MASTER DAPT Complex PCI sub-analysis

Overview

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Investigator-initiated
global randomized study
global randomized study
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4,579 patients,
140 hospital worldwide, 30 countries
140 hospital worldwide, 30 countries
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All-comers trial in
HBR patients after PCI
HBR patients after PCI
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Abbreviated vs prolonged
DAPT in patients treated with
 the Utltimaster™and Ultimaster™ Tansei™ DES
DAPT in patients
treated with the
Ultimaster™ and
Ultimaster™Tansei™
DES

Study Design

MASTER DAPT Trial

MASTER DAPT Complex PCI study design (image)

 

 

Complex PCI Definition

MASTER DAPT Complex PCI definition (image)

 

 

Procedural Characteristics: Complex PCI Criteria

 

MASTER DAPT Complex PCI Procedural Characteristics (image)

 

Primary Endpoint

  • Net adverse clinical events (NACE) defined as a composite of death from any cause, myocardial infarction, stroke or major bleeding.
  • Major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of death from any cause, myocardial infarction, stroke or major bleeding.
  • Major or clinically relevant non-major bleeding (MCB), defined as BARC 2, 3 or 5 bleeding.

Result

NACE

Abbreviated DAPT is non-inferior to standard DAPT in terms of NACE

Complex HR 1.03, 95% CI 0.69- 1.52; p=0.90  
Not Complex HR 0.90, 95% CI 0.71- 1.15; P=0.42

 

MASTER DAPT Complex PCI NACE result chart (image)

 

MACCE

Abbreviated DAPT is non-inferior to standard DAPT in terms of MACCE

Complex HR 1.24, 95% CI 0.79-1.92; p=0.35  
Not Complex HR 0.91, 95% CI 0.69- 1.21; p=0.52

MASTER DAPT Complex PCI MACCE result chart (image)

Major or clinically relevant non-major bleeding

Abbreviated DAPT is non-inferior to standard DAPT in terms of MACCE

Complex HR 0.64, 95% CI 0.42-0.98; p=0.04  
Not Complex HR 0.70, 95% CI 0.55- 0.89; p=0.00

MASTER DAPT Complex PCI MCB result chart (image)

 

 

Conclusion

In HBR patients who had undergone implantation of Ultimaster™ stent, regardless of PCI-complexity, the discontinuation of DAPT at a median of 34 days compared with continuation of treatment for a median of 193 days after PCI was consistently associated with:

  • Similar rates of net adverse clinical events(NACE) and major adverse cardiac or cerebral events(MACCE)
  • A lower rate of major or clinically relevant nonmajor bleeding

Trial Limitations

  • Open label study.
  • Randomization was not stratified based on PCI complexity. The absence of a universally accepted definition for complex PCI is notable.
  • The results may not apply to patients not treated with UltimasterTM biodegradable-polymer sirolimus eluting stents.
  • The type of monotherapy after discontinuing dual antiplatelet therapy was at discretion of the treating physicians.
MASTER DAPT study is sponsored by the European Cardiovascular Research Institute (ECRI, Rotterdam, The Netherlands) and supported with a restricted research grant by Terumo Europe.