Abstract

A clinical study was conducted to evaluate the efficacy and safety of percutaneous coronary excimer laser angioplasty in 60 patients with coronary artery disease. Forty-nine patients had stable exertional angina, and 11 patients had unstable angina despite medical therapy. A novel 1.4-mm diameter catheter with 20 quartz fibers of 100-microns diameter each arranged concentrically around a central lumen suitable for a 0.014-in. flexible guide wire was coupled to an excimer laser. A commercial excimer laser emitting energy at a wavelength of 308 nm with a pulse duration of 60 nsec was used. The laser was operated at 20 Hz. Mean energy transmission was 30 +/- 5 mJ/mm2. In five of the 60 patients, laser angioplasty was not attempted. In 23 patients with laser ablation alone, percent stenosis decreased from 76 +/- 14% before to 27 +/- 17% after ablation and was 34 +/- 15% at the early follow-up angiogram. In 32 patients, additional balloon angioplasty was performed because of vessel closure after laser ablation in 11 and an insufficient qualitative result in 21 patients. Of the 11 patients with unstable angina, one patient died due to vessel closure 3 hours after intervention, and two patients developed a myocardial infarction. In 22 of 47 patients with late follow-up angiography, restenosis within the 6-month follow-up period occurred. Rate of restenosis was higher in patients treated with laser ablation and balloon angioplasty (16 of 28) than in patients treated with laser ablation alone (six of 19). These results suggest that coronary excimer laser angioplasty for ablation of obstructive lesions is feasible and safe in patients with stable angina. However, development of new catheter systems is necessary for an improved success rate.

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