Tigerolol plus aspirin is the first-line recommendation for antithrombotic therapy in patients with acute coronary syndrome, and its efficacy and safety have been repeatedly verified in international and domestic studies. The full text of the Dayu study was published to add to the Chinese evidence.
Source丨 Medical Community Cardiovascular Channel
The Dayu study enriched the data on the effectiveness and safety of antithrombotic therapy in patients with ACS in China
The prevalence of cardiovascular disease (CVD) in China is in a continuously rising stage, with about 290 million people currently affected. In 2015, the CVD mortality rate remained the highest, higher than tumors and other diseases. AS one of these emergencies, ACS has a high fatality rate. Aspirin plus tigrelor for 1 year is the first-line option for antithrombotic therapy in patients with ACS. As the only P2Y12 receptor antagonist that can reduce cardiovascular mortality, tigrelor has become the first-line recommendation of international and domestic authoritative guidelines for antithrombotic therapy for ACS patients.
Tiggrelor 90 mg in combination with aspirin for 1 year of treatment in patients with ACS can reduce the incidence of cardiovascular death, myocardial infarction and stroke. Not long ago, ticagrelor 60 mg in combination with aspirin was approved in China for use in patients with a history of myocardial infarction with at least one risk factor for atherosclerotic thrombotic events (age ≥65 years, diabetes requiring medication, relapse of previous myocardial infarction, evidence of multi-vessel coronary artery disease, or chronic end-stage renal insufficiency), which reduced the incidence of cardiovascular death, myocardial infarction, and stroke.
Guidelines recommend that the approval of new indications affirm the role of tigrelor in antithrombotic therapy. In November 2012, ticagrelor was approved for marketing by the China Food and Drug Administration (CFDA), and in accordance with the requirements of the CFDA and in order to obtain more evidence of the application of tegrelor in Chinese ACS patients, the open label, multicenter, single-arm, phase IV Dayu study was launched in June 2013.
Published online on February 28, 2018, the full text of the study, in Cardiovascular Drugs and Therapy, included 104 centers of 2,004 patients with ACS (2,001 in the safety population) who received ticagrelor (180 mg loading dose, 90 mg twice daily maintenance dose) plus low-dose aspirin (75–100 mg/day) for at least 12 months. The study further refines the data on the efficacy and safety of tegrelor in antithrombotic therapy in Chinese populations.
Dayu certification: Ticagrelor combined with aspirin for ACS patients has excellent efficacy and good safety
Dayu Research is in line with the Harmonization Guidelines of the Helsinki Declaration and the International Association for Coordinated Good Clinical Practice (ICH-GCP) and follows applicable regulatory requirements. Of the 104 participating research centers, 89.4% (93) are CFDA-GCP accredited clinical trial institutions. Upon completion of the study, the study implementation team self-validated 1575 patients in 84 centers in accordance with CFDA guidelines, and all 104 participating centers were approved for quality control and certification center material summaries were submitted.
In strict monitoring mode, the main results show:
In terms of safety, only 27 patients experienced a PLATO-defined major bleeding event (1.3%), of which 17 (0.8%) were fatal/life-threatening bleeding, and the Kaplan Meier method estimated the primary bleeding risk (95% CI) at 1.6% (1.1% to 2.3%).
In terms of efficacy, only 83 patients (4.1%) followed up in one year had a major CV event (CV death, myocardial infarction, or stroke).
Compared with plato study data, plato defined the incidence of major bleeding as low and the incidence of major cardiovascular events as defined by PLATO. The Dayu researchers considered that compared with the PLATO study, the Population enrolled in the Dayu Study was younger, less female, and had fewer CV risk factors. In the PLATO study, 10.0% (931/9333) of patients with coronary artery bypass grafting (CABG) were enrolled in the Tiggrelo group, while such patients were not included in the Dayu study, and the incidence of non-CABG major bleeding in the PLATO study was 4.5%. In addition, the Dayu study was only carried out 7-8 years after the PLATO study, and with the advancement of medicine, it is reasonable that the CV event incidence of the Dayu study was lower.
The Dayu study confirmed that one-year antithrombotic therapy with tegrelor with tegrelor in Chinese ACS with aspirin was safe and effective, and the risk of major bleeding and the incidence of CV events were low. The study found no new safety incidents, which are consistent with current Chinese tigrelor prescription information.
Dayu's 104 centers cover most of the country, so its results are representative of Chinese ACS patients, which strongly confirms the efficacy and safety of tigrelor in antithrombotic therapy in Chinese ACS patients. In ancient times, there was Dayu Zhishui, and now there is Dayu Zhixin, and the Chinese evidence of Tirelot adds strength to the antithrombotic treatment of ACS patients.
Expert reviews
Ticagrelor is an oral direct, rapidly acting antiplatelet drug that binds reversibly to P2Y12 receptor antagonists. The safety and efficacy of therapy for Ticagrelor in patients with ACS have been confirmed by the PLATO study, and the Dayu study, as a large-sample study against Chinese population, enriched the efficacy and safety data of Ticagrelor in the ACS population in China. The results of the Dayu study confirm that tigrelor combined with aspirin is a safe and effective option for patients with ACS in China.
Expert Profiles
Academician Gao Runlin
Gao Runlin, Chief Physician, Professor. He is a senior consultant expert, researcher and doctoral supervisor of Fuwai Hospital, and serves as the executive director of the Chinese Medical Association, the chairman of the Expert Committee of the National Cardiovascular Disease Center, the editor-in-chief of the Chinese Journal of Circulation, the deputy editor-in-chief of the Chinese edition of the British Medical Journal, the international deputy editor of the European Journal of Cardiology and the editorial board of many journals at home and abroad. In 1999, he was elected as an academician of the Chinese Academy of Engineering. He also served as a member of the 9th, 10th and 11th National Committee of the Chinese People's Political Consultative Conference.
He has long been engaged in clinical and scientific research of cardiovascular diseases, is one of the pioneers of interventional cardiology in China, and has taken the lead in carrying out emergency interventional treatment and a number of new technologies for acute myocardial infarction and complicated cardiogenic shock in China, contributing to the popularization, promotion and standardization of interventional treatment for coronary heart disease in China and the expansion of China's influence in the international interventional community. He is committed to the research of interventional treatment restenosis mechanism and prevention, combining production, education and research, promoting the innovation and localization of drug-eluting stents, and completing the transformation of a variety of new drug-eluting stents from laboratory to clinical. It has also made remarkable achievements in the clinical treatment of coronary heart disease, pathophysiology and treatment of angina pectoris, myocardial infarction reperfusion therapy, clinical trials of new drugs and epidemiological research of cardiovascular diseases, and has won 3 second prizes of national scientific and technological progress and 6 provincial (ministerial) awards. He has published more than 500 papers. It has trained 4 master's students, 16 doctoral students and 2 postdoctoral fellows.