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

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.