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