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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Late restenosis following sirolimus-eluting stent implantation
John Cosgrave1, Simon J Corbett, Gloria Melzi
1EMO Centro Cuore Columbus, Milan, Italy. cosgravejohn@yahoo.co.uk
Insights
Late restenosis after sirolimus-eluting stent implantation is a real, though infrequent, clinical entity. This finding suggests that restenosis should be considered when patients experience symptoms more than one year post-procedure.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Sirolimus-eluting stents (SES) show promising short-term results.
- Long-term outcomes and late complications of SES require further investigation.
Purpose of the Study:
- To ascertain if in-stent restenosis occurring more than one year after SES implantation is a genuine clinical occurrence.
- To evaluate the incidence and characteristics of late restenosis following SES implantation.
Main Methods:
- Retrospective analysis of SES implantation data from a single institution (pre-March 2003).
- Inclusion criteria for late restenosis: patent stent at 6-9 months and documented restenosis after 1 year.
- Angiographic follow-up data from 433 patients (928 lesions) were analyzed.
Main Results:
- Overall restenosis rate was 23.5% (160/679 lesions).
- Late restenosis, defined as occurring >1 year post-implantation, was documented in 2.6% of lesions (18/679).
- The median time for documentation of late restenosis was 607 days.
Conclusions:
- Late restenosis is an infrequent but confirmed clinical entity after sirolimus-eluting stent implantation.
- The possibility of restenosis should not be dismissed for symptoms arising beyond one year post-SES implantation.
- Further research into the mechanisms and management of late restenosis is warranted.
Abstract:
Despite encouraging results from randomized trials, concerns exist about long-term results of sirolimus-eluting stent implantation. We sought to determine whether in-stent restenosis occurring >1 year ("late") after sirolimus-eluting stent implantation is a real clinical entity. We analyzed data on all sirolimus-eluting stents implanted in our institution before March 2003. During the study period 928 lesions in 433 patients were treated. Angiographic follow-up was performed in 306 patients (70.6%) with 679 lesions (73.2%). Angiography after 1 year was performed only in symptomatic patients. We considered restenosis "early" if it occurred during the first year and late if after 1 year. Late restenosis required demonstration of a widely patent stent at 6 to 9 months, with repeat angiography after 1 year demonstrating restenosis. Restenosis occurred in 160 lesions overall (23.5%). Of the 31 (4.6%) that were documented after 1 year, 13 were excluded from analysis due to absence of 6- to 9-month angiography; the remaining 18 (2.6%, 1.7 to 4.2) fulfilled our criteria for late restenosis (median time of documentation 607 days, interquartile range 511 to 923). In conclusion, late restenosis is an infrequent but real entity; its existence implies we should not discount the possibility of restenosis as the cause of symptoms that develop >1 year after sirolimus-eluting stent implantation.
