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Ridaforolimus-eluting stent noninferior to zotarolimus-eluting stent for TLF at 1 year
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WASHINGTON — One-year data from the BIONICS trial demonstrate that a ridaforolimus-eluting stent was noninferior to a zotarolimus-eluting stent for the primary outcome of target lesion failure in patients with complex CAD.
The 1-year TLF rate was 5.3% with the ridaforolimus-eluting stent (RES; Medinol Ltd.) and the zotarolimus-eluting stent (ZES; Resolute, Medtronic; P for noninferiority = .0012). When the researchers evaluated components of the primary outcome, rates of cardiac death (0.5% RES vs. 0.2% ZES; P = .29), target vessel MI (3.1% vs. 3.3%; P = .81) and ischemia-driven TLR (3% vs. 2.4%; P = .38) were also similar.
Moreover, the rate of definite or probable stent thrombosis was “very low,” at 0.4% with RES compared with 0.6% with ZES, David E. Kandzari, MD, director of interventional cardiology and chief scientific officer, Piedmont Heart Institute, Atlanta, said during a presentation at TCT 2016.
“These findings endorse the safety and efficacy of BioNIR in patients representative of real-world clinical practice,” Kandzari told the audience.
A total of 1,919 more-comers patients with symptomatic CAD and complex lesions were enrolled in BIONICS. Patients were randomly assigned to PCI with RES (n = 958; 1,275 lesions) or ZES (n = 961; 1,277 lesions). The trial was conducted at 76 sites in eight countries.
The novel RES is a thin-strut cobalt chromium stent. It elutes ridaforolimus from a durable elastomeric polymeric coating. Over 180 days, more than 95% of ridaforolimus is eluted from the stent.
According to other data presented during the Late-Breaking Clinical Trials session, both groups had well-balanced baseline and angiographic characteristics; however, the presence of severe calcification was higher in the RES group (13.3% vs. 10.5%; P = .03).
Procedural success was high at 97%.
The researchers also performed prespecified subgroup analyses, in which the primary outcome was not significantly different, according to Kandzari.
Earlier in 2016, results of the NIREUS trial were presented at EuroPCR showing that the RES was noninferior to the ZES for the primary endpoint of 6-month angiographic late loss (P for noninferiority < .0001). Clinical outcomes at 6 months were also similar between the two stents.
Reference:
Kandzari DE, et al. Late-Breaking Clinical Trials 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.
Disclosure: Kandzari reports receiving grant or research support from Abbott Vascular, Ablative Solutions, Biotronik, Boston Scientific, Medtronic and St. Jude Medical/Thoratec; he also reports receiving consultant fees/honoraria from Boston Scientific, Medtronic, Micell Technologies and St. Jude Medical.