119 results match your criteria: "CA K.W.M.; Boston University School of Medicine[Affiliation]"
J Am Heart Assoc
December 2015
Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada (S.D., M.P., C.M.W., P.W.A.) Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada (P.W.A.).
Background: Perioperative antiplatelet agents potentially increase bleeding after non-ST-segment elevation (NSTE) acute coronary syndromes (ACS). The protease-activated receptor 1 antagonist vorapaxar reduced cardiovascular events and was associated with increased bleeding versus placebo in NSTE ACS, but its efficacy and safety in noncardiac surgery (NCS) remain unknown. We aimed to evaluate ischemic, bleeding, and long-term outcomes of vorapaxar in NCS after NSTE ACS.
View Article and Find Full Text PDFN Engl J Med
November 2015
From the College of Medical and Dental Sciences, University of Birmingham (A.C., H.W., E.T., J.J.C., A. Eapen, M.D.K.), Heart of England NHS Foundation Trust (R.S., P.G.), and Sandwell and West Birmingham Hospitals NHS Teaching Trust (A. Ewies), Birmingham, King's College London and King's Health Partners at St. Thomas' Hospital (P.T.S.), Women's Health Research Center, Imperial College at St. Mary's Hospital Campus (R.B., R.C., L.S., L.R., R.R.), King's Health Partners at St. Thomas' Hospital (A.L.B.), King's College Hospital NHS Foundation Trust (J.A.R.), and Assisted Conception Unit, Guy's and St. Thomas' Foundation Trust (Y.K.), London, Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick (S.Q.), Liverpool Women's NHS Foundation Trust (F.D., R.G.F.), Liverpool, The Miscarriage Association, Wakefield (R.B.A.), University of Southampton Faculty of Medicine, Princess Anne Hospital, Southampton (Y.C.C.), Royal Hallamshire Hospital, Sheffield (T.-C.L.), Ayrshire Maternity Unit, University Hospital of Crosshouse, Kilmarnock (M.M.), Nottingham University Hospitals NHS Trust, Nottingham (J.M.), Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.S.), and Portsmouth Hospitals NHS Trust, Portsmouth (N.V.) - all in the United Kingdom; the Department of Reproductive Medicine, University Medical Center Utrecht, Utrecht (Y.E.M.K.), the Department of Obstetrics, Leiden University Medical Center, Leiden (K.W.M.B.), the Department of Reproductive Medicine and Gynecology, University of Groningen, Groningen (A.H.), the Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis (E.M.K.), and Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Academic Medical Center (M.G.), Amsterdam, and the Department of Obstetrics and Gynecology, Maxima Medical Center Veldhoven, Veldhoven (C.A.M.K.) - all in the Netherlands; and the Robinson Institute, School of Pediatrics and Reproductive Health, University of Adelaide, Ade
Background: Progesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain.
Methods: We conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage.
J Am Heart Assoc
September 2015
Duke University Medical Center, Durham, NC (B.A.S., E.D.P., J.P.P.) Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., F.H., E.D.P., J.P.P.).
Background: Most patients with atrial fibrillation (AF) require rate control; however, the optimal target heart rate remains under debate. We aimed to assess rate control and subsequent outcomes among patients with permanent AF.
Methods And Results: We studied 2812 US outpatients with permanent AF in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation.
Circ Cardiovasc Qual Outcomes
July 2015
From the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Background: Adequate representation by sex in trials allows generalizability of results. We examined representation of women in clinical trials during a 17-year period in which inclusion criteria were broadened and federal mandates for representativeness were launched.
Methods And Results: Using mixed models, we studied sex-stratified temporal trends in enrollment, clinical characteristics, treatment, and outcomes among 76 148 non-ST-segment elevation acute coronary syndrome patients using patient-level data merged from 11 phase III trials conducted from 1994 to 2010.
J Am Heart Assoc
June 2015
Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W.).
Background: Little is known about the incidence, predictors, or outcomes of intracranial hemorrhage (ICH) in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). We aimed to determine the incidence and timing of ICH, characterize the location of ICH, and identify independent baseline predictors of ICH in NSTE ACS patients.
Methods And Results: We pooled patient-level data from 4 contemporary antithrombotic therapy trials.
Circulation
July 2015
From Indiana University School of Medicine and Roudebush Veterans Administration Medical Center, Indianapolis (S.M.M.); Stanford University School of Medicine, Palo Alto, CA (G.M.C., K.W.M.); Health Sciences Center, St. John's, NL, Canada (P.S.P.); Amgen Inc, Thousand Oaks, CA (Y.K., M.S., B.D., W.G.G.); Denver Nephrology, CO (G.A.B.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico (R.C.-R.); Inserm Unit 1088, UFR Médecine/Pharmacie, Université de Picardie, Amiens, France (T.B.D.); University of Minnesota, Minneapolis (C.A.H.); Hôpital Manhès, Paris, France (G.M.L.); University College London, London, UK (D.C.W.); and Universitätsklinikum der RWTH Aachen, Germany (J.F.).
Background: Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events.
View Article and Find Full Text PDFCirc Cardiovasc Qual Outcomes
July 2015
From the Yale University School of Medicine, New Haven, CT (J.V.F.); Duke Clinical Research Institute, Durham, NC (D.N.S., L.E.T., E.D.P., J.P.P.); Division of Research, Kaiser Permanente of Northern California, Oakland, CA (A.S.G.); Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City (J.S.); Ronald Reagan-UCLA Medical Center, Los Angeles, CA (G.C.F.); Mayo Clinic Medical Center, Rochester, Minnesota (B.J.G.); Boston University Medical Center, Boston, MA (E.M.H.); Lankenau Institute for Medical Research and Jefferson Medical College, Philadelphia, PA (P.R.K.); and Stanford University School of Medicine, Stanford, CA (K.W.M.); Janssen Pharmaceuticals Inc., Bridgewater, NJ (P.C.).
Background: Instruments to assess symptom burden and quality of life among patients with atrial fibrillation (AF) have not been well evaluated in community practice or associated with patient outcomes.
Methods And Results: Using data from 10 087 AF patients in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF), symptom severity was evaluated using the European Heart Rhythm Association (EHRA) classification system, and quality of life was assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire. The association between AF-related symptoms, quality of life, and outcomes was assessed using Cox regression.
Circ Cardiovasc Interv
June 2015
From the Terrence Donnelly Heart Center, St. Michael's Hospital, University of Toronto, Ontario, Canada (A.B.); Department of Medicine, Duke Clinical Research Center, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (A.B., Z.H., Y.L., S.L., P.T.); Department of Medicine, Stanford University, CA (R.A.H., K.W.M.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Merck & Co, Whitehouse Station, NJ (J.S.); Department of Medicine, Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.); Department of Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (S.L.); Department of Medicine, Uppsala Clinical Research Center, Uppsala University, Sweden (C.H., L.W.); and Department of Medicine, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.).
Background: In patients with non-ST-segment-elevation acute coronary syndrome (NSTE ACS), elevated troponin levels identify patients at high risk for adverse outcomes; however, it is unknown whether the magnitude of troponin elevation during hospitalization remains predictive of subsequent events in patients undergoing coronary revascularization.
Methods And Results: We studied 12 635 patients with NSTE ACS in the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) study with at least 1 troponin measurement during index hospitalization. Cox proportional hazards regression was used to examine the relationship between peak troponin level (standardized as the ratio of peak troponin value measured during hospitalization and local laboratory upper reference limit [URL]) and revascularization on all-cause mortality at 2 years.
Trials
May 2015
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
Background: A large number of studies have shown an association between inherited thrombophilia and recurrent miscarriage. It has been hypothesized that anticoagulant therapy might reduce the number of miscarriages and stillbirth in these women. In the absence of randomized controlled trials evaluating the efficacy of anticoagulant therapy in women with inherited thrombophilia and recurrent miscarriage, a randomized trial with adequate power that addresses this question is needed.
View Article and Find Full Text PDFJ 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 PDFCirculation
February 2015
From the Duke University Medical Center, Durham, NC (B.A.S., E.D.P., M.W.S., J.P.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., E.D.P., S.K., L.T., M.W.S., J.P.P.); Mayo Clinic, Rochester, MN (B.J.G.); UCLA Division of Cardiology, Los Angeles, CA (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Janssen Scientific Affairs, Raritan, NJ (P.C.); and New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.).
Background: Temporary interruption of oral anticoagulation for procedures is often required, and some propose using bridging anticoagulation. However, the use and outcomes of bridging during oral anticoagulation interruptions in clinical practice are unknown.
Methods And Results: The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry is a prospective, observational registry study of US outpatients with atrial fibrillation.
J Am Heart Assoc
November 2014
Hennepin County Medical Center, University of Minnesota, Minneapolis, MN (C.A.H.).
Background: Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial.
Methods And Results: EVOLVE was a randomized, double-blind, placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months.
Circulation
September 2014
From the Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada (B.W.M., C.M., L.R.B.); Duke University Medical Center, Duke University, Durham, NC (J.S.L., T.L.O.); Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (J.S.T.); Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA (T.M.G., R.I.); Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada (M.P.M.); Royal Children's Hospital, Murdoch Children's Research Institute, University of Melbourne, Melbourne, Australia (P.M.); Texas Children's Hospital, Baylor College of Medicine, Houston, TX (R.K.); Department of Medicine, Stanford University School of Medicine, Stanford, CA (K.W.M.); Boston Children's Hospital, Harvard Medical School, Boston, MA (A.D.M., C.S.A., J.W.N.); Children's National Medical Center, George Washington University, Washington, DC (N.V.); Coagulation Biology Laboratory, Oklahoma Medical Research Foundation, Oklahoma City, OK (C.T.E.); Children's Hospital of Colorado, University of Colorado, Aurora, CO (M.J.M-.J.); McMaster Children's Hospital, McMaster University, Hamilton, Ontario, Canada (A.K.C.); Bristol-Myers Squibb, Princeton, NJ (R.P.); Division of Cardiovascular and Renal Protocol, Food & Drug Administration, Silver Spring, MD (M.R.); Merck, Whitehouse Station, NJ (J.S.); and Division of Cardiovascular Sciences, NHLBI/NIH, Bethesda, MD (J.R.K.).
J Am Heart Assoc
July 2014
Division of Cardiology, University of Alberta, Edmonton, Canada (P.W.A.).
Background: Clinical trials traditionally use time-to-first-event analysis embedded within the composite endpoint of cardiovascular death (CVD), myocardial infarction (MI), or stroke. However, many patients have >1 event, and this approach may not reflect overall experience. We addressed this by analyzing all cardiovascular events in TRACER.
View Article and Find Full Text PDFCirculation
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 PDFStroke
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.
Circulation
May 2014
From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
Background: Physicians treating patients with atrial fibrillation (AF) must weigh the benefits of anticoagulation in preventing stroke versus the risk of bleeding. Although empirical models have been developed to predict such risks, the degree to which these coincide with clinicians' estimates is unclear.
Methods And Results: We examined 10 094 AF patients enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF) registry between June 2010 and August 2011.
Circulation
May 2014
Division of Cardiovascular Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.W.S., M.R.P., J.P.P., A.S.H., Y.L., R.M.C., R.C.B.); Department of Medicine, Division of Hematology and Thromboembolism, McMaster University, Hamilton, Ontario, Canada (J.D.D.); Department of Medicine, Division of Hematology, Hofstra North Shore/LIJ School of Medicine, Lenox Hill Hospital, New York, NY (A.C.S.); School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia (G.J.H.); Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA (D.E.S.); Johnson & Johnson Pharmaceutical Research and Development, Raritan, NJ (C.C.N.); Department of Medicine, Stanford University Medical Center, Palo Alto, CA (K.W.M.); and Department of Medicine, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom (K.A.A.F.).
Background: During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI.
Methods And Results: 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 randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non-central nervous system systemic embolism, death, myocardial infarction, and bleeding, were reported in participants who experienced TI (3-30 days) for any reason.
Circulation
January 2014
Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W., D.L., L.W., C.H., S.K.J.); Department of Medical Sciences, Clinical Chemistry and Uppsala Clinical Research Center Uppsala University, Uppsala, Sweden (A.S.); Division of Cardiovascular Health and Disease, Heart, Lung and Vascular Institute, Academic Health Center, Cincinnati, OH (R.C.B.); Department of Medicine, Stanford University, Stanford, CA (R.A.H., K.W.M.); TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (C.P.C.); Department of Cardiology, Medisch Centrum Alkmaar, Alkmaar, Netherlands (J.H.C.); AstraZeneca Research and Development, Mölndal, Sweden (A.H.); Medizinische Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany (E.G., H.A.K.); Medical Department, Hospital Unit West, Herning/Holstbro, Denmark (S.H.); INSERM-Unité 698, Paris, France; Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France; NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK (P.G.S.); and Department of Cardiovascular Science, University of Sheffield, Sheffield, UK (R.F.S.).
Background: Risk stratification and the use of specific biomarkers have been proposed for tailoring treatment in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). We investigated the prognostic importance of high-sensitivity troponin T (hs-TnT), N-terminal pro-brain natriuretic peptide (NT-proBNP), and growth differentiation factor-15 (GDF-15) in relation to randomized treatment (ticagrelor versus clopidogrel) and management strategy (with or without revascularization) in the NSTE-ACS subgroup of the Platelet Inhibition and Patient Outcomes (PLATO) trial.
Methods And Results: Of 18 624 patients in the PLATO trial, 9946 had an entry diagnosis of NSTE-ACS and baseline blood samples available.