Related Experiment Video
Updated: Oct 1, 2025
Testing Acetylcholine Followed by Adenosine for Invasive Diagnosis of Coronary Vasomotor Disorders
Published on: February 3, 2021
Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in
Daniel B Mark1, John A Spertus2, Robert Bigelow1
1Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).
Insights
The ISCHEMIA trial found that an invasive strategy improved quality of life for patients with chronic coronary disease and frequent angina. Patients with rare or no angina showed no significant quality-of-life differences between invasive and conservative treatments.
Area of Science:
- Cardiology
- Interventional Cardiology
- Quality of Life Research
Background:
- The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) investigated optimal treatment strategies for chronic coronary disease.
- A key substudy focused on the impact of invasive versus conservative treatment on participants' quality of life (QOL).
Purpose of the Study:
- To evaluate the effect of an initial invasive (INV) versus conservative treatment strategy on QOL in patients with chronic coronary disease and moderate to severe ischemia.
- To determine if treatment strategy influences QOL dimensions such as angina symptoms, physical functioning, and psychological well-being.
Main Methods:
- The QOL substudy involved 1819 participants, assessing QOL using validated instruments like the Seattle Angina Questionnaire (SAQ) and Duke Activity Status Index (DASI).
- Data were collected at baseline, multiple follow-up points (3, 12, 24, 36 months), and study closeout.
- Participants were stratified based on baseline angina frequency (frequent vs. rare/absent).
Main Results:
- Patients with frequent baseline angina (SAQ Angina Frequency score <80) showed significantly greater improvements in SAQ Summary scores with the invasive strategy (mean difference 3.7 points).
- Specific SAQ subscales (Physical Limitations, Angina Frequency, Quality of Life/Health Perceptions) also favored the invasive approach in this subgroup.
- No significant QOL differences were observed between treatment groups for patients with rare/absent baseline angina.
- Depression symptoms were infrequent and unaffected by treatment assignment.
Conclusions:
- An invasive treatment strategy offers superior QOL benefits for patients with chronic coronary disease experiencing frequent angina.
- For patients with rare or absent angina, the choice between invasive and conservative strategies does not appear to impact QOL.
- These findings highlight the importance of baseline symptom severity in guiding treatment decisions for optimal patient outcomes.
Background:
ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy.
Methods:
In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index).
Results:
Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment.
Conclusions:
In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT01471522.
More Related Videos
10:28Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
05:41Left Anterior Descending Coronary Artery Ligation for Ischemia-Reperfusion Research: Model Improvement via Technical Modifications and Quality Control
Published on: December 16, 2022
Related Concept Videos
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:27Coronary Artery Disease V: Interprofessional Care
01:20Angina V: Nursing Management
01:26Angina IV: Management
01:26Acute Coronary Syndrome V: Nursing Management
01:30Acute Coronary Syndrome III: Diagnostic Studies