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

[摘要] 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 mere 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 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 PTCA 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 PTCA alone. Conclusions. Compared with stand alone PTCA, laser-facilitated PTCA results in a more complicated hospital course, without immediate or long-term benefits. (C) 1997 by the American College of Cardiology.

[发布日期] 1997-12-01