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CENTURY II Trial

06/09/2018 -  

  • Multicentre, intercontinental study: 58 sites in 13 countries across Europe, Japan, and South Korea 
  • Primary endpoint: freedom from TLF at 9 months
  • Secondary endpoint: rate of TVF; patient-oriented composite endpoint; rate of TLR, TVR, ST, cardiac death, MI; composite of cardiac death and MI; rate of bleeding and vascular complications 
  • Clinical follow-up up to 5 years 
  • Stage: Published and completed

Study design and key features

   Study design and key features 4_V2.png

 "Xience" is a product and trademark of the Abbott Group of Companies
* Intention-to-treat population PCI, percutaneous coronary intervention R, randomization


Ultimaster was non-inferior to Xience in terms of the primary endpoint: freedom from TLF at 9 months

century_II_2.png

Saito S et al. Presented at EuroPCR 2018, abstract LBT8784.  

Data on file at Terumo Europe

TLR, target lesion revascularization

TLF, target lesion failure

CI, confidence interval

MI, myocardial infarction; 

NS, not significant; 

ST, stent thrombosis; 

TV, target vessel.


TLF rates similar for Xience and Ultimaster in the first 300 days

century_II_3.png

Long-term follow-up of CENTURY II: consistent and sustained safety at 1 year and 5 years

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Patient numbers are from the per-protocol analysis at baseline.


CENTURY II included pre-specified assessment of complex subgroups

Bifurcation: clinical evidence from CENTURY II

  • There were no significant differences in baseline patient characteristics or bifurcation lesion characteristics between the two groups
  • TLF up to 5 years was 7.4% with Ultimaster, compared with 11.1% with Xience (p=0.37)
  • Cardiac death at 5-year follow up was significantly lower in the Ultimaster group than in the Xience group (0.0% vs 5.1%; p=0.03)

TLF, target lesion failure.

Orvin K et al. Catheter Cardiovasc Interv 2016;87:1092–100; Chevalier B. Presented at EuroPCR 2018, abstract POS101.

CENTURY II bifurcation subgroup: clinical outcomes up to 5 years

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*Composite endpoint of cardiac death, TV-related MI, and CD-TLR. †Composite endpoint of cardiac death, TV-related MI, and CD-TVR. ‡Composite endpoint of all death, any MI, and any coronary revascularisation. CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction; POCE, patient-oriented composite endpoint; ST, stent thrombosis; TLF, target lesion failure; TV, target vessel; TVF, target vessel failure.

Chevalier B et al. Presented at EuroPCR 2018, abstract POS101.


Multivessel disease: clinical evidence from CENTURY II

  • There were no significant differences in baseline patient characteristics, lesion characteristics, or procedural characteristics between the two groups
  • 69.8% of procedures that used Ultimaster were performed using transradial access, and the overall procedure success rate was 97.8%
  • At 5 years, there was a trend towards better clinical outcomes with Ultimaster than with Xience (statistical significance not met)
  • Any death: 9.3% vs 10.8% (p=0.60)
  • Any MI: 3.1% vs 5.6% (p=0.19)
  • Stent thrombosis: 0.9% vs 1.7% (p=0.43)


MI, myocardial infarction.

Chevalier B et al. Presented at EuroPCR 2017, abstract OP0698; Iniguez-Romo A et al. Presented at EuroPCR 2018, abstract LBT8727.

CENTURY II MVD subgroup: clinical outcomes up to 5 years 

century_II_6.png

*Definite or probable ST. CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction; MVD, multivessel disease; ST, stent thrombosis; TV, target vessel. Iniguez-Romo A et al. Presented at EuroPCR 2018, abstract LBT8727.

CENTURY II MVD subgroup: target lesion failure up to 5 years

century_II_7.png 

*TLF: composite endpoint of cardiac death, TV-related MI, and clinically driven target lesion revascularisation. FU, follow-up; MI, myocardial infarction; MVD, multivessel disease; TLF, target lesion failure; TV, target vessel. Iniguez-Romo A et al. Presented at EuroPCR 2018, abstract LBT8727.


Acute coronary syndrome: clinical evidence from CENTURY II

  • There were no significant differences in baseline patient characteristics, lesion characteristics, or procedural characteristics between the two groups
    • In the Ultimaster and Xience groups, 23.0% and 23.1% of patients, respectively, had STEMI, and 76.9% and 76.8%, respectively, had NSTEMI
    • Transradial access was used in 73.0% and 71.7% of procedures with Ultimaster and Xience, respectively
  • In general, clinical outcomes at 2 years were numerically better with Ultimaster than with Xience
    • Any death: 1.5% vs 2.9% (p=0.48)
    • Cardiac death: 0.0% vs 2.1% (p=0.10)
    • TV-related MI: 0.7% vs 3.6% (p=0.12)

MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; STEMI, ST-segment elevation myocardial infarction; TV, target vessel.

Jimenez VA et al. Cardiovasc Revasc Med 2016;17:355–61; Data on file at Terumo Europe.


CENTURY II ACS subgroup: target lesion failure at 2 years

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ACS, acute coronary syndrome; HR, hazard ratio.

Jimenez VA et al. Cardiovasc Revasc Med 2016;17:355–61


NSTEMI: clinical evidence from CENTURY II

  • In general, there were no significant differences in baseline patient characteristics, lesion characteristics, or procedural characteristics between the two groups
  • The number of lesions treated was 1.3 with Ultimaster vs 1.5 with Xience (p<0.02)
  • Clinical outcomes with Ultimaster were favourable, with low incidences of cardiac death, TV-related MI, and stent thrombosis


MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; TV, target vessel.

Iñiguez-Romo A. Presented at EuroPCR 2017, abstract OPO704; 


CENTURY II NSTEMI subgroup: clinical outcomes at 2 years

century_II_9.png

ST=Definite and probable stent thrombosis – 1 subacute ST in each arm.
CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; MI, myocardial infarction;
NSTEMI, non-ST-segment elevation myocardial infarction; ST, stent thrombosis; TV, target vessel; TVF, target vessel failure.
Iñiguez-Romo A. Presented at EuroPCR 2017, abstract OPO704.