Worsening Clinical Outcome with Increasing Number of So-Called Off-Label or Unapproved Indications for Use of Drug Eluting Stents

Anders M. Galløe, Ulrik Abildgaard, Henning Kelbæk, Niels Bligaard, Jørgen L. Jeppesen, Leif Thuesen, Peter R. Hansen
2016 World Journal of Cardiovascular Diseases  
Objective: We explored the impact of increasing number of off-label patient and lesion characteristics 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 characteristics 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
more » ... tual 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.
doi:10.4236/wjcd.2016.67025 fatcat:srypsflkbramfgxgcdua7awdbu