Abstract P029: Factors Associated With Participation of Patients With Coronary Artery Disease in a Randomized Study of a Vegan versus American Heart Association-recommended Diet: Interim Analysis
Introduction: Patients with coronary artery disease (CAD) who make healthy lifestyle changes can greatly impact their disease trajectories. However, the clinical profile of patients more likely to participate in programs aimed at improving lifestyle choices remains uncertain. The objective of this analysis was to examine the baseline clinical profile of patients with CAD motivated to enroll in an eight-week diet study versus those who chose not to enroll.
Methods: The study population included patients with angiographically-defined CAD (≥50% lesion in an artery ≥2 mm caliber or prior percutaneous coronary intervention) who provided informed consent to participate in a single-center, prospective, blinded end-point, randomized trial assessing the impact of a vegan versus AHA-recommended diet on inflammatory and glucometabolic profiles. Data collection was obtained by direct interview and exam of patients who chose to enroll in and complete the trial. Electronic medical records were reviewed for patients who provided informed consent but subsequently declined to participate in the study prior to any study intervention, including randomization. Normally distributed and skewed continuous variables were examined by enrollment status with independent samples t-test and Mann-Whitney U test, respectively. Categorical variables were examined by enrollment status by Fisher’s exact test or Chi-square test.
Results: Of the 90 patients consented, 60 chose to enroll into the study while 30 chose not to enroll. Compared to those who chose to participate in the study, those who chose not to participate were less likely to be of white race (70% (21/30) vs. 85% (51/60), p=0.002). Other demographic variables including age, sex, ethnicity or BMI did not differ by enrollment. Regarding medical history, patients who chose not to participate were more likely to have diagnoses associated with cardiovascular risk, including hypertension (86.7% (26/30) vs. 56.7% (34/60), p=0.005), hyperlipidemia (96.7% (29/30) vs. 71.7% (43/60), p=0.005), and diabetes mellitus (43.3% (13/30) vs. 21.7% (13/60), p=0.048). Analyses of laboratory parameters revealed that patients who did not participate in the study also had poorer risk factor control, including higher hemoglobin A1c (6.0% (IQR 5.7-7.8%) vs. 5.8% (IQR 5.5-6.3%), p=0.043) as well as lower HDL cholesterol levels (42 g/dL (IQR 34-47) vs. 45 g/dL (IQR 37-55), p=0.046).
Conclusion: Among this sample of patients with angiographically-defined CAD, those who chose not to participate in an eight week dietary intervention to lower disease risk were more likely to be of a minority race with a higher proportion of poorly controlled cardiovascular risk factors at baseline. This analysis emphasizes the need for health care teams to consider different strategies of encouraging these high-risk patients to enroll in programs aimed at healthy lifestyle changes.
Author Disclosures: E. Driggin: None. L. Ganguzza: None. B. Velez de Villa: None. E. Farid: None. S. Heffron: None. J. Newman: None. J. Slater: None. K. Woolf: None. B. Shah: None.
- © 2017 by American Heart Association, Inc.