Randomized study of the safety and clinical utility of rotational vs. standard coronary angiography using a flat-panel detector.

The purpose of this study was to test the hypothesis that rotational angiography improves patient safety while maintaining diagnostic accuracy for patients undergoing coronary angiography. Despite advances in angiographic technique, patients remain at risk for complications of coronary angiography, including contrast-induced nephropathy and radiation exposure. Technology has been developed to perform coronary angiography with active rotation of the imaging system that may reduce the quantity of contrast and radiation to which the patient is exposed. Fifty patients undergoing diagnostic cardiac catheterization were randomized to either standard vs. rotational angiography of the coronary arteries using a prespecified protocol with a flat-panel single-plane imaging system. We measured the quantity of radiographic contrast utilized and radiation exposure. Using an intention-to-treat analysis, there was a 40% reduction (24 +/- 5 vs. 40 +/- 10 ml; P < 0.0001) in contrast utilization in the rotational group compared to the standard group. Neither radiation exposure (35 +/- 14 vs. 30 +/- 20 Gycm(2); P = 0.35), fluoroscopic time (44 +/- 33 vs. 44 +/- 40 sec; P = 0.99), nor procedure time (249 +/- 137 vs. 214 +/- 79 sec; P = 0.26) differed, although significant intraoperator variability was noted for both standard and rotational angiography. The radiation exposure using this flat-panel system is significantly lower than prior reports that used an image intensifier system. Rotational coronary angiography has the potential to improve patient safety by markedly reducing radiographic contrast exposure while maintaining comparable diagnostic accuracy, radiation exposure, and procedure time compared to standard coronary angiography. Copyright 2005 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes