May 10, 2001

Benefits of EECP sustained at 2 years, says preliminary
analysis

 

Westbury, NY - The relief from severe angina achieved by enhanced external counterpulsation (EECP®) is sustained for at least 2 years, according to a press release from Vasomedical Inc, the makers of the EECP system. The press release cites a preliminary analysis of 254 patients enrolled in the three-year multicenter International EECP Patient Registry (IEPR) for whom 2-year data were available. The registry is tracking long-term outcome following EECP in over 4300 patients with angina.

EECP therapy attracted attention earlier this year at the ACC Scientific Sessions, when it produced positive results in several trials including a 1-year analysis from IEPR. IEPR investigators reported that in 1254 patients, 73% experienced a reduction of at least one angina class that was maintained out to 1 year. The treatment effect was most pronounced in Class III-IV angina patients who represented 69% of the population at baseline, but only 16% at follow-up.

Here, Vasomedical reports that IEPR patients followed for 2 years continue to enjoy the early benefits of EECP therapy. A preliminary analysis of patients with 2-year data (n=254) showed the incidence of Class III-IV angina was 80% at baseline but dropped to 17% immediately following therapy and remained at this level over follow-up. Vasomedical did not specify how many of their patients had received additional EECP therapy during follow-up; in the 1-year IEPR analysis, nearly one quarter of patients had received additional couterpulsation.

      
                                            (Source: Vasomedical, Inc)

"The 24-month [analysis] is really just a snapshot of the first patients that came in, [and] we do not yet have a statistical analysis," Dr Lisa Kennard (Registry Coordinator, University of Pittsburgh Graduate School of Public Health, Epidemiology Data Center) told heartwire. For this reason, Kennard does not yet have the rate of adverse events in the 2-year population. The press release cited 11% of patients underwent CABG or angioplasty over follow-up, but the rates of death or MI, and cardiac hospitalization were not published. The 1-year IEPR analysis found a 5% rate of death and 4% rate of MI, which Kennard says is not out of line for high-risk coronary patients.

The mechanism by which EECP confers the lasting angina relief is not certain, and is presently the subject of investigation by Vasomedical. EECP's noninvasive pulsating pneumatic cuffs, attached to the calves, thighs, and buttocks of patients, are supposed to drive retrograde flow into ischemic myocardium, and indeed there has been evidence of improved myocardial perfusion from uncontrolled thallium and stress test studies. Further evidence has suggested that EECP may stimulate formation of collateral blood vessels and may elicit a beneficial neurohumoral response.

External counterpulsation therapy, including Vasomedical's EECP, is presently indicated for the treatment of stable and unstable angina, acute MI, and cardiogenic shock. Vasomedical is looking to expand EECP application with trials in CHF, diabetes, and silent ischemia