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 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 30 min 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.
|Keywords||Aged, Angioplasty, Transluminal, Percutaneous Coronary/*instrumentation, Comparative Study, Coronary Angiography, Coronary Disease/mortality/radiography/*therapy, Equipment Safety, Female, Follow-Up Studies, Humans, Lasers/*therapeutic use, Male, Middle Aged, Probability, Severity of Illness Index, Survival Rate, Treatment Outcome|
|Persistent URL||dx.doi.org/10.1053/euhj.2000.2263, hdl.handle.net/1765/12887|
Serruys, P.W.J.C., Hamburger, J.N., Koolen, J.J., Fajadet, J., Haude, M., Klues, H., … Simon, R.. (2000). Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial.. European Heart Journal, 1797–1805. doi:10.1053/euhj.2000.2263