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MASTER Trial

11/11/2015 -  

500 STEMI patients, randomised 1:3 vs Kaname BMS, primary endpoint TVF 12M. Published and completed

Designed to:

  • confirm safety and efficacy of Ultimaster drug eluting stent used in STEMI patients by proving superiority in efficacy and non-inferiority in safety versus bare metal stent
  • generate further evidence for benefits of primary PCI with DES in patients with STEMI
  • generate further evidence for benefits of bioresorbable polymer

 

Study Design

  • randomized (3:1) Ultimaster vs Kaname, single blind
  • 500 patients with acute STEMI
  • 16 sites
  • 5 countries
  • Triple primary endpoint at 1 (safety), 6 (efficacy) and 12 months (safety/efficacy)
  • Secondary endpoints: clinical, procedural, device related, angiographic...

master_1.png

BMS, bare-metal stent; MI, myocardial infarction; R, randomisation; ST, stent thrombosis; STEMI, ST-segment elevation myocardial infarction;
TV, target vessel; TVF, target vessel failure; TVR, target vessel revascularisation.
Valdes-Chavarri M. Presented at EuroPCR 2016.


Triple primary endpoint

  • Safety (1 month):

composite of all-cause death, recurrent MI, unplanned infarct related artery revascularization, stroke, 
definite ST, and major bleeding

  • Efficacy (6 months):

In-stent late loss 
Efficacy and safety (12 months):
TVF and a composite of cardiac death, recurrent TV MI, TVR

MI, myocardial infarction; ST, stent thrombosis; TV, target vessel; TVF, target vessel failure; TVR, target vessel revascularisation. 

Valdes-Chavarri M. Presented at EuroPCR 2016.


 STEMI: clinical evidence from MASTER

  • In general, there were no significant differences in baseline patient characteristics, lesion characteristics, or procedural characteristics between the two groups, with the following exceptions:
    • The number of stents per lesion was significantly higher with Ultimaster than with Kaname (1.5 vs 1.3; p=0.04)
    • Total stent length per patient was significantly longer with Ultimaster than with Kaname (29.7 mm vs 26.1 mm; p=0.01)
  • At 3 years, clinical outcomes were significantly better with Ultimaster than with Kaname for all clinically driven revascularisation, CD-TLR, and CD-TVR


CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; STEMI, ST-segment elevation myocardial infarction.
Valdes-Chavarri et al. Eurointervention 2018; doi: 10.4244/EIJ-D-17-01087. Stankovic G et al. Presented at EuroPCR 2018, abstract LBT8754.


MASTER (STEMI): clinical outcomes at 1 year

master_4.png

*Composite endpoint of cardiac death and MI not clearly attributable to a non-TV and CD-TVR.
†Definite or probable ST according to ARC.
N numbers are the number of patients at baseline in the per-protocol analysis: 98.4% follow-up achieved at 12 months.
ARC, Academic Research Consortium; CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation;
MI, myocardial infarction; ST, stent thrombosis; STEMI, ST-segment elevation myocardial infarction; TV, target vessel; TVF, target vessel failure.
Valdes-Chavarri et al. Eurointervention 2018; doi: 10.4244/EIJ-D-17-01087


MASTER (STEMI): clinical outcomes at 3 years

master_5.png


*Definite or probable ST.
CD, clinically driven; CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation;
MI, myocardial infarction; ST, stent thrombosis; STEMI, ST-segment elevation myocardial infarction; TV, target vessel.
Stankovic G et al. Presented at EuroPCR 2018, abstract LBT8754.