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.

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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.

References

1
Hamburger
JN
, de Feyter PJ, Serruys PW. The laser wire experience: ‘crossing the Rubicon’.
Semin Intervent Cardiol
 .
1996
;
1/2
:
163
–171
2
Puma
JA
, Sketch MH Jr, Tcheng JE. Percutaneous revascularization of chronic coronary occlusion: an overview.
J Am Coll Cardiol
 .
1995
;
26
:
1
–11
3
Holmes
DR
, Vlietstra RE, Reeder GS. Angioplasty in total coronary artery occlusion.
J Am Coll Cardiol
 .
1984
;
3
:
845
–849
4
Kereiakes
DJ
, Selmon MR, McAuley BJ, McAuley DB, Sheehan DJ, Simpson JB. Angioplasty in total coronary artery occlusion: experience in 76 consecutive patients.
J Am Coll Cardiol
 .
1985
;
6
:
526
–533
5
DiScascio
G
, Vetrovec GW, Cowley MJ, Wolfgang TC. Early and late outcome of percutaneous transluminal coronary angioplasty for sub acute and chronic total coronary occlusion.
Am Heart J
 .
1986
;
111
:
833
–839
6
Finci
L
, Meyer B, Favre J, Righetti A, Rutishauser W. Long-term results of successful and failed angioplasty for chronic total coronary artery occlusion.
Am J Cardiol
 .
1990
;
66
:
660
–662
7
Serruys
PW
, Umans V, Heyndrickx GR. Elective P.T.C.A. of totally occluded coronary arteries not associated with acute myocardial infarction; short-term and long-term results.
Eur Heart J
 .
1985
;
6
:
2
–12
8
Stone
GW
, Rutherford BD, McConahay DR. Procedural outcome of angioplasty for total coronary artery occlusion: an analysis of 971 lesions in 905 patients.
J Am Coll Cardiol
 .
1990
;
15
:
849
–865
9
Hamburger
JN
, Gijsbers GHM, Ozaki Y, Ruygrok PN, de Feyter PJ, Serruys PW. Recanalisation of chronic total coronary occlusions using a laser wire: a pilot-study.
J Am Coll Cardiol
 .
1997
;
30
:
649
–656
10
Hamburger
JN
, Serruys PW, Gomes R. Recanalisation of total coronary occlusions using a laser guide wire: The European TOTAL Surveillance Study.
Am J Cardiol
 .
1997
;
80
:
1419
–1423
11
Oesterle
SN
, Bittl JA, Leon MB. Laser wire for crossing total occlusions— ‘learning phase’ results from the U.S. TOTAL Trial.
Cathet Cardiovasc Diagn
 .
1998
;
44
:
235
–243
12
N Engl J Med
 .
1985
;
31
:
932
–936
13
Cohen
M
, Rentrop KP. Limitation of myocardial ischemia by collateral circulation during sudden controlled coronary artery occlusion in human subjects: a prospective study.
Circulation
 .
1986
;
74
:
469
–476
14
Reiber
JHC
, Serruys PW. Advances in quantitative coronary arteriography. Massachusetts: Kluwer Academic Publishers; 1993.
15
Serruys
PW
, Di Mario C, Piek JJ. Prognostic value of intra coronary flow velocity and diameter stenosis in assessing short- and long-term outcomes of coronary balloon angioplasty: the DEBATE study (Doppler Endpoints Balloon Angioplasty Trial Europe).
Circulation
 .
1997
;
96
:
3369
–3377
16
Haase
KK
, Athanasiadis A, Mahrholdt H. Acute and one year follow-up results after vessel size adapted PTCA using coronary ultrasound.
Eur Heart J
 .
1998
;
19
:
263
–272
17
Narins
CR
, Holmes DR Jr, Topol EJ. A call for provisional stenting: the balloon is back.
Circulation
 .
1998
;
97
:
1298
–1305
18
Foley
DP
, Serruys PW. Provisional stenting—stent like balloon angioplasty: evidence to define the continuing role of balloon angioplasty in percutaneous revascularization.
Semin Intervent Cardiol
 .
1996
;
1
:
269
–273
19
Sirnes
PA
, Gol S, Myreng Y. Stenting in chronic coronary occlusion (SICCO): a randomised, controlled trial of adding stent implantation after successful angioplasty.
J Am Coll Cardiol
 .
1996
;
28
:
1444
–1451
20
Hancock
J
, Thomas MR, Holmberg S, Wainwright RJ, Jewitt DE. Randomised trial of elective stenting after successful percutaneous transluminal coronary angioplasty of occluded coronary arteries.
Heart
 .
1998
;
79
:
18
–23
21
Lancet
 .
1998
;
352
:
87
–92

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