Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial.
OBJECTIVE
A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions.


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).


CONCLUSIONS
Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.
Serruys
P W
PW
Department of Interventional Cardiology, Heart Centre of the University Hospital Rotterdam, Rotterdam, The Netherlands.
Hamburger
J N
JN
Koolen
J J
JJ
Fajadet
J
J
Haude
M
M
Klues
H
H
Seabra-Gomes
R
R
Corcos
T
T
Hamm
C
C
Pizzuli
L
L
Meier
B
B
Mathey
D
D
Fleck
E
E
Taeymans
Y
Y
Melkert
R
R
Teunissen
Y
Y
Simon
R
R
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053685:Laser Therapy; D008297:Male; D008875:Middle Aged; D011336:Probability; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome