Late-Breaking BIOTRONIK Study Results to Be Presented at ESC Congress 2017

The presentations and discussions will shed light on recent advances in the treatment of atrial fibrillation (AF) in heart failure patients, evaluate patients’ response to cardiac resynchronization therapy (CRT) and compare the safety and efficacy of drug-eluting
stents (DES).

Held this year in Barcelona on August 26-30, the ESC Congress is the world’s largest cardiovascular congress, featuring more than 500 expert sessions. “BIOTRONIK is a recognized partner in supporting scientific research,” commented Manuel Ortega, Senior Vice President at BIOTRONIK. “At ESC Congress 2017, BIOTRONIK studies will contribute to the dialogue, reflecting on therapies that could have a significant impact on a variety of patient groups.”

CASTLE-AF

Results from CASTLE-AF (Catheter Ablation versus Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation) will be presented by Dr. Nassir Marrouche, University of Utah Hospital, Salt Lake City, US, during a Late-Breaking Clinical Trials Hot Line session. CASTLE-AF is currently the only randomized clinical trial comparing catheter ablation to pharmacological therapy for patients with coexisting heart failure and AF that measures the hard primary outcomes of mortality and hospitalization for worsening heart failure.

BIOFLOW-V

Data from the BIOFLOW-V randomized control trial comparing Orsiro^* and Xience DES with 12-month target lesion failure (TLF) as the primary endpoint will be presented by US principal investigator Dr. David Kandzari, Piedmont Atlanta Hospital, Georgia, US, during a Late-Breaking Science in PCI session. This pivotal Investigational Device Exemption (IDE) trial included a large, complex patient population and was designed in collaboration with the US Food and Drug Administration (FDA) to support an upcoming FDA submission in the US. Orsiro is currently available in more than 100
countries worldwide.

EchoCRT Subgroup Analysis

A subgroup analysis from the BIOTRONIK-sponsored EchoCRT trial investigates the effect of QRS duration normalized for left ventricular size as an indicator of CRT response in patients with a narrow QRS complex (<130 ms). Dr. Niraj Varma, Cleveland Clinic, Ohio, US, will present his analysis in a moderated late-breaking science
ePoster session.

Tenth Edition of the EHRA White Book

ESC Congress 2017 also marks the release of the EP Europace journal supplement to the 10^th edition of the annual EHRA White Book. Supported by BIOTRONIK, the EHRA White Book is an annual collection of statistics about the number of cardiac rhythm device implantations and catheter ablations in more than 50 ESC member countries. This year’s supplement analyzes the last 10 years of data, offering various insights into regional trends. Dr. Béla Merkely, Semmelweis University, Budapest, Hungary, will present an analysis of the trends in ICD implantations across Europe during
EHRA’s symposium.

Congress delegates are invited to attend the following presentations and poster session:

Saturday, August 26, 2:47-3:00 p.m.

Dr. David Kandzari, “BIOFLOW-V: A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro* Sirolimus Eluting Coronary Stent System in the Treatment
Of Subjects With up to Three De Novo or Restenotic Coronary
Artery Lesions”

Late-Breaking Science in PCI 1

Dali – The Hub

Sunday, August 27, 11:18-11:48 a.m.

Dr. Nassir Marrouche, “Catheter Ablation Versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation: The CASTLE-AF Trial”

Hot Line: Late-Breaking Clinical Trials 1

Barcelona – Main Auditorium

Sunday, August 27, 8:30 a.m.-6:00 p.m.

Dr. Niraj Varma, “Effect of QRS duration Normalized for Left Ventricular Size on Cardiac Resynchronization Therapy in Heart Failure Patients with a Narrow (<130 ms) QRS complex: A Subgroup Analysis of the EchoCRT Trial”

Late-Breaking Science Posters

Poster Area

Tuesday, August 29, 2:22-2:45 p.m.

Dr. Béla Merkely, “ICD Utilisation Across Europe – Trends, Inequalities and Challenges. The EHRA White Book”
European Heart Rhythm Association Symposium – Fighting Sudden Cardiac Death: Challenges and New Strategies

Skopje – Village 5

Delegates are also invited to visit BIOTRONIK’s booth (H100), which will showcase a range of CRT devices and leads, BIOTRONIK Home Monitoring^® and coronary artery disease treatment options during
the congress.

*CAUTION – Investigational device in the United States. Limited by US law to investigational use.