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Total Occlusion Trial with Angioplasty by using Laser guidewire - TOTAL
Description:
Laser vs. mechanical guidewires for crossing total coronary occlusions.
Hypothesis:
To compare the safety and efficacy of a laser guidewire to mechanical guidewires for chronic total occlusions.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 305
Mean Follow Up: 6 months
Mean Patient Age: 58.8
Patient Populations:
Patients with angina or ischemia
Chronic total occlusion > 1 month old
TIMI 0 flow
Exclusions:
Angiographic absence of any entry point
Inability to visualize distal lumen through collateral circulation
Primary Endpoints:
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.
Secondary Endpoints:
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
Drug/Procedures Used:
Excimer laser energy transmitted through an 0.018-inch guidewire containing 12 silica fibers and a support catheter providing additional coaxial backup support.
Principal Findings:
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.
Interpretation:
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.
References:
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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