TY - JOUR
T1 - Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention
T2 - A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)
AU - Maeng, M.
AU - Christiansen, Evald Høj
AU - Raungaard, B.
AU - Kahlert, J.
AU - Terkelsen, C.J.
AU - Kristensen, S.D.
AU - Carstensen, S.
AU - Aarøe, J.
AU - Jensen, S.E.
AU - Villadsen, A.B.
AU - Lassen, J.F.
AU - Thim, T.
AU - Eftekhari, A.
AU - Veien, K.T.
AU - Hansen, K.N.
AU - Junker, A.
AU - Bøtker, H.E.
AU - Jensen, L.O.
AU - SORT OUT VIII Investigators
A2 - Raungaard, Bent
A2 - Jensen, Svend Eggert
PY - 2019/4/8
Y1 - 2019/4/8
N2 - Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)
AB - Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)
KW - biodegradable polymer
KW - biolimus
KW - drug-eluting stent(s)
KW - everolimus
KW - percutaneous coronary intervention
KW - randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85063315267&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2018.12.036
DO - 10.1016/j.jcin.2018.12.036
M3 - Journal article
SN - 1936-8798
VL - 12
SP - 624
EP - 633
JO - J A C C: Cardiovascular Interventions
JF - J A C C: Cardiovascular Interventions
IS - 7
ER -