title: 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.
abstract: 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. 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). 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.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.forename: Ming Kai
authors.initials: MK
authors.lastname: Lam
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.forename: Mounir W Z
authors.initials: MW
authors.lastname: Basalus
authors.forename: Frits H A F
authors.initials: FH
authors.lastname: de Man
authors.forename: J Hans W
authors.initials: JH
authors.lastname: Louwerenburg
authors.forename: Martin G
authors.initials: MG
authors.lastname: Stoel
authors.forename: Gert K
authors.initials: GK
authors.lastname: van Houwelingen
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.forename: Gerard C M
authors.initials: GC
authors.lastname: Linssen
authors.forename: Salah A M
authors.initials: SA
authors.lastname: Saïd
authors.forename: Mark B
authors.initials: MB
authors.lastname: Nienhuis
authors.forename: Patrick M J
authors.initials: PM
authors.lastname: Verhorst
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D054058:Acute Coronary Syndrome / Q000453:epidemiology; D002114:Calcinosis / Q000453:epidemiology; D003402:Creatine Kinase / Q000032:analysis; D003920:Diabetes Mellitus / Q000453:epidemiology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D056687:Off-Label Use; D063868:Patient Outcome Assessment; D062645:Percutaneous Coronary Intervention; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000068338:Everolimus; D003402:Creatine Kinase; C489443:zotarolimus; D020123:Sirolimus