Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis

BMC Cardiovascular Disorders

Zbigniew Śliwiński³  Piotr Seweryniak³  Tomasz Pawłowski³  Adam Kern¹  Robert J. Gil³  Jacek Bil² 

[1] Faculty of Medical Sciences University of Varmia and Masuria, Olsztyn, Poland;Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland;Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland

关键词: Prolim® stent;    OCT;    Biodegradable polymer;    Sirolimus-eluting stent;   

Others  :  1234494
DOI  :  10.1186/s12872-015-0139-5

 received in 2015-07-26, accepted in 2015-10-30,  发布年份 2015

【 摘 要 】

Background

The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.

Methods

We prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.

Results

There were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate – 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %.

Conclusions

Sirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness.

Trial registration number

ClinicalTrials.gov NCT02545985.

【 授权许可】

   
2015 Bil et al.

【 图 表 】

Fig. 1.

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