary PCI. The primary end point was major adverse cardiac events (MACE) at 3 years after the procedure, defined as the composite of cardiac death, recurrent infarction, and target vessel revascularization. The secondary end points included in-segment late luminal loss (LLL) and binary restenosis at 9 months and cumulative stent thrombosis (ST) event rates up to 3 years.ResultsThe rate of the primary end points and the secondary end points including major adverse cardiac events, in-segment late luminal loss, binary restenosis, and cumulative thrombotic event rates were comparable between biodegradable polymer DES and durable polymer DES in these 332 STEMI patients treated with primary PCI at 3 years.ConclusionsBiodegradable polymer DES has similar efficacy and safety profiles at 3 years compared with durable polymer DES in STEMI patients treated with primary PCI.

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“…The safety and efficacy of these devices have been assessed clinically in first in man (FIM) and observational studies [30][31][32] . For example, in the Paclitaxel In Stent Controlled Elution Study, the pharmacokinetics of the DES and not dose of the immunosuppressive agent appears to be associated with neointimal suppression and clinical outcome [30] .…”

Section: Technologymentioning

confidence: 99%

Advantages and disadvantages of biodegradable platforms in drug eluting stents

Rodriguez-Granillo

Rubilar²,

Rodríguez-Granillo³

et al. 2011

WJC

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Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to baremetal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place.Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

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Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in “Real-World” Practice

Cited by 79 publications

References 36 publications

Experience with Biodegradable Polymer Coated Sirolimus-Eluting Coronary Stent System in “Real-Life” Percutaneous Coronary Intervention: 24-Month Data from the Manipal-S Registry

Experience with Biodegradable Polymer Coated Sirolimus-Eluting Coronary Stent System in “Real-Life” Percutaneous Coronary Intervention: 24-Month Data from the Manipal-S Registry

Efficacy and safety of a biodegradable polymer sirolimus-eluting stent in primary percutaneous coronary intervention: a randomized controlled trial

Advantages and disadvantages of biodegradable platforms in drug eluting stents

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