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Comparison of Transmyocardial Revascularization with Medical Therapy in Patients with Refractory Angina - TMR Holmium Laser
Description:
This trial examined the efficacy of transmyocardial revascularization (TMR)in patients with class IV angina and found improvements in angina class and quality of life with TMR therapy compared with medical management.
Hypothesis:
To compare the safety and efficacy of transmyocardial revascularization performed with a holmium laser with those of medical therapy in patients with refractory class IV angina (according to the criteria of the Canadian Cardiovascular Society).
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 275
Patient Populations:
Refractory class IV angina not amenable to CABG or PTCA; reversible ischemia within distal two thirds of left ventricle; LVEF greater than 25%.
Exclusions:
Contraindication to general anesthesia; severe chronic obstructive pulmonary disease (indicated by a forced expiratory volume in one second that was less than 55 percent of the predicted value); the need for continued use of intravenous antiangina medications; an inability to undergo dipyridamole-thallium stress scintigraphy; a non-Q-wave myocardial infarction within the previous two weeks or a Q-wave myocardial infarction within the previous three weeks; the need for long-term anticoagulant therapy; the presence of a ventricular mural thrombus; severe arrhythmias; and decompensated congestive heart failure.
Primary Endpoints:
Angina, treatment failure, myocardial perfusion (thallium) at 12 months; improvement in angina = reduction of 2 or more CCS classes from baseline.
Secondary Endpoints:
Freedom from cardiac-related rehospitalization, survival free of cardiac events, use of cardiac medications, performance on an exercise treadmill test, and quality-of-life score.
Drug/Procedures Used:
Transmyocardial revascularization
Principal Findings:
After one year of follow-up, 76 percent of the patients who had undergone transmyocardial revascularization had improvement in angina (a reduction of two or more classes), as compared with 32 percent of the patients who received medical therapy alone (P<0.001).
At one year, the patients in the transmyocardial-revascularization group had a significantly higher rate of survival free of cardiac events (54 percent, vs. 31 percent in the medical-therapy group; P<0.001), a significantly higher rate of freedom from treatment failure (73 percent 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).
Exercise 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).
There were no differences in myocardial perfusion between the two groups, as assessed by thallium scanning.
Interpretation:
Patients with refractory angina who underwent transmyocardial revascularization and received continued medical therapy, as compared with similar patients who received medical therapy alone, had a significantly better outcome with respect to improvement in angina, survival free of cardiac events, freedom from treatment failure, and freedom from cardiac-related rehospitalization.
References:
N Engl J Med 1999;341:1029-36
Keywords: Exercise Tolerance, Treatment Failure, Follow-Up Studies, Quality of Life, Thallium, Metabolic Equivalent, Lasers, Solid-State
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