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JACC Cardiovasc Interv. 2018 Dec 24;11(24):2467-2476. doi: 10.1016/j.jcin.2018.09.033.

Outcomes Among Diabetic Patients Undergoing Percutaneous Coronary Intervention With Contemporary Drug-Eluting Stents: Analysis From the BIONICS Randomized Trial.

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Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
Maasstad Ziekenhuis, Rotterdam, the Netherlands.
University of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada.
Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel.
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
Piedmont Heart Institute, Atlanta, Georgia. Electronic address:



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.


Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI).


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.


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.


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.


clinical outcomes; diabetes; percutaneous coronary intervention; ridaforolimus-eluting stent(s)


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