![]() ![]() Roxana Mehran, 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. 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% and 3.9%, respectively for ticagrelor plus placebo and ticagrelor plus aspirin (HR 0.99 95% CI 0.78 to 1.25 non-inferiority p<0.001). The incidence of BARC 3 or 5 bleeding was also lower (1.0% vs 2.0%, HR 0.49 95% CI 0.33 to 0.74) with ticagrelor plus placebo versus 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 4.0% in patients treated with ticagrelor plus placebo compared to 7.1% in patients treated with ticagrelor plus aspirin (HR 0.56 95% CI 0.45 to 0.68 p<0.001). Ticagrelor monotherapy was associated with a 44% lower risk of BARC 2, 3 or 5 bleeding over one year, with an absolute risk reduction of 3.1%, compared to ticagrelor plus aspirin. 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. 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. Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.WILMINGTON, Del.-( BUSINESS WIRE)-New data from TWILIGHT, a Phase IV independent trial (funded by AstraZeneca), showed that in patients at high-bleeding risk who underwent PCI and completed three months of dual antiplatelet therapy, BRILINTA (ticagrelor) monotherapy (90 mg twice daily) reduced the risk of BARC (Bleeding Academic Research Consortium) type 2, 3 or 5 bleeding compared to BRILINTA plus low-dose aspirin after 12 months. ![]() Persons with a history of ischemic stroke.Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin.Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start.Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start.Persons who are currently taking aspirin between 75 and 150 mg once daily.Females of child-bearing potential must have a negative pregnancy test at enrollment.Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction. ![]()
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