MADIT II Type Patients Successfully Risk
Stratified By MTWA; Microvolt T-Wave Alternans Negative Patients are at
Extremely Low Risk Of Sudden Cardiac Death
New clinical data demonstrate that MTWA can risk
stratify MADIT II type patients to determine which ones will benefit from ICD
therapy BEDFORD, Mass., Jun 24, 2002 (BW HealthWire) -- Cambridge Heart, Inc.
(NASDAQ:CAMH) today announced clinical results presented at the Cardiostim
meeting in Nice, France that demonstrate that Microvolt T-Wave Alternans (MTWA)
testing can play a critical role in risk stratifying MADIT II type patients.
Dr. Stephan Hohnloser, Director of Electrophysiology at J.W. Goethe
University, Frankfurt, Germany presented compelling clinical data
demonstrating that MADIT II type patients who tested negative for MTWA are at
very low risk of dying suddenly from a cardiac event. The MADIT II trial demonstrated that patients with prior myocardial
infarction and left ventricular ejection fraction of 0.30 or less have a
mortality benefit from prophylactic placement of an implantable cardioverter
defibrillator (ICD). Dr. Hohnloser presented data on 120 MADIT II type
patients drawn from two previously published prospective clinical trials
involving 957 patients. The primary endpoint of the analysis was sudden
cardiac death and resuscitated cardiac arrest. The secondary endpoint also
included sustained ventricular tachycardia. Twenty-eight percent of the
patients tested MTWA negative, 59% tested positive, and 13% had an
indeterminate result. Kaplan Meier analysis at 24 months of follow-up for the
primary endpoint revealed an event rate of zero for patients who tested MTWA
negative and an event rate of 16.4% for the remaining patients. Similar
analysis for the secondary endpoint revealed an event rate of 6% for patients
who tested MTWA negative and an event rate of 33% for the remaining patients.
MTWA testing successfully identified a subgroup of MADIT II type
patients who are at low risk of dying suddenly and therefore should not
require ICD therapy. Conversely, MADIT II type patients who do not test MTWA
negative would be expected to have a greater mortality benefit from ICD
therapy than that reported in the original MADIT II study. "It is not unanticipated that these results show that MTWA testing
is a valuable tool to help further risk stratify this important patient
group. We expect that these data will be welcome news to both physicians and
payers who are looking for a tool to help determine which of their MADIT II
type patients will most benefit from ICD therapy " said David
Chazanovitz, Cambridge Heart President and CEO. "Physicians may use MTWA
testing for risk stratification in order to save MADIT II type patients who
test MTWA negative from unnecessary morbidity, psychological trauma and cost
of an ICD. At the same time, physicians will have a compelling reason to
refer for ICD therapy those MADIT II type patients who test MTWA
positive." |