Biodegradable-polymer-based, sirolimus-eluting Supralimus® stent: 6-month angiographic and 30-month clinical follow-up results from the Series I prospective study

Dani, Sameer; Kukreja, Neville; Parikh, Prakashvir; Joshi, Hasit; Prajapati, Jayesh; Jain, Sharad; Thanvi, Sunil; Shah, Bhupesh; Dutta, Jyoti-Prakash

doi:10.4244/eijv4i1a11

Cited by 47 publications

(27 citation statements)

References 29 publications

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“…Hence, the question arises whether the DAPT may shorten post implantation. As previously shown, BP-SES implantation presented good clinical and angiographic outcomes in patients subjected to six months of DAPT [18,22]. Initial optical coherence tomography reports showed that BP-SES characterised faster coverage with neointima, as compare to durable SES [8].…”

Section: (89%)mentioning

confidence: 59%

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

et al. 2016

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A b s t r a c tBackground: Data from clinical trials suggested that biodegradable-polymer-based drug-eluting stents (DES) might improve long-term clinical outcomes. PROLIM (Balton, Warsaw, Poland) DES is based on a stainless steel platform with a closed cell design releasing sirolimus from biodegradable copolymer (lactic and glycolic acid) in eight weeks. Aim:In the present study the safety and the efficacy of a PROLIM stent was assessed in patients with de novo coronary lesions in 12-month clinical follow-up. Methods:It was a single-centre, observational, prospective registry to assess the safety and efficacy of a PROLIM stent implantation in all consecutive patients with de novo coronary artery lesions treated with percutaneous coronary intervention (PCI). The primary study endpoint was a composite safety (cardiac death, non-fatal myocardial infarction), and the second study endpoint was the efficacy of PROLIM implantation-clinically driven target vessel revascularisation (TVR) assessed at 12-month follow-up. Results:One hundred patients were enrolled into the study and 118 PROLIM stents were implanted. Thirty-two (32%) patients had diabetes, 46 (46%) patients were prior PCI, and 17 (17%) patients had coronary artery bypass grafting. 67% of stented lesions were complex ones (B2/C) and 17% were bifurcations. During the 12-month follow-up primary study endpoints occurred in five (5%) patients. Two (2%) cardiac deaths were reported and three (3%) TVRs were performed, of which one was related to in-PROLIM stent restenosis.Conclusions: PCI with biodegradable-polymer PROLIM DES seems to be safe and effective in 12-month follow-up. A larger trial is warranted to assess clinical outcomes post PROLIM stent implantation.

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Section: (89%)mentioning

confidence: 59%

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

et al. 2016

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“…Efficacy of a sirolimus-eluting stent with the use of a stainless steel platform and a biostable polymer has been well documented in medical literature [22][23][24][25][26]. 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.…”

Section: Discussionmentioning

confidence: 99%

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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“…No estudo SERIES I, com 100 pacientes predominantemente com angina estável e anatomia coronária não-complexa, esse stent farmacológico apresentou perda tardia de 0,09 ± 0,28 mm no reestudo angiográfico de seis meses. Mais relevante, porém, foi o fato de que, após 30 meses de seguimento, 93% dos pacientes encontravam-se livres de qualquer evento cardíaco adverso maior, com apenas 1% de trombose definitiva/provável 23 .…”

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Emprego do stent farmacológico Supralimus, com sirolimus e polímero absorvível, no tratamento de pacientes com síndrome coronária aguda submetidos a intervenção coronária percutânea

Costa

Abizaid

et al. 2009

Rev. Bras. Cardiol. Invasiva

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Biodegradable-polymer-based, sirolimus-eluting Supralimus® stent: 6-month angiographic and 30-month clinical follow-up results from the Series I prospective study

Cited by 47 publications

References 29 publications

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective 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

Emprego do stent farmacológico Supralimus, com sirolimus e polímero absorvível, no tratamento de pacientes com síndrome coronária aguda submetidos a intervenção coronária percutânea

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Biodegradable-polymer-based, sirolimus-eluting Supralimus® stent: 6-month angiographic and 30-month clinical follow-up results from the Series I prospective study

Cited by 47 publications

References 29 publications

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective 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

Emprego do stent farmacológico Supralimus, com sirolimus e polímero absorvível, no tratamento de pacientes com síndrome coronária aguda submetidos a intervenção coronária percutânea

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Emprego do stent farmacológico Supralimus, com sirolimus e polímero absorvível, no tratamento de pacientes com síndrome coronária aguda submetidos a intervenção coronária percutânea