Comparative safety of the novel anticoagulants vs warfarin

Size: px
Start display at page:

Download "Comparative safety of the novel anticoagulants vs warfarin"

Transcription

1 Comparative safety of the novel anticoagulants vs warfarin Sonal Singh, MD, MPH Phd Candidate ( Epidemiology- Part time) Johns Hopkins University Research in Progress Seminar, Center for Drug Safety and Effectiveness, Johns Hopkins University October 15

2 Conflicts of Interest None Funding sources: None

3 Background Atrial fibrillation (AF) is the most common arrhythmia in the US. AF carries substantial morbidity and mortality because of stroke based on CHADS2 score For more than half a century, oral warfarin has been the cornerstone for the prevention of stroke in atrial fibrillation. Am J Cardiol 2009; 104:

4 Novel anticoagulants ( noacs) Dabigatran etexilate is the only direct thrombin inhibitor (DTI) clinically available for oral administration Rivaroxaban also approved for stroke prevention recently-oral direct factor Xa inhibitor Apixaban pending approval later this year RELY Trial, ROCKET AF, ARISTOTLE;NEJM 2009; 361: NEJM 2011; 365: NEJM; 2011;365:

5 BJCP 2010;70 (1):14-15 Journal compilation Copyright 2010 The British Pharmacological Society

6 Patterns of use Dabigatran etexilate had become the DOC at about 19% of office visits for oral anticoagulation, compared with 81% for warfarin by end of 2011 ( Rivaroxaban only approved Nov 2011) increasing rates of off-label use of dabigatran over time Circ Cardiovasc Qual Outcomes 2012; 5:

7 Pivotal Trials of noacs Dabigatran at 150 mg associated with lower rates of stroke and systemic embolism (1.11% vs. 1.71%, p<0.001) in RELY Rivaroxaban at 10 mg dose non-inferior on stroke and systemic embolism in the ROCKET-AF. Apixaban similar effect in the ARISTOTLE trial. Annual major bleeding risk 3.32% vs. 3.57%, p=0.32 for dabigatran compared to warfarin). However the rates of serious ICB were lower but the rates of GIB higher with dabigatran. No differences in rates of major bleeding between warfarin and rivaroxaban in the ROCKET-AF trial. 3 Rates of ICH were also lower in the rivaroxaban arm RELY Trial, ROCKET AF, ARISTOTLE;NEJM 2009; 361: NEJM 2011; 365: NEJM; 2011;365:

8 Pharmacologic hypothesis Is the risk of bleeding and GI bleeding higher with noacs compared to warfarin The active compound dabigatran is hardly absorbed from the gastrointestinal tract Spontaneous reports to FAERS of uncontrollable GI bleed not reversible by any agent with dabigatran; * BJCP 2010;70 (1):14-15; ISMP report

9 Operational hypothesis 1, 2 Operational : Does this increase risk of bleeding represent differences between users Why me? Operational : Does this differential risk of bleeding represent differences within users Why now? McLure, PDS 2012; 21(S1): 50 61

10 Specific aims AIM 1.To determine the comparative safety of noacs and warfarin on major bleeding (including gastrointestinal hemorrhage and hemorrhagic stroke) among patients with atrial fibrillation. AIM 2. To determine the timing of the occurrence of major bleeding with rivaroxaban and dabigatran AIM 3. To determine whether periods on rivaroxaban or dabigatran use represent greater risk for bleeding than periods off anticoagulants among adult patients with atrial fibrillation in a general population.

11 Analytic Framework AIM 1SR and network MA AIM 3 New user incipient cohort propensity matched portal HTN; UGIB gastric or duodenal ulcer and coagulation disorders Charlson comorbidity index, CHADS 2,trauma, renalfailure and demographics( Age, Sex) Adult user of noac with AF Intervention: Dabigatran, Rivaroxaban and Apixaban Comparator: Warfarin Primary Outcomes; Major bleeding ; Secondary outcome GI bleeding Antiplatelet agents Bidirectional SCCS Time-invariant within person confounders and selection- healthy users, aspirin, alcohol

12 Rationale for Designs-I Variation within exposure to noacs Variation between individuals Variation between providers Propensity score new user RC Self controlled case series Instrumental vari Adapted from Schneiweissl PEDS :

13 Rationale for designs- II Proportion of users stop and restart ( within person exposure variation- SCCS) ( RELY trial approximated > 20% interruption Also variation between persons on anticoagulant use- PS Variation between provider use patterns- IV analysis Adapted from Schneiweissl PEDS : ; Madigan et al Report to OMOP on SCCS designs; ** Blood 2008;

14 Population Study : Random sample of adult AF users on OACs from the source Source: Adults > 18 enrolled in exposure to OACs Target : Adult >18 yr with AF in the US Study Source Target

15 Population in RCTs Study : adult AF users on OACs in RCTs (selective) Source: Adults > 18 enrolled in RCTs of anticoagulants from through Target : Adult >18 yr with AF in the US from Oct Target Source Study

16 Steps of the systematic review Question Literature search Selection of studies Assessment of methodological quality including ROB and strength of evidence Data extraction Synthesis of the data (network metaanalysis) Conclusions 16

17 Primary Outcomes for SR Primary : anticoagulant associated major bleeding (includes hemorrhagic stroke, fatal bleed) using International Society of Thrombosis and Hemostasis criteria Secondary : Gastrointestinal Bleeding Journal of Thrombosis and Haemostasis, 3:

18 ISTH major bleed 1 Fatal bleeding, and/or 2 Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or 3 Bleeding causing a fall in hemoglobin level of 20 g L)1 (1.24 mmol L)1) or more, or leading to transfusion of two or more units of whole blood or red cells. Should result in death, life-threatening, cause chronic sequelae or consume major health-care resources. Journal of Thrombosis and Haemostasis, 3:

19 Mills et al ( Puhan). JAMA Users Guide on how to interpret a study of network MA 2012; J Clin Epidemiol 1997; 50(6):683-91; Indirect treatment calculator from CADTH. Statistical analysis -SR Relative Risk meta-analysis with sensitivity analysis for rare events for direct metaanalysis Network meta-analysis has been sparingly used for safety outcomes-concerns about consistency and power Dabigatran Rivaroxaban Warfarin Placebo Apixaban

20 Limitations of trials in documenting safety 1. Selectiveness : All noac trials excluded those with previous GIB *; in real world about one-third of participants who would receive noacs have GI bleed risk factors. ** 2. Limitation in statistical power 3. Detection of unexpected SAEs 4. Commercial biases unpublished data- anonymous ; ** Blood 2008; ; Singh and Loke Trials 2012 [ epub ahead of print]

21 Analytic Challenges Network MA: Inhomogeneity and inconsistency; secular trends over time since warfarin trials are older with changes of pattern of treatments over time Mills, Puhan et al. JAMA users guide 2012

22 Ideal Population Study : Random sample of adult AF users on OACs from the source Source: Adults > 18 enrolled in exposure to OACs Target : Adult >18 yr with AF in the US Study Source Target

23 Population in RC study Study : Random sample of adult AF users on OACs from the source ( continuous users and continuous nonusers) Source: Adults > 18 enrolled in administrative health database with claims for AF and exposure to oral anticoagulants from Target : Adult >18 yr with AF in the US from Oct Minimize random error by using entire source Study Source Target

24 Study Cohort Open cohort patients >18 y who have a prescription for any OAC between October and Dec Claims run out would be 90 days following this date to ensure all claims are filed. To capture new users we will require no prescription claim for any OAC in the previous 180 days Minimum number of dispensing events for inclusion in the cohort (2 events). Exclude perioperative AF

25 Followup fill date for 1 st qualifying RX define date of entry New users followed until outcomes, death, loss of eligibility in enrollment, a gap in continous treatment exceeding 14 days, a Rx fill for another anticoagulant, a non-end point hospitalization, or end of study period (December 2012). To avoid informative censoring endpoints occurring within 30 d following a gap in continuous treatment will be counted in. For e.g., bleeding events occurring 15 days after the last dose of OACs will be captured. Not applicable to administrative censoring at end of study or when there are switches between OACs

26 New User open RC New users of dabigatran, rivaroxaban Study end date June 2012; 7 and 30 day washout 6 months of look back for covariate information, to ensure no use of OACs. New users of warfarin

27 J Manag Care Pharm 2011; 17: J Manag Care Pharm 2011; 17: Data Source Commercially insured with million patients in various practice sites across the USA. Available files needed include enrollment records, inpatients and outpatient claims, and records of filled prescriptions (date, name, dose quantity, duration). The population age and sex is representative of commercially insured, working populations in the US, except for racial differences. Social Security s Death Master Data is linked to claims to ascertain deaths. Each matching record here has a code indicating the quality of the match from a perfect match of all names, DOB and SSN to less restrictive matches. All data on patients in the study are appropriately de-identified. J Managed Care Pharmacy 2011;17;531-46

28 Exposure and Validation Prescription data as a proxy for drug exposure. Using 10 digit NDC codes for OACs-Define active compounds, the drug dose and route of exposure, the number of units prescribed and the actual prescriptions and duration Although exposure to OACs has not been previously validated, it is likely similar to exposure to other drugs which is reasonably accurate in the Optum Database. High correlation between claims and prescription taken for chronic meds. Med Care 1999;37:846-57

29 Outcomes & Validation Dichotomous, Binary, Incident, recurrent (?) bleeding outcome Major bleeding ( PPV 89 99%) ICH PPV ( 77%) GIB PPV( 67%) Pharmacoepidemiol Drug Saf 2011; 20:560-6; Med Care 2005;43: ; APT 2006;24:

30 Validation of outcomes and select covariates

31 Pharmacoepidemiol Drug Saf 2011; 20: Propensity Score PS for exposure to OACs using multivariate LR to control for confounding and improve balance between patients in exposure cohorts. Variables included will include covariates in AF if associated with bleeding and anticoagulants (confounders) or bleeding alone (outcome). Consider psmatch2 command in Stata v11.0 to match individuals in the dabigatran or rivaroxaban cohort using 1:1 matching without replacement within a caliper width of 0.1. Consider weighting or full matching after examining data, sample size, and overlap Pharmacoepi and Drug Safety 2011; 20;551-9

32 Statistical Analysis Baseline comparisons of the cohorts using SMD KM cumulative incidence plots for time to event Time-dependant Cox proportional hazard model. HR 30 d, 90 d, 180 days, 365 days with 7 and 30 days washouts The proportional hazard assumption will be examined using weighted residuals and Wald Chi square test for the respective time windows. Stat Med 97: 16:611-26

33 Controlled Clinical Trials 1990; 11: Sample Size-cohort Matched sets of patients receiving the dabigatran and warfarin treatments with 10 matched warfarin(s) per patient on dabigatran because we will have a larger number of warfarin users. Prior data indicate that the probability of bleeding among warfarin is We assume that the correlation coefficient for exposure between matched experimental and a control subject is 0. If the true relative risk for bleeding in dabigatran subjects relative to warfarin subjects is 1.3, we will need to study 3656 subjects on dabigatran with 10 matched control(s) on warfarin to be able to reject the null hypothesis that this risk ratio equals 1 with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is Controlled Clinical Trials 1990:11:116-28

34 Ideal Population Study : Random sample of adult AF users on OACs from the source Source: Adults > 18 enrolled in administrative health database with claims for AF and exposure to oral anticoagulants from Target : Adult >18 yr with AF in the US from Oct Study Source Target

35 SCCS Population Study : Random sample of adult AF users on OACs from the source- ( intermittent users who switch between levels of exposure) Source: Adults > 18 enrolled in administrative database with claims for AF and exposure to OACs from Target : Adult >18 yr with AF in the US from Oct Study Source Target

36 A single participant in SCCS Adapted from Expert Opin Drug Saf 2011; 10:337-40

37 SCCS Population individuals aged > 18 years who filled at least one Rx for any OAC between October 2010 and December 2012 and have experienced a bleed AND switch between levels of exposure to OACs (cross-over) Cases in which the diagnosis of major bleeding is recorded at the same time as first prescription will be excluded. The date of onset of bleeding will be altered to the first date for participants who have recently [last 8 weeks] had claims for either GI endoscopy or colonoscopy or emergency room visits before their diagnosed date of major bleeding events indicative of bleeding. Those who receive transfusion or IV PPI more than 8 wks prior to the diagnosis of major bleed will be excluded as prevalent events

38 Unidirectional vs Bidirectional SCCS Unidirectional SCCS reduce reverse causality bias ( bleeding may cause transient stopping of anticoagulants.) but prone to exposure trend biases- Exposure to product rising rapidly so only discordant pairs are discordant exposed few discordant unexposed- spurious high RR Bidirectional SCCS designs reduce exposure trend bias. Pharmacoepidemiology and Drug Safety; 2012;21 S1:50-61

39 Biometrics 1995; 51: Statistical Analysis for SCCS Crude and adjusted incidence rate ratios (IRR) and 95% CI for the outcome of incident major bleeding associated with use of anticoagulants during risk periods compared with baseline periods using conditional Poisson regression. Adjust for age using 10 year bands, sex and potential confounders that are time-varying. No need to adjust for time invariant confounders ( Sex) Sensitivity analyses to determine risks among those with long term exposure [6 mos] Biometrics 95;51:228-35

40 Stat Med 2006; 25: Sample size SCCS Sample size estimates for our self controlled case series study will vary depending on underlying assumptions about the incidence of major bleeding and its variation with age. Assuming a 2 tailed alpha of 0.05 and power of. 8 and accounting for increasing age effects, we will need 592 bleeding events to reliably estimate a 1.5 increased incidence rate ratio of major bleeding. Stat Med 2006; 25:2618-3

41 Analytic challenges Misclassification of exposure and outcome. Confounding by indication: Missing confounders : OTC Aspirin, PS: examine for matching ( if no overlap- PS=0). In that case Multivariate regression will be imprecise and PS not applicable

42 Analytic challenge Selection bias : Loss of participants from competing risks, dropout, missing data;; linkages to death master accounts for competing risk of death Prevalent user bias minimized by new user design Missing data : Multiple imputation for Missing at Random, unable to test for MNAR since unobserved variables J Clin Epidemiol 2006; 59:1102-9

43 Complementary information SCCS intermittent users that switch between use and non-use to evaluate acute transient effect of an exposure after controlling within person confounding, selection bias, cumulative exposure. Tradeoff that prescription data reflect an accurate timing of drug exposure. two different operational hypothesis for the same biologically plausible effect ; cumulative vs transient effects. Plausible that RR higher for SCCS and RR lower for Cohort. Pharmacoepidemiology and Drug Safety. 2007; 16(8):

44 ?' versus 'why now?'--differences between operational hypotheses in casecontrol versus case-crossover studies. Pharmacoepidemiology and Drug Safety. 2007; 16(8): Complementary [ /pds.1438] information Trials: internal validity at the cost of representativeness New user RC propensity score: better exposure classification if focused on continuous users and nonusers; control for available confounders; tradeoff unavailable confounders ( healthy users, ASA, alcohol) SCCTs cases only; intermittent users that switch between use and non-use; acute transient effect of noacs after controlling within person confounding and timeinvariant selection bias and also cumulative exposure; tradeoff prescription data reflect an accurate timing of drug exposure. Madigan et al. Report.pdf

45 Synthesis- Concordance If both observational study designs consistently show similar results in direction of effect more confidence in the estimates Inconsistency in direction will be examined for explanation by population, intervention and outcome Why me vs Why now? Pharmacoepidemiology and Drug Safety. 2007; 16(8):

46 Inferential challenges Generalizability to target population, especially since smaller sample of > 65 or in administrative claims data Type 2 errors : absence of statistically significant effect in underpowered studies does not constitute absence of effect Singh and Loke Trials 2012 [ epub ahead of print

47 Investigators: Advisory Committee Caleb Alexander, MD, MS ( Primary)- Associate Professor, Medicine & Epidemiology, JHU; keywords: pharmacoepi and longitudinal administrative claims Milo A Puhan, MD, PhD Associate Professor- Epidemiology and Medicine, JHU. Keywords Network MA Stephan Ehrhardt MD, PhD Associate Professor- Epidemiology, JHU; Epi, Keywords : selection bias, epidemiology Elizabeth Stuart, PhD Associate Professor- Biostatistics and Mental Health, JHU, key words : propensity score

48 Extra-PPV claims For GIB Restricting the diagnosis of a UGIE to ICD-9 CM code 531.xx (gastric ulcer), ICD-9 CM code 532.xx (duodenal ulcer) or ICD- 9 CM code 578.xx (GI haemorrhage) with a CPT procedural code for upper endoscopy (432.xx, 443.xx) in any position, yielded a sensitivity of 66% and an NPV of 88% while improving the specificity to 88% and the PPV to 67% (c-statistic of 0.75). Aliment Pharmacol Ther Jul 15;24(2): OMOP%20Systematic%20Literature%20Review%20Hemorrhage%20Final%20Report% pdf

49 Extra-Validation of major outcome Jensen et al. A systematic review of validated methods for atrial fibrillation using administrative data. Pharmacoepidemiol Drug Saf 2012; 21(S1): Cunningham A, Stein CM, Chung CP, Daugherty JR, Smalley WE, Ray WA. An automated database case definition for serious bleeding related to oral anticoagulant use. Pharmacoepidemiol Drug Saf 2011; 20: Choma NN, Griffin MR, Huang RL, Mitchel EF Jr, Kaltenbach LA, Gideon P, Stratton SM, Roumie CL. An algorithm to identify incident myocardial infarction using Medicaid data. Pharmacoepidemiol Drug Saf 2009; 18:

New Anticoagulants and GI bleeding

New Anticoagulants and GI bleeding New Anticoagulants and GI bleeding DR DANNY MYERS MD FRCP(C) CLINICAL ASSISTANT PROFESSOR OF MEDICINE, UBC Conflicts of Interest None I am unbiased in the use of NOAC s vs Warfarin based on risk benefit

More information

Novel Anticoagulation Agents DISCLOSURES. Objectives ATRIAL FIBRILLATION TRIALS. NOAC Comparison 6/12/2015

Novel Anticoagulation Agents DISCLOSURES. Objectives ATRIAL FIBRILLATION TRIALS. NOAC Comparison 6/12/2015 Novel Anticoagulation Agents DISCLOSURES James W. Haynes, MD Department of Family Medicine Univ of TN Health Science Center (Chattanooga) Objectives Understand mechanism of action behind the NOAC agents

More information

New Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013

New Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 New Treatments for Stroke Prevention in Atrial Fibrillation John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 Classification Paroxysmal atrial fibrillation (AF) Last < 7

More information

4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285: 2864-71

4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285: 2864-71 Anticoagulation in the 21 st Century Adam Karpman, D.O. Saint Francis Medical Center/Oklahoma State University Medical Center Disclosures: None Atrial Fibrillation Most common arrhythmia in clinical practice.

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) Indication: Stroke Prevention in Atrial Fibrillation This recommendation supersedes the Canadian Drug Expert Committee (CDEC) recommendation for

More information

New Oral AntiCoagulants (NOAC) in 2015

New Oral AntiCoagulants (NOAC) in 2015 New Oral AntiCoagulants (NOAC) in 2015 William R. Hiatt, MD Professor of Medicine and Cardiology University of Colorado School of Medicine President CPC Clinical Research Disclosures Received research

More information

Committee Approval Date: September 12, 2014 Next Review Date: September 2015

Committee Approval Date: September 12, 2014 Next Review Date: September 2015 Medication Policy Manual Policy No: dru361 Topic: Pradaxa, dabigatran Date of Origin: September 12, 2014 Committee Approval Date: September 12, 2014 Next Review Date: September 2015 Effective Date: November

More information

Anticoagulation For Atrial Fibrillation

Anticoagulation For Atrial Fibrillation Anticoagulation For Atrial Fibrillation New Agents In A New Era Arjun V Gururaj, MD Arrhythmia and Electrophysiology Nevada Heart and Vascular Center Disclosures Biotronik Speaker Clinical investigator

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Atrial Fibrillation, Stroke Prevention Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that rivaroxaban be

More information

RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) 3.75

RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) 3.75 ALL-CAUSE MORTALITY RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) Rate per year (%) 5.0 4.0 3.0 2.0 1.0 0 3.64 D150 mg BID 3.75 D110 mg BID RR 0.91 (95% CI: 0.80 1.03) P=0.13 (superiority) 4.13 Warfarin

More information

Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain

Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain Dr Alexander (Ander) Cohen Guy s and St Thomas Hospitals, King s College London, UK Pavia Spring Meeting 13 June 2014 Overview

More information

STROKE PREVENTION IN ATRIAL FIBRILLATION. TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVE: ABBREVIATIONS: BACKGROUND:

STROKE PREVENTION IN ATRIAL FIBRILLATION. TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVE: ABBREVIATIONS: BACKGROUND: STROKE PREVENTION IN ATRIAL FIBRILLATION TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVE: To guide clinicians in the selection of antithrombotic therapy for the secondary prevention

More information

Cardiovascular Subcommittee of PTAC Meeting held 27 February 2014. (minutes for web publishing)

Cardiovascular Subcommittee of PTAC Meeting held 27 February 2014. (minutes for web publishing) Cardiovascular Subcommittee of PTAC Meeting held 27 February 2014 (minutes for web publishing) Cardiovascular Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology

More information

None. Dual Antiplatelet Therapy Plus Systemic Anticoagulation: Bleeding Risk and Management. 76 year old male LINGO 1/5/2015

None. Dual Antiplatelet Therapy Plus Systemic Anticoagulation: Bleeding Risk and Management. 76 year old male LINGO 1/5/2015 Financial Disclosure Information Dual Antiplatelet Therapy Plus Systemic Anticoagulation: Bleeding Risk and Management Robert D. McBane, M.D. Division of Cardiology Mayo Clinic Rochester Dual Antiplatelet

More information

Xarelto (Rivaroxaban)

Xarelto (Rivaroxaban) Xarelto (Rivaroxaban) Hightly selective, reversible, direct oral FXa inhibitor Maxium concentratiion after 2 to 4 hrs High bioavailability(66%),increase with food ( suggest with food) 1/3 from renal excretion,

More information

indications November 2 nd, 2012 Dalhousie University

indications November 2 nd, 2012 Dalhousie University + New oral anticoagulants: A review of current indications November 2 nd, 2012 Dr. Sudeep Shivakumar, Hematology Dalhousie University + Objectives es To review indications for anticoagulation To discuss

More information

The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012

The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012 The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era CCRN State of the Heart 2012 June 2, 2012 Disclosures I have I have been involved in trials of new anticoagulants and have received

More information

Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation

Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation Drew Baldwin, MD Virginia Mason Seattle, Washington NCVH May 29,

More information

The Role of the Newer Anticoagulants

The Role of the Newer Anticoagulants The Role of the Newer Anticoagulants WARFARIN = Coumadin DAGIBATRAN = Pradaxa RIVAROXABAN = Xarelto APIXABAN = Eliquis INDICATION DABIGATRAN (Pradaxa) RIVAROXABAN (Xarelto) APIXABAN (Eliquis) Stroke prevention

More information

Breadth of indications matters One drug for multiple indications

Breadth of indications matters One drug for multiple indications Breadth of indications matters One drug for multiple indications Sylvia Haas, MD, PhD Formerly of the Technical University of Munich Munich, Germany Disclosures: Sylvia Haas 1 Novel oral anticoagulants:

More information

Goals 6/6/2014. Stroke Prevention in Atrial Fibrillation: New Oral Anti-Coagulants No More INRs. Ashkan Babaie, MD

Goals 6/6/2014. Stroke Prevention in Atrial Fibrillation: New Oral Anti-Coagulants No More INRs. Ashkan Babaie, MD Stroke Prevention in Atrial Fibrillation: New Oral Anti-Coagulants No More INRs Ashkan Babaie, MD Arrhythmia Service Providence Heart Clinic June 8 th, 2014 Goals Discuss the data behind approval of NOACs

More information

Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial

Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Connie N. Hess, MD, MHS, Stefan James, MD, PhD, Renato D. Lopes, MD, PhD, Daniel M. Wojdyla,

More information

New Anticoagulation Options for Stroke Prevention in Atrial Fibrillation. Joy Wahawisan, Pharm.D., BCPS April 25, 2012

New Anticoagulation Options for Stroke Prevention in Atrial Fibrillation. Joy Wahawisan, Pharm.D., BCPS April 25, 2012 New Anticoagulation Options for Stroke Prevention in Atrial Fibrillation Joy Wahawisan, Pharm.D., BCPS April 25, 2012 Stroke in Atrial Fibrillation % Stroke 1991;22:983. Age Range (years) CHADS 2 Risk

More information

Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation

Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation ERRATUM This report was commissioned by the NIHR HTA Programme as project number 11/49 This document

More information

Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical

Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Center A.Fib affects 2.2 million Americans. The lifetime

More information

9/5/14. Objectives. Atrial Fibrillation (AF)

9/5/14. Objectives. Atrial Fibrillation (AF) Novel Anticoagulation for Prevention of Stroke in Patients with Atrial Fibrillation Objectives 1. Review current evidence on use of warfarin in individuals with atrial fibrillation 2. Compare the three

More information

Novel oral anticoagulant (NOAC) for stroke prevention in atrial fibrillation Special situations

Novel oral anticoagulant (NOAC) for stroke prevention in atrial fibrillation Special situations Novel oral anticoagulant (NOAC) for stroke prevention in atrial fibrillation Special situations Dardo E. Ferrara MD Cardiac Electrophysiology North Cascade Cardiology PeaceHealth Medical Group Which anticoagulant

More information

New Oral Anticoagulants

New Oral Anticoagulants New Oral Anticoagulants Tracy Minichiello, MD Associate Professor of Medicine Chief, San FranciscoVA Anticoagulation and Thrombosis Service Ansell, J. Hematology Copyright 2010 American Society of Hematology.

More information

Gruppo di lavoro: Malattie Tromboemboliche

Gruppo di lavoro: Malattie Tromboemboliche Gruppo di lavoro: Malattie Tromboemboliche 2381 Soluble Recombinant Thrombomodulin Ameliorates Hematological Malignancy-Induced Disseminated Intravascular Coagulation More Promptly Than Conventional Anticoagulant

More information

Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Brief Comparison of Four Agents

Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Brief Comparison of Four Agents Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Brief Comparison of Four Agents Abbreviations AF: Atrial fibrillation ARISTOTLE: Apixaban for Reduction in Stroke and Other Thromboembolic

More information

Atrial Fibrillation: A Different Perspective. Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital

Atrial Fibrillation: A Different Perspective. Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital Atrial Fibrillation: A Different Perspective Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital Faculty/Presenter Disclosure Faculty: Dr. Michael Heffernan Relationships with commercial

More information

Traveller s Thrombosis. Dr. Peter Verhamme Vascular Medicine and Haemostasis UZ Leuven

Traveller s Thrombosis. Dr. Peter Verhamme Vascular Medicine and Haemostasis UZ Leuven Traveller s Thrombosis Dr. Peter Verhamme Vascular Medicine and Haemostasis UZ Leuven Case 1: To thromboprophylaxe or not Women, aged 49, BMI 29, Combined Oral Contraceptives. Family history of provoked

More information

WOEST TRIAL- NO ASPIRIN IN STENTED PATIENTS REQUIRING ANTICOAGULATION. Van Crisco, MD, FACC, FSCAI First Coast

WOEST TRIAL- NO ASPIRIN IN STENTED PATIENTS REQUIRING ANTICOAGULATION. Van Crisco, MD, FACC, FSCAI First Coast WOEST TRIAL- NO ASPIRIN IN STENTED PATIENTS REQUIRING ANTICOAGULATION Van Crisco, MD, FACC, FSCAI First Coast Conflicts of Interest I have been a paid consultant and speaker for AstraZeneca, makers of

More information

New Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis

New Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis New Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET Departments of Gastroenterology and Hepatology,

More information

Safety & Effectiveness of Drug Therapies for Type 2 Diabetes: Are pharmacoepi studies part of the problem, or part of the solution?

Safety & Effectiveness of Drug Therapies for Type 2 Diabetes: Are pharmacoepi studies part of the problem, or part of the solution? Safety & Effectiveness of Drug Therapies for Type 2 Diabetes: Are pharmacoepi studies part of the problem, or part of the solution? IDEG Training Workshop Melbourne, Australia November 29, 2013 Jeffrey

More information

Novel OACs: How should we use them?"

Novel OACs: How should we use them? Novel OACs: How should we use them?" Iqwal Mangat, MD FRCPC" Director, Arrhythmia Service, St. Michaelʼs Hospital" Assistant Professor of Medicine, University of Toronto" Presenter Disclosure Dr. Iqwal

More information

THE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT

THE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT THE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT Stroke Prevention in Atrial Fibrillation Gregory Albers, M.D. Director Stanford Stroke Center Professor of Neurology and Neurological

More information

TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation

TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation Service Notification in response to DHSSPS endorsed NICE Technology Appraisals TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation 1 Name of Commissioning

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Pulmonary Embolism Note: The Canadian Drug Expert Committee (CDEC) previously reviewed rivaroxaban for the treatment of deep vein

More information

Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013

Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Family physician with Rivergrove Medical Clinic Practice in the north end since 1985 Medical Director of the Wellness

More information

Optimizing Anticoagulation Selection for Your Patient. C. Andrew Brian MD, FACC NCVH 2015

Optimizing Anticoagulation Selection for Your Patient. C. Andrew Brian MD, FACC NCVH 2015 Optimizing Anticoagulation Selection for Your Patient C. Andrew Brian MD, FACC NCVH 2015 Who Needs to Be Anticoagulated and What is the Patient s Risk? 1. Atrial Fibrillation ( nonvalvular ) 2. What regimen

More information

Thrombosis and Hemostasis

Thrombosis and Hemostasis Thrombosis and Hemostasis Wendy Lim, MD, MSc, FRCPC Associate Professor, Department of Medicine McMaster University, Hamilton, ON Overview To review the important developments in venous thromboembolism

More information

NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl

NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl Mikele Wissing, RN June 2014 Introduction until recently, was the unrivaled medication for treatment

More information

Antiplatelet and Antithrombotic Therapy. Dr Curry Grant Stroke Prevention Clinic Quinte Health Care

Antiplatelet and Antithrombotic Therapy. Dr Curry Grant Stroke Prevention Clinic Quinte Health Care Antiplatelet and Antithrombotic Therapy Dr Curry Grant Stroke Prevention Clinic Quinte Health Care Disclosure of Potential for Conflict of Interest Dr. F.C. Grant Atrial Fibrillation FINANCIAL DISCLOSURE:

More information

PGY1 Pharmacy Practice St. Vincent Hospital PGY2 Ambulatory Care St. Vincent Primary Care Center

PGY1 Pharmacy Practice St. Vincent Hospital PGY2 Ambulatory Care St. Vincent Primary Care Center Speaker Introduction Jessica Wilhoite, PharmD, BCACP Doctor of Pharmacy: Purdue University Postgraduate Residency Training: PGY1 Pharmacy Practice St. Vincent Hospital PGY2 Ambulatory Care St. Vincent

More information

Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012

Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012 Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012 Agenda Ideal anticoagulant. Drawbacks of warfarin. Rivaroxaban in clinical trails. Present

More information

Anticoagulation Therapy Update

Anticoagulation Therapy Update Anticoagulation Therapy Update JUDY R. WALLING, FNP-BC ARRHYTHMIA MANAGEMENT MUSC CARDIOLOGY Outline Who do we anticoagulate? Review classes of Anticoagulants Review examples of Anticoagulants Review CHADS2

More information

Clinical Guideline N/A. November 2013

Clinical Guideline N/A. November 2013 State if the document is a Trust Policy/Procedure or a Clinical Guideline Clinical Guideline Document Title: Document Number 352 Version Number 1 Name and date and version number of previous document (if

More information

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S.

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S. Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint

More information

The author has no disclosures

The author has no disclosures Mary Bradbury, PharmD, BCPS Clinical Pharmacy Specialist, Cardiac Surgery September 18, 2012 Mary.bradbury@inova.org This presentation will discuss unlabeled and investigational use of products The author

More information

What s New in Stroke?

What s New in Stroke? 5 th McMaster University Review Course in INTERNAL MEDICINE What s New in Stroke? Robert Hart, M.D. HHS / McMaster Stroke Program Department of Medicine (Neurology) McMaster University Hamilton, Ontario

More information

Bridging the Gap: How to Transition from the NOACs to Warfarin

Bridging the Gap: How to Transition from the NOACs to Warfarin Bridging the Gap: How to Transition from the NOACs to April 24 th 2015 UAN: 0048-0000-15-034-L01-P Amanda Styer, Pharm.D. Marion General Hospital, OhioHealth Objectives: 1. Review labeling regarding transition

More information

Elisabetta Toso, MD Dipartment of Medical Sciences University of Turin

Elisabetta Toso, MD Dipartment of Medical Sciences University of Turin Security and efficacy of Rivaroxaban in real life in the prevention of the stroke in non valvular AF patients: presentation of the results of the international study Xantus Elisabetta Toso, MD Dipartment

More information

Anticoagulation in Atrial Fibrillation

Anticoagulation in Atrial Fibrillation Anticoagulation in Atrial Fibrillation Parag P. Patel, MD FACC Disclosures Eliquis Speakers Bureau 1 Clinical Scenario Ms. L is a 76F admitted to the stroke service with a dense right sided hemiparesis

More information

STROKE PREVENTION IN ATRIAL FIBRILLATION

STROKE PREVENTION IN ATRIAL FIBRILLATION STROKE PREVENTION IN ATRIAL FIBRILLATION OBJECTIVE: To guide clinicians in the selection of antithrombotic therapy for the secondary prevention of ischemic stroke and arterial thromboembolism in patients

More information

Atrial Fibrillation: Stroke and Thromboprophylaxis. Derek Waller

Atrial Fibrillation: Stroke and Thromboprophylaxis. Derek Waller Atrial Fibrillation: Stroke and Thromboprophylaxis Derek Waller Atrial Fibrillation in the Elderly: Risk of Stroke Framingham study AGE 50-59 60-69 70-79 80-89 Prevalence of AF % Attributable Risk of AF

More information

New Oral Anticoagulants. July 2012

New Oral Anticoagulants. July 2012 New Oral Anticoagulants July 2012 Objectives Review coagulation cascade and previous treatment options for anticoagulation Understand points of interaction within coagulation cascade and new oral agents

More information

Stop the Bleeding: Management of Drug-induced Coagulopathy. Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery

Stop the Bleeding: Management of Drug-induced Coagulopathy. Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery Stop the Bleeding: Management of Drug-induced Coagulopathy Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery Objectives Discuss contemporary management of warfarin reversal in patients

More information

Randomized trials versus observational studies

Randomized trials versus observational studies Randomized trials versus observational studies The case of postmenopausal hormone therapy and heart disease Miguel Hernán Harvard School of Public Health www.hsph.harvard.edu/causal Joint work with James

More information

NICE TA 275: Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation

NICE TA 275: Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation Service Notification in response to DHSSPS endorsed NICE Technology Appraisals NICE TA 275: Apixaban for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation 1

More information

New Oral Anticoagulants. How safe are they outside the trials?

New Oral Anticoagulants. How safe are they outside the trials? New Oral Anticoagulants How safe are they outside the trials? Objectives The need for anticoagulant therapy Indications for anticoagulation Traditional anticoagulant therapies Properties of new oral anticoagulants

More information

Long term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial

Long term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial Long term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial Camillo Autore Università di Roma Sapienza II Facoltà di Medicina e Chirurgia

More information

Authors: Partha Sardar MDa; Saurav Chatterjee MDb; Joydeep Ghosh MDc; Debabrata Mukherjee MD, MS d, Gregory Y H Lip MD, FRCP, FACC, FESCe.

Authors: Partha Sardar MDa; Saurav Chatterjee MDb; Joydeep Ghosh MDc; Debabrata Mukherjee MD, MS d, Gregory Y H Lip MD, FRCP, FACC, FESCe. Risk of Major Bleeding in Different Indications for New Oral Anticoagulants: Insights from a Meta- Analysis of Approved Dosages from 48 Randomized Trials Authors: Partha Sardar MDa; Saurav Chatterjee MDb;

More information

New Real-World Evidence Reaffirms Low Major Bleeding Rates for Bayer s Xarelto in Patients with Non-Valvular Atrial Fibrillation

New Real-World Evidence Reaffirms Low Major Bleeding Rates for Bayer s Xarelto in Patients with Non-Valvular Atrial Fibrillation Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Late-Breaking Science at ESC Congress 2015: New Real-World Evidence Reaffirms

More information

ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ. Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν

ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ. Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν The AF epidemic Mayo Clinic data (assuming a continued increase in the AF incidence) Mayo

More information

The New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012. Jeff Healey

The New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012. Jeff Healey The New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012 Jeff Healey RELY: A New Era in AF Connolly SJ et al. N Engl J Med 2009;361:1139-1151 ROCKET-AF:

More information

HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below

HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below Name: generic (trade) Rivaroxaban (Xarelto ) HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below What it is Indications

More information

Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation

Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation Issued: May 2012 guidance.nice.org.uk/ta256 NICE has accredited the process used by the Centre for Health

More information

Big data size isn t enough! Irene Petersen, PhD Primary Care & Population Health

Big data size isn t enough! Irene Petersen, PhD Primary Care & Population Health Big data size isn t enough! Irene Petersen, PhD Primary Care & Population Health Introduction Reader (Statistics and Epidemiology) Research team epidemiologists/statisticians/phd students Primary care

More information

Bios 6648: Design & conduct of clinical research

Bios 6648: Design & conduct of clinical research Bios 6648: Design & conduct of clinical research Section 1 - Specifying the study setting and objectives 1. Specifying the study setting and objectives 1.0 Background Where will we end up?: (a) The treatment

More information

1/12/2016. What s in a name? What s in a name? NO.Anti-Coagulation. DOACs in clinical practice. Practical aspects of using

1/12/2016. What s in a name? What s in a name? NO.Anti-Coagulation. DOACs in clinical practice. Practical aspects of using What s in a name? Practical aspects of using DOACs (Direct Oral Anticoagulants) James L. Sebastian, MD, MACP Professor of Medicine (GIM) Medical College of Wisconsin February 5, 2016 DOAC NOAC NOAC ODI

More information

The Anti coagulated Patient: The Cardiologist s View. February 28, 2015

The Anti coagulated Patient: The Cardiologist s View. February 28, 2015 The Anti coagulated Patient: The Cardiologist s View February 28, 2015 Conflicts Dr. McMurtry has no conflicts to disclose. CanMeds Medical Expert (as Medical Experts, physicians integrate all of the CanMEDS

More information

Adherence to NOACs. Disclosure. Patricia van den Bemt EAHP Hamburg 2015

Adherence to NOACs. Disclosure. Patricia van den Bemt EAHP Hamburg 2015 Adherence to NOACs Patricia van den Bemt EAHP Hamburg 2015 Disclosure Unrestricted research grants from Glaxo-SmithKline Boehringer Ingelheim Daiichi Sankyo Bayer Pfizer For research on medication safety

More information

Le conferme dalla real life superano gli studi registrativi

Le conferme dalla real life superano gli studi registrativi Le conferme dalla real life superano gli studi registrativi E. Gronda, MD, FESC Cardiologyand and Research Unit IRCCS MultiMedicaSesto S. Giovanni CardiovascularDepartment MultiMedicaGroup. Rate (% / yr)

More information

Management of Antithrombotics with Procedures. Jordan Weinstein, MD

Management of Antithrombotics with Procedures. Jordan Weinstein, MD Management of Antithrombotics with Procedures Jordan Weinstein, MD Presenter Disclosure Information Cardiology Update 2013 I have no relevant financial interest and/or arrangement with industry. Novel

More information

Prevention of stroke in patients with atrial fibrillation

Prevention of stroke in patients with atrial fibrillation www.sign.ac.uk Prevention of stroke in patients with atrial fibrillation A guide for primary care January 2014 Evidence Contents 1 Introduction... 1 2 Detection...2 3 Risk stratification... 3 4 Treatment

More information

Objectives of Session

Objectives of Session Objectives of Session Project Background Why the need Decision Support Tool summary of key evidence Promotion Key Messages Project Background Grasp AF Audit Initial Grasp AF project undertaken in NHS Buckinghamshire

More information

New in Atrial Fibrillation

New in Atrial Fibrillation New in Atrial Fibrillation September 2011 Stroke prevention more options Rhythm Control -drugs - alternatives to drugs; ablation Rate Control - pace + ablate A-FIB Dell Stroke Risk AFib Two Principles

More information

Traditional anticoagulants

Traditional anticoagulants TEGH Family Practice Clinic Day April 4, 03 Use of Anticoagulants in 03: What s New (and What Isn t) Bill Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University

More information

1/7/2012. Objectives. Epidemiology of Atrial Fibrillation(AF) Stroke in AF. Stroke Risk Stratification in AF

1/7/2012. Objectives. Epidemiology of Atrial Fibrillation(AF) Stroke in AF. Stroke Risk Stratification in AF Objectives Atrial Fibrillation and Prevention of Thrombotic Complications: Therapeutic Update Andrea C. Flores Pharm.D Pharmacy Resident at the Miami VA Healthcare System Review the epidemiology, pathophysiology

More information

New Anticoagulants: What to Use What to Avoid

New Anticoagulants: What to Use What to Avoid New Anticoagulants: What to Use What to Avoid Bruce Davidson, MD, MPH Clinical Professor of Medicine Pulmonary and Critical Care Medicine Division University of Washington School of Medicine Seattle USA

More information

Stopping Anti-platelet Agents: Will You Cause a Stroke?

Stopping Anti-platelet Agents: Will You Cause a Stroke? Stopping Anti-platelet Agents: Will You Cause a Stroke? Glenn M. Eisen MD,MPH The Oregon Clinic-West Hills GI Clinical Professor of Medicine, OHSU Thanks for staying. 1 Don t cause a stroke Objective(s)

More information

Novel OAC s : How should we use them?

Novel OAC s : How should we use them? Novel OAC s : How should we use them? Jean C. Grégoire MD, FRCP(c), FACC, FACP Associate Professor, Université de Montréal, IntervenJonal Cardiologist, InsJtut de cardiologie de Montréal Disclosures Speaker

More information

3/3/2015. Patrick Cobb, MD, FACP March 2015

3/3/2015. Patrick Cobb, MD, FACP March 2015 Patrick Cobb, MD, FACP March 2015 I, Patrick Cobb, MD, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict

More information

Cardiology Update 2014

Cardiology Update 2014 Cardiology Update 2014 Update on the Novel Oral Anticoagulants (NOACS) Raymond Kawasaki, MD AMG Cardiology December 6, 2014 Disclosures I have no disclosures relevant to this presentation Contents I. The

More information

Correlation of Drug Levels and Outcomes in Phase III New Oral Anticoagulant (NOAC) Trials

Correlation of Drug Levels and Outcomes in Phase III New Oral Anticoagulant (NOAC) Trials Correlation of Drug Levels and Outcomes in Phase III New Oral Anticoagulant (NOAC) Trials October 26, 2015 CDER/OTS/OCP/DPM Jeffry Florian, Ph.D. CDER/OND/ODE1/DCRP Martin Rose, M.D. 1 Outline Overview

More information

Anticoagulation: How Do I Pick From All the Choices? Jeffrey H. Neuhauser, DO, FACC BHHI Primary Care Symposium February 28, 2014

Anticoagulation: How Do I Pick From All the Choices? Jeffrey H. Neuhauser, DO, FACC BHHI Primary Care Symposium February 28, 2014 Anticoagulation: How Do I Pick From All the Choices? Jeffrey H. Neuhauser, DO, FACC BHHI Primary Care Symposium February 28, 2014 Atrial Fibrillation 2 Atrial Fibrillation The most common arrhythmia encountered

More information

Non- Valvular Atrial Fibrillation and Stroke Prevention: Which OAC Do I Choose. Warfarin vs the NOACs

Non- Valvular Atrial Fibrillation and Stroke Prevention: Which OAC Do I Choose. Warfarin vs the NOACs Non- Valvular Atrial Fibrillation and Stroke Prevention: Which OAC Do I Choose Warfarin vs the NOACs Dr. Lori McIntosh D.O. Board Certified Neurologist Objectives Be able to list the current options of

More information

Medicines Management Programme. Oral anticoagulants for stroke prevention in non-valvular atrial fibrillation

Medicines Management Programme. Oral anticoagulants for stroke prevention in non-valvular atrial fibrillation Medicines Management Programme Oral anticoagulants for stroke prevention in non-valvular atrial fibrillation Drugs in this review include: Warfarin Apixaban Dabigatran Rivaroxaban Approved by Prof. Michael

More information

Service Specification Template Department of Health, updated June 2015

Service Specification Template Department of Health, updated June 2015 Service Specification Template Department of Health, updated June 2015 Service Specification No. : 2 Service: Commissioner Lead: Provider Lead: Period: Anti-coagulation monitoring Date of Review: 31 st

More information

New therapeutic approaches for the protection of AF patients from stroke: Do aspirin or warfarin have a role anymore?

New therapeutic approaches for the protection of AF patients from stroke: Do aspirin or warfarin have a role anymore? New therapeutic approaches for the protection of AF patients from stroke: Do aspirin or warfarin have a role anymore? Dr Tina Biss Consultant Haematologist The Newcastle Hospitals NHS Foundation Trust

More information

Supplementary Table 1: Risk of bias in included studies. Blinding of participants and personnel (performance bias)

Supplementary Table 1: Risk of bias in included studies. Blinding of participants and personnel (performance bias) Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) Blinding of outcome assessment (detection bias) Incomplete

More information

The importance of adherence and persistence: The advantages of once-daily dosing

The importance of adherence and persistence: The advantages of once-daily dosing The importance of adherence and persistence: The advantages of once-daily dosing Craig I. Coleman, PharmD Professor, University of Connecticut School of Pharmacy Storrs, CT, USA Conflicts of interest Dr

More information

With Big Data Comes Big Responsibility

With Big Data Comes Big Responsibility With Big Data Comes Big Responsibility Using health care data to emulate randomized trials when randomized trials are not available Miguel A. Hernán Departments of Epidemiology and Biostatistics Harvard

More information

Limitations of VKA Therapy

Limitations of VKA Therapy Fibrillazione Atriale Non Valvolare Ischemia o Emorragia le Due Utopie Rivali nella Scelta dei NAO Gianluca Botto, MD, FESC, UO Elettrofisiologia, Dip Medicina Limitations of VKA Therapy Unpredictable

More information

Antiplatelet and Antithrombotics From clinical trials to guidelines

Antiplatelet and Antithrombotics From clinical trials to guidelines Antiplatelet and Antithrombotics From clinical trials to guidelines Ashraf Reda, MD, FESC Prof and head of Cardiology Dep. Menofiya University Preisedent of EGYBAC Chairman of WGLVR One of the big stories

More information

Anticoagulation at the end of life. Rhona Maclean Rhona.maclean@sth.nhs.uk

Anticoagulation at the end of life. Rhona Maclean Rhona.maclean@sth.nhs.uk Anticoagulation at the end of life Rhona Maclean Rhona.maclean@sth.nhs.uk Content Anticoagulant Therapies Indications for anticoagulation Venous thromboembolism (VTE) Atrial Fibrillation Mechnical Heart

More information

Current and new oral Anti-coagulation. Lancashire and Cumbria Network 2 February 2012

Current and new oral Anti-coagulation. Lancashire and Cumbria Network 2 February 2012 Current and new oral Anti-coagulation Lancashire and Cumbria Network 2 February 2012 Question Warfarin is an abbreviation What does the W stand for? What is this plant and what is the connection with warfarin?

More information

Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com. News Release. Not intended for U.S. and UK Media

Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com. News Release. Not intended for U.S. and UK Media News Release Not intended for U.S. and UK Media Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com Bayer Forms Collaboration with Academic and Governmental Institutions for Rivaroxaban

More information