Pulmonary artery pressureguided management of patients with. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and. The year results from the woest trial, an openlabel multicenter, randomized, controlled trial, looked at 573 patients receiving anticoagulants and undergoing pci, and showed that bleeding episodes were seen in 54 patients assigned to clopidogrel alone, and in 126 patients receiving clopidogrel plus aspirin hazard ration hr 0. At pcp office ecg suggestive of ischemia transferred to emergency department troponin t. Management of patients with af undergoing pci must balance stroke and bleeding risk dewilde et al. Clinical and applied prevention of bleeding in patients.
Woest trial 573 patients toat warfarin plus clopidogrel patients. The what is the optimal antiplatelet and anticoagulant therapy in patients with oral anticoagulation and coronary stenting woest study was. Trials that evaluated dual versus triple antithrombotic therapy demonstrated. Woest 49 was an openlabel randomized controlled trial that studied the safety of antiplatelet regimens in patients on anticoagulation requiring percutaneous coronary interventions. Publications home of jama and the specialty journals of the. Bleeding and ischaemic outcomes in patients treated with dual. Heestermans aa, vis mm, tijsen jg, van t hof aw, ten berg jm. Aspirin targets a specific pathophysiological process that is considered fundamental to the progression from stable to unstable coronary syndromesplatelet.
While appearing to be the most effective regimen in preventing the combined incidence of stroke, death, myocardial infarction, re. Use of clopidogrel with or without aspirin in patients. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Study design12 contemporary design shows evolution in clinical management and trial design augustus trial. Feb 15, 20 the year results from the woest trial, an openlabel multicenter, randomized, controlled trial, looked at 573 patients receiving anticoagulants and undergoing pci, and showed that bleeding episodes were seen in 54 patients assigned to clopidogrel alone, and in 126 patients receiving clopidogrel plus aspirin hazard ration hr 0.
Rvrxbased regimens, combined with either p2y 12 or dapt, reduced bleeding compared to vka and dapt. Observational studies have corroborated the findings of the woest trial. The results of these two trials were similar to those of the woest trial, which compared warfarinbased triple therapy with dual therapy with warfarin and clopidogrel in 573 af patients undergoing pci. Isis2 first definitively positive secondary prevention trial with asa lancet 2019. Patients were randomized to double therapy with anticoagulant and clopidogrel vs triple therapy with additional aspirin following percutaneous coronary intervention. Stability is defined as the absence of coronary revascularization or acute. The three established specialty journals the lancet neurology, the lancet oncology, and the lancet infectious diseases have built up strong reputations in their medical specialty. The trial was therefore designed to enroll 550 patients per group, for a total of 1650 patients.
Longterm treatment with oral anticoagulants is necessary in patients with mechanical heart valves and in most with atrial fibrillation. Woest days ing 0 30 60 90 120 180 270 365 0 % 10 % 20 % 30 % 40 % 50 % n at risk. Woest trial finds clopidogrel administered without aspirin. Aug 27, 2018 the global leaders trial, which is published simultaneously in the lancet, was an openlabel, superiority trial conducted at sites in 18 countries. Optimal antiplatelet and anticoagulant therapy in patients. As we go into practice, we are using evidence to inform ourselves rather than simply choosing what we think is our best choice. What is the optimal antiplatelet and anticoagulant therapy. Ich hx, shock, pud, tpenia, major bleed hx primary endpoint. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease. Patients undergoing pci with a biolimus a9eluting stent biomatrix, biosensors international for acs or stable coronary disease were randomized to 75100 mg aspirin daily plus 90 mg ticagrelor. All eligible patients referred to the study centres from november, 2008, to november, 2011, were included.
Clinical pharmacistassociate professor mercy clinic. Dual therapy with oral anticoagulants and clopidogrel showed a large reduction in bleeding without increasing ischemic events compared with triple therapy including aspirin. Horton defended the lancets publication of the trial and called the critics. What is the optimal antiplatelet and anticoagulation therapy in patients with oral anticoagulation and coronary stenting clinical ischemic events were a secondary end point, and results suggested these were not increased by dropping aspirin. Inclusion criteria were a longterm indication for oral anticoagulation treatment until at least 1 year after the study. The pioneer population is composed entirely of participants with atrial fibrillation, whereas only 69% 162 of the participants in the group receiving standard triple therapy in the woest trial. Journal club 11 12012 woest trial linkedin slideshare.
A danish registry of over 12,000 patients with atrial fibrillation undergoing pci evaluated safety, efficacy, and mortality of a triple therapy regimen compared to oac with the addition of a single antiplatelet agent 4. What is the optimal antiplatelet and anticoagulant therapy in. The trial was underpowered to detect differences in thrombotic events. Randomization in fact, gives each participant in the. Patients undergoing pci with an oac indication exclusions. The prospective, multicenter, randomized design is a major strength of the woest study, making it the only prospective randomized trial carried out so far on oac patients submitted to pcis, and fulfilling most of the formal requirements for optimal clinical research. Woest trial finds clopidogrel administered without aspirin reduces bleeding. Given these results and the other wellknown advantages of noacs over vka, we concluded that noac plus p2y12 inhibitor is the preferred treatment option for. Woest esc, hotline iii, munchen, august 28th, 2012 the woest trial. Similar to the pioneeraf trial, no significant differences in efficacy endpoints were present between the three treatment groups. Because of the underpowered size of the woest study for a reliable evaluation of the efficacy. An openlabel, randomized, controlled, multicenter study. Drop aspirin in stent patients on oral anticoagulants.
Publications home of jama and the specialty journals of. Esc recommendations european heart journal 2016 37, 267315. A clinical trial comparing three antithromboticdrug regimens. Use of clopidogrel with or without aspirin in patients taking oral.
Use of clopidogrel with or without aspirin in patients taking. Paul m haller, patrick sulzgruber, christoph kaufmann, bastiaan geelhoed, juan tamargo, sven wassmann, renate b schnabel, dirk westermann, kurt huber, alexander niessner, thomas gremmel, bleeding and ischaemic outcomes in patients treated with dual or triple antithrombotic therapy. The augustus trial had an arm that included 1126 patients treated with vka plus p2y 12 inhibitor, which was much larger than the 279 patients receiving vka plus p2y 12 inhibitor in woest. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention. Indeed, patients enrolled in the woest study 4 are younger than those generally. Citescore values are based on citation counts in a given year e. Fda approves asa for secondary prevention based on metaanalysis data of individually inconclusive trials 1989. Triple antithrombotic therapy after acs and pci in patients on. It is among the worlds oldest, and best known general medical journals, although it has been at the center of recent controversies. Background antithrombotic drugs are used after coronaryartery stenting to prevent stent thrombosis. The study was a prospective, openlabel, randomized controlled trial conducted at 15 centers in belgium and netherlands between november.
Reconsidering the necessity of aspirin in stable coronary. According to the journal citation reports, the lancet oncology has a 2017 impact factor of 36. Woest risk of bleeding is high using triple oral antithrombotic therapy at 1 year oral anticoagulation was being used by 92. Backgroundtriple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention pci for patients with atrial fibrillation, but. Jul 01, 2019 observational studies have corroborated the findings of the woest trial. Dual antiplatelet therapy and anticoagulation in patients.
Pci in patients with af optimizing oral anticoagulation. We compared the efficacy and safety of three antithromboticdrug regimens aspirin alone. Dual antiplatelet therapy for acute coronary syndromes. Antiplatelet therapy and anticoagulants the lancet. Augustus was a prospective, multicenter, twobytwo factorial, randomized clinical trial, supported by the pharmaceutic industry, including 4614 patients with atrial fibrillation who had a recent acute coronary syndrome acs andor underwent pci with stent, all of them on a p2y12 inhibitor clopidogrel in most of the cases with a 6 months follow up. Patient case ba is a 63yearold man who presents with worsening chest pain over the past week. Woest was the first prospective study to evaluate dual therapy clopidogrel plus an oral anticoagulant oac versus triple therapy aspirin, clopidogrel, and oac in patients requiring longterm anticoagulation undergoing pci. Pci in patients with af optimizing oral anticoagulation regimen. Augustus was a prospective, multicenter, twobytwo factorial, randomized clinical trial, supported by the pharmaceutic industry, including 4614 patients with atrial fibrillation who had a recent acute coronary syndrome acs andor underwent pci with stent, all of them on a p2y12 inhibitor clopidogrel in most of the cases with a 6 months. Randomization in fact, gives each participant in the study equal chances of. Background despite increased use of guidelinedirected medical therapy gdmt, some patients with heart failure and reduced ejection fraction hfref remain at high risk for hospitalization and mortality. Prevention of bleeding in patients with atrial fibrillation. Triple therapy tt of warfarin, aspirin, and clopidogrel is currently recommended as the antithrombotic therapy for patients with an indication for oral anticoagulation oac undergoing percutaneous coronary intervention pci with stent implantation pci.
Although that finding cannot be clearly explained, it cannot be excluded that it might have affected the results of the study. Worst bleeding per patient 3 3 16 20 25 7 30 20 48 8 p lancet 20. Still, the woest trial was the first important piece of evidence. Aspirin has been a cornerstone of secondary prevention in patients with stable coronary artery disease cad for more than 4 decades. Remote monitoring of pulmonary artery pa pressures provides clinicians with actionable information to help further optimize medications and improve outcomes. A clinical trial comparing three antithromboticdrug.
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