Bristol-Myers Squibb And Pfizer To Highlight Commitment To Reducing The Risk Of Stroke Caused By Non-Valvular Atrial Fibrillation (NVAF) And Treating Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) At ESC Congress 2017

Eliquis® (apixaban) Clinical Data Include Results from a Phase 4 Trial – EMANATE – to be Featured in Late-Breaking Science Sessions

Analyses from the ACROPOLIS™ Global Real-World Data Program Provide Insight into the Anticoagulation of a Broad Range of NVAF Patients at Risk for Stroke

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that 15 abstracts have been accepted for presentation at the ESC Congress 2017, organized by the European Society of Cardiology, on August 26-30 in Barcelona, Spain. Investigational data from the EMANATE [Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with non-valvular atrial fibrillation (NVAF)] clinical trial will be presented during the Late-Breaking Science hot line session and official ESC press conference. EMANATE is a Phase 4 clinical trial exploring Eliquis® (apixaban) versus standard of care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist) in patients with NVAF expected to undergo cardioversion to re-establish a regular heart rhythm.

“As physicians evaluate options for reducing stroke risk in patients with non-valvular atrial fibrillation, they often face questions about the effectiveness and safety of therapies in day-to-day practice”

In addition, analyses from ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) – the real-world data program which aims to contribute to the growing body of evidence related to anticoagulation – will be presented at this year’s ESC Congress. These analyses focus on the use of Eliquis in routine clinical practice, including in NVAF patient populations considered at high risk or particularly vulnerable to stroke or major bleed due to age, risk prediction scores, and other cardiovascular comorbidities.

“We are proud to share both clinical trial results and real-world data analyses that continue to support the medical community in the advancement of patient care and add to the body of evidence for Eliquis as a treatment for DVT/PE and for reducing the risk of stroke in NVAF patients,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “These data supplement our pivotal trial results, providing additional insight into how Eliquis performs in specific clinical settings such as cardioversion and broad patient populations representing common clinical practice settings.”

“As physicians evaluate options for reducing stroke risk in patients with non-valvular atrial fibrillation, they often face questions about the effectiveness and safety of therapies in day-to-day practice,” said Rory O’Connor, M.D., Chief Medical Officer, Pfizer Innovative Health. “Real-world data analyses, such as the results shared at this year’s ESC Congress, allow us to better understand the usage of Eliquis and other anticoagulants in a variety of settings and alongside clinical data, and have the potential to help healthcare providers make more informed decisions about their patient’s care.”

Initial findings from a Bristol-Myers Squibb (BMS)- and Pfizer- commissioned global policy research project conducted by The Economist Intelligence Unit (EIU), the research analysis division of The Economist Group, will also be presented at the ESC Congress. These findings bring attention to the global disparity of stroke risk reduction policies, and inadequate detection of risk factors for stroke – including NVAF – in clinical practice. The full report, which will be released by The EIU on September 21, is part of the BMS-Pfizer Alliance’s commitment to collaborating with patient advocacy and research organizations around the world to uncover barriers to atrial fibrillation screening and appropriate treatment to reduce the risk of stroke for patients with NVAF.

  • Data from the EMANATE trial will be presented during various sessions on August 28:
    • 09:17 – 09:25 CET - Press Conference – Hot Line: Late-Breaking Clinical Trials 2
    • 11:18 – 11:28 CET - Hot Line: Late-Breaking Clinical Trials 2
    • 15:40 – 16:00 CET - Meet the Trialists - EMANATE
    • 15:37 – 18:00 CET - Anticoagulation for cardioversion of atrial fibrillation: exploring areas of uncertainty
  • One-year follow-up data evaluating the safety and effectiveness of continued oral anticoagulation treatment beyond one year after venous thromboembolism (VTE) in patients at intermediate risk of recurrence will be presented as an oral presentation on August 26, from 14:24 to 14:42 CET.
  • A real-world data analysis investigating the safety and effectiveness of Eliquis in high-risk patient subgroups will be featured as part of the Stroke Prevention poster session on August 28, from 8:30 to 12:30 CET.
  • A real-world data analysis evaluating the safety and effectiveness of Eliquis specifically in NVAF patients aged 65 years and older will be presented as an oral presentation during the Anticoagulation in Atrial Fibrillation Rapid Fire Abstract session on August 29 from 15:12 to 15:21 CET.
  • Top-line findings from The EIU report on stroke risk reduction and screening policies in 12 countries will be presented as a poster on August 28, from 8:30 to 12:30 CET. The full report will be released by The EIU on September 21.

Below is a complete list of BMS and Pfizer Alliance presentations during the ESC Congress. Abstracts can be accessed through the ESC Congress 2017 Scientific Programme.

Title Presenting Author/Type Date/Time (CET) Location/Session
Clinical Data
INR prior to bleeding is below 3.0 most of the time in patients with atrial fibrillation using warfarin

Session: Poster Session 3 – Drug Treatment

Oliveira Guimaraes et al./ Poster Aug. 27,

14:00-18:00

Poster Area
Apixaban vs conventional therapy in anticoagulation-naive patients with atrial fibrillation undergoing cardioversion: The EMANATE Trial

Sessions:

Hot Line: Late-Breaking Clinical Trials 2

Meet the Trialists - EMANATE

Ezekowitz et al./

Hot Line

Meet the Trialists

Aug. 28,
Hot Line: 11:18-11:28
Meet the Trialists: 15:40 – 16:00
Hot Line:

Main Auditorium

Meet the Trialists:

Dali – The Hub

Serial IL-6 levels and risk of death in anticoagulated patients with atrial fibrillation: Insights from the ARISTOTLE trial

Session: Poster Session 4 – Stroke Prevention

Aulin et al./

Poster

Aug. 28,

8:30-12:30

Poster Area
Clinical outcomes in patients with atrial fibrillation and echocardiographic risk factors for stroke anticoagulated with apixaban or warfarin

Session: Poster Session 4 – Stroke Prevention

Vinereanu et al./ Poster Aug. 28,

8:30-12:30

Poster Area
Low apolipoprotein A1 is significantly associated with decreased risk of cardiovascular events in anticoagulated patients with atrial fibrillation: Insights from the ARISTOTLE trial

Session: Poster Session 4 – Atrial Fibrillation Obesity

Pol et al./

Poster

Aug. 28,

8:30-12:30

Poster Area

A novel biomarker-based risk score to predict death in patients with atrial fibrillation: Insights from the ARISTOTLE and RE-LY trials

Session: Stroke risk prediction in atrial fibrillation

Hijazi et al./

Poster

Aug. 29,

14:54-15:12

Valetta – Village 5
Real-World Data and Other Analyses

Effectiveness and safety of continued oral anticoagulation treatment beyond 1 year after venous thromboembolism in patients at intermediate risk: a nationwide propensity score weighted-cohort study

Session: After pulmonary embolism: optimising treatment and follow up

Johnsen et al./Oral Aug. 26,

14:24-14:42

Rabat – Village 7
Real-world comparison of major bleeding risk associated with direct oral anticoagulants or warfarin in patients with non-valvular atrial fibrillation: a systematic review and network meta-analysis

Session: Poster Session 3 – Drug Treatment

Deitelzweig et al./Poster Aug. 27,

14:00-18:00

Poster Area

Effectiveness and safety of apixaban versus warfarin among high-risk subgroups of non-valvular atrial fibrillation patients: a propensity score matched analysis

Session: Poster Session 4 – Stroke Prevention

Li et al./

Poster

Aug. 28,

8:30-12:30

Poster Area

Predictors of warfarin discontinuation or switching among non-valvular atrial fibrillation patients

Session: Poster Session 4 – Stroke Prevention

Luo et al./

Poster

Aug. 28,

8:30-12:30

Poster Area
Effectiveness and safety of standard and lower dose apixaban compared to warfarin in non-valvular atrial fibrillation patients: a propensity score matched analysis

Session: Poster Session 4 – Stroke Prevention

Li et al./

Poster

Aug. 28,

8:30-12:30

Poster Area
Stroke prevention: From policy to clinical practice in the U.S. and Europe

Session: Poster Session 4 – Cardiovascular risk factors in general population

Karnad et al./Poster

Aug. 28,

8:30-12:30

Poster Area
A changing landscape: temporal trends in incidence and characteristics of patients hospitalised with venous thromboembolism.

Session: Best Posters – Best Posters in acute pulmonary embolism

Johnsen et al./Poster Aug. 28, 14:00-18:00 Poster Area

Risk of major bleeding among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, rivaroxaban or warfarin in the U.S. Medicare population

Session: Poster Session 5 - Bleeding and LAA Occlusion

Trocio et al./

Poster

Aug. 28,

14:00-18:00

Poster Area

Comparison of stroke and major bleeding risk of treatment with apixaban vs. rivaroxaban and dabigatran among elderly non-valvular atrial fibrillation patients in the United States

Session: Anticoagulation in Atrial Fibrillation

Deitelzweig et al./Rapid Fire Abstract Aug. 29,

15:12-15:21

Agora 2

About Eliquis

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from multiple Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.

ELIQUIS Important Safety Information

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WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.