The power of n (image)
The power of n (image)

The Power of n - Ultimaster™

Do you believe in the Power of n? The Ultimaster™ clinical program included more than 50,000 patients covering 16 CE marked indications.

The Ultimaster™ Clinical Program

The Ultimaster™ clinical program included more than 50,000 patients covering 16 CE marked indications.1-3
Icon of the power of n (image)

Complex PCI: n=10,241 patients

Demonstrates favorable outcomes in both complex and non-complex PCI patients.

Icon of the power of n (image)

Bifurcation : n=4,395 patients

Demonstrates proximal optimization technique (POT) is associated with improved outcomes.

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MVD : n=15,441 patients

Suggests that complete revascularization is associated with better outcomes versus incomplete revascularization.

Abbreviated DAPT. Groundbreaking results

Data driving your clinical decisions

The Ultimaster™ clinical program included one of the largest, prospective worldwide registries, the e-ULTIMASTER™ with 37,198 patients.5 The Ultimaster™ clinical program2 demonstrates the safe and effective use of the Ultimaster™ stent in different patient cohorts, representative of daily PCI practice.
The power of n (image)
Total Population
  • 37,178 patients enrolled in the e-ULTIMASTER™ registry, one of the largest, prospective worldwide registries.
  • e-ULTIMASTER™ – a truly all comer’s DES clinical registry.
Complex PCI
  • e-ULTIMASTER all-comer registry enrolled more than 10,000 patients meeting complex D62PCI criteria.
  • Complex PCI was defined as:
    - Multivessel PCI 3 stents implanted > 3 lesions treated.
    - Bifurcation PCI with > 2 stents, total stent length > 60mm and chronic total occlusion.
Bifurcation
  • 4,395 patients with bifurcation lesions treated with Ultimaster™ DES showed excellent clinical outcomes with TLF of 5.1% at 1 year.
  • Use of the proximal optimization technique (POT) was associated with a better clinical outcome with respect to TLF and TVF at 1 year. This was due to a strong impact on the risk of TV-MI, stent thrombosis and revascularization.
Multivessel Disease
  • The revascularization strategy (complete versus incomplete revascularization) in multivessel disease patients treated with Ultimaster™ DES was assessed at 1-year follow-up.
  • Complete revascularization was associated with better relief from angina, lower mortality, less target vessel failure (TVF), and lower patient oriented composite endpoint (POCE).
  • Ultimaster™ DES demonstrated excellent results in this complex population.

The most studied BP-DES,Over 50,000 patients world wide¹′²

The Ultimaster™ has been studied worldwide by enrolling over 50,000 patients in Terumo sponsored trial and investigator sponsored research. The clinical programs have consistently shown favorable efficacy and safety of the Ultimaster™ even in complex lesions.
  Number of patients Design Primary outcomes Sub Study
MASTER DAPT 4,300

Investigator-initiated

Randomised

Short vs standard DAPT

NACE

MACCE

MCB at 11 months (12 months post-index PCI)

OAC
e-Ultimaster 37,198

Single arm

All-comers

Real-world use

TLF at 1 year Bifurcation Left Main
CENTURY II 1,123 Randomised 1:1 vs Xience Freedom from TLF at 9 months Bifurcation Multivessel disease
DISCOVERY 1TO3 60

Single arm

Patients with multivessel disease

OFDI strut coverage at 3 months  
MODEL U-SES 1,695 Prospective multicenter single-arm registry, Investigators initiated study Composite endpoint of all-cause death, MI, stroke, ARC definite / probable stent thrombosis, and BARC 3 or 5 during 12months after stenting  
SCAAR 3,253 Multicenter registry in Sweden

ST

Restenosis rate

 
SCC registry 1,727

Single arm

All-comers

Single center study

TLR

TLF

MACE

 
ULISS 1,660

Single arm

All-comers

Multi-center study

TLF

TLR

Composite endpoint of cardiac death, TV-MI

 
MASTER 500 Randomised 3:1 vs BMS in patients with STEMI

Safety at 1 month

Efficacy at 6 months

Safety and efficacy at 12 months

 
COLOR 388

Investigator-initiated

Randomised complexed large-bore radial PCI trial

BARC bleeding or vascular complication related to access site  
CENTURY 105

Single arm

First-in-man study

Late loss at 6 months  
CENTURY JSV 70

Single arm

Patients requiring 2.25 mm diameter stents

Freedom from MACE at 9 months  
TCD-10023PK 22

Single arm

Pharmaco kinetics

Sirolimus concentration in peripheral blood samples 28 days after Ultimaster implantation  

Video

The Summary on the Power of n

Three experts guide you to understand the power of the big data and how large registry data can impact your practice.

Ultimaster™ Tansei™

Ultimaster™

Reference