Clinical outcome following second-generation drug-eluting stent use for off-label versus on-label indications: Insights from the two-year outcome of the TWENTE trial

Hanim Sen, Ming Kai Lam, Kenneth Tandjung, Mounir W.Z. Basalus, Frits H.A.F. de Man, J. Hans W. Louwerenburg, Martin G. Stoel, Gert K. van Houwelingen, Marije M. Löwik, Gerard C.M. Linssen, Salah A.M. Saïd, Mark B. Nienhuis, Patrick M.J. Verhorst, Job van der Palen, Clemens von Birgelen

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)
165 Downloads (Pure)


Aims: Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only.

Methods and results: We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5-) had more diabetes (22.9- vs. 17.5-; p=0.032), previous MI (35.9- vs. 22.3-; p<0.001), type B2/C lesions (84.7- vs. 62.7-; p<0.001), and acute coronary syndromes (57.8- vs. 33.3-; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0- vs. 1.4-; p=0.003), of which only 1.1- reached creatine kinase levels >5x the upper limit of normal (ULN).

Conclusions: Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.

Original languageEnglish
Article number117
Pages (from-to)664-671
Issue number6
Publication statusPublished - 2014


  • IR-92391
  • METIS-306227
  • Percutaneous Coronary Intervention (PCI)
  • Drug-eluting stent(s)
  • Randomised controlled trial
  • TWENTE trial
  • Complex patients
  • Off-label

Cite this