Eine Stentimplantation außerhalb der FDA-Indikationen für DES ist unabhängig von der Wahl des Stenttyps mit einer erhöhten Stentthromboserate verbunden

For decades, implantation of stents in coronary lesions after baloon dilatation has been the gold standard therapy in stenotic coronary artery disease. With the use of bare-metal stents, the cardiologist often saw an instent restenosis, which led to the invention of drug-eluting-stents. Unfortunately, the incidence of stent thrombosis rose with the use of drug-eluting stents. Knowing that many of the drug-eluting stents were used in lesions that were considered off-label, e.g. complex lesions, the rise of incidence of stent thrombosis has to be interpreted with care. There is no knowledge yet to wether the use of bare-metal stents in off-label lesions also raises the rate of stent thrombosis. The aim of this study is to determine the rate of stent thrombosis in drug-eluting vs. bare metal stents in off- vs. on-label use. Also, the predictors for stent thrombosis were sought after. Between 07/2002 and 10/2006, PCI was performed on 5945 patients using BMS (68%) or DES (32%). The follow-up period for definitive stent thrombosis (ARC criteria) was one year. 76 patients (1,27%) suffered from a definitive stent thrombosis. An additional consecutive 786 patients without stent thrombosis were included in the analysis. Procedural, angiographic and clinical parameters were analysed to define predictors of stent thrombosis. On-label or off-label implantation of stents (FDA-approved indications) was included as parameter in the analysis. 51% of the patients (n=434) received a stent according to the FDA-guidelines, 49% (n=428) of the patients had a stent implanted for an off-label indication. Predictors of stent thrombosis were percutaneous coronary intervention (PCI) in acute myocardial infarction (OR=4,91, p<0.001), treatment of bifurcation lesions (OR=3,43, p<0,001), stent length per mm (OR=1,07, p<0,001), implantation of multiple stents (OR=4,31, p<0,001), and stent implantation outside of FDA indications (OR=6,13, p<0,001). The risk of stent thrombosis was increased for bare-metal as well as drug-eluting stents. In a multivariate analysis PCI in acute myocardial infarction (OR=3,68, p=0,004), treatment of bifurcation lesion (OR=3,63, p=0,003), stent length in mm (OR=1,04, p=0,012) and implantation of multiple stents (OR=2,47; p=0,003) remained predictors of stent thrombosis. Off-label stent implantation remained hidden as combined parameter of the other criteria but was no independent predictor. In conclusions, implantation of coronary stents outside of the FDA approved indications for DES is associated with an increased risk of stent thrombosis using drug-eluting and bare-metal stents.

Grantor dc:publisher

Publikationsserver der RWTH Aachen University

Year dc:date

2010

Author dc:creator

• Klinker, Helene

Contributors dc:contributor

• Hoffmann, Rainer

• info:eu-repo/classification/ddc/610
• Koronarendoprothese
• Stent
• Risikofaktor
• Medizin
• Stentthrombose
• stent thrombosis
• predictor

Statement dc:rights

• info:eu-repo/semantics/openAccess

Language dc:language

ger

Identifier

https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-114059%22

OAI record oai:identifier

https://publications.rwth-aachen.de/oai2d?verb=GetRecord&metadataPrefix=oai_dc&identifier=oai%3Apublications.rwth-aachen.de%3A51807