BERLIN–(BUSINESS WIRE)–BIOTRONIK today announced the publication of the COMPAS
clinical trial results in the European Heart Journal1. COMPAS is the first
large-scale, prospective, multi-center, randomized clinical trial to
demonstrate the safety and efficacy of remote monitoring with BIOTRONIK Home Monitoring® in pacemaker patients. The
results further confirm BIOTRONIK Home Monitoring® as the remote monitoring
system with the strongest and most robust clinical evidence in the industry.
The publication, “A randomized trial of long-term remote monitoring of pacemaker
recipients (The COMPAS trial),” by Professor Philippe Mabo et al. provides
long-awaited scientific evidence that daily automatic wireless remote
monitoring in pacemaker patients is at least as safe and effective as
conventional in-clinic care. Importantly, the unique early detection
capabilities of BIOTRONIK Home Monitoring® were demonstrated to advance
physician intervention for clinically relevant events by almost 4 months versus
the control group. Further, COMPAS showed that BIOTRONIK Home Monitoring®
significantly decreases the follow-up burden for clinics by virtually halving
the need for interim in-clinic visits and at the same time doubling the
clinical actionability of these fewer in-clinic visits.
COMPAS enrolled a total of 538 patients across 43 centers,
randomizing them 1:1 to BIOTRONIK Home Monitoring® or conventional in-clinic
care. Follow-up duration was 18 months, at the end of which both groups were
scheduled for a protocol-defined in-clinic follow-up. Interim in-office
follow-ups occurred in the Home Monitoring group if triggered by a notification
from the system, and in the conventional care group based on the clinics
standard of care.
“Most impressively, the COMPAS trial is the first study to
demonstrate a 66% reduction of hospitalizations for atrial arrhythmia and
related stroke with Home Monitoring, clearly underlining the value of
continuous remote monitoring in pacemaker patients,” commented Professor Philippe Mabo, Principal Investigator of COMPAS
and author of the publication, from University Hospital Rennes, France. “The system reliably
notified the clinic of medical and technical events, thus enabling us
physicians to treat our patients months before a routine in-office follow-up
might have been scheduled – and before their clinical condition could
deteriorate to the point of a more serious outcome,” added Professor Mabo. “We
believe that the reliable early detection of events which enabled us physicians
to intervene earlier originates in the uniqueness of the Home Monitoring
system. The system works fully automatically and has a track record of high transmission
success proven in previous studies2-3 and also observed in COMPAS.”
“Furthermore, COMPAS has shown that it is no longer
necessary to continue the old routine of calendar-based follow-ups that often
doesnt result in clinical action but may lead to an inefficient use of scarce
resources,” commented Professor Jean-Claude Daubert, one of the co-authors of the
publication, University Hospital Rennes, France. “This could reduce the
administrative burden of busy clinics by enabling physicians to focus on
patients who are more critically in need of medical attention. Patients also
benefit through improved overall convenience because they don’t have to travel
so frequently to potentially unnecessary in-clinic visits. And, of course, it
is reassuring for them to know their device is being monitoring on a daily
basis.”
“Given the large numbers of new pacemaker implantations4,
there is substantial potential for BIOTRONIK Home Monitoring® to enhance
patient care and reduce administrative burden on the health care system”,
commented Dr. Werner Braun, Managing Director, BIOTRONIK.
“BIOTRONIK is currently building one of the most substantial
portfolios of landmark clinical trials in the industry,” continued Dr. Braun.
“Taking into consideration studies such as COMPAS, ECOST, TRUST, EchoCRT,
IMPACT, REPLACE, and CASTLE-AF, we intend to continue providing significant
evidence upon which paradigm changing clinical decisions and enhancements to
therapy guidelines can be made.”
References:
1 Mabo P et al. European Heart Journal 2011; doi:
10.1093/eurheartj/ehr419
2 Varma N et al. Europace 2011;13(3):P1026
3 Varma N et al. Europace Journal (2011);13 (suppl 3):P1026
4 Vardas P et al. The EHRA White Book 2011: The Current
Status of Cardiac Electrophysiology in ESC Member Countries. www.escardio.org/EHRA
5 Varma N et al. Circulation 2010;122:325-332
6 Varma N et al. Circulation Arrhythmia and Electrophysiology
2010;3:428-436
About BIOTRONIK Home Monitoring®
BIOTRONIK Home Monitoring® is the first and only remote patient management
system with FDA and CE approvals for safe reduction of in-office follow-ups and
for early detection of clinically relevant events, leading to earlier
intervention, based on results of the TRUST landmark trial5-6. The system is
unique because it allows continuous automatic wireless remote monitoring of patient
and device status with daily updates, all independent from any patient
interaction. BIOTRONIK Home Monitoring® has pioneered advances in remote
patient management since its first clinical application in the year 2000.
Today, BIOTRONIK Home Monitoring® is extensively used in a growing number of
patients in more than 3,800 clinics and 55 countries worldwide.
About BIOTRONIK SE & Co. KG
As one of the worlds leading manufacturers of cardiovascular medical devices,
with several million devices implanted, BIOTRONIK is represented in over 100
countries by its global workforce of over 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. More information: www.biotronik.com.
Posted by Sean Fenske, Editor-in-Chief, MDT