Transmyocardial laser revascularisation compared with continued medical therapy for treatment of refractory angina pectoris: A prospective randomised trial

Background. Transmyocardial revascularisation (TMR) is an operative treatment for refractory angina pectoris when bypass surgery or percutaneous transluminal angioplasty is not indicated. We did a prospective randomised trial to compare TMR with continued medication. Methods. We recruited 182 patients from 16 US centres with Canadian Cardiovascular Society Angina (CCSA) score III (38%) or IV (62%), reversible ischaemia, and incomplete response to other therapies. Patients were randomly assigned TMR and continued medication (n = 92) or continued medication alone (n = 90). Baseline assessments were angina class, exercise tolerance, Seattle angina questionnaire for quality of life, and dipyridamole thallium stress rest. We reassessed patients at 3 months, 6 months, and 12 months, with independent masked angina assessment at 12 months. Findings. At 12 months, total exercise tolerance increased by a median of 65 s in the TMR group compared with a 46 s decrease in the medication-only group (p < 0.0001, median difference 111 s). Independent CCSA score was II or lower in 47.8% in the TMR group compared with 14.3% in the medication-only group (p < 0.001). Each Seattle angina questionnaire index increased in the TMR group significantly more than in the medication-only group (p < 0.001). Interpretation. TMR lowered angina scores, increased exercise tolerance time, and improved patients' perceptions of quality of life. This operative treatment provided clinical benefits in patients with no other therapeutic options.