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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Circulation
2017 ; 136
(14
): 1304-1314
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents
in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial
(BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis)
#MMPMID28794001
Kandzari DE
; Smits PC
; Love MP
; Ben-Yehuda O
; Banai S
; Robinson SD
; Jonas M
; Kornowski R
; Bagur R
; Iniguez A
; Danenberg H
; Feldman R
; Jauhar R
; Chandna H
; Parikh M
; Perlman GY
; Balcells M
; Markham P
; Ozan MO
; Genereux P
; Edelman ER
; Leon MB
; Stone GW
Circulation
2017[Oct]; 136
(14
): 1304-1314
PMID28794001
show ga
BACKGROUND: The safety and efficacy of a novel cobalt alloy-based coronary stent
with a durable elastomeric polymer eluting the antiproliferative agent
ridaforolimus for treatment of patients with coronary artery disease is
undetermined. METHODS: A prospective, international 1:1 randomized trial was
conducted to evaluate in a noninferiority design the relative safety and efficacy
of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting
stents among 1919 patients undergoing percutaneous coronary intervention at 76
centers. Inclusion criteria allowed enrollment of patients with recent myocardial
infarction, total occlusions, bifurcations lesions, and other complex conditions.
RESULTS: Baseline clinical and angiographic characteristics were similar between
the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and
39.7% presented with acute coronary syndromes. At 12 months, the primary end
point of target lesion failure (composite of cardiac death, target vessel-related
myocardial infarction, and target lesion revascularization) was 5.4% for both
devices (upper bound of 1-sided 95% confidence interval 1.8%,
P(noninferiority)=0.001). Definite/probable stent thrombosis rates were low in
both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month
angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm
(P(noninferiority)=0.004) for the RES and zotarolimus-eluting stent groups,
respectively, and intravascular ultrasound percent neointimal hyperplasia was
8.10±5.81 and 8.85±7.77, respectively (P(noninferiority)=0.01). CONCLUSIONS: In
the present trial, which allowed broad inclusion criteria, the novel RESs met the
prespecified criteria for noninferiority compared with zotarolimus-eluting stents
for the primary end point of target lesion failure at 12 months and had similar
measures of late lumen loss. These findings support the safety and efficacy of
RESs in patients who are representative of clinical practice. CLINICAL TRIAL
REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487.