EditorialLate Stent Thrombosis: Problem or Not?
Section snippets
Very Late Stent Thrombosis
Stent thrombosis has been recognized since the earliest days of stent implantation. With the use of modern deployment techniques and antiplatelet therapy, thrombosis in bare metal stents occurs in several phases: a peri-implant phase—typically <7 days after implantation, an early phase—until 30 days after implant, and a late phase—typically within the first year. Stent thrombosis that occurred after the first year was believed to be very uncommon in the BMS era.
At the recent FDA Panel meeting,
Recommendations
A number of recommendations came out of the Advisory Panel Meeting that may aid in the care of patients and the development of future stents. First, DESs are devices that require concomitant drug therapy (dual antiplatelet therapy). A patient buys both, not 1 without the other. Studies need to assess antiplatelet therapy (dose, response, duration) along with device assessment. The variability of response due to genetic polymorphism, drug interaction at CYP3A4, and lack of clopridogrel
References (25)
- et al.
Effectiveness and safety of sirolimus stent implantation for coronary in-stent restenosis
J Am Coll Cardiol
(2006) - et al.
Clinical outcomes for sirolimus-eluting stents and polymer-coated paclitaxel-eluting stents in daily practice
Am J Cardiol
(2006) - et al.
Sirolimus-eluting stents remain superior to bare-metal stents at two years
J Am Coll Cardiol
(2006) - et al.
Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents
J Am Coll Cardiol
(2006) - et al.
Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand
J Pharma Biomed Ana
(2004) - et al.
Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk
J Am Coll Cardiol
(2006) - et al.
Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction
J Am Coll Cardiol
(2005) Safety of drug-eluting stents: a meta-analysis of first generation drug eluting stent programs
(2006)- et al.
Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis
Eur Heart J
(2006) - et al.
Safety and efficacy of the sirolimus-eluting BX Velocity stent in the treatment of patients with de novo native small vessel coronary artery lesions: integrated analysis of the Cypher randomized control trials
Am J Cardiol
(2006)
Drug eluting stents in patients with acute coroncary syndromes undergoing percutaneous coronary intervention: the ACUITY Trial
Am J Cardiol
Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents
Circulation
Cited by (4)
Micropatterning of a 2-methacryloyloxyethyl phosphorylcholine polymer surface by hydrogenated amorphous carbon thin films for endothelialization and antithrombogenicity
2019, Acta BiomaterialiaCitation Excerpt :Once the drug elution was completed, LST could occur because of the endothelial dysfunction. The incompleteness of the endothelial-cell coverage over the stent surface due to the strong drug effect could eventually result in an acute myocardial infarction or even sudden death [5]. The improvement of the biocompatibility including the enhancement of the anti-thrombogenicity of stent surface, which can facilitate re-endothelialization and release drugs in a controlled fashion, has therefore been much needed for the development of new stents.
Time course analysis of antithrombogenic properties of fluorinated diamond-like carbon coating determined via accelerated aging tests: Quality control for medical device commercialization
2016, Diamond and Related MaterialsCitation Excerpt :Drug-eluting stents (DES), which have been developed to improve BMS, markedly reduce early restenosis to a greater extent than BMS by eluting drugs from stent surfaces. However, the risk of late stent thrombosis and late restenosis beyond 1 year after stenting still remains due to the delay of endothelialization by the strong side effects of released drugs [5,6]. Thus, to develop a new stage of stents, antithrombogenic properties and endothelium compatibility are essential.
Pharmaco-active stent and antiaggregation. Preoperative attitude
2008, FMC Formacion Medica Continuada en Atencion PrimariaHuman umbilical vein endothelial cell interaction with fluorine- incorporated amorphous carbon films
2012, Japanese Journal of Applied Physics
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Drs. Somberg and Weinberger served on the Circulatory Device Panel convened to discuss stent thrombosis December 7 and 8, 2006. The observations and opinions presented do not necessarily represent those of the Panel or the United States Food and Drug Administration.