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Thromb Haemost 2012; 107(06): 1161-1171
DOI: 10.1160/TH12-01-0043
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH

Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation

Tobias Koppara   *
1   Deutsches Herzzentrum München, Munich, Germany
,
Michael Joner   *
1   Deutsches Herzzentrum München, Munich, Germany
,
Gerd Bayer
2   BIOTRONIK SE & Co. KG, Erlangen, Germany
,
Kristin Steigerwald
1   Deutsches Herzzentrum München, Munich, Germany
,
Tobias Diener
2   BIOTRONIK SE & Co. KG, Erlangen, Germany
,
Eric Wittchow
2   BIOTRONIK SE & Co. KG, Erlangen, Germany
› Author Affiliations Financial support: This study was funded by BIOTRONIK SE & Co. KG, Erlangen, Germany.
Further Information

Publication History

Received: 24 January 2012

Accepted after major revision: 21 March 2012

Publication Date:
29 November 2017 (online)

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Summary

Biodegradable stent coatings were recently introduced as a potential solution to overcome sustained inflammatory responses observed with permanent polymer-based drug-eluting stents. In a preliminary study, selected biodegradable or permanent polymer-based sirolimus-eluting stent (SES) formulations were screened for effectiveness in comparison to bare metal stents (BMS) at 28 days. Subsequently, the most favourable SES formulation was compared to commercially available SES (CypherTM) at 28,90 and 180 days to investigate the histopathologic response as well as tissue, blood and organ pharmacokinetics. Overlapping SES implantation was conducted to evaluate vascular healing at 28 days in this particular setting. SES with biodegradable poly (L-lactide) polymer (PLLA) or poly(lactide-co-glycolide) showed the most favourable outcome with regards to reductions in neointimal area in comparison to BMS at 28 days. The PLLA SES showed a similar reduction in neointimal area compared to CypherTM at 28 days, with significant greater reductions at 90 and 180 days (1.7 ± 0.7 mm2 vs. 3.1 ± 1.5 mm2, p=0.03 and 1.8 ± 1.2 mm2 vs. 3.0 ± 1.5 mm2, p=0.01, respectively). Sirolimus vascular tissue concentrations were detectable up to 90 days following implantation. Overlapping stented segments showed favourable histopathologic results with respect to fibrin deposition and endothelialisation at 28 days. In conclusion, the use of PLLA as drugeluting matrix resulted in mild inflammatory responses in the presence of effective sirolimus tissue concentrations. The greater efficacy observed at long-term follow-up in PLLA SES compared to CypherTM may be a multifactorial result of stent design, polymer biocompatibility and improved release kinetics.

Keywords

Porcine model - sirolimus-eluting stents - restenosis

* These authors contributed equally to this manuscript.


 

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