Janssen Announces 25 Presentations at ESC Congress (JNJ)

August 22, 2016 8:22 AM EDT

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Janssen Pharmaceuticals, Inc., today announced that 25 abstracts have been accepted for presentation by Janssen and its development partner, Bayer, at the ESC Congress 2016, taking place August 27-31 in Rome, Italy. New real-world evidence from the EXPLORER research program, including latest findings from the REVISIT-US study, will address how XARELTO® (rivaroxaban), a non-vitamin K antagonist oral anticoagulant (NOAC), is performing in routine clinical practice. Also, the companies will unveil the design of the GALILEO trial, which seeks to address blood clot prevention for patients following successful transcatheter aortic valve replacement (TAVR).

"As more real-world research on the NOAC class of medicines becomes available, we continue to see that the benefit-risk profile of XARELTO® remains favorable and consistent with clinical trials," said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. "Our significant presence and the robustness of data at this year's ESC Congress 2016 underscore our commitment to providing physicians with the latest evidence on how XARELTO® is performing in the real world."

A listing of the data presentations is below:

Abstract Type/Title

Presentation Information

New Real-World Insights In Non-Valvular Atrial Fibrillation

Poster Presentation (P2576):

Real-world evidence of stroke prevention

in patients with non-valvular atrial fibrillation in

the United States: the REVISIT-US study

Poster Session 3: Anticoagulation inAtrial Fibrillation II Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2597): Oral anticoagulant prescribing patterns forstroke prevention in atrial fibrillation amonggeneral practitioners and cardiologists in threeEuropean countries

Poster Session 3: Anticoagulation in Atrial Fibrillation III Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2570):

Real-world evidence of stroke prevention in

patients with non-valvular atrial fibrillation

Poster Session 3: Anticoagulation in Atrial Fibrillation II Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2606): Predictors of major bleeding in patients with atrial fibrillation treated with rivaroxaban in XANTUS: findings from a real-world prospective study

Poster Session 3: Anticoagulation in Atrial Fibrillation III Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2508): Economic evaluation of rivaroxaban versusacenocoumarol in the prevention of stroke inpatients with non-valvular atrial fibrillation in Spain

Poster Session 3: Stroke and More Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Oral Presentation (2067): Major bleeding among patients with atrialfibrillation treated with rivaroxaban or warfarinin Sweden: interim results from an on-goingpost-authorization study

Are You Still Afraid about Bleeding Risk

of Antithrombotic Therapy in Atrial Fibrillation? Sunday, August 28 2:54 pm CEST Minsk – Village 4

Oral Presentation (2953): XAPASS: evidence of safety and effectiveness in Japanese patients treated with rivaroxaban for stroke prevention in atrial fibrillation under real-world clinical practice

Registries Atrial Fibrillation Monday, August 29 9:15 am CEST Raphael – The Hub

Rapid Fire Abstract - Oral Presentation (3071): The CHA2DS2-VASc score strongly correlates with glomerular filtration rate and predicts decline in renal function over time in patients with atrial fibrillation and chronic kidney disease

Clinical Features and Management of Atrial Fibrillation Monday, August 29 9:33 am CEST Agora 1 – Poster Area

New Unmet Medical Need Research

Oral Presentation (5012):GALILEO: rivaroxaban in TAVR patients

The Future is in the Pipeline Tuesday, August 30 10:30 am CEST Agora 1 – Poster Area

Registry Data

Oral Presentation (2950): Identifying patients with atrial fibrillation and"truly low" thromboembolic risk who are poorlycharacterized by CHA2DS2-VASc: superiorperformance of a novel machine learning tool in GARFIELD-AF

Registries Atrial Fibrillation Monday, August 29 8:30 am CEST Raphael – The Hub

Poster Presentation (P3479): Pharmacotherapy for atrial fibrillation inpatients with chronic kidney disease: insightsfrom the Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT-AF)

Poster Session 4: Miscellaneous inArrhythmia Monday, August 29 8:30 am – 12:30 pm CEST Poster Area

Poster Presentation (P3482): Patterns of amiodarone use and outcomes in clinical practice for atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

Poster Session 4: Miscellaneous in Arrhythmia Monday, August 29 8:30 am – 12:30 pm CEST Poster Area

Oral Presentation (2954): Association of inappropriate dosing of non-vitamin K oral anticoagulants and risk of adverse events: results from the ORBIT-AF II registry

Registries Atrial Fibrillation Monday, August 29 9:30 am CEST Raphael – The Hub

Moderated Poster Presentation (P4100): Do baseline characteristics account forgeographical variations in event rates inpatients with newly diagnosed atrial fibrillation?The GARFIELD-AF registry

Antithrombotic Therapy in Atrial Fibrillation 1 Monday, August 29 3:56 pm CEST Moderated Poster Station – Poster Area

Moderated Poster Presentation (P4971): Vitamin K antagonist control for patients withnon-valvular atrial fibrillation in Eastern andSoutheastern Asia: an analysis of event ratesfrom GARFIELD-AF

Antithrombotic Therapy in Atrial Fibrillation 2Tuesday, August 30 10:35 am CEST Moderated Poster Station – Poster Area

Additional Non-Valvular Atrial Fibrillation Research

Poster Presentation (P2602): Systemic embolization in patients with atrialfibrillation: results from ROCKET AF

Poster Session 3: Anticoagulation inAtrial Fibrillation III Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2569): Left atrial thrombus resolution in atrialfibrillation or flutter: results of a prospectivestudy with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF)

Poster Session 3: Anticoagulation in Atrial Fibrillation II Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2574): Left atrial thrombus resolution in non-valvularatrial fibrillation or flutter: results of aprospective study with rivaroxaban (X-TRA)biomarker substudy

Poster Session 3: Anticoagulation in Atrial Fibrillation II Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Poster Presentation (P2566): Net clinical benefit of rivaroxaban comparedwith warfarin in patients with atrial fibrillation

Poster Session 3: Anticoagulation in Atrial Fibrillation II Sunday, August 28 2:00 – 6:00 pm CEST Poster Area

Pulmonary Embolism and Deep Vein Thrombosis Research

Oral Presentation (2359): Is rivaroxaban associated with shorter hospitalstays and reduced costs vs. parenteral bridgingto warfarin among pulmonary embolism patients?

Optimizing the Treatment of Pulmonary Embolism Sunday, August 28 5:24 pm CEST Vienne – Village 9

Poster Presentation (P3710): Outcomes associated with observation versusinpatient stays for pulmonary embolism

Poster Session 4: Acute Pulmonary Embolism Monday, August 29 8:30 am – 12:30 pm CEST Poster Area

Poster Presentation (P3717): External validation of a multivariable claims-based prediction rule for in-hospital pulmonaryembolism mortality

Poster Session 4: Acute Pulmonary Embolism Monday, August 29 8:30 am – 12:30 pm CEST Poster Area

Poster Presentation (P3813): Hospitalizations and other healthcare resourceutilization among patients with deep veinthrombosis treated with rivaroxaban versuslow-molecular-weight heparin and warfarin in the outpatient setting

Poster Session 4: Thrombosis and Coagulation Monday, August 29 8:30 am – 12:30 pm CEST Poster Area

Moderated Poster Presentation (P4124): Subgroup analysis of patients with concomitantpulmonary embolism in XALIA, a non-interventionalstudy of rivaroxaban in routine treatment of deep vein thrombosis

Advances in Pulmonary Embolism Monday, August 29 3:35 pm CEST Moderated Poster Station – Poster Area

Rapid Fire Abstract - Oral Presentation (5964): Risk of venous thromboembolism recurrences inpatients who continued versus discontinued rivaroxaban therapy after an initial six-monththerapy

Antithrombotics in Daily Clinical Practice Tuesday, August 30 4:39 pm CEST Galileo – The Hub



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