Another (better) version of news release:
EECP(R) Proven Safe and Effective First-Choice Intervention for
Treatment of Chronic Stable Angina
Noninvasive Outpatient Alternative Offers Relief from Chest Pain for Millions of Sufferers
ORLANDO, Fla., Nov. 11 /PRNewswire/ -- A groundbreaking study presented today at the 70th Annual Scientific Sessions of the American Heart Association shows that a new noninvasive outpatient treatment for chronic angina pectoris and coronary artery disease is a safe and effective choice for more than seven million sufferers. This multicenter, placebo-controlled, double-blind, randomized trial of Enhanced External Counterpulsation (EECP(R)) provided scientific evidence of this novel treatment's effectiveness, even in patients
on maximal medication and for whom invasive revascularization procedures are no longer an option.
Results of the Multicenter Study of Enhanced External Counterpulsation
(MUST-EECP), a study conducted with stringent scientific requirements, confirm clinical benefits shown in previous open trials: a decline in anginal frequency, an increase in the ability to exercise and a decrease in exercise-induced signs of myocardial ischemia.
"This rigorous, well-designed clinical trial proves that EECP is a viable treatment for coronary artery disease and chronic angina pectoris," said Rohit Arora, MD, a principal investigator of MUST-EECP and Associate Professor of Clinical Medicine, Columbia-Presbyterian Medical Center, NY. "Not only is EECP effective, but it is also noninvasive, making it a practical treatment option for those patients who are unlikely or are unwilling to undergo invasive procedures, and who need relief from the pain and exercise restrictions associated with chronic angina."
EECP(R) relies on basic hemodynamic principles to increase coronary blood flow and relieve angina. Patients are treated on a padded table equipped with electronically controlled inflation and deflation valves connected to specially designed cuffs applied to the lower extremities and buttocks.
When the heart enters diastole or its resting phase, the cuffs are
inflated sequentially and rapidly from the calves toward the buttocks. Just before systole or when the heart contracts, the cuffs are instantaneously deflated. This sequence causes the heart muscle to receive an increased supply of blood and, at the same time, reduces its workload. Increased venous return raises cardiac output.
EECP is well tolerated in most patients. Generally, treatment is
comfortable; patients read, watch television, listen to music or even sleep during a session. Occasionally, some do experience discomfort of the lower legs, but rarely is there a need to discontinue counterpulsation. No serious complications occurred in study patients.
MUST-EECP: Setting a New Standard in Medical Device Studies
MUST-EECP investigators have agreed that this clinical trial set a new
standard in device trial design. The MUST-EECP study had a unique rigorous scientific protocol for a medical device. "This design is similar to that established by the Food & Drug Administration for pharmaceutical therapies," said Peter Cohn, MD, Chief of Cardiology and Professor of Medicine at the University Medical Center Stony Brook, State University of New York where previous studies had taken place. "Because of the trial's strict entry requirements and exclusion criteria, MUST-EECP appears to be a one-of-a-kind
clinical study in the treatment of angina pectoris -- a trial that will most likely not be repeated."
MUST-EECP, a multicenter study, was conducted from May 1995 to July 1997. One hundred and thirty-nine (139) patients suffering from chronic angina pectoris and on maximal medication were randomized to receive treatment or sham. The sham group was treated in a manner identical in every way to the treatment group except that cardiovascular hemodynamics were not affected. Neither patients nor physicians involved with the study knew to which group an individual patient belonged.
Commenting on the sham arm, Dr. Cohn said it was technically difficult to achieve a level of totally inactive treatment because of the process of EECP, but it was essential to create a credible control. Both Vasomedical, Inc. and investigators felt that the sham treatment was the best way to assess the true efficacy of EECP and to obtain optimal scientific results.
Dr. Cohn concluded, "MUST-EECP results confirmed our expectations. The same degree of effectiveness of EECP was found in the treatment of coronary artery disease and angina pectoris as in our prior Stony Brook studies. After treatment, patients reported remarkable improvement in their capability to walk or move around without developing chest pain or discomfort. They often described an improved sense of well-being and increased levels of energy."
Selection Criteria
Patients with a documented history of coronary artery disease, positive exercise stress tests and who were classified with Canadian Cardiovascular Society Classes I, II and III angina pectoris were randomized to treatment counterpulsation or sham counterpulsation.
Exclusion criteria included unstable angina, myocardial infarction or
bypass surgery three months prior, cardiac catheterization two weeks prior, greater than 50% stenosis in the left main artery, electrocardiogram ECG abnormalities that would interfere with the interpretation of stress tests and overt congestive heart failure, or inability to provide consent or cooperate with the study protocol for the duration of the trial.
Participants were representative of patients with severe coronary artery disease. Average age was 63 years (range 40-81 years): 88% were males; 58% had undergone either coronary artery bypass surgery or angioplasty; and 49% had experienced prior myocardial infarctions. In addition, among those who benefited, 74% were in Canadian Class II or III, and 55% had "residual" multivessel coronary artery disease despite revascularization.
Despite a considerable amount of medication prior to and during treatment, patients in the treated group still were able to show improvement averaging 11% in the time before the onset of ischemia demonstrated by stress electrocardiogram. Those in the sham (control) group showed no improvement at all. Additionally, even in the maximally medicated patients, exercise duration increased 10% in the average participant receiving treatment as measured by exercise treadmill; exercise duration increased only 6% in the sham group.
"The results from MUST-EECP and the Stony Brook trials clearly show that EECP(R) benefits a broad spectrum of patients with symptomatic coronary artery disease, particularly those who have failed evascularization attempts such as angioplasty or bypass surgery," Dr. Arora noted.
Study participants followed a four to seven week treatment program. The protocol required patients to undergo EECP in one-hour sessions, until they had completed 35 hours of treatment.
Cost-Effectiveness of EECP
While EECP may not replace invasive revascularization procedures for all patients, it is a clinically effective and cost-minimizing option. The charges for EECP are approximately $7,000 per full treatment course or one-third the charges associated with balloon angioplasty (PTCA) at $23,183 and one-fifth those of bypass surgery (CABG) at $35,710. The Bypass Angioplasty Revascularization Investigation (BARI) Study outlined charges for PTCA and CABG in an analysis published in the January 1997 issue of the New England Journal of Medicine.
The BARI Study noted that over a five-year period, total charges
associated with PTCA and CABG were $65,298 and $67,271, respectively, because of post treatment recovery expenses. The comparative charge for EECP over the same period is projected to be $26,102.
Participating Centers
Seven centers of excellence in cardiology across the United States
participated in enrolling and treating patients. They were Beth Israel Deaconess Medical Center, a teaching affiliate of Harvard Medical School; Columbia University College of Physicians & Surgeons at the Columbia-Presbyterian Medical Center in New York; rant/Riverside Methodist Hospitals in Columbus, Ohio; Loyola University Medical Center in Maywood, Illinois; University of California, San Francisco; University of Pittsburgh Medical Center; and Yale University School of Medicine.
Marketing Clearance
Vasomedical, Inc. received marketing clearance from the U.S. Food and Drug Administration for the current version of EECP in 1995. Until the summer of the same year, EECP was only available in the United States for patients participating in clinical studies. Today, EECP is available in more than 30 treatment centers around the country.
The company provides hospitals, clinics and private practices with
equipment, EECP treatment guidance and a staff training and maintenance program to ensure optimal patient outcomes.
Vasomedical, Inc. (Nasdaq: VASO) (www.vasomedical.com), located in
Westbury, NY, is a healthcare company dedicated to providing superior
solutions in the management of cardiovascular disease through products and procedures that make improved clinical and economic outcomes possible.
SOURCE Vasomedical, Inc.
/CONTACT: Chermerdene Jordan, 212-886-3525, or Sue Helondovitch,
2l2-886-3287, both of GHG Public Relations for Vasomedical; or Anthony Peacock
of Vasomedical, 516-997-4600, ext. 20/
/Web site: vasomedical.com / |
