Does higher diastolic augmentation predict clinical benefit from enhanced external counterpulsation?: Data from the international EECP Patient Registry (IEPR)

Background: Enhanced external counterpulsation (EECP) has been demonstrated to be an effective treatment for stable angina in patients with coronary disease. The hemodynamic effects of EECP are maximized when the ratio of diastolic to systolic pressure area is in the range of 1.5 to 2.0. Hypothesis: It is hypothesized that patients undergoing EECP who are able to achieve higher diastolic augmentation (DA) ratios may derive greater clinical benefit. This study examines the relationship between the DA ratio and clinical outcomes in patients undergoing EECP. Methods: We analyzed demographic, noninvasive hemodynamic, and clinical outcome data on 1,004 patients enrolled in the International EECP Patient Registry (IEPR) for treatment of chronic angina between January 1998 and August 1999 Blood pressure waveforms were recorded from finger plethysmography. Six-month clinical outcomes were obtained by telephone interview. Results: At the end of EECP treatment, 370 (37%) patients had a higher DA ratio (defined as greater than or equal to 1.5) and 634 (63%) had a lower DA ratio (defined as <1.5). Factors associated with a lower DA ratio included age greater than or equal to 65 years (p < 0.001), female gender (p < 0.00 1), left ventricular ejection fraction < 35% (p < 0.05), hypertension (p < 0.01), prior coronary bypass surgery (p < 0.01), noncardiac vascular disease (p < 0.001), multivessel disease (p < 0.01), congestive heart failure (p < 0.01), current smoking (p < 0.01), unsuitability for further revascularization (p < 0.001), and higher baseline angina class (p < 0.00 1). There were no significant differences regarding diabetes mellitus, prior coronary angioplasty, prior myocardial infarction, or antianginal medication use between patients with higher or lower DA ratios. Based on a multiple logistic regression model, independent predictors of a DA ratio < 1.5 at the end of EECP included current smoking (odds ratio 3.3; 95% confidence intervals 2.0-5.4); multivessel disease(1.7; 1.3-2.3); female gender(2.2; 1.7-3.0); no prior EECP(1.9; 1.1-3.3); noncardiac vascular disease (2.3; 1.7-2.9); age greater than or equal to 65 years (1.7; 1.4-2.2), and patients not suitable for revascularization (1.6; 1.2-2.0). By the end of therapy, there were no significant differences in myocardial infarction, revascularization rates, or nitroglycerin use with respect to higher DA ratios. At 6-month follow-up, patients with higher DA had a trend toward a greater reduction in angina class compared with those with lower DA (p = 0.069). There was a significantly higher rate of unstable angina and congestive heart failure in the group not achieving higher augmentation (p < 0.05). Conclusions: Patients who are younger, male, nonsmoking, and without multivessel coronary or noncardiac vascular disease are most likely to have higher DA with EECP. Patients with higher DA tended to have a greater reduction in angina class at 6-month follow-up compared with those with lower DA ratios. There is evidence that higher DA ratios are associated with improved short- or long-term clinical outcomes, suggesting that clinical benefit from EECP is associated with the magnitude of DA.