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e-ULTIMASTER Trial

15/06/2017 -  

Up to 37,000 all-comers patients, single arm, primary endpoint: TLF @ 12M. Follow-up

​Designed to:

  • further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice
  • assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implantation
    (frequently observed in every day clinical practice), on stent thrombosis


Study Design

  • Prospective, single arm, multi-centre, observational registry
  • ~ 37.000 patients suitable to be treated with the Ultimaster DES
  • ~ 200 sites worlwide

Primary Outcome Measure:

Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related Myocardial Infarction (MI)
and clinically driven Target Lesion Revascularization (TLR) at 1 year.

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Substudies

According to pre-specified criteria patients will be allocated to 1 or more substudies:

ULTIMASTER Acute Coronary Syndrome
ULTIMASTER STEMI
ULTIMASTER NSTEMI
ULTIMASTER Stable Angina
ULTIMASTER Diabetes

  • (IDDM)
  • (NIDDM)

ULTIMASTER Renal Insufficiency
ULTIMASTER Octogenarians
ULTIMASTER Female
ULTIMASTER Female with ACS

ULTIMASTER Small Vessels
ULTIMASTER Long Lesions
ULTIMASTER Restenosis
ULTIMASTER Bifurcation
ULTIMASTER Multivessel Treatment
ULTIMASTER Diabetes with multivessel disease
ULTIMASTER SVG
ULTIMASTER Left Main
ULTIMASTER CTO
ULTIMASTER Imaging guidance
ULTIMASTER Midnight-Midnight (real all-comers population)

Geographic Substudies

In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas.


Clinical Follow-up

e-Ultimaster: largest real-world registry investigating Ultimaster in clinical practice

e-ultimaster_2.png

CD-TLR, clinically driven target lesion revascularisation; MI, myocardial infarction; TLF, target lesion failure; TV, target vessel. e-Ultimaster trial. Available at https://clinicaltrials.gov/ct2/show/NCT02188355?term=e-ULTIMASTER&rank=1 (accessed April 2018); Kauer F. Presented at EuroPCR 2018, LBT8753; Data on file at Terumo Europe: e-Ultimaster interim analysis n=13,089 patients. 


Rates of TLF* in clinical practice were low at 1 year 

e-ultimaster_3.png

n= 13,089

*Composite endpoint of cardiac death, TV-related MI, and CD-TLR.
CD-TLR, clinically driven target lesion revascularisation; CI, confidence interval; MI, myocardial infarction; TLF, target lesion failure; TV, target vessel.
Data on file at Terumo Europe.


Bifurcation: clinical evidence from e-Ultimaster

  • In total, 80,6% of bifurcation procedures involved transradial access

  • Half of patients had 'true bifurcation lesions'

  • Clinical outcomes at 1 year were favourable for patients classified as having bifurcation lesions, and 'true bifurcation lesions'*

*Bifurcation lesions were described as true bifurcations if classified as Medina 1.1.1, 1.0.1, or 0.1.1.
Mamas M et al. Presented at EuroPCR 2018, abstract OP042.


e-Ultimaster bifurcation and true bifurcation subgroups: propensity-matched clinical outcomes at 1 year

e-ultimaster_5.png

Bifurcation lesions were described as true bifurcations if classified as Medina 1.1.1, 1.0.1, or 0.1.1. Patient numbers shown are for those with information on type of bifurcation. *Definite or probable ST.
CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction;
ST, stent thrombosis; TLF, target lesion failure; TV, target vessel; TVF, target vessel failure.
Mamas M et al. Presented at EuroPCR 2018, abstract OP042.e-Ultimaster bifurcation subgroup: propensity-matched clinical outcomes for 1- and 2-stent techniques at 1 year


e-Ultimaster bifurcation subgroup: propensity-matched clinical outcomes for 1- and 2-stent techniques at 1 year

e-ultimaster_6.png

One-stent technique included patients with a stent in the main branch and a balloon a side branch; two-stent technique includes patients with a stent in the main branch and in the side branch. Patients comprise those with information about stent technique, excluding stent in side branch only. *Definite or probable ST.
CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction;
ST, stent thrombosis; TLF, target lesion failure; TV, target vessel; TVF, target vessel failure.
Mamas M et al. Presented at EuroPCR 2018, abstract OP042.


Left main: clinical evidence from e-Ultimaster

  • Almost half of patient had ACS, and about one-third of patients had experienced a previous MI
  • Almost one-third of cases involved a moderate or severe calcification
  • Transradial access was used in up to 70.0% of procesdures
  • Overall, 170 patients had isolated LM disease, and 221 patients had LM and multivessel disease


ACS, acute coronary syndrome; LM, left main; MI, myocardial infarction. 

Witkowski A et al. Presented at EuroPCR 2018, abstract POS180.


Left main subgroup: clinical outcomes at 1 year

e-ultimaster_8.png

CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction;
NS, not significant; ST, stent thrombosis; TLF, target lesion failure; TV, target vessel.
Witkowski A et al. Presented at EuroPCR 2018, abstract POS180.


Multivessel disease: clinical evidence from e-Ultimaster

  • The mean (SD) number of diseased vessels per patient was 2.4 (0.5), and the mean (SD) number of lesions identified was 2.7 (1.1)
  • Most (81.8%) procedures were performed via a transradial access site
  • Good clinical outcomes were obtained at 1 year, with low incidences of cardiac death, TV-related MI, CD-TLR, and ST


CD-TLR, clinically driven target lesion revascularisation; MI, myocardial infarction; SD, standard deviation; ST, stent thrombosis;
TV, target vessel.
Data on file at Terumo Europe.

e-Ultimaster MVD subgroup: clinical outcomes at 1 year

e-ultimaster_10.png

MVD subgroup n=5852.CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction;
MV, multiple vessels; MVD, multivessel disease; ST, stent thrombosis; TLF, target lesion failure; TV, target vessel; TVF, target vessel failure. Data on file at Terumo Europe.


NSTEMI: clinical evidence from e-Ultimaster

  • At 1 year, good clinical outcomes with Ultimaster were observed, with low incidences of cardiac death (1.9%), TV-related MI (1.2%), and stent thrombosis (0.8%) 

MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; TV, target vessel.
Data on file at Terumo Europe.


e-Ultimaster NSTEMI subgroup: clinical outcomes at 1 year

e-ultimaster_12.png

NSTEMI subgroup n=3387.CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; CV, cardiovascular;
MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; ST, stent thrombosis; TLF, target lesion failure;
TV, target vessel; TVF, target vessel failure.
Data on file at Terumo Europe.


Chronic total occlusion: clinical evidence from e-Ultimaster

  • The mean (SD) number of diseased vessels per patient was 1.7 (0.8), and 23.3% of patients had multiple vessels treated
  • Patients had a mean (SD) of 1.9 (1.0) lesions, and 71.8% of procedures were performed via transradial access
  • At 1 year, favourable clinical outcomes were observed with Ultimaster, with low incidences of cardiac death, TV-related MI, CD-TLR, CD-TVR, and stent thrombosis


CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation;
MI, myocardial infarction; SD, standard deviation; TV, target vessel.
Polad J. Presented at EuroPCR 2018, abstract POS6761


e-Ultimaster CTO subgroup: clinical outcomes at 1 year

e-ultimaster_14.png

CTO subgroup n=648
CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; CTO, chronic total occlusion;
MI, myocardial infarction; ST, stent thrombosis; TLF, target lesion failure; TV, target vessel; TVF, target vessel failure.
Polad J. Presented at EuroPCR 2018, abstract POS6761.