First Patient Enrolls in St. Jude Medical Supported Landmark Study Investigating Atrial Fibrillation Treatment Options
August 02 2011 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that the first patient was enrolled in the
EAST (Early comprehensive
Atrial fibrillation
Stroke prevention Trial) clinical trial. The
investigator-initiated study seeks to determine whether an early,
comprehensive, standardized intervention program can help prevent
adverse cardiovascular outcomes associated with prolonged Atrial
Fibrillation (AF), including stroke and death. More specifically,
the EAST study will evaluate whether an early and comprehensive
rhythm control treatment of patients with early onset AF produces
better patient outcomes than usual care alone.
The clinical sponsor of EAST is AFNET (German Competence Network
on Atrial Fibrillation). The European Heart Rhythm Association
(EHRA) is an equal scientific partner in the trial. The planned
enrollment is more than 3,000 patients from 200 centers in Europe,
with locations in Belgium, Czech Republic, Denmark, France,
Germany, Italy, Netherlands, Poland, Spain, Switzerland, and the
United Kingdom.
"St. Jude Medical believes it is important to marshal together
the resources, people and technologies to help find a cure for AF,”
said Jane J. Song, president of the St. Jude Medical Atrial
Fibrillation Division. “We can help accelerate the achievement of
this goal by investing in clinical trials such as EAST, which
address some of the most important questions about AF within the
scientific community.”
In addition to EAST, St. Jude Medical also is a major supporter
of the CABANA (Catheter
Ablation Versus Antiarrhythmic Drug Therapy for
Atrial Fibrillation) pivotal
trial.
Günter Breithardt, AFNET speaker, Angelo Auricchio, and Panos
Vardas, current and past EHRA president, said in a joint statement
today, “Investigator-initiated clinical research with a relevant
impact requires good ideas, perseverance, a network of colleagues,
but also financial resources. As sponsor and co-organizer of the
EAST trial, we therefore highly appreciate the financial support
from St. Jude Medical and Sanofi to make this important clinical
research possible.”
Trial Background
AF is a condition in which the upper chambers of the heart
(atria) beat rapidly and erratically, affecting the heart’s ability
to adequately pump blood to its lower chambers (ventricles) and
subsequently to the rest of the body. Some of the complications
caused by AF are increased risk of death or stroke, increased
severity of stroke, increased hospitalizations, and reduced quality
of life due to palpitations and other AF-related symptoms.
AF can have an impact on the heart as early as a few weeks after
onset, causing cycles of remodeling, dysfunction and additional
triggers which help progress the disease. These cycles both
maintain and perpetuate AF from the state of initial detection, to
paroxysmal (AF that begins suddenly and ends spontaneously) to
persistent (recurring episodes lasting more than seven days) to
permanent (ongoing and long term).
EAST is a prospective, parallel-group, randomized, open,
blinded, end-point assessment. The multicenter study seeks to
understand whether improved rhythm control therapy could prevent
death and stroke. Specifically, whether an earlier initiation of
rhythm control therapy, when included in a comprehensive AF
management strategy, has the potential to maintain the heart’s
rhythm more effectively, prevent AF-related complications, and
disrupt the cycles that maintain AF and cause complications.
Commenting on the need for the EAST study, Prof. Dr. Paulus
Kirchhof, coordinating investigator of the trial said, “The trial
is based on the observation that insufficient, non-structured and
delayed therapy of the multiple factors that maintain AF and cause
its complications has most likely contributed to the limited
effectiveness of rhythm control interventions in past trials. This
trial takes an important step forward to learn more about the value
of rhythm control therapy to improve the lives of AF patients by
accounting for the cycles that initiate and maintain the disease
and contribute to AF-related complications.”
Patients with recent-onset AF at risk for stroke or death are
eligible for trial enrollment. Participants will be randomized to
either an “early, comprehensive, standardized” intervention to
maintain sinus rhythm in addition to usual care, or to usual care
alone. Early intervention will include antiarrythmic drug therapy
and/or pulmonary vein isolation (PVI) using catheter ablation as
well as ECG monitoring of therapy. Usual care follows standardized
therapy under the 2010 ESC guidelines for the treatment of AF.
The primary outcome of EAST is the composite of cardiovascular
death, stroke and heart failure or acute coronary syndrome
(hospitalization). There will be outpatient follow-up at 12, 24 and
36 months.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn. and has four major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Annual Report on Form 10-K for the fiscal year ended
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2011. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
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