Transmyocardial CO2 laser revascularization improves symptoms, function, and quality of life: 12-Month results from a randomized controlled trial

John A. Spertus, Philip G. Jones, Michael Coen, Mukesh Garg, Brent Bliven, James O'Keefe, Robert J. March, Keith Horvath

Research output: Contribution to journalArticle

Abstract

PURPOSE: 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. SUBJECTS AND 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. CONCLUSION: Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.

Original languageEnglish (US)
Pages (from-to)341-348
Number of pages8
JournalAmerican Journal of Medicine
Volume111
Issue number5
DOIs
StatePublished - Oct 1 2001
Externally publishedYes

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Transmyocardial Laser Revascularization
Gas Lasers
Randomized Controlled Trials
Quality of Life
Health Status
Confidence Intervals
Therapeutics
Intention to Treat Analysis
Multicenter Studies
Coronary Artery Disease

ASJC Scopus subject areas

  • Nursing(all)

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Transmyocardial CO2 laser revascularization improves symptoms, function, and quality of life : 12-Month results from a randomized controlled trial. / Spertus, John A.; Jones, Philip G.; Coen, Michael; Garg, Mukesh; Bliven, Brent; O'Keefe, James; March, Robert J.; Horvath, Keith.

In: American Journal of Medicine, Vol. 111, No. 5, 01.10.2001, p. 341-348.

Research output: Contribution to journalArticle

Spertus, John A. ; Jones, Philip G. ; Coen, Michael ; Garg, Mukesh ; Bliven, Brent ; O'Keefe, James ; March, Robert J. ; Horvath, Keith. / Transmyocardial CO2 laser revascularization improves symptoms, function, and quality of life : 12-Month results from a randomized controlled trial. In: American Journal of Medicine. 2001 ; Vol. 111, No. 5. pp. 341-348.
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AU - Garg, Mukesh

AU - Bliven, Brent

AU - O'Keefe, James

AU - March, Robert J.

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N2 - PURPOSE: 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. SUBJECTS AND 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. CONCLUSION: Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.

AB - PURPOSE: 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. SUBJECTS AND 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. CONCLUSION: Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.

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