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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.

Author information

1
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
2
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
3
Maasstad Ziekenhuis, Rotterdam, the Netherlands.
4
University of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada.
5
Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
6
Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel.
7
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
8
Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.

Abstract

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.

KEYWORDS:

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

PMID:
30573057
DOI:
10.1016/j.jcin.2018.09.033

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