Author + information
- Received August 1, 2018
- Revision received September 6, 2018
- Accepted September 11, 2018
- Published online December 17, 2018.
- Maayan Konigstein, MDa,b,
- Ori Ben-Yehuda, MDa,c,
- Pieter C. Smits, MDd,
- Michael P. Love, MDe,
- Shmuel Banai, MDb,
- Gidon Y. Perlman, MDf,g,
- Mordechai Golomb, MDa,
- Melek Ozgu Ozan, MSa,
- Mengdan Liu, MSa,
- Martin B. Leon, MDa,c,
- Gregg W. Stone, MDa,c and
- David E. Kandzari, MDh,∗ ()
- aClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- bTel-Aviv Sourasky Medical Center, Tel Aviv, Israel
- cDivision of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- dMaasstad Ziekenhuis, Rotterdam, the Netherlands
- eUniversity of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada
- fHadassah Hebrew University Medical Center, Jerusalem, Israel
- gMedinol Ltd., Tel Aviv, Israel
- hPiedmont Heart Institute, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. David E. Kandzari, Piedmont Heart Institute, 95 Collier Road, Suite 2065, Atlanta, Georgia 30309.
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.
Dr. Ben-Yehuda, Ms. Ozan, and Ms. Liu are employees of the Cardiovascular Research Foundation, which received funding from Medinol Ltd. for the conduct of the trial. Dr. Smits has received consulting/speakers fees from Medinol, Abbott Vascular, AstraZeneca, Terumo, and St. Jude Medical; and research support from Abbott Vascular, St. Jude Medical, and Terumo. Dr. Perlman is an employee of Medinol. Dr. Leon has an equity relationship with Medinol. Dr. Kandzari has received consulting fees from Medtronic, Cardinal Health, Boston Scientific, and Micell; and research support from Medtronic, Abbott Vascular, Boston Scientific, Biotronik, and Medinol. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 1, 2018.
- Revision received September 6, 2018.
- Accepted September 11, 2018.
- 2018 American College of Cardiology Foundation
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