Impact of radial access site utilization for PCI with a bioresorbable sirolimus-eluting stent on vascular complications and bleeding - Andres Iniguez Romo

1. 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 Cardiology
Cardiology Division, Hospital Do Meixoeiro
Complejo Hospitalario Universitario de Vigo
Vigo, Spain

2. Disclosure
• NO CONFLICT OF INTEREST
AIM RADIAL 2017

3. • 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

4. 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

5. 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%)

6. Baseline patient characteristics
Radial
N=4474
Femoral
N=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

7. Lesion and procedure characteristics
Radial
N=4474
Femoral
N=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

8. 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

9. 1 year clinical outcomes RAD vs FEM
3.15
1.94
1.2
1.63
4.05
4.88
0.4
3.45
2.34
2.2
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

10. 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

11. Bleeding and vascular complications
ACS 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

12. 1 year clinical outcomes RAD vs FEM
ACS 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

13. • 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