DSA versus multi-detector row CT angiography in peripheral arterial disease: randomized controlled trial.

Purpose: To prospectively compare therapeutic confidence in, patient outcomes (in terms of quality of life) after, and the costs of digital subtraction angiography (DSA) with those of multi-detector row computed tomographic (CT) angiography as the initial diagnostic imaging test in patients with peripheral arterial disease (PAD).
Materials and Methods: Institutional medical ethics committee approval and patient informed consent were obtained. Between April 2000 and August 2001, patients with PAD were randomly assigned to undergo either DSA or multi-detector row CT angiography as the initial diagnostic imaging test. Outcomes were the therapeutic confidence assessed by physicians (on a scale from 0 to 10), the need for additional imaging, the health-related quality of life at 6-month follow-up, diagnostic and therapeutic costs, and the costs for a hospital stay. Costs were computed from a hospital perspective according to Dutch guidelines for cost calculations in health care. Mean outcomes were compared between groups with unpaired t testing and were adjusted for predictive baseline characteristics with multivariable regression analysis.
Results: Among the 145 patients, 72 were randomly allocated to the DSA group and 73 to the CT angiography group. One patient in the DSA group had to be excluded. Mean age was 63 years in the DSA group and 64 years in the CT angiography group. There were 47 men in the DSA group and 58 men in the CT angiography group. Physician confidence in making a correct therapeutic choice was significantly higher at DSA (mean confidence score, 8.2) than at CT angiography (mean score, 7.2; P < .001). During 6-month follow-up, 14% less additional imaging was performed in the DSA group than in the CT angiography group (P = .3). No significant quality-of-life differences were found between groups. The diagnostic cost associated with DSA (564 +/- 210 euro [standard deviation]) was significantly higher than that associated with CT angiography (363 +/- 273 euro), a difference of -201 euro (95% confidence interval: -281 euro, -120 euro; P < .001). Therapeutic and hospitalization costs were similar for both strategies.
Conclusion: These results suggest that use of noninvasive multi-detector row CT angiography instead of DSA as the initial diagnostic imaging test for PAD provides sufficient information for therapeutic decision making and reduces imaging costs.