Stopping Aspirin after 3 months of DAPT okay in high risk patients: TWILIGHT

Subgroup analysis of ticagrelor alone versus ticagrelor + aspirin in NSTE-ACS after PCI found less clinically relevant bleeding; similar rates of death, MI, and stroke.

USA: Withdrawal of aspirin after 3 months of DAPT (dual antiplatelet therapy) with ticagrelor (Brilinta) alone following PCI (percutaneous coronary intervention) was beneficial for high-risk patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS), finds a recent study. According to the study, the bleeding risk was lower in the 12 months in people on ticagrelor (Brilinta) monotherapy compared with ticagrelor plus aspirin sans any increase in the rate of ischemic events.

These are the results from a pre-specified subgroup analysis of the TWILIGHT trial called TWILIGHT-ACS that evaluated the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in high-risk ACS patients undergoing PCI with DES. The study was presented by Usman Baber of Icahn School of Medicine at Mount Sinai in New York City at the 2019 American Heart Association (AHA) meeting.

TWILIGHT-ACS reaffirms the September 2019 main TWILIGHT results of patients undergoing PCI with drug-eluting stents who met one or more high-risk features.

The study included 5,739 patients (64% of the overall TWILIGHT trial cohort of 9,006 patients) who had undergone a successful 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 the continuation of open-label ticagrelor.

Read Also: Groundbreaking study-High-risk patients may not require long-term aspirin after PCI

Key findings of the study include:

• 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%). 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 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%).


• Rates of the key secondary endpoint – a 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]).

Current practice is to combine aspirin with an anti-clotting medication, such as ticagrelor, to lower the risk of a heart attack after stenting. However, this treatment also increases bleeding complications, and therefore identifying therapies that lower bleeding without increasing heart attack risk has emerged as a clinical priority.

"The results indicate that, aside from STEMI patients and those who have adverse events within 3 months of PCI, dropping aspirin might be a strategy that could be applicable for a large population of patients," wrote the authors. "It provides novel and clinically relevant insight for an antiplatelet strategy of ticagrelor alone after ACS."

About Ticagrelor

Ticagrelor is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

Ticagrelor is not indicated for use without aspirin or in patients undergoing PCI who have not had an ACS event.

Source: Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention for Acute Coronary Syndrome