TY - JOUR
T1 - Outcomes Among Diabetic Patients Undergoing Percutaneous Coronary Intervention With Contemporary Drug-Eluting Stents
T2 - Analysis From the BIONICS Randomized Trial
AU - Konigstein, Maayan
AU - Ben-Yehuda, Ori
AU - Smits, Pieter C.
AU - Love, Michael P.
AU - Banai, Shmuel
AU - Perlman, Gidon Y.
AU - Golomb, Mordechai
AU - Ozan, Melek Ozgu
AU - Liu, Mengdan
AU - Leon, Martin B.
AU - Stone, Gregg W.
AU - Kandzari, David E.
N1 - Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/12/24
Y1 - 2018/12/24
N2 - Objectives: The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. Background: Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). Methods: A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. Results: The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent– and zotarolimus-eluting stent–treated patients. Conclusions: Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.
AB - Objectives: The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. Background: Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). Methods: A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. Results: The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent– and zotarolimus-eluting stent–treated patients. Conclusions: Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.
KW - clinical outcomes
KW - diabetes
KW - percutaneous coronary intervention
KW - ridaforolimus-eluting stent(s)
UR - http://www.scopus.com/inward/record.url?scp=85058047190&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2018.09.033
DO - 10.1016/j.jcin.2018.09.033
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C2 - 30573057
AN - SCOPUS:85058047190
VL - 11
SP - 2467
EP - 2476
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 24
ER -
