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Ridaforolimus-eluting stent safe, effective in symptomatic CAD treatment
A novel ridaforolimus-eluting stent was noninferior to a zotarolimus-eluting stent for the primary outcome of target lesion failure in patients with symptomatic CAD, according to the results of the BIONICS trial, published in Circulation.
The publication confirmed results presented at the Transcatheter Cardiovascular Therapeutics Scientific Symposium in November.
David E. Kandzari, MD, director of interventional cardiology and chief scientific officer of the Piedmont Heart Institute in Atlanta, and colleagues conducted a prospective, international, 1:1 randomized noninferiority trial to evaluate the relative safety and efficacy of RES (BioNIR, Medinol Ltd.) and slow-release zotarolimus-eluting stent (ZES; Resolute, Medtronic) among patients with PCI.
A total of 1,919 more-comers patients with symptomatic CAD and complex lesions were enrolled in BIONICS.
Patients who participated in the trial at 76 sites in eight countries were randomly assigned to PCI with either RES (n = 958; 1,275 lesions) or ZES (n = 961; 1,277 lesions).
Both groups shared similar baseline clinical and angiographic characteristics. The mean age of the participants was 63 years, 32.5% had diabetes and 39.7% presented with ACS.
The 1-year primary endpoint of TLF was 5.4% for both devices (upper bound of one-sided 95% CI, 1.8%; P for noninferiority = .001).
Definite/probable stent thrombosis rates were low in both groups (0.4% RES vs. 0.6% ZES; P = 0.75).
At 13 months, angiographic in-stent late lumen loss was 0.22 ± 0.41 mm and 0.23 ± 0.39 mm (P for noninferiority = .004) for the RES and ZES groups, respectively, and IVUS percent neointimal hyperplasia was 8.1 ± 5.81 and 8.85 ± 7.77, respectively (P for noninferiority = .01).
According to Kandzari and colleagues, these results were consistent in predefined patient and lesion subgroups and support the safety and efficacy of RES in patients representative of consistent clinical use.
“The results of the trial showed, for this particular new DES, that the safety and efficacy were reaffirmed and in a broad complex patient population that are representative of those that are encountered in clinical practice,” Kandzari told Cardiology Today’s Intervention. “The outcomes were at least at parity with contemporary DES that are routinely used in clinical practice and we're hopeful these results, as a pivotal U.S. trial, will extend to approval and then commercial availability to patients treated in U.S. clinical practice.” – by Dave Quaile
For more information:
David E. Kandzari, MD, can be reached at david.kandzari@piedmont.org.
Disclosure: The trial was funded by Medinol Ltd. Kandzari reports receiving consultant fees from Boston Scientific, Medtronic, Micell and St. Jude Medical, as well as research support from Abbott Vascular, Biotronik, Boston Scientific, Medinol, Medtronic and St. Jude Medical. Please see the study for all other authors’ relevant financial disclosures.
Editor’s Note: This article was revised on August 21, 2017 to remove a passage that may have misinterpreted the findings. The Editors regret the error. The article was further revised on August 23, 2017 to add comments from Dr. Kandzari.