TY - JOUR
T1 - Clinical outcome following second-generation drug-eluting stent use for off-label versus on-label indications
T2 - Insights from the two-year outcome of the TWENTE trial
AU - Sen, Hanim
AU - Lam, Ming Kai
AU - Tandjung, Kenneth
AU - Basalus, Mounir W.Z.
AU - de Man, Frits H.A.F.
AU - Louwerenburg, J. Hans W.
AU - Stoel, Martin G.
AU - van Houwelingen, Gert K.
AU - Löwik, Marije M.
AU - Linssen, Gerard C.M.
AU - Saïd, Salah A.M.
AU - Nienhuis, Mark B.
AU - Verhorst, Patrick M.J.
AU - van der Palen, Job
AU - von Birgelen, Clemens
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - IR-92391
KW - METIS-306227
KW - Percutaneous Coronary Intervention (PCI)
KW - Drug-eluting stent(s)
KW - Randomised controlled trial
KW - TWENTE trial
KW - Complex patients
KW - Off-label
U2 - 10.4244/EIJV10I6A117
DO - 10.4244/EIJV10I6A117
M3 - Article
SN - 1774-024X
VL - 10
SP - 664
EP - 671
JO - EuroIntervention
JF - EuroIntervention
IS - 6
M1 - 117
ER -