Total occlusion trial with angioplasty by using laser guidewire - The total trial

Aims A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions. Methods and Results In 18 European centres, 303 patients with a chronic cor onary occlusion were randomized to treatment with either the laser guidewir e (n=144) or conventional guidewires (mechanical guidewire, n=159). The pri mary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30 min of f luoroscopic time: laser guidewire vs mechanical guidewire; 52.8% (n=76) vs 47.2% (n=75), P=0.33. Serious adverse events following the initial guidewir e attempt were 0% (laser guidewire) and 0.6% (mechanical guidewire), respec tively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewir e n=100), followed by stent implantation in 149 (79%). At the 6-month angio graphic follow-up, the difference in binary restenosis rate (laser guidewir e vs mechanical guidewire; 45.5% vs 38.3%, P=0.72) or reocclusion rate (25. 8% vs 16.1%, P=0.15) did not reach statistical significance. At 1, 6 and 12 months, angina and event-free survival were 69%, 35% and 24% (laser guidew ire) vs 74%, 40% and 31% (mechanical guidewire). Conclusion Although laser guidewire technology was safe, the increase in cr ossing success did not reach statistical significance. (Eur Heart J 2000; 2 1: 1797-1805, doi:10,1053/enhj,2000, 2263) (C) 2000 The European Society of Cardiology.