Venous Thromboembolism (VTE) Management

Objectives

Disease Burden of VTE

Venous Thromboembolism (VTE)

Clinical Presentations of VTE

Goals of Treatment for VTE

Evidence-based Guidelines for Treatment of VTE

VTE Treatment Studies Direct Oral Anticoagulants

Pros and Cons of Heparin Lead-In

VTE Treatment Studies Direct Oral Anticoagulants

AMPLIFY TrialRandomized, Double-blind, Noninferiority Study

AMPLIFY Trial Outcomes

AMPLIFY TrialBleeding Outcomes

Hokusai-VTE TrialEfficacy Outcomes

Hokusai-VTE Trial Bleeding Outcomes

Anticoagulant Treatment of VTE Risk-Benefit of NOAC vs Vitamin K Antagonist

Extended Treatment of VTE (Secondary Prevention) Risk-Benefit of NOAC and ASA vs Placebo

Understanding Pharmacokinetics and Drug Exposure to Optimize Outcomes

AnticoagulationBalancing Risks

Key Pharmacokinetics of NOACs Absorption, Distribution, Metabolism, Excretion

Renal Function Impact on NOAC Half Lives

Meta-analysis of All NOACs vs Warfarin Subgroups

Dabigatran Concentration vs Clinical Outcomes

Balancing Benefit/Risk vs Drug ConcentrationTailoring NOAC Dose to the Patient

Stroke/SEE in Patients With and Without Dose Reduction

Major Bleeding in Patients With and Without Dose Reduction

Practical Guidance for Renal Insufficiency

Drug-Drug Interactions of NOACs

NOACs and Cancer-associated VTE

Cancer and Thrombosis -- A Long-recognized Association

Warfarin Is Often Ineffective for Cancer-associated VTE

Warfarin Is More Dangerous in Patients With Cancer

LMWH vs VKA for Cancer-associated VTE

Tinzaparin vs Warfarin for Cancer-associated VTEPrimary End Points

The Standard of Care for Cancer-associated VTE Is ≥ 6 Months of LMWH

Coagulation Cascade

Patients With Active Cancer From Phase 3 VTE Rx Studies

Patients With Active Cancer From Phase 3 VTE Rx Studies

Recurrent VTE Rates on VKAHow do the Subgroups of the NOAC Registration Trials Compare?

NOACs in Cancer-associated VTEObservational Data Reported at ASH 2015

Recent Cohort Studies With NOACs

Prospective, Comparative Studies* of NOACs for Cancer-associated VTE

Conclusions

Update on NOAC Antidotes

NOACsDOACsTSOACsNOACs

Major Outcomes of NOACs vs Adjusted-Dose Warfarin in SPAF

Meta-analysis of NOAC VTE Treatment

To Summarize . . .

Major Bleeding on NOAC Treatment

Major Bleeding on Warfarin

General Approach to NOAC-relatedMajor Bleeding

Clotting Studies With NOACs

General Management of Bleeding

There Are Times...

NOAC Reversal Agents

Andexanet alfaAntidote for Factor Xa Inhibitors

Reversal of Factor Xa Inhibitors With Andexanet alfa

Idarucizumab Is a True, Specific Antidote to Dabigatran

RE-VERSE ADA Multicenter, Ongoing, Open-label, Single-arm Phase 3 Study

Primary End PointClinical Outcomes

Secondary End PointClinical Outcomes

RE-VERSE AD

Conclusions

Abbreviations

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