[Long-term results with the off-label use of paclitaxel-eluting stents].
OBJECTIVE
Little information is available about the results obtained with the off-label use of drug-eluting stents. Our aim was to investigate clinical findings on long-term follow-up.


METHODS
The study included 604 consecutive patients who received > or = 1 paclitaxel-eluting stents (PES) at our catherization laboratory between June 2003 and February 2005. Patients were divided into two groups according to whether stent use was on-label or off-label as defined by current practice. The primary study endpoints were the combination of death and non-fatal acute myocardial infarction (AMI) and the combination of death, AMI and target-vessel revascularization (TVR). Secondary endpoints were these events individually and late stent thrombosis (ST).


RESULTS
During the median follow-up period of 34.3 months (interquartile range 8.6 months), PESs had been used off-label in the majority of patients (i.e., 464, 76.8% of the sample) and their use was associated with an increased risk of death or AMI (hazard ratio [HR]=2.2; 95% confidence interval [CI], 1.2-4) and of death, AMI or TVR (HR=1.8; 95% CI, 1.1-3). There was no significant difference in individual events (i.e., death, AMI or TVR). The group who used stents off-label had poorer clinical characteristics (i.e., older age, and higher likelihoods of previous AMI or previous revascularization and multivessel disease), as well as a higher incidence of ST (5% vs. 0; log-rank test, P=.015).


CONCLUSIONS
The off-label use of PESs was associated with an increased risk of a combined clinical endpoint during long-term follow-up. Further studies are needed to determine the efficacy and safety of these devices in these settings.
Flores Ríos
Xacobe
X
Unidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Area del Corazón, Complexo Hospitalario Universitario Juan Canalejo, A Coruña, España. xacobeflores@yahoo.es
Marzoa Rivas
Raquel
R
Abugattás de Torres
Juan P
JP
Piñón Esteban
Pablo
P
Aldama López
Guillermo
G
Salgado Fernández
Jorge
J
Calviño Santos
Ramón
R
Vázquez Rodríguez
José M
JM
Vázquez González
Nicolás
N
Castro Beiras
Alfonso
A
D018795:Device Approval; D017277:Drug Approval; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D013997:Time Factors
D017239:Paclitaxel