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

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• 作者：Usman Baber ; MD ; MS^a ; George Dangas ; MD ; PhD^a ; David J. Cohen ; MD ; MSc^b ; C. Michael Gibson ; MD^c ; Shamir R. Mehta ; MD ; MSc^d ; Dominick J. Angiolillo ; MD ; PhD^e ; Stuart J. Pocock ; PhD^f ; Mitchell W. Krucoff ; MD^g ; Adnan Kastrati ; MD^h ; E. Magnus Ohman ; MD^g ; Philippe Gabriel Steg ; MDⁱ ; Juan Badimon ; PhD^a ; M. Urooj Zafar ; MBBS^a ; Jaya Chandrasekhar ; MBBS^a ; Samantha Sartori ; PhD^a ; Melissa Aquino ; MS^a ; Roxana Mehran ; MD^a ; ^{roxana.mehran@mountsinai.org}
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：182
• 期：Complete
• 页码：125-134
• 全文大小：373 K
• 卷排序：182

文摘

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.MethodsTWILIGHT 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.ConclusionsTWILIGHT 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.