News | Antiplatelet and Anticoagulation Therapies | September 26, 2019

TWILIGHT Study Shows Ticagrelor Monotherapy Reduces Bleeding Risk Post-PCI in High-Risk Patients

Secondary endpoint of non-inferiority achieved for the risk of composite of MI, death or stroke in TWILIGHT trial

Brilinta Monotherapy Reduces Clinically Relevant Bleeding Risk Post-PCI in High-Risk Patients

September 26, 2019 — New data from the Phase IV independent TWILIGHT trial showed Brilinta (ticagrelor) monotherapy reduced the risk of BARC type 2, 3 or 5 bleeding in high-bleed-risk patients who underwent percutaneous coronary intervention (PCI) and completed three months of dual antiplatelet therapy (DAPT) at 12 months. Brilinta monotherapy (90 mg twice daily) was compared to Brilinta plus low-dose aspirin.

Results from TWILIGHT were presented at 2019 Transcatheter Cardiovascular Therapeutics (TCT annual scientific conference of the Cardiovascular Research Foundation and published simultaneously in the New England Journal of Medicine.[1]

In the trial, 9,006 patients received open-label ticagrelor (90 mg twice daily) and aspirin (81-100 mg daily) for three months after a PCI. The 7,119 patients that remained event-free of major bleeding or an ischemic event during the three months of treatment with ticagrelor and aspirin were randomized to either double-blinded aspirin or placebo for an additional 12 months, with continuation of open-label ticagrelor.

Ticagrelor monotherapy was associated with a 44 percent lower risk of BARC (Bleeding Academic Research Consortium) 2, 3 or 5 bleeding over one year, with an absolute risk reduction of 3.1 percent, compared to ticagrelor plus aspirin. The incidence of the primary endpoint — time to first occurrence of BARC type 2, 3 or 5 bleeding between month 3 and 15 — was 4 percent in patients treated with ticagrelor plus placebo compared to 7.1 percent in patients treated with ticagrelor plus aspirin (HR 0.56; 95 percent CI 0.45 to 0.68; p<0.001).

The incidence of BARC 3 or 5 bleeding was also lower (1 percent vs 2 percent, HR 0.49; 95 percent CI 0.33 to 0.74) with ticagrelor plus placebo versus ticagrelor plus aspirin. Rates of the composite of all-cause death, myocardial infarction (MI) or stroke, a key secondary endpoint, were similar between the two groups — 3.9 percent and 3.9 percent, respectively for ticagrelor plus placebo and ticagrelor plus aspirin (HR 0.99; 95 percent CI 0.78 to 1.25; non-inferiority p<0.001).

Roxana Mehran, M.D., TWILIGHT's global principal investigator and director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Heart and professor of cardiology, and population health science and policy, at Icahn School of Medicine at Mount Sinai, said “In high-risk PCI patients, further ischemic events remain a life-threatening concern. As seen in TWILIGHT, in patients who tolerated three months of dual antiplatelet therapy, lowering the risk of major bleeding while preserving the ischemic benefit using ticagrelor monotherapy is an important clinical advance for these patients.”

VIDEO: TWILIGHT Trial Shows Benefit to Ticagrelor Monotherapy After Stent Implantation — Interview with Roxana Mehran, M.D., at TCT 2019

Watch the VIDEO: Strategies to Avoid Acute Kidney Injury Caused by Cath Lab Contrast, an interview with Mehran

Find information on other late-breaking TCT trials

For more information: www.nejm.org

 

Reference

1. Mehran R., Baber U., Sharma S.K., et al. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. New England Journal of Medicine, published online Sept. 26, 2019. DOI: 10.1056/NEJMoa1908419

Related Content

Videos | Antiplatelet and Anticoagulation Therapies | October 11, 2019
Ajay J. Kirtane, M.D., associate professor of medicine at Columbia University Irving Medical Center and director of the...
Videos | Antiplatelet and Anticoagulation Therapies | October 08, 2019
American Heart Association President Robert Harrington, M.D., explains the reasons for shorter duration dual-...
Three-Month DAPT Post-PCI Demonstrates Low Adverse Event Rate in High-Bleeding Risk Patients
News | Antiplatelet and Anticoagulation Therapies | September 30, 2019
Data from the EVOLVE Short DAPT study found that shortened three-month dual antiplatelet therapy (DAPT) did not...
Aspirin Should Not Be Recommended for Healthy People Over 70
News | Antiplatelet and Anticoagulation Therapies | September 20, 2019
Low-dose aspirin does not prolong disability-free survival of healthy people over 70, even in those at the highest risk...
Ticagrelor Plus Aspirin Reduces Ischemic Events in Stable Coronary Patients With Diabetes
News | Antiplatelet and Anticoagulation Therapies | September 10, 2019
The combination of ticagrelor and aspirin reduces ischemic events compared with aspirin alone in patients with stable...
Prasugrel Cuts Ischemic Events in Acute Coronary Syndrome Patients
News | Antiplatelet and Anticoagulation Therapies | September 09, 2019
Prasugrel is superior to ticagrelor for reducing ischemic events in patients with acute coronary syndrome and a planned...
Advances in Anticoagulants Expand Options for VTE Prevention, Treatment
News | Antiplatelet and Anticoagulation Therapies | July 26, 2019
A new article published in AACN Advanced Critical Care outlines the traditional anticoagulant therapies familiar to...
Fragmin (dalteparin sodium) injection was cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Fragmin (dalteparin sodium) injection is now cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Technology | Antiplatelet and Anticoagulation Therapies | May 17, 2019
May 17, 2019 — The U.S.
Overlay Init