Page 16 - biotronik_BIOFLOW-I

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BIOFLOW-I results in perspective
Overview of in stent late lumen loss
in FIM trials
* Randomized trial. Only number of patients in device arm displayed
1
Serruys et al. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial; Eurointervention
2
Ormiston et al. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte
paclitaxel-eluting stent in de novo native coronary artery lesions; Circ.Cardiovasc.Interv.
3
Sousa et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional
intravascular ultrasound study; Circulation
4
Meredith et al. The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial; EuroIntervention
5
Meredith et al. Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial; JACC.Cardiovasc.Interv.
FIM SR
3
4 m
n=15
Nevo
Nevo Res-I
2*
6 m
n=186
XienceV
SPIRIT First
1
6 m
n=28
Endeavor Resolute Orsiro
BIOFLOW-I
9 m
n=30
FIM FR
3
4 m
n=15
FIM
4
4 m
n=30
FIM
5
9 m
n=92
Cypher
±
0.21
±
0.31
±
0.30
±
0.26
±
0.27
±
0.22
(mm)
0.10
0.13
0.09
-0.01
0.12
0.22
0.05