CLINICAL STUDY: TRANSMYOCARDIAL REVASCULARIZATION
A prospective, multicenter, randomized trial of percutaneous transmyocardial laser revascularization in patients with nonrecanalizable chronic total occlusions
Gregg W. Stone, MD, FACC*,*,
Paul S. Teirstein, MD, FACC ,
Ronald Rubenstein, MD, FACC ,
Dwayne Schmidt, MD, FACC ,
Patrick L. Whitlow, MD, FACC||,
Edward J. Kosinski, MD, FACC¶,
Gregory Mishkel, MD, FACC# and
John A. Power, MD, FACC**
* Cardiovascular Research Foundation, New York, New York, USA
Scripps Clinic and Research Institute, La Jolla, California, USA
Jersey Shore Medical Center, Neptune, New Jersey, USA
Presbyterian Hospital, Oklahoma City, Oklahoma, USA
|| Cleveland Clinic Foundation, Cleveland, Ohio, USA
¶ St. Vincent’s Medical Center, Bridgeport, Connecticut, USA
# St. John’s Hospital and Memorial Medical Center, Springfield, Illinois, USA
** St. Francis Hospital, Lawrenceville, Pennsylvania, USA
Manuscript received December 28, 2001;
revised manuscript received February 25, 2002,
accepted February 27, 2002.
* Reprint requests and correspondence: Dr. Gregg W. Stone, The Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10021, USA.
gstone{at}crf.org
OBJECTIVES: We sought to evaluate the safety and efficacy of percutaneous transmyocardial revascularization (PTMR) in patients with refractory angina caused by one or more chronic total occlusions (CTOs) of a native coronary artery.
BACKGROUND: Previous unblinded, randomized trials of PTMR in patients with end-stage coronary artery disease and refractory angina have demonstrated significant relief of angina and increased exercise duration. Whether such benefits would be realized in blinded patients with less extensive coronary artery disease is unknown.
METHODS: A total of 141 consecutive patients with class III or IV angina caused by one or more chronically occluded native coronary arteries in which a percutaneous coronary intervention (PCI) had failed were prospectively randomized, at 17 medical centers, in the same procedure, to PTMR plus maximal medical therapy (MMT) (n = 71) or MMT only (n = 70). Blinding was achieved through heavy sedation, dark goggles and the concurrent performance of PCI in all patients.
RESULTS: Baseline characteristics were similar between the two groups. A median number of 20 laser channels were created in patients randomized to PTMR. At six months, the anginal class improved by two or more classes in 49% of patients assigned to PTMR and in 37% of those assigned to MMT (p = 0.33). The median increase in exercise duration from baseline to six months was 64 s with PTMR versus 52 s with MMT (p = 0.73). There were no differences in the six-month rates of death (8.6% vs. 8.8%), myocardial infarction (4.3% vs. 2.9%) or any revascularization (4.3% vs. 5.9%) in the PTMR and MMT groups, respectively (p = NS for all).
CONCLUSIONS: In patients with class III or IV angina caused by nonrecanalizable CTOs, the performance of PTMR does not result in a greater reduction in angina, improvement in exercise duration or survival free of adverse cardiac events, as compared with MMT only.
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Abbreviations and Acronyms
| | CABG | | coronary artery bypass graft surgery | | CTO | | chronic total occlusion | | DIRECT | | Direct myocardial revascularization In Regeneration of Endomyocardial Channels Trial | | MI | | myocardial infarction | | MMT | | maximal medical therapy | | PCI | | percutaneous coronary intervention | | PTMR | | percutaneous transmyocardial revascularization | | YAG | | yttrium aluminum garnet |
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