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

Abstract

BACKGROUND:

Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT.

METHODS:

TWILIGHT is a randomized, double-blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES. Upon enrollment after successful PCI, all patients will be treated with open label low-dose aspirin (81-100 mg daily) plus ticagrelor (90 mg twice daily) for 3 months. Event-free patients will then be randomized in a double-blind fashion to low-dose aspirin versus matching placebo with continuation of open-label ticagrelor for an additional 12 months. The primary hypothesis is that a strategy of ticagrelor monotherapy will be superior with respect to the primary endpoint of bleeding academic research consortium type 2, 3 or 5, while maintaining non-inferiority for ischemic events compared with ticagrelor plus ASA.

CONCLUSIONS:

TWILIGHT is the largest study to date that is specifically designed and powered to demonstrate reductions in bleeding with ticagrelor monotherapy versus ticagrelor plus ASA beyond 3 months post-procedure in a high-risk PCI population treated with DES. The trial will provide novel insights with respect to the potential role of ticagrelor monotherapy as an alternative for long-term platelet inhibition in a broad population of patients undergoing PCI with DES.

• Authors: Usman Baber, George Dangas, David J Cohen, C Michael Gibson, Shamir R Mehta, Dominick J Angiolillo, Stuart J Pocock, Mitchell W Krucoff, Adnan Kastrati, E Magnus Ohman, Philippe Gabriel Steg, Juan Badimon, M Urooj Zafar, Jaya Chandrasekhar, Samantha Sartori, Melissa Aquino, Roxana Mehran
• Journal: American heart journal (Am Heart J) Vol. 182 Pg. 125-134 (Dec 2016) ISSN: 1097-6744 [Electronic] United States
• PMID: 27914492 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2016 Elsevier Inc. All rights reserved.

Chemical References

• Platelet Aggregation Inhibitors
• Ticagrelor
• Adenosine
• Aspirin

Topics

• Acute Coronary Syndrome (therapy)
• Adenosine (administration & dosage, adverse effects, analogs & derivatives)
• Aged
• Aspirin (administration & dosage, adverse effects)
• Coronary Restenosis (etiology, prevention & control)
• Double-Blind Method
• Drug Therapy, Combination (methods)
• Drug-Eluting Stents
• Female
• Hemorrhage (chemically induced, prevention & control)
• Humans
• Male
• Percutaneous Coronary Intervention (adverse effects, methods)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Risk Adjustment (methods)
• Ticagrelor
• Treatment Outcome