Transmyocardial CO(2) laser revascularization improves symptoms, function, and quality of life: 12-month results from a randomized controlled trial.
OBJECTIVE
To describe differences in health status (symptoms, physical function, and quality of life) between continued medical management and transmyocardial revascularization with a carbon dioxide laser in patients with severe, symptomatic, inoperable coronary artery disease.


METHODS
This prospective, multicenter trial randomized 98 patients to transmyocardial revascularization and 99 to continued medical therapy. Health status was assessed with the Seattle Angina Questionnaire and the Short Form-36 at baseline and at 3, 6, and 12 months. A new analytic technique, the benefit statistic, was developed to facilitate interpretability of disease-specific health status assessments over time.


RESULTS
Of the 99 patients assigned to medical therapy, 59 (60%) subsequently underwent transmyocardial revascularization. By an intention-to-treat analysis, patients initially randomized to transmyocardial revascularization had 44% of their angina eliminated versus 21% for the medical treatment group (difference = 23%; 95% confidence interval [CI], 11% to 34%). Differences in the benefits of transmyocardial revascularization on physical limitations (33% vs 11% in the medical arm [difference = 23%; 95% CI, 15% to 31%]) and quality of life (47% vs 20% in the medical arm [difference = 26%; 95% CI, 18% to 35%]) were similarly large. These benefits were apparent at 3 months and sustained throughout the 1 year of follow-up. An efficacy analysis that excluded patients who crossed over from the medical treatment to transmyocardial revascularization arm suggested greater treatment benefits.


CONCLUSIONS
Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.
Spertus
J A
JA
Section of Cardiology, Mid America Heart Institute/University of Missouri--Kansas City 64111, USA.
Jones
P G
PG
Coen
M
M
Garg
M
M
Bliven
B
B
O'Keefe
J
J
March
R J
RJ
Horvath
K
K
D000787:Angina Pectoris / Q000628:therapy; D002245:Carbon Dioxide; D003326:Coronary Circulation; D003327:Coronary Disease / Q000628:therapy*; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D053685:Laser Therapy; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D002245:Carbon Dioxide