Koolen, J.J.

Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial. (Article)

2000-01-01T00:00:00Z

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.

Clinical events following excimer laser angioplasty or balloon angioplasty for complex coronary lesions: subanalysis of a randomised trial (Article)

1998-01-01T00:00:00Z

OBJECTIVES: To compare clinical outcome in patients with complex coronary lesions treated with either excimer laser coronary angioplasty (ELCA) or balloon angioplasty. PATIENTS AND DESIGN: 308 patients with stable angina and a coronary lesion of more than 10 mm in length were randomised to ELCA (151 patients, 158 lesions) or balloon angioplasty (157 patients, 167 lesions). The primary clinical end points were death, myocardial infarction, coronary bypass surgery, or repeated coronary angioplasty of the randomised segment during six months of follow up. Subanalysis was performed to identify a subgroup of patients with a beneficial clinical outcome following ELCA or balloon angioplasty. SETTING: Two university hospitals and one general hospital. RESULTS: There were no deaths. Myocardial infarction, coronary bypass surgery, and repeated angioplasty occurred in 4.6, 10.6, and 21.2%, respectively, of patients treated with ELCA compared with 5.7, 10.8, and 18.5%, respectively, of those treated with balloon angioplasty. ELCA did not yield a favourable clinical outcome in subgroups of patients with long (more than 20 mm) coronary lesions, calcified lesions, small diseased vessels (< or = 2.5 mm reference diameter), or total coronary occlusions. There was a worse clinical outcome in patients with tandem lesions treated with ELCA compared with balloon angioplasty (9/18 v 3/26 lesions; p = 0.01); while a trend towards an unfavourable clinical outcome was found in patients with vessels with a reference diameter of more than 2.5 mm (23/66 v 13/63 lesions, p = 0.07) and left circumflex coronary lesions (12/41 v 6/42 lesions, p = 0.08). CONCLUSIONS: The findings indicate a worse clinical outcome in patients with lesions of more than 10 mm treated with ELCA compared with balloon angioplasty who have tandem coronary lesions and in those with vessels with a reference diameter of more than 2.5 mm and left circumflex coronary lesions.

Excimer laser coronary angioplasty in the Netherlands: preamble for a randomized study (Article)

1993-01-01T00:00:00Z

The immediate outcome of ELCA by XeCl excimer laser radiation is described in 53 patients who were selected to undergo ELCA from December 1990 to September 1991 in two centers that are currently performing ELCA in the Netherlands. Immediate success rates on the basis of visual assessment of the angiogram were as follows. Laser success (> 20% reduction of diameter stenosis after ELCA alone) was observed in 77% of patients, procedural success (< 50% residual stenosis after ELCA with or without adjunctive balloon dilatation [PTCA]) in 91%, and clinical success (procedural success without clinical complications) in 83% of patients. Quantitative coronary angiography by automated contour detection was performed in 31 patients who underwent ELCA in the Thoraxcenter. The minimal luminal diameter (mean +/- SD) of the treated coronary segments increased from 0.77 +/- 0.41 mm to 1.24 +/- 0.25 mm after ELCA and further to 1.67 +/- 0.29 mm after adjunctive PTCA in 25 patients. The present experience is put in perspective of results initially reported by other centers and compared with data from multicenter registries of ELCA. Finally, a short description is given of the design of a prospective, randomized trial of ELCA versus conventional PTCA (AMRO trial).