Ticagrelor with aspirin or alone in high-risk patients after coronary intervention: Rationale and design of the...

Area of Science:

• Cardiology
• Pharmacology
• Clinical Trials

Background:

• Dual antiplatelet therapy (DAPT) is crucial for preventing thrombosis after percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
• However, DAPT increases bleeding risk, necessitating exploration of safer antiplatelet strategies.
• Potent P2Y12 receptor antagonists offer a potential alternative for monotherapy.

Purpose of the Study:

• To evaluate the efficacy and safety of antiplatelet monotherapy versus DAPT in high-risk patients undergoing PCI with DES.
• To determine if ticagrelor monotherapy reduces bleeding events while maintaining anti-thrombotic protection.
• To assess the role of ticagrelor monotherapy as a long-term platelet inhibition strategy.

Main Methods:

• The TWILIGHT trial is a randomized, double-blind, placebo-controlled study of up to 9000 high-risk patients.
• Patients received aspirin plus ticagrelor for 3 months post-PCI.
• Eligible patients were then randomized to ticagrelor monotherapy or DAPT (ticagrelor plus aspirin) for 12 additional months.

Main Results:

• The primary endpoint is superiority in reducing bleeding academic research consortium (BARC) types 2, 3, or 5 events.
• Secondary analysis will assess non-inferiority for ischemic events.
• The study is powered to detect significant differences in bleeding outcomes.

Conclusions:

• TWILIGHT is the largest trial designed to assess ticagrelor monotherapy versus DAPT in high-risk PCI patients with DES.
• Results will provide insights into reducing bleeding risk with ticagrelor monotherapy.
• Findings may support ticagrelor monotherapy as an alternative for long-term platelet inhibition.