Comparison of one month DAPT with standard DAPT in high bleeding risk patients after PCI

ESC 2021 In patients with high bleeding risk who underwent PCI, one month DAPT was noninferior to standard DAPT for the outcome of net and major adverse clinical events and reduced major or clinically relevant nonmajor bleeding.

Presented at the ESC congress 2021 by: Marco Valgimigli, MD, PhD Lugano, Switzerland

Introduction and methods

The MASTER DAPT trial was designed to evaluate whether the effect of an abbreviated dual antiplatelet therapy (DAPT) regimen compared with a standard DAPT regimen was preserved on net and major clinical events in a high bleeding risk (HBR) population who underwent percutaneous coronary intervention (PCI) with biodegradable polymer Ultimaster stent. In addition, the effect on bleeding risk was assessed.

4579 HBR patients who underwent PCI who were free from ischemic events were randomized at 1 months to immediately stop DAPT or continue DAPT for at least 2 additional months (median duration of additional DAPT was 193 days after PCI). Outcomes were assessed at 1 year. There were 3 co-primary endpoints: net adverse clinical events, which were a composite of death, MI, stroke and major bleeding defined as BARC 3 (first end point); major adverse cardiac or cerebral events (MACE), the composite of death, MI or stroke (second); major or clinically relevant nonmajor bleeding (third).

Main results

• The first co-primary endpoint occurred in 7.5% of patients in the abbreviated DAPT group and in 7.7% of patients with standard DAPT (P<0.001 for non-inferiority).
• In 6.1% of patients with abbreviated DAPT the second co-primary endpoint occurred vs. 5.9% in the standard DAPT group (P=0.001 for non-inferiority).
• The third co-primary endpoint occurred in 6.5% of patients with abbreviated DAPT compared with 9.4% in the standard DAPT group (P<.0.001 for non-inferiority, and P<0.001 for superiority, NNT was 35)

Conclusion

One-month DAPT was noninferior to treatment continuation of DAPT for at least 2 extra months for the outcome of net and major adverse clinical events and reduced major or clinically relevant nonmajor bleeding in HBR patients after PCI with Ultimaster stent implantation.

This results indicate that coronary stents have become safer and the last generation DES such as the Ultimaster stent requires only limited duration of DAPT therapy.

• Our reporting is based on the information provided at the ESC Congress -

The results were simultaneously presented in N Engl J Med.