Total Occlusion Trial with Angioplasty by using Laser guidewire - TOTAL
Laser vs. mechanical guidewires for crossing total coronary occlusions.
To compare the safety and efficacy of a laser guidewire to mechanical guidewires for chronic total occlusions.
Patients Screened: Not given
Patients Enrolled: 305
Mean Follow Up: 6 months
Mean Patient Age: 58.8
Patients with angina or ischemia
Chronic total occlusion > 1 month old
TIMI 0 flow
Angiographic absence of any entry point
Inability to visualize distal lumen through collateral circulation
Treatment success, defined as reaching the true lumen of any branch distal to the occlusion by the allocated wire within 30 minutes of fluoroscopy time.
Cross-over treatment success, after initial failure of the allocated wire
Death, MI, CABG, or tamponade acutely and at 1 month
6-month binary restenosis
Excimer laser energy transmitted through an 0.018-inch guidewire containing 12 silica fibers and a support catheter providing additional coaxial backup support.
Of the 305 patients enrolled, 145 were randomized to the laser wire and 160 to a conventional mechanical guidewire.The median angiographic age of the total occlusions studied was 9 weeks. Occlusion length was 15 ± 9 mm by QCA.
Treatment success, based on intention to treat, was 47.5% with the mechanical wire and 53.1% with the laser wire (p = 0.33).
Patients who failed their initial therapy with the assigned wire were crossed over to the other guidewire. Treatment success was 45.5% for patients treated with the laser wire after failed mechanical wire attempts, and 27.3% for patients treated with a mechanical wire after a failed laser wire attempt.
The average cumulative success rate for the laser wire (either as initial or crossover therapy) was 63.9% (c.i. 58.5-69.3%), whereas the success rate after the initial and sole attempt with the MW was 47.5% (c.i. 39.8-55.2%).
Complications following the first attempt (death, MI, emergency CABG, tamponade) were 0% in the LW arm and 0.6% in the MW arm.
At 1 Month, 90.3% of the laser wire and 90.0% of the mechanical wire patients were event-free. There were no significant differences in the rates of death (0% vs 0.6%), MI (4.1% vs 2.5%), CABG(4.8% vs 6.9%); or repeat PTCA ( 0.7% vs 0%) between the laser and mechanical wire groups, respectively.
Laser wire technology appeared to increase the crossing success rate from 47.5% (cath lab with MW only) to 63.9% (cath lab with laser wire technology), without increasing the risk of complications. This study obviously predates newer wire technologies available at this time.
1. J Am Coll Cardiol 1998;30:81A. Preliminary results
Keywords: Coronary Artery Disease, Prednisolone, Coronary Artery Bypass, Coronary Occlusion, Lasers, Excimer
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