ACC.24 – Data are limited on the use of a potent P2Y12 inhibitor starting 1 month after DAPT in patients with ACS who underwent PCI, and no such trials have been placebo-controlled. The efficacy and safety of ticagrelor alone after 1 month DAPT was evaluated in the ULTIMATE-DAPT trial.

This summary is based on the presentation of Gregg Stone, MD (New York, NY, US) at the ACC.24 Scientific Session – One-month Ticagelor Monotherapy After PCI in Acute Coronary Syndromes: Principal Results From the Double-blind Placebo-controlled ULTIMATE-DAPT Trial

Introduction and methods

Dual antiplatelet therapy (DAPT) consisting of aspirin plus a potent P2Y12 receptor inhibitor for 12 months is recommended in international guidelines for most patients with ACS treated with PCI to prevent MI and stent thrombosis. Although there have been several trials evaluating shorter DAPT duration, there are limited data on the use of a potent P2Y12 inhibitor starting 1 month after PCI in patients with ACS, and no such trials have been placebo-controlled.

The ULTIMATE-DAPT RCT was part of a larger study program. In this trial, 3400 patients with ACS who underwent PCI with contemporary drug-eluting stents were randomized after 1 months of DAPT (ticagrelor plus aspirin) to continuation of DAPT or to ticagrelor plus placebo. Follow-up was after 1 year.

The co-primary endpoint was BARC types 2, 3 or 5 bleeding, and the other primary endpoint was MACCE, a composite of cardiac death, MI, ischemic stroke, definite stent thrombosis or clinically-driven TVR.

Main results

• The primary endpoint of clinically -relevant bleeding occurred less in the ticagrelor-only group (2.1%) than in the DAPT group (4.6%) (HR 0.45, 95%CI: 0.30-0.66, P<0.0001).
• The event rate of MACCE was 3.6% in the ticagrelor-only group vs. 3.7% in the DAPT group, demonstrating noninferiority (HR 0.98, 95%CI: 0.69-1.39, P<0.0001).

Conclusion

In patients with ACS who were treated with PCI and were free from major adverse events after 1 month of DAPT, treatment with the P2Y12 inhibitor ticagrelor alone between 1 and 12 months decreased clinically-relevant bleeding and was safe with regard to similar reduction in MACCE compared to DAPT.

Gregg Stone concluded: “It is time to change the guidelines and it is time to change clinical practice pattern”. He explained that most patients with ACS after PCI with contemporary drug-eluting stents should now be managed with a P2Y12 inhibitor (with the strongest evidence supporting ticagrelor) after a one-month with DAPT.

- Our reporting is based on the information provided at the ACC.24 Scientific Session -

The findings of this study were simultaneously published in The Lancet