More Effective Risk-Stratification for ICD Interventions Needed: BIOTRONIK PARCADIA Study Aims to Address Open Clinical Questions
2012 - BIOTRONIK, a leading manufacturer of innovative medical technology, today announced the start of the prospective multicenter PARCADIA study. The study aims to identify risk factors that can help predict appropriate ICD (implantable cardioverter defibrillator) interventions in patients with ischemic cardiomyopathy who have received an ICD for primary prevention according to the current ESC (European Society of Cardiology) guidelines. The first patient has now been enrolled in the Isala Clinics, Zwolle, the Netherlands.
"Findings from the MADIT-II trial showed that only one-quarter of patients who had a myocardial infarction and got an ICD for primary prevention received an adequate shock therapy," explained Dr. Arif Elvan, Coordinating Clinical Investigator, Isala Clinics. "With the PARCADIA study, we want to assess if there are additional parameters that could help us to better predict who should get an ICD and who will benefit most."
Current ESC guidelines indicate ICDs for primary prevention for patients who have a left ventricular ejection fraction (LVEF) of less than 35%. In addition to this, there is a need for a more effective risk-stratification method besides LVEF to identify patients that would benefit the most from an ICD.
"Most data regarding risk factors associated with appropriate ICD interventions comes from retrospective analysis of the major ICD trials with a primary goal of demonstrating ICD treatment survival benefit," continued Dr. Elvan. "The PARCADIA study is designed to provide a clinical database to allow an explorative analysis of risk markers for more appropriate and effective ICD intervention."
The primary objective of the PARCADIA study is to explore the potential of myocardial scar, assessed by MRI, as a predictor for appropriate ICD intervention. Myocardial scar is an important substrate for developing ventricular arrhythmias in ischemic cardiomyopathy. "Late Gadolinium Enhanced Cardiac MRI has a very high sensitivity to detect the amount of myocardial scar and might thus be useful in the prediction of future arrhythmic events," says Dr. Elvan. Secondary objectives are to identify baseline risk factors that could help to design a risk score system based on the MRI data, electrocardiographical (24-hour Holter ECG) and biochemical (blood analyses) information.
The PARCADIA study is a prospective, nonrandomized, multicenter clinical investigation of 200 eligible patients performed in four centers in the Netherlands. All patients in the study are identified with ischemic cardiomyopathy indicated for a "de novo" ICD implantation for primary prevention, according to European Society of Cardiology (ESC) guidelines or local standards. Patients will be analyzed in two groups: one receiving appropriate ICD intervention and the other without an appropriate ICD intervention during Follow-up. In the first group a higher burden of myocardial scar is expected. Final study results are expected in 2017.
"With our extensive clinical study program, BIOTRONIK consistently invests in research with the goal of discovering the best and most effective treatments. BIOTRONIK's comprehensive portfolio of clinical trials supports our quality solutions and is aimed at making a real difference in advancing effective, efficient, comprehensive healthcare delivery. We address important unanswered clinical questions and have the potential to impact therapy guidelines," commented Christoph Böhmer, President International of BIOTRONIK. "The PARCADIA study will help us define the best tools for predicting patients who would most benefit from receiving an ICD. Developing better, more accurate indication markers are in the best interests of patients, physicians and the health care system in general."
As one of the world's leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success-and deliver confidence and peace of mind to physicians and their patients worldwide.
For more information: www.biotronik.com