Comparison of transmyocardial revascularization with medical therapy in patients with refractory angina

Background Transmyocardial revascularization involves the creation of chann els in the myocardium with a laser to relieve angina. We compared the safet y and efficacy of transmyocardial revascularization performed with a holmiu m laser with those of medical therapy in patients with refractory class IV angina (according to the criteria of the Canadian Cardiovascular Society). Methods In a prospective study conducted between March 1996 and July 1998 a t 18 centers, 275 patients with medically refractory class IV angina and co ronary disease that could not be treated with percutaneous or surgical reva scularization were randomly assigned to receive transmyocardial revasculari zation followed by continued medical therapy (132 patients) or medical ther apy alone (143 patients). Results After one year of follow-up, 76 percent of the patients who had und ergone transmyocardial revascularization had improvement in angina (a reduc tion of two or more classes), as compared with 32 percent of the patients w ho received medical therapy alone (P<0.001). Kaplan-Meier survival estimate s at one year (based on an intention-to-treat analysis) were similar for th e patients assigned to undergo transmyocardial revascularization and those assigned to receive medical therapy alone (84 percent and 89 percent, respe ctively; P = 0.23). At one year, the patients in the transmyocardial-revasc ularization group had a significantly higher rate of survival free of cardi ac events (54 percent, vs. 31 percent in the medical-therapy group; P<0.001 ), a significantly higher rate of freedom from treatment failure (73 percen t vs. 47 percent, P<0.001), and a significantly higher rate of freedom from cardiac-related rehospitalization (61 percent vs. 33 percent, P<0.001). Ex ercise tolerance and quality-of-life scores were also significantly higher in the transmyocardial-revascularization group than in the medical-therapy group (exercise tolerance, 5.0 MET [metabolic equivalent] vs. 3.9 MET; P = 0.05; quality-of-life score, 21 vs. 12; P = 0.003). However, there were no differences in myocardial perfusion between the two groups, as assessed by thallium scanning. Conclusions Patients with refractory angina who underwent transmyocardial r evascularization and received continued medical therapy, as compared with s imilar patients who received medical therapy alone, had a significantly bet ter outcome with respect to improvement in angina, survival free of cardiac events, freedom from treatment failure, and freedom from cardiac-related r ehospitalization. (N Engl J Med 1999;341:1029-36.) (C)1999, Massachusetts M edical Society.