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Multicenter Enhanced External Counterpulsation - MUST-EECP
Description:
EECP for exercise-induced ischemia and angina in CAD.
Hypothesis:
Enhanced external counterpulsation (EECP) reduces exercise-induced ischemia and angina in patients with CAD.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 139
Mean Follow Up: 1 year
Patient Populations:
Abnormal ETT studies
Primary Endpoints:
Ischemic symptoms
Principal Findings:
The MUST-EECP trial randomized 139 patients to 35 hours of outpatient therapy with active EECP (n=60) or sham counterpulsation (n=65) over 4-7 weeks. 57% of patients had prior revascularization procedures, and 74% were Canadian angina Class 2 or 3.
Extended (> 3 months) follow-up data were available for 40 patients in each group, with mean follow-up time 11.9 months. There was a significant improvement in exercise duration and a decrease in weekly anginal episodes. There was no difference detected in hospitalization rates among the two groups (13% EECP vs 13% placebo).
A quality-of-life (QOL) outcomes substudy was designed to assess 1-year QOL measures using the SF-36 and QLI-CV-3 survey instruments. among chronic stable angina patients. At 1 year, 44 patients were lost to follow-up, leaving 37 patients in the EECP arm and 44 in the placebo arm.
Based on the Quality of Life Index (QLI-CV3), patients who underwent EECP reported: less activity-limiting physical pain (at 12 months p=0.006); improved general health 1-year post-treatment (p=0.018); and more satisfaction with their energy level and current degree of stress, chest pain, and shortness of breath. At 1 year, sham-treated patients reported no improvements on these or any other measured QOL outcomes.
Interestingly, the sham group showed improvement in bodily pain measures during treatment, but these scores began to decline shortly after treatment; whereas the EECP group continued to improve during follow-up.
Interpretation:
EECP is an intriguing technology which may offer benefit for patients with severe chronic angina, who are often no longer suitable candidates for revascularization procedures. The heterogeneous nature of the limited study population as well as the number of patients lost to follow-up limit the conclusions that can be drawn from the MUST-EECP study. Variation in severity of illness at baseline contributed to a broad range of QOL scores during follow-up. The benefit of this technology remains to be quantified in larger trials.
References:
Circulation 1998;98(Suppl I):I-350.
Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardio. 1999;33:1833-40.
Keywords: Coronary Artery Disease, Follow-Up Studies, Angina, Stable, Chest Pain, Quality of Life, Personal Satisfaction, Lost to Follow-Up, Dyspnea, Counterpulsation
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