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 PTC 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 variety of plaque subtypes and may be particularly useful in high risk acute ischemic syndromes. Methods. 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 PTCA. After laser treatment, all patients underwent PTCA; 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 PTC 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 PTC (18.3% ± 13.6% vs. 19.5% ± 15.1%, p = 0.50). However, use of the laser, versus PTC 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 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 PTC alone. Conclusions. Compared with stand-alone PTCA, laser-facilitated PTC results in more complicated hospital course, without immediate or long-term benefits.