Background: Monotherapy with a P2Y inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI).
Methods: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points.
Results: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority).
Conclusions: Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1056/NEJMoa1908419 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Randomised controlled trials of dual antiplatelet therapy versus aspirin in patients with stroke or transient ischaemic attack: an updated meta-analysis.
Singapore Med J
January 2025
Department of Radiology, Armed Forces Institute of Radiology, Pakistan.
Introduction: We explored the efficacy and safety of dual antiplatelet therapy (DAPT) for individuals diagnosed with stroke or transient ischaemic attack (TIA), incorporating the latest insights from randomised controlled trials (RCTs). The emerging evidence surrounding DAPT in stroke and TIA plays a pivotal role in guiding clinical decisions.
Methods: Our study included five RCTs (INSPIRES, THALES, POINT, CHANCE, FASTER) on DAPT (aspirin + P2Y12 inhibitor) initiated within 72 hours of acute stroke or TIA, which evaluated DAPT efficacy and safety over 21-90 days, focusing on new strokes and major bleeding.
Progress Analysis of Personalized Antiplatelet Therapy in Patients with Coronary Heart Disease Undergoing Interventional Therapy.
Rev Cardiovasc Med
December 2024
Department of Emergency, People's Hospital of Dali Bai Autonomous Prefecture, 671000 Dali, Yunnan, China.
Coronary atherosclerosis (or coronary heart disease [CHD]) is a common cardiovascular disease that seriously damages human health. Percutaneous coronary stent implantation represents the primary treatment option for severe CHD in clinical practice; meanwhile, dual antiplatelet therapy (DAPT) is widely used to reduce the risk of postoperative thrombosis. Although the mechanisms of action of the two most commonly used antiplatelet drugs, aspirin and clopidogrel, remain unclear, clinical studies have shown that some patients are susceptible to stent thrombosis-antiplatelet resistance (high on-treatment platelet reactivity [HTPR])-despite using these drugs.
View Article and Find Full Text PDFComparative Efficacy and Safety of Different Low-Dose Platelet Inhibitors in Patients With Coronary Heart Disease: A Bayesian Network Meta-Analysis.
J Evid Based Med
December 2024
Department of Respiratory and Critical Care Medicine, Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine, Beijing, China.
Objective: The optimal low-dose antiplatelet agents in patients with coronary heart disease (CHD) had not been determined. The objective of this study was to compare the impact of different low-dose antiplatelet agents on cardiovascular outcomes and bleeding risks in patients with CHD.
Methods: We searched PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, VIP, WanFang Data, and China Biology Medicine.
Switching Platelet P2Y Receptor Inhibiting Therapies.
Interv Cardiol Clin
October 2024
Division of Cardiology, University of Florida College of Medicine-Jacksonville, ACC Building 5th Floor, 655 West 8th Street, Jacksonville, FL 32209, USA.
Antiplatelet therapy involving aspirin and a P2Y receptor inhibitor is fundamental in managing patients with atherothrombotic disease. Switching between P2Y inhibitors is frequently observed in clinical settings for various reasons, such as safety, efficacy, patient adherence, or cost concerns. Although it occurs often, the optimal method for switching remains a concern owing to potential drug interactions, which can result in either inadequate platelet inhibition and subsequent thrombotic events or low platelet reactivity and increased bleeding risks due to therapy overlap.
View Article and Find Full Text PDFPostoperative bleeding in myocardial revascularization under cardiopulmonary bypass for patients treated with aspirin or dual antiplatelet therapy using reduced goal-directed anticoagulation.
Eur J Cardiothorac Surg
December 2024
Cardiac Surgery Department, University Hospital of Angers, 4 Rue Larrey, Angers, 49100, France.
Objectives: Antiplatelet therapy increases the risk of bleeding and transfusion in patients undergoing extracorporeal circulation. Reduced goal-directed anticoagulation is a personalized approach to reduce the anticoagulation based on a lower targeted activated clotting time. We assessed whether reduced goal-directed anticoagulation using optimized extracorporeal circulation alleviates the risk of severe bleeding in patients treated by dual antiplatelet therapy (DAPT) compared to aspirin alone during coronary artery bypass grafting (CABG).
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!