Copyright © 2000 by the European Society of Cardiology.
Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial
Department of Interventional Cardiology, Heart Centre of the University Hospital Rotterdam, Rotterdam, The Netherlands
Received March 7, 2000; accepted April 12, 2000
Abstract
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 coronary occlusion were randomized to treatment with either the laser guidewire (n=144) or conventional guidewires (mechanical guidewire, n=159). The primary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30min of fluoroscopic time: laser guidewire vs mechanical guidewire; 52·8% (n=76) vs 47·2% (n=75), P=0·33. Serious adverse events following the initial guidewire attempt were 0% (laser guidewire) and 0·6% (mechanical guidewire), respectively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewire n=100), followed by stent implantation in 149 (79%). At the 6-month angiographic follow-up, the difference in binary restenosis rate (laser guidewire 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 guidewire) vs 74%, 40% and 31% (mechanical guidewire).
Conclusion Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.
Key Words: Chronic total coronary occlusion, randomized trial, laser angioplasty
f1 Correspondence: P. W. Serruys, MD, PhD, FACC, FESC, Prof. of Interventional Cardiology, Erasmus University, Bd 412, Head of the Department of Interventional Cardiology, Heart Centre, PO Box 1738, 3000 DR Rotterdam, The Netherlands.
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