Transmyocardial Laser Revascularization in Patients with Refractory Angina: A Randomised Controlled Trial - TMLR

Description:

TMLR is a randomized trial evaluating clinical outcomes with the use of transmyocardial laser revascularization (TMLR) compared with standard medical therapy alone among patients with refractory angina.

Hypothesis:

The addition of TMLR to standard medical therapy may improve clinical outcomes among patients with refractory angina.

Study Design

Study Design:

Patients Screened: 312
Patients Enrolled: 188
Mean Follow Up: 1 year
Mean Patient Age: Mean of 60/61 in the intervention/control
Female: 12
Mean Ejection Fraction: 48/49 in the intervention/control

Patient Populations:

  • Refractory Angina due to diffuse or distal distribution of disease
  • Reversible perfusion defects on radionuclide myocardial perfusion scan

Exclusions:

  • Candidates for suitable coronary revascularization
  • Unable to perform treadmill exercise test
  • Left Ventricular Ejection Fraction of less than 30%
  • Dependence on intravenous anti-anginal therapy
  • Life expectancy of less than 12 months due to a non-cardiac condition

Primary Endpoints:

12-month survival

Secondary Endpoints:

  • Canadian Cardiovascular Society score for angina
  • Treadmill time and distance
  • Hospital admission due to unstable angina

Drug/Procedures Used:

  • TMLR with a 1000 W carbon dioxide device with a mean of 30 channels per patient and a mean pulse energy of 34 J
  • Standard medical therapy

Principal Findings:

  • 12-month survival was 89% for the TMLR group compared with 96% for the medical management group (p=0.14)
  • On exercise walk test, the TMLR group walked for a farther than the medical management group
  • More patients in TMLR group had improvement in Canadian Cardiovascular Society Score for angina by 2 score classes compared with control, as follows: 34% vs 3% at 3 months, 22% vs. 4% at 6 months, and 25% vs. 4% at 12 months (p=0.001)
  • Interpretation:

    Among patients with stable angina, the addition of transmyocardial laser revascularization, was not associated with improved functional capacity or survival compared with standard medical therapy alone. TMLR was, however, significantly associated with improvement by 2 classes in Canadian Cardiovascular Score for Angina at 3, 6 and 12-month follow-up.

    References:

    Schofield PM, et al. Transmyocardial Laser Revascularization in Patients with Refractory Angina: A Randomised Controlled Trial. Lancet 1999; 353:519-24

    Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Cardiac Surgery and SIHD, Chronic Angina

    Keywords: Carbon Dioxide, Follow-Up Studies, Radioisotopes, Angina, Stable, Transmyocardial Laser Revascularization, Coronary Disease, Exercise Test


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