Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in...

Area of Science:

• Cardiology
• Clinical Trials
• Pharmacology

Background:

• International guidelines recommend 12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS).
• Limited data exist on early de-escalation to single antiplatelet therapy (SAPT) with a P2Y12 inhibitor post-PCI for ACS.
• This study evaluated ticagrelor monotherapy versus ticagrelor plus aspirin after initial DAPT.

Purpose of the Study:

• To assess if ticagrelor monotherapy reduces clinically relevant bleeding compared to ticagrelor plus aspirin.
• To determine if ticagrelor monotherapy is non-inferior to ticagrelor plus aspirin regarding major adverse cardiovascular or cerebrovascular events (MACCE).
• To evaluate the safety and efficacy of early SAPT de-escalation post-PCI for ACS.

Main Methods:

• Randomized, placebo-controlled, double-blind clinical trial involving patients post-PCI for ACS.
• Patients received 1 month of DAPT, then were randomized to ticagrelor plus aspirin or ticagrelor plus placebo for 11 months.
• Primary endpoints were superiority for clinically relevant bleeding (BARC types 2, 3, or 5) and non-inferiority for MACCE.

Main Results:

• Clinically relevant bleeding occurred in 2.1% with ticagrelor monotherapy vs. 4.6% with ticagrelor plus aspirin (HR 0.45; p<0.0001).
• Major adverse cardiovascular or cerebrovascular events (MACCE) occurred in 3.6% with ticagrelor monotherapy vs. 3.7% with ticagrelor plus aspirin (HR 0.98; p_{non-inferiority}<0.0001).
• Ticagrelor monotherapy demonstrated superiority in reducing bleeding and non-inferiority in preventing ischemic events.

Conclusions:

• Ticagrelor monotherapy significantly reduces bleeding events compared to dual therapy after 1 month post-PCI for ACS.
• Ticagrelor monotherapy is a safe and effective strategy, maintaining similar cardiovascular protection as dual therapy.
• Aspirin discontinuation and maintenance on ticagrelor monotherapy can be considered for selected ACS patients post-PCI.