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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Transmyocardial revascularization using an XeCl excimer laser: results of a randomized trial.
Annals of Thoracic Surgery 2004 September
BACKGROUND: CO2 and holmium:yttrium aluminum garnet (YAG) transmyocardial laser revascularization (TMLR) are used to treat patients with refractory angina. A randomized trial to investigate the efficacy and safety of XeCl excimer TMLR was performed.
METHODS: Thirty patients with refractory angina were randomized in pairs to excimer TMLR or maximal medication. We assessed angina, quality of life (QOL), exercise time, myocardial perfusion, and ventricular wall motion at base line and at 3, 6, and 12 months after TMLR.
RESULTS: TMLR patients manifested a significantly better outcome with respect to angina class and quality of life. One TMLR patient died perioperatively versus none in the control group. After TMLR angina decreased from class 3.8 +/- 0.4 at base line to 1.9 +/- 0.9 at 12 months versus 3.9 +/- 0.3 to 3.7 +/- 0.6 in the control group, respectively (p = 0.000001). At 12 months a decrease of greater than or equal to two angina classes was indicated in 11 out of 14 TMLR patients versus none in the control group (p = 0.00001). Improved myocardial perfusion or exercise time was not indicated despite a small decrease in reversible wall motion abnormality score.
CONCLUSIONS: Excimer TMLR significantly relieves angina and improves QOL without evidence of improved cardiac perfusion or function.
METHODS: Thirty patients with refractory angina were randomized in pairs to excimer TMLR or maximal medication. We assessed angina, quality of life (QOL), exercise time, myocardial perfusion, and ventricular wall motion at base line and at 3, 6, and 12 months after TMLR.
RESULTS: TMLR patients manifested a significantly better outcome with respect to angina class and quality of life. One TMLR patient died perioperatively versus none in the control group. After TMLR angina decreased from class 3.8 +/- 0.4 at base line to 1.9 +/- 0.9 at 12 months versus 3.9 +/- 0.3 to 3.7 +/- 0.6 in the control group, respectively (p = 0.000001). At 12 months a decrease of greater than or equal to two angina classes was indicated in 11 out of 14 TMLR patients versus none in the control group (p = 0.00001). Improved myocardial perfusion or exercise time was not indicated despite a small decrease in reversible wall motion abnormality score.
CONCLUSIONS: Excimer TMLR significantly relieves angina and improves QOL without evidence of improved cardiac perfusion or function.
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