Subgroup Analysis of TWILIGHT Trial Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Who Underwent PCI Showed BRILINTA Monotherapy Reduced the Risk of Clinically Relevant Bleeding Compared With Dual Antiplatelet Therapy (DAPT)
New results from a pre-specified subgroup analysis of the TWILIGHT trial showed that BRILINTA (ticagrelor) monotherapy reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT) over 12 months in high-risk patients with non-ST elevation acute coronary syndromes (NSTE-ACS).
The pre-specified subgroup analysis included 5,739 patients (64% of the overall TWILIGHT trial cohort of 9,006 patients) who had undergone successful percutaneous coronary intervention (PCI) with at least one drug eluting stent (DES) for NSTE-ACS. Following a three-month open-label treatment phase with ticagrelor (90mg BID) plus low-dose aspirin (81–100mg daily), 4,614 patients, who were free from major ischemic or bleeding events, were randomized to either continue low-dose aspirin or matching placebo for an additional 12 months, with continuation of open-label ticagrelor.
Results of the NSTE-ACS subgroup analysis showed:
- Ticagrelor monotherapy was associated with a 53% relative reduction in the risk of the primary endpoint – Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding – over one year, with an absolute risk reduction of 4.0%, compared to ticagrelor plus aspirin (3.6% vs. 7.6%, HR 0.47; 95% CI: 0.36-0.61).
- Also seen was the BARC 3 or 5 bleeding for ticagrelor monotherapy versus ticagrelor plus aspirin at one year (0.8% vs. 2.1%).
- Thrombolysis in Myocardial Infarction (TIMI) major bleeding at one year was 0.5% for ticagrelor plus placebo and 1.0% for ticagrelor plus aspirin.
- Rates of the key secondary endpoint – composite outcome of all-cause death, myocardial infarction (MI) or stroke – were similar between the two groups at one year (4.3% for ticagrelor plus placebo and 4.4% for ticagrelor plus aspirin [HR 0.97; 95% CI: 0.74-1.28]).
- Rates of other secondary endpoints also were similar between the two groups at one year – all-cause death (1.0% for ticagrelor plus placebo and 1.5% for ticagrelor plus aspirin), MI (3.1% and 3.1%), ischemic stroke (0.5% and 0.3%), and definite or probable stent thrombosis (0.4% and 0.6%).
Danilo Verge, Vice President Global Medical Affairs, Cardiovascular, Renal and Metabolism said: “The TWILIGHT trial provided important information about the longer-term management of high-risk patients who had undergone PCI. In this pre-specified subgroup analysis of patients with NSTE-ACS enrolled in TWILIGHT, treatment with ticagrelor monotherapy, without aspirin, after three months of DAPT was associated with a lower risk of bleeding compared with standard 12 months of dual antiplatelet therapy with ticagrelor plus aspirin.”