Healing and early stent coverage after ultrathin strut biodegradable polymer-coated sirolimus-eluting stent implantation: SiBi optical coherence tomography study
Catheter. cardiovasc. interv
; 98(7): 1335-1342, Dec. 2021. ilus, graf, tab
Article
in English
| CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1352807
Responsible library:
BR79.1
ABSTRACT
ABSTRACT AIMS:
The aim of SiBi study was to evaluate the early vascular healing and neointimal coverage after implantation of ultrathin (60 µm) biodegradable polymer-coated Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent (SES) using optical coherence tomography (OCT) at 4 to 6 weeks after implantation.METHODS:
SiBi was a single-center, observational, investigator-initiated study. From January 15, 2018 to April 15, 2018, total 29 consecutive patients who had consented and underwent OCT examination at 46 weeks after Tetriflex SES implantation were enrolled. All OCT images were analyzed at an independent core laboratory by analysts who were blinded to patient and procedural information.RESULTS:
Of 29 patients, four patients were excluded, as those OCT images were technically inadequate for analysis. Therefore, 25 patients were included in final OCT analysis. Average OCT analysis was performed after 35.3 ± 5 days of Tetriflex implantation. Total 14,024 stent struts in 1,520 cross sections were analyzed. Strut tissue coverage was observed in 91.26 ± 5.53% of struts and malapposed struts were seen in 0.89 ± 1.67%. The mean neointimal hyperplasia (NIH) thickness on the covered struts was 50 ± 30 µm.CONCLUSION:
A large percentage of struts were found to be covered with thin layer of NIH evenly distributed along the stent length at around 1 month from stent implantation. The results of this pilot study serve as ethical and scientific backbone to conduct an adequately powered clinical trial to evaluate outcomes of short dual-antiplatelet therapy in context of ultrathin strut stent.
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Collection:
National databases
/
Brazil
Database:
CONASS
/
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Main subject:
Stents
/
Sirolimus
/
Tomography, Optical Coherence
Aspects:
Ethical aspects
Language:
English
Journal:
Catheter. cardiovasc. interv
Year:
2021
Document type:
Article
Institution/Affiliation country:
Department of Cardiology, Shree B. D. Mehta Mahavir Heart Institute/IN
/
Interventional Cardiology Department, University of São Paulo/BR
/
Invasive Cardiology Department, Dante Pazzanese Institute of Cardiology/BR