Transmyocardial laser revascularisation compared with continued medical therapy for treatment of refractory angina pectoris: a prospective randomisedtrial

Background Transmyocardial revascularisation (TMR) is an operative treatmen t for refractory angina pectoris when bypass surgery or percutaneous transl uminal 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 Cardiova scular Society Angina (CCSA) score III (38%) or IV (62%), reversible ischae mia, and incomplete response to other therapies. Patients were randomly ass igned TMR and continued medication (n=92) or continued medication alone (n= 90). Baseline assessments were angina class, exercise tolerance, Seattle an gina questionnaire for quality of life, and dipyridamole thallium stress te st. We reassessed patients at 3 months, 6 months, and 12 months, with indep endent 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 gr oup (p<0.0001, median difference 111 s), Independent CCSA score was II or l ower in 47.8% in the TMR group compared with 14.3% in the medication-only g roup (p<0.001). Each Seattle angina questionnaire index increased in the TM R 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 tre atment provided clinical benefits in patients with no other therapeutic opt ions.