Transcript Off Label Indications

Frequency of off label drug eluting stent use in clinical practice
Michael Y. Huang, Taha Akhtar, Yoshihito Sakata , Michael H. Salinger , Thomas G. Frohlich, Timothy J. McDonough,
RS
RC
David I. Koenigsberg, Alan Kogan, Carl L. Tommaso, Timothy A. Sanborn , Ted Feldman
R
R
Poster
A-1
Evanston Hospital, Evanston IL
INTRODUCTION
100%
The efficacy and safety of FDA approved Drug
Eluting Stents (DES) in simple lesions has been
established in the SIRIUS and TAXUS IV trials.
In clinical practice, DES are used in more
complicated lesions which are outside of those
originally approved by the FDA, so called offlabel use. We investigated off-label use of DES
in the initial 1 year after their release
atherectomy
90%
2
4
5
ostial segment
lesion > 30mm
AMI
80%
60%
three or more stents
multivessel disease
21
70%
left main
10
50%
20
in-stent restenosis
3/404 DES STENT THROMBOSIS
n=2 <30 days
bifurcation
30%
10
n=1 after 5 months
20%
10
10%
1st year of DES use
486 patients 683 lesions in 575 vessels
DES ISR 1.5%
BMS ISR 7.2%
DES SAT 0.7%
5
40%
SVG
.
11
0%
STENT THROMBOSIS &
IN-STENT RESTENOSIS
Off Label Indications
mean 1.7 stents/patient, 1.4 stents/vessel
46%
BMS & DES patients clinical characteristics were not different. DES were used in 84% vs BMS
in 16%. Reasons for BMS use were thrombus rich lesions, long-term antiplatelet intolerance, or
PCI prior to non-cardiac surgery. 8% of all cases were treated by both BMS and DES, in which
BMS were added due to vessels too small for DES (less than 2.5mm) or failure of DES delivery
54%
CONCLUSIONS
Off-label DES use comprised more than half (54%) of the total
st
case load during the 1 year after release at our institution.
*Disclosures: Research support (R), Consultant (C), Speaker (S) for Boston Scientific, Cordis or Guidant
No excess SAT or ISR occurred in this series with high
frequency off-label use, although the sample size is small.