Randomized trial of laser-assisted passage through occluded femoro-popliteal arteries

A randomized trial was carried out in patients with occlusions of the femoro-popliteal artery to compare the passage of metal-tipped optical fibres with guide wires and catheters through the occlusions, prior to balloon angioplasty. The study was in a provincial English teaching hospital providing a vascular service for the area. Fifty patients were entered; 25 into the "laser" group and 25 into the "control" group. End points were (a) the success in passage through the occlusion and (b) the outcome 1 month after passage. Comparison of the groups showed no appreciable difference between the two methods with regard to age, sex, symptoms, incidence of diabetes, or previous myocardial infarctions. Successful passage through the occlusion followed by dilatation was achieved in 18 (72%) patients in the laser group and 20 (80%) in the control group. After 1 month, 13 (52%) arteries in the laser group were patent compared to 13 (57%) in the control group. Confidence limits for the difference in success of passage are -15% to +31%, and -24% to +33% for patency after 1 month. Since these limits include zero, it is unlikely that a longer trial would alter the difference between the two methods. The results suggest that the laser system currently in use is no better than conventional methods.