56 results match your criteria: "University of Edinburgh and Royal Infirmary of Edinburgh[Affiliation]"
Outcome of Patients Receiving Thrombolytic Therapy While on Rivaroxaban for Nonvalvular Atrial Fibrillation (from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).
Am J Cardiol
November 2017
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address:
The safety of intravenous thrombolysis in patients taking rivaroxaban has not been well established. We retrospectively analyzed the outcomes of all patients who received thrombolytic therapy in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). A review of medical and adverse event records for patients receiving thrombolytic therapy while enrolled in ROCKET AF was performed to determine their baseline characteristics, indications for thrombolysis, and type of agent used.
View Article and Find Full Text PDFSafety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial.
J Am Heart Assoc
June 2017
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
Background: Although implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting.
Methods And Results: Using data from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) (n=14 264), we compared baseline characteristics and clinical outcomes in patients with atrial fibrillation randomized to rivaroxaban versus warfarin who did and did not undergo CIED implantation or revision. In this post-hoc, postrandomization, on-treatment analysis, only the first intervention per patient was analyzed.
Noncentral Nervous System Systemic Embolism in Patients With Atrial Fibrillation: Results From ROCKET AF (Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).
Circ Cardiovasc Qual Outcomes
May 2017
From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.O., D.W., W.S.J., M.R.P.); Department of Statistics, North Carolina State University, Raleigh (D.H.); Mount Sinai Medical Center, New York, NY (J.L.H.); Department of Cardiovascular Medicine, Hospital of the University of Münster, Germany (G.B.); Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.); University of Edinburgh and Royal Infirmary of Edinburgh, Scotland, United Kingdom (K.A.A.F.); School of Medicine and Pharmacology, University of Western Australia, Crawley (G.J.H.); and Stanford University School of Medicine, CA (K.W.M.).
Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial.
Thromb Res
August 2017
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States. Electronic address:
Background: The ROCKET AF study evaluated once-daily rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). In this analysis, we compared rivaroxaban with warfarin in patients with AF from China, East Asia, and the rest of the world (ROW).
Methods And Results: We assessed baseline demographics and interaction of treatment effects of rivaroxaban versus warfarin among patients from mainland China, other East Asian countries, and ROW.
Personalising the decision for prolonged dual antiplatelet therapy: development, validation and potential impact of prognostic models for cardiovascular events and bleeding in myocardial infarction survivors.
Eur Heart J
April 2017
The Farr Institute of Health Informatics Research, University College London, London, UK.
Aims: The aim of this study is to develop models to aid the decision to prolong dual antiplatelet therapy (DAPT) that requires balancing an individual patient's potential benefits and harms.
Methods And Results: Using population-based electronic health records (EHRs) (CALIBER, England, 2000-10), of patients evaluated 1 year after acute myocardial infarction (MI), we developed (n = 12 694 patients) and validated (n = 5613) prognostic models for cardiovascular (cardiovascular death, MI or stroke) events and three different bleeding endpoints. We applied trial effect estimates to determine potential benefits and harms of DAPT and the net clinical benefit of individuals.
Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin: A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis.
Circulation
March 2017
From Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.M.L., C.B.F., A.S.H., Y.L., J.P.P., M.R.P.); Division of Cardiology, University of British Columbia, Vancouver, Canada (C.B.F.); Department of Cardiovascular Medicine, University of Münster, Germany (G.B.); Stanford University School of Medicine, CA (K.W.M.); Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.); Ruprecht-Karls-University, Heidelberg, Germany (W.H.); Cardiovascular Institute, Mount Sinai Medical Center, NY (J.L.H.); School of Medicine and Pharmacology, The University of Western Australia, Crawley (G.J.H.); Bayer HealthCare Pharmaceuticals, Parsippany, NJ (S.D.B.); Janssen Research and Development LLC, Raritan, NJ (C.C.N.); University of Cincinnati College of Medicine, OH (R.C.B.); and University of Edinburgh and Royal Infirmary of Edinburgh, UK (K.A.A.F.).
Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI.
N Engl J Med
December 2016
From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (C.M.G., S.K., Y.D.); the Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M., J.H.); Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg (C.B.), and Bayer Pharmaceuticals, Leverkusen (M.E.) - both in Germany; Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam (F.W.V.); Janssen Pharmaceuticals, Titusville (P.W., M.B., J.I., P.B.), and the Division of Cardiology, Newark Beth Israel Medical Center, Newark (M.C.) - both in New Jersey; University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (G.Y.H.L.); Aarhus University Hospital, Medical Department, Hospital Unit West, Herning, Denmark (S.H.); Duke Clinical Research Institute, Durham, NC (E.D.P.); and the Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh (K.A.F.).
Background: In patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) with placement of stents, standard anticoagulation with a vitamin K antagonist plus dual antiplatelet therapy (DAPT) with a P2Y inhibitor and aspirin reduces the risk of thrombosis and stroke but increases the risk of bleeding. The effectiveness and safety of anticoagulation with rivaroxaban plus either one or two antiplatelet agents are uncertain.
Methods: We randomly assigned 2124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting to receive, in a 1:1:1 ratio, low-dose rivaroxaban (15 mg once daily) plus a P2Y inhibitor for 12 months (group 1), very-low-dose rivaroxaban (2.
Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.
Circulation
January 2017
From Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.M.G., D.S.P., G.C., D.A., M.Y., S.K., Y.D., P.J.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M., J.H.); Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany (C.B.); Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (F.W.A.V.); Janssen Pharmaceuticals, Inc, Beerse, Belgium (P.W., P.B.); Bayer Pharmaceuticals, Inc, Berlin, Germany (M.v.E.); University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (G.Y.H.L.); Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ (M.C.); Duke Clinical Research Institute, Durham, NC (E.D.P.); and Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom (K.A.A.F.).
Background: Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization.
Methods: Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y inhibitor for 12 months (group 1); rivaroxaban 2.
Use of concomitant aspirin in patients with atrial fibrillation: Findings from the ROCKET AF trial.
Am Heart J
September 2016
Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC. Electronic address:
Background: We aimed to investigate the relationship between aspirin use and clinical outcomes in patients enrolled in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), in particular, those with known coronary artery disease (CAD).
Methods: Patients in ROCKET AF, comparing rivaroxaban and warfarin, were analyzed. Aspirin use was assessed at baseline.
Use of Dual Antiplatelet Therapy and Patient Outcomes in Those Undergoing Percutaneous Coronary Intervention: The ROCKET AF Trial.
JACC Cardiovasc Interv
August 2016
Duke Clinical Research Institute, Durham, North Carolina; Duke Heart Center, Duke University School of Medicine, Durham, North Carolina.
Objectives: The authors assessed the use of dual antiplatelet therapy (DAPT) and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).
Background: The frequency, patterns, and outcomes when adding DAPT to non-vitamin K antagonist oral anticoagulants in the setting of PCI in patients with AF are largely unknown.
Methods: The study population included all patients in the treatment group of the ROCKET AF trial divided by the receipt of PCI during follow-up.
Blood pressure control and stroke or bleeding risk in anticoagulated patients with atrial fibrillation: Results from the ROCKET AF Trial.
Am Heart J
August 2016
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Background: We conducted a retrospective analysis examining the association between systolic blood pressure (SBP) or hypertension bracket and stroke risk in patients with atrial fibrillation (AF).
Methods: The study included 14,256 anticoagulated patients in the ROCKET AF trial. Cox proportional hazards models were used to compare the risk of adverse outcomes by European Society of Cardiology hypertension bracket and screening SBP.
Response by Piccini et al to Letters Regarding Article, "Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation".
Circulation
July 2016
From the Duke Clinical Research Institute (J.P.P., A.S.H., M.R.P.) and Duke Heart Center (J.P.P., J.B.W., M.R.P.), Duke University Medical Center, Durham, NC; University of Cincinnati College of Medicine, Cincinnati, OH (R.C.B.); Hospital of the University of Münster, Germany (G.B.); Bayer HealthCare Pharmaceuticals, Parsippany, NJ (S.D.B.); Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Medical Center, New York, NY (J.L.H.); School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia (G.J.H.); Ruprecht-Karls-University, Heidelberg, Germany (W.H.); Department of Medicine, Stanford University, CA (K.W.M.); Janssen Pharmaceutical Research and Development, Raritan, NJ (C.C.N.); Massachusetts General Hospital, and Harvard Medical School, Boston (D.E.S.); and University of Edinburgh and Royal Infirmary of Edinburgh, UK (K.A.A.F.).
On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF.
Circulation
July 2016
From Duke Clinical Research Institute, Durham, NC (C.B.F., A.S.H., Y.L., S.M.L., J.P.P., M.R.P.); University of Cincinnati College of Medicine, OH (R.C.B.); Bayer HealthCare Pharmaceuticals, Whippany, NJ (S.D.B); Department of Cardiovascular Medicine, Division of Electrophysiology, University Hospital Münster, Germany (G.B.); Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, UK (K.A.A.F.); Department of Medicine, Stanford University, CA (K.W.M.); Janssen Research and Development, Raritan, NJ (C.C.N.); and Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.).
Background: Despite rapid clinical adoption of novel anticoagulants, it is unknown whether outcomes differ among patients with worsening renal function (WRF) taking these new drugs compared with warfarin. We aimed to determine whether the primary efficacy (stroke or systemic embolism) and safety (major bleeding and nonmajor clinically relevant bleeding) end points from the ROCKET AF trial (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial) differed among participants with WRF taking rivaroxaban and those taking warfarin.
Methods: After excluding patients without at least 1 follow-up creatinine measurement (n=1624), we included all remaining patients (n=12 612) randomly assigned to either rivaroxaban or dose-adjusted warfarin.
Hospitalizations in patients with atrial fibrillation: an analysis from ROCKET AF.
Europace
August 2016
Duke Clinical Research Institute, Durham, NC, USA Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Aims: The high costs associated with treatment for atrial fibrillation (AF) are primarily due to hospital care, but there are limited data to understand the reasons for and predictors of hospitalization in patients with AF.
Methods And Results: The ROCKET AF trial compared rivaroxaban with warfarin for stroke prophylaxis in AF. We described the frequency of and reasons for hospitalization during study follow-up and utilized Cox proportional hazards models to assess for baseline characteristics associated with all-cause hospitalization.
Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation.
Circulation
January 2016
From Duke Clinical Research Institute, Durham, NC (J.P.P., A.S.H., M.R.P.); Duke Heart Center, Duke University Medical Center, Durham, NC (J.P.P., J.B.W., M.R.P.); University of Cincinnati College of Medicine, OH (R.C.B.); Hospital of the University of Münster, Germany (G.B.); Bayer HealthCare Pharmaceuticals, Whippany, NJ (S.D.B.); Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Medical Center, New York, NY (J.L.H.); School of Medicine and Pharmacology, University of Western Australia, Crawley, WA (G.J.H.); Ruprecht-Karls-University, Heidelberg, Germany (W.H.); Department of Medicine, Stanford University, Palo Alto, CA (K.W.M.); Janssen Pharmaceutical Research and Development, Raritan, NJ (C.C.N.); Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.); and University of Edinburgh and Royal Infirmary of Edinburgh, UK (K.A.A.F.).
Background: Patients with atrial fibrillation (AF) often take multiple medications.
Methods And Results: We examined characteristics and compared adjusted outcomes between rivaroxaban and warfarin according to number of concomitant baseline medications and the presence of combined cytochrome P450 3A4 and P-glycoprotein inhibitors in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study. At baseline, 5101 patients (36%) were on 0 to 4 medications, 7298 (51%) were on 5 to 9, and 1865 (13%) were on ≥ 10.
Gastrointestinal Bleeding in Patients With Atrial Fibrillation Treated With Rivaroxaban or Warfarin: ROCKET AF Trial.
J Am Coll Cardiol
December 2015
Division of Cardiovascular Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.
Background: Gastrointestinal (GI) bleeding is a common complication of oral anticoagulation.
Objectives: This study evaluated GI bleeding in patients who received at least 1 dose of the study drug in the on-treatment arm of the ROCKET AF (Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial.
Methods: The primary outcome was adjudicated GI bleeding reported from first to last drug dose + 2 days.
Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial).
Am Heart J
October 2015
University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
Background: The prevalence of both atrial fibrillation (AF) and diabetes mellitus (DM) are rising, and these conditions often occur together. Also, DM is an independent risk factor for stroke in patients with AF. We aimed to examine the safety and efficacy of rivaroxaban vs warfarin in patients with nonvalvular AF and DM in a prespecified secondary analysis of the ROCKET AF trial.
View Article and Find Full Text PDFAn open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI).
Am Heart J
April 2015
Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
Background: Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes.
View Article and Find Full Text PDFAlternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial.
J Am Heart Assoc
March 2015
Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC (R.M.C.).
Background: In the ROCKET AF (Rivaroxaban-Once-daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial, marked regional differences in control of warfarin anticoagulation, measured as the average individual patient time in the therapeutic range (iTTR) of the international normalized ratio (INR), were associated with longer inter-INR test intervals. The standard Rosendaal approach can produce biased low estimates of TTR after an appropriate dose change if the follow-up INR test interval is prolonged. We explored the effect of alternative calculations of TTR that more immediately account for dose changes on regional differences in mean iTTR in the ROCKET AF trial.
View Article and Find Full Text PDFHigher risk of death and stroke in patients with persistent vs. paroxysmal atrial fibrillation: results from the ROCKET-AF Trial.
Eur Heart J
February 2015
Duke Clinical Research Institute, PO Box 17969, NC 27715 Durham, NC, USA.
Aim: Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation (AF). We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation.
View Article and Find Full Text PDFEfficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF).
Circulation
July 2014
From Icahn School of Medicine at Mount Sinai, New York, NY (J.L.H.); School of Medicine and Pharmacology, University of Western Australia School of Medicine and Pharmacology, Perth, Australia (G.J.H.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (D.M.W., J.P.P., Y.L., M.R.P.); University of Münster, Münster, Germany (G.B.); Massachusetts General Hospital and Harvard Medical School, Boston, MA (D.E.S.); University of Cincinnati College of Medicine, Cincinnati, OH (R.C.B.); Ruprecht-Karls University, Heidelberg, Germany (W.H.); Cerenis Therapeutics, Labege, France (J.F.P.); Janssen Research and Development, Raritan, NJ (C.C.N.); Stanford University School of Medicine, Stanford, CA (K.W.M.); Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC (R.M.C.); and University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom (K.A.A.F.).
Background: Nonvalvular atrial fibrillation is common in elderly patients, who face an elevated risk of stroke but difficulty sustaining warfarin treatment. The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). This prespecified secondary analysis compares outcomes in older and younger patients.
View Article and Find Full Text PDFUse and outcomes of antiarrhythmic therapy in patients with atrial fibrillation receiving oral anticoagulation: results from the ROCKET AF trial.
Heart Rhythm
June 2014
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
Background: Antiarrhythmic drugs (AADs) and anticoagulation are mainstays of atrial fibrillation (AF) treatment.
Objective: To study the use and outcomes of AAD therapy in anticoagulated patients with AF.
Methods: Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial (N = 14,264) were stratified by AAD use at baseline: amiodarone, other AAD, or no AAD.
Rivaroxaban for stroke prevention in East Asian patients from the ROCKET AF trial.
Stroke
June 2014
From the Department of Medicine and Therapeutics, Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China (K.S.L.W.); Heart Center, Peking University People's Hospital, Beijing, China (D.Y.H.); Department of Cardiology, Apollo Hospital, Chennai, India (A.O.); National Heart Centre, Singapore, Singapore (R.-S.T.); Department of Medicine, Division of Cardiology, Duke Clinical Research Institute (M.R.P., K.W.M., R.C.B.) and Department of Medicine, Division of Cardiology, Duke Translational Medicine Institute (R.C.), Duke University Medical Center, Durham, NC; Department of Epidemiology, Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.); Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany (G.B.); Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, Scotland (K.A.A.F.); Bayer HealthCare Pharmaceuticals, Montville, NJ (S.D.B.); Department of Neurology, Ruprecht-Karls-University, Heidelberg, Germany (W.H.); and Stroke Unit, Department of Neurology, Royal Perth Hospital, University of Western Australia, Perth, Australia (G.J.H.).
Background And Purpose: In Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban was noninferior to dose-adjusted warfarin in preventing stroke or systemic embolism among patients with nonvalvular atrial fibrillation at moderate to high stroke risk. Because of differences in patient demographics, epidemiology, and stroke risk management in East Asia, outcomes and relative effects of rivaroxaban versus warfarin were assessed to determine consistency among East Asians versus other ROCKET AF participants.
Methods: Baseline demographics and interaction of treatment effects of rivaroxaban and warfarin among patients within East Asia and outside were assessed.
Intracranial hemorrhage among patients with atrial fibrillation anticoagulated with warfarin or rivaroxaban: the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation.
Stroke
May 2014
From the School of Medicine and Pharmacology, The University of Western Australia, Perth, Australia (G.J.H.); Department of Neurology, Sir Charles Gairdner Hospital, Perth, Australia (G.J.H.); Duke Clinical Research Institute (S.R.S., J.P.P., Y.L., M.R.P.) and Duke Translational Medicine Institute (R.M.C.), Duke University Medical Center, Durham, NC; Department of Medicine, Stanford University, CA (K.W.M.); Cardiovascular Institute, Mount Sinai Medical Center, New York (J.L.H.); Department of Cardiovascular Medicine, Hospital of the University of Münster, Münster, Germany (G.B.); Massachusetts General Hospital and Harvard Medical School, Boston (D.E.S.); University of Cincinnati College of Medicine, OH (R.C.B.); Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ (S.D.B.); Cerenis Therapeutics, Labege, France (J.F.P.); Janssen Research and Development, Raritan, NJ (C.C.N.); Ruprecht- Karls-University, Heidelberg, Germany (W.H.); and University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom (K.A.A.F.).
Background And Purpose: Intracranial hemorrhage (ICH) is a life-threatening complication of anticoagulation.
Methods: We investigated the rate, outcomes, and predictors of ICH in 14 264 patients with atrial fibrillation from Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Cox proportional hazards modeling was used.
Aims: There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors.
Methods And Results: Using data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and according to the randomized treatment. During a median follow-up of 1.