Quality of Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial
Background—The PROMISE trial found that initial use of ≥64 detector-row CT angiography versus standard functional testing strategies (exercise ECG, stress nuclear, or stress echo) did not improve clinical outcomes in 10,003 stable symptomatic patients with suspected coronary artery disease (CAD) requiring noninvasive testing. Symptom burden and quality of life (QOL) were major secondary outcomes.
Methods and Results—We prospectively collected a battery of QOL instruments in 5985 patients at baseline and 6, 12, and 24 months post-randomization. The pre-specified primary QOL measures were the Duke Activity Status Index (DASI) and the Seattle Angina Questionnaire (SAQ) frequency and QOL scales. All comparisons were made as randomized. Baseline variables were well balanced in the 2982 patients randomized to CTA testing and 3003 to functional testing. The DASI improved substantially in both groups over the first 6 months following testing but we found no evidence for a strategy-related difference [mean difference (anatomic - functional) at 24 months of follow-up 0.1 (95% CI -0.9 to 1.1)]. Similar results were seen for the SAQ frequency scale (mean difference at 24 months -0.2, 95% CI -0.8 to 0.4) and quality of life scale (mean difference at 24 months -0.2, CI -1.3 to 0.9). None of the secondary QOL measures showed a consistent strategy-related difference.
Conclusions—In symptomatic patients with suspected CAD who required noninvasive testing, symptoms and QOL improved significantly. However, a strategy of initial anatomic testing, as compared with functional testing, did not provide an incremental benefit for QOL over two years of follow-up.
Clinical Trial Registration Information—clinicaltrials.gov. Identifier: NCT01174550.
- Received November 2, 2015.
- Revision received March 21, 2016.
- Accepted March 28, 2016.