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A prospective multicenter registry of laser therapy for degenerated saphenous vein graft stenosis: the COronary graft Results following Atherectomy with Laser (CORAL) trial
Authors:Gregory R Giugliano  M Wayne Falcone  David Mego  Doug Ebersole  Steve Jenkins  Tony Das  Esmund Barker  Joseph M Ruggio  Brijeshwar Maini  Steven R Bailey
Institution:1. National Heart and Lung Institute, Imperial College London, London, UK;2. Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan;3. James Cook University, Queensland, Australia;4. Department of Cardiovascular Medicine, St. Marianna University School of Medicine Yokohama City Seibu Hospital, Yokohama, Japan;1. The First Clinical College of Lanzhou University, Lanzhou, China;2. Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China;3. Yale School of Public Health, Yale University, USA;4. Fu Wai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences, Beijing, China;5. Fu Wai Hospital, National Center for Cardiovascular Disease, Peking Union Medical College, Beijing, China;1. San Giovanni Hospital, Rome, Italy;2. Centro per la Lotta Contro L’Infarto–CLI Foundation, Rome, Italy;3. Misericordia Hospital, Grosseto, Italy;4. Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland;5. Sandro Pertini Hospital, Rome, Italy;6. Ospedale Civile Ferdinando Veneziale, Isernia, Italy;7. GVM Care and Research, E.S. Health Science Foundation, Cotignola, Italy;8. Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY
Abstract:PurposeThe primary aim of this study was to prospectively evaluate the safety and efficacy of Excimer laser atherectomy as a primary treatment strategy in consecutively eligible patients presenting for percutaneous coronary intervention (PCI) of degenerated saphenous vein graft (SVG) lesions using a multicenter registry. Prior single-center experience suggested that laser atherectomy may decrease acute procedural complications during treatment of degenerated SVGs, including lesions not amenable to distal protection devices (DPDs).Methods and materialsThe COronary graft Results following Atherectomy with Laser investigators enrolled 98 patients at 18 centers between June 23, 2003, and October 4, 2004, with greater than 50% stenosis of an SVG who presented for PCI due to angina pectoris or objective evidence of myocardial ischemia in a concordant myocardial distribution. Laser atherectomy was planned. Patients were excluded if the operator planned to utilize a DPD. Inclusion and exclusion criteria were aligned to those in the Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial.ResultsThe primary end point 30-day major adverse cardiac events (MACE)] occurred in 18/98 (18.4%) patients driven primarily by non-q-wave myocardial infarction. Major procedural complications included no reflow (n=5) and major dissection (n=1). No perforations occurred. Univariate predictors of 30-day MACE included lesion length, vessel angulation, plaque burden, SVG degeneracy score, number of laser pulses used, and larger-sized laser catheters.ConclusionsThis study demonstrated that Excimer laser atherectomy of diseased SVGs is feasible with results comparable to the 30-day MACE in the control population from the SAFER trial. Whether the addition of laser to embolic protection devices is of any clinical utility remains to be tested in future studies.
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