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J Am Coll Cardiol, 2002; 39:1581-1587
© 2002 by the American College of Cardiology Foundation
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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{dagger}, Ronald Rubenstein, MD, FACC{ddagger}, 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
{dagger} Scripps Clinic and Research Institute, La Jolla, California, USA
{ddagger} 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.

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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