Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial

Area of Science:

• Cardiology
• Pharmacology
• Clinical Trials

Background:

• Dual antiplatelet therapy (DAPT) is standard after percutaneous coronary intervention (PCI).
• Optimizing antiplatelet strategies to balance efficacy and safety is crucial for patients undergoing PCI.
• Ticagrelor monotherapy is being explored as an alternative to prolonged DAPT.

Purpose of the Study:

• To evaluate the impact of a 23-month ticagrelor monotherapy regimen following one month of DAPT post-PCI.
• To compare patient-oriented composite endpoints (POCE) and net adverse clinical events (NACE) between the experimental and reference antiplatelet strategies.

Main Methods:

• The GLOBAL LEADERS study was a randomized, multicenter, open-label trial involving 15,991 patients post-PCI.
• The experimental group received aspirin with ticagrelor for one month, followed by 23 months of ticagrelor monotherapy.
• The reference group received 12 months of DAPT followed by 12 months of aspirin monotherapy. Outcomes were assessed up to two years.

Main Results:

• At two years, POCE rates were 13.2% in the experimental group versus 14.2% in the reference group (HR 0.93, p=0.085).
• NACE rates were 14.4% in the experimental group and 15.5% in the reference group (HR 0.92, p=0.057).
• No significant treatment-by-subgroup interactions were observed for POCE or NACE.

Conclusions:

• A treatment strategy of one-month DAPT followed by 23 months of ticagrelor monotherapy did not significantly reduce POCE or NACE compared to the reference treatment.
• The findings suggest that this specific ticagrelor monotherapy regimen may not offer a significant advantage over standard DAPT durations for these composite endpoints.
• Further research may be needed to explore optimal antiplatelet durations and combinations post-PCI.