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.