Prospective, randomized, multicenter comparison of laser-facilitated balloon angioplasty versus stand-alone balloon angioplasty in patients with obstructive coronary artery disease

Objectives. The goal of this study was to examine the relative safety and efficacy of laser-facilitated percutaneous transluminal coronary angioplasty (PTCA) versus 'stand-alone' PTCA. Background. Plaque debulking with lasing before PTCA may result in improved lumen dimensions and decreased rates of periprocedural ischemic complications, thus improving short-and long-term outcomes after percutaneous intervention. The mid-infrared holmium:yttrium-aluminum-garnet (YAG) laser has been shown to be effective in a variety of plaque subtypes and may be particularly useful in high risk acute ischemic syndromes. Methods. A total of 215 patients (mean [ ± SD] age 61 ± 12 years) with 244 lesions were prospectively randomized at 14 clinical centers to laser versus stand-alone PICA. After laser treatment, all patients underwent PICA; 148 patients (69%) had unstable angina. Results. The procedural success rate without major catheterization laboratory complications was similar in patients assigned to laser treatment or PTCA alone (96.6% vs. 96.9%, p = 0.88), as was the in-hospital clinical success rate (89.7% vs. 93.9%, p = 0.27). There was no difference in postprocedural diameter stenosis after laser treatment compared with PTCA (18.3% ± 13.6% vs. 19.5% ± 15.1%, p = 0.50). However, use of the laser, versus PICA alone, did result in significantly more major and minor procedural complications (18.0% vs. 3.1%, p = 0.0004), myocardial infarctions (4.3% vs. 0%, p = 0.04) and total in-hospital major adverse events (10.3% vs. 4.1%, p = 0.08). At a mean follow-up time of 11.2 ± 7.7 months, there were no differences in late or event-free survival in patients assigned to laser treatment versus PICA alone. Conclusions. Compared with stand-alone PTCA, laser-facilitated FICA results in a more complicated hospital course, without immediate or long- term benefits.