TITLE:
Worsening Clinical Outcome with Increasing Number of So-Called Off-Label or Unapproved Indications for Use of Drug Eluting Stents
AUTHORS:
Anders M. Galløe, Ulrik Abildgaard, Henning Kelbæk, Niels Bligaard, Jørgen L. Jeppesen, Leif Thuesen, Peter R. Hansen
KEYWORDS:
Drug Eluting Stents
JOURNAL NAME:
World Journal of Cardiovascular Diseases,
Vol.6 No.7,
July
12,
2016
ABSTRACT: Objective: We explored the impact of
increasing number of off-label patient and lesion character-istics on 5-year
clinical outcome following implantation of first generation drug eluting
stents. Furthermore we tried to assess if stent performance might be improved
if the off-label character-istics present were taken into account to guide the
stent brand selection. Design: A total of 2888 coronary lesions treated with
first generation drug eluting stents were classified for eventual presence of
18 different off-label characteristics and correlated to the 5-year clinical
outcome by multiple stepwise Cox regression analysis. Results: The composite of
cardiac death, myocardial infarction and target vessel revascularization (major
adverse cardiac event, MACE) was 16.7% in cases with zero off-label
characteristics and showed a stepwise increased rate up to 32.7% in cases with
5 off-label characteristics. The MACE rate for the sirolimus eluting stent
appears to be 10% lower than the paclitaxel stent group and it may be further
reduced by 10% - 18% if the off-label characteristics present in each case were
taken into account to guide the stent brand selection. Conclusion: With
increasing number of concomitantly appearing off-label characteristics there is
a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label
characteristics were used to guide the stent brand selection.