e-poster09 iniguez aimradial20170921 transradial bioresorbable stent
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de Miguel Castro A, Jimenez Diaz VA, Iniguez Romo A, Baz Alonso JA,Ortiz Saez A, , Bastos Fernandez G, Fernandez Barbeira S
on behalf of e-Ultimaster investigators
AIM RADIAL 2017
Impact of radial access site utilization for PCI with a bioresorbable sirolimus-eluting stent on vascular
complications and bleeding
Department of Interventional CardiologyCardiology Division, Hospital Do Meixoeiro
Complejo Hospitalario Universitario de VigoVigo, Spain
Disclosure
• NO CONFLICT OF INTEREST
AIM RADIAL 2017
• Use of radial access site for PCI procedures has been shown to
reduce bleeding complications.
• e-ULTIMASTER is a prospective, single-arm worldwide all-comer
registry, designed to further validate the safety and efficacy of a
thin-strut sirolimus eluting stent with bioresorbable polymer
(Ultimaster) in unselected patients enrolled worldwide.
• In this interim analysis, we compared 1-year clinical outcomes in
patients treated via radial versus femoral access in total
population and in patients treated for acute coronary
syndrome.
• We performed propensity score matching in order to reduce
confounding of baseline characteristics.
Radial vs femoral access e-Ultimaster
Drug release kinetics matching biological response
Sirolimus 3.9 µg/mm stent
PDLLA-PCL polymer resorption time: 3–4 months80 µm CoCr
struts Stent
Gradient Coating: No drug polymer coating on parts of the stent that experience high physical stress in order to prevent cracking and delamination
Abluminal coating: Drug delivered specifically where needed; the abluminal side
Study device – Ultimaster DES
e-Ultimaster registry
First interim analysis
1-year follow-up or death
Radial access
N=4474 (84%)
All-comer registry, 4 continents
Study enrolment ongoing
>25.000 patients enrolled
0d0d 3mo 1yr
Clinical Follow-up
Femoral access
N=860 (16%)
Baseline patient characteristics
RadialN=4474
FemoralN=860
P-value*
Mean age ± SD, years 65.7±10.8 65.7±11.5 0.99
Gender, male % 74.0 74.0 0.99
Diabetes, % 29.4 29.4 0.99
Hypertension, % 67.1 65.2 0.28
Hypercholesterolemia, % 57.7 56.3 0.46
Current smoker, % 19.9 19.5 0.80
Previous MI, % 24.6 24.3 0.84
Previous PCI, % 27.3 27.1 0.87
Family history of CAD, % 29.1 27.1 0.29
ACS, % 53.2 53.1 0.96
* Data were analyzed using weighted propensity score matching
Lesion and procedure characteristics
RadialN=4474
FemoralN=860
P-value*
N of detected lesions 1.9±1.1 1.9±1.1 0.99
N of treated lesions 1.4±0.7 1.4±0.7 0.99
Multivessel disease, % 51.6 51.6 0.99
Complex lesions type B2 and C, %
63.0 61.9 0.76
Bifurcation, % 18.1 17.9 0.90
Moderate or severe calcification, %
21.0 20.7 0.89
Postdilatation, % 50.3 50.3 0.98
Nr of study stent implanted, n
1.5±0.9 1.5±0.9 0.99
Total stent length, mm 33.5±22.8 33.5±23.1 0.99
* Data were analyzed using weighted propensity score matching
Bleeding and vascular complications
2.49
0.62
3.33
1.92
0
0.5
1
1.5
2
2.5
3
3.5
4
Any bleeding Major bleeding
RAD FEM
0.92
0.23
1.06
2.03
1.09
3.22
0
0.5
1
1.5
2
2.5
3
3.5
4
Any bleeding Major bleeding Vascular complications
related to access site
RAD FEM
At 1 month At 1 year
% %
* Data were analyzed using weighted propensity score matching
1 year clinical outcomes RAD vs FEM
3.15
1.94
1.2
1.63
4.05
4.88
0.4
3.45
2.342.2
2.44
5.44
6.14
1.2
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
Any death Cardiac death TV-MI CD-TLR TLF TVF ST definite
RAD FEM
%
TV-MI: targe vessel MI, CD-TLR: clinically driven TLR, TLF: target lesion failure* Data were analyzed using weighted propensity score matching
e-Ultimaster registry – ACS subgroup
Patients with ACS
N=3151
Radial access
N=2704 (86%)
All-comer registry, 4 continents
Study enrolment ongoing
>25.000 patients enrolled
0d0d 3mo 1yr
Clinical Follow-up
Femoral access
N=447 (14%)
First interim analysis
1-year follow-up or death
Bleeding and vascular complicationsACS subgroup
2.81
0.77
3.89
2.1
0
0.5
1
1.5
2
2.5
3
3.5
4
Any bleeding Major bleeding
RAD FEM
1.2
0.32
0.81
2.06
0.98
3.06
0
0.5
1
1.5
2
2.5
3
3.5
4
Any bleeding Major bleeding Vascular complications
related to access site
RAD FEM
At 1 month At 1 year
% %
* Data were analyzed using weighted propensity score matching
1 year clinical outcomes RAD vs FEMACS subgroup
3.81
2.09
0.99
1.7
4.27
5.59
0.33
3.81
2.52 2.41
3.31
6
6.74
1.8
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
Any death Cardiac death TV-MI CD-TLR TLF TVF ST definite
RAD FEM
%
TV-MI: targe vessel MI, CD-TLR: clinically driven TLR, TLF: target lesion failure* Data were analyzed using weighted propensity score matching
• Data from this large worldwide registry showed a high
penetration of radial access, regardless of the clinical
scenario (stable CAD or ACS).
• Major bleeding rates and vascular complications related to
access sites were significantly higher at 1 month in femoral
compared to radial access group, which confirmed the
benefits of radial access.
• 1 year clinical outcomes showed lower TV-MI, TLF and stent
thrombosis rates, in both, total population and ACS cohort.
Conclusions