AstraZeneca announces Brilinta PHASE IV Clinical Subgroup Analysis Data

Recently, AstraZeneca published the results of the two subgroups (TWILIGHT-DM, TWILIGHT-COMPLEX) of the independent study of TWILIGHT IN phase IV of the anticoagulant Brilinta (Ticagra)The data showed that in patients with high-risk coronary artery disease, Brilinta single-drug treatment reduced the risk of clinically-related bleeding for 12 months compared to aspirin-brilinta double antiplatelet therapy (DAPT), and did not increase the risk of bleeding eventsTWILIGHT is a randomized, double-blind, placebo-controlled PHASE IV study that enrolled 9006 patients from 187 clinical centers in 11 countriesThese patients had high-risk clinical and/or anatomical characteristics of ischemia or bleeding after receiving epidermal coronary artery interventiontherapy (PCI) and inserting at least one drug elution stent (DES), and 64% of patients had elevated acute coronary artery syndrome (NSTE-ACS) for non-ST segmentsIn the study, all patients received Brilinta (90mg, twice daily) and aspirin intestinal tablets (81-100 mg, 1 time per day) for 3 months after PCI surgeryWithin 3 months of treatment with Brilinta and aspirin, patients who adhered to DAPT and did not experience haemorrhage or ischemic events (7119 cases), continued to receive aspirin or placebo treatment for 12 months in a 1:1 random group, both groups continued to receive open label Brilinta treatmentresults showed that during the 12-month period of continued treatment, Brilinta single-drug reduced the relative risk of BARC (Hemorrhagic Academic Research Association Standard) type 2, type 3, type 5 bleeding events by 44%, and the absolute risk reduced by 3.1% (4.0% vs7.1%; In addition, the two groups were similar due to a compound risk of death, heart attack, or stroke (3.9% vs 3.9%, HR : 0.99, 95% CI: 0.78-1.25, non-effect p 0.001)the two subgroups published this time, all patients who completed three months of DAPT without haemorrhage or ischemia were randomly assigned to receive placebo or aspirin treatment while continuing to receive Brilinta open label treatment for 12 monthsTWILIGHT-DM subgroup included 2620 patients with diabetes who had received 2620 successful PCI, and TWILIGHT-COMPLEX subgroup included 2342 patients who successfully received complex PCIPCI is an operation to open a blocked or narrow coronary artery, complex PCI is defined as any of the following: treatment of 3 blood vessels, treatment of at least 3 lesions, total stent length of 60 mm, implantation of 2 stents at the fork, use of any kind of angiocecizer, left trunk PCI, surgical bypass transplantation, target lesions for chronic complete blockingsubgroup analysis showed that brilinta monotherapy was associated with lower clinically related bleeding rates without increasing the risk of ischemic events compared to DAPT for 3 to 15 months after PCI surgery (i.eduring 12 months of randomized treatment)IN THE TWILIGHT-DM AND TWILIGHT-COMPLEX SUBGROUPS, THE RISK OF CLINICALLY RELATED BLEEDING WAS REDUCED BY 35 PERCENT, 46 PERCENT, AND THE RISK OF ISCHEMIC EVENTS WAS SIMILAR IN PATIENTS TREATED WITH DAPTsubgroup results are consistent with the overall test resultsAt present, in the clinical treatment of PCI patients, there is a clear medical need for treatment strategies to reduce the risk of bleeding but not to impair ischemic protectionThese subgroup analyses provide very important insights into Brilinta's single-drug therapy for these high-risk patientsacute coronary artery syndrome (ACS) is a cardiovascular disease that causes a complete or completely closed thrombosis to form a complete or completely closed blood clot, resulting in a severe reduction in myocardial blood supply (unstable angina) or complete obstruction (myocardial infarction)Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activationTo date, Brilinta has been approved for the treatment of ACS in more than 110 countries and secondary prevention of cardiovascular events in patients at high risk of experiencing a heart attack in more than 70 countriesBrilinta combined aspirin has been shown to significantly reduce the risk of major adverse cardiovascular events in patients with ACS or in patients with a history of myocardial infarction (IM)Brilinta Combined Aspirin Program for patients with an ACS adult, or those with an IM history and a high risk of atherosclerosis thrombosis events, to prevent atherosclerosis thrombosis eventsreference source: Brilinta reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trialoriginal title: AstraZeneca announces Brilinta IV Clinical Subgroup Analysis Data: Single Drug Reduces Bleeding Risk