PROMISE TRIAL: QUALITY OF LIFE STUDY

Overview

The PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial was the first large scale randomized trial to compare clinical outcomes from the initial use of coronary computed tomographic angiography (CTA) versus the usual care strategy of functional testing in patients with chest pain and low-intermediate coronary artery disease (CAD) risk. Comparison of quality of life outcomes from these two strategies was a major secondary objective of the PROMISE research program.

Results

Circulation. 2016 May 24;133(21):1995-2007. 

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.

Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS, for the PROMISE Investigators.

OPEN ACCESS in PubMed Central

Abstract

BACKGROUND:

The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial found that initial use of ≥64 detector-row computed tomography angiography versus standard functional testing strategies (exercise ECG, stress nuclear methods, or stress echocardiography) did not improve clinical outcomes in 10 003 stable symptomatic patients with suspected coronary artery disease 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 postrandomization. The prespecified primary QOL measures were the Duke Activity Status Index and the Seattle Angina Questionnaire frequency and QOL scales. All comparisons were made as randomized. Baseline variables were well balanced in the 2982 patients randomly assigned to computed tomography angiography testing and the 3003 patients randomly assigned to functional testing. The Duke Activity Status Index 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% confidence interval, -0.9 to 1.1]). Similar results were seen for the Seattle Angina Questionnaire frequency scale (mean difference at 24 months, -0.2; 95% confidence interval, -0.8 to 0.4) and QOL scale (mean difference at 24 months, -0.2; 95% confidence interval, -1.3 to 0.9). None of the secondary QOL measures showed a consistent strategy-related difference.

CONCLUSIONS:

In symptomatic patients with suspected coronary artery disease who required noninvasive testing, symptoms and QOL improved significantly. However, a strategy of initial anatomic testing, in comparison with functional testing, did not provide an incremental benefit for QOL over 2 years of follow-up.

DOI: 10.1161/CIRCULATIONAHA.115.020259