title: Transmyocardial laser revascularization combined with coronary artery bypass grafting: a multicenter, blinded, prospective, randomized, controlled trial.
abstract: OBJECTIVE
  We sought to assess the safety and efficacy of transmyocardial revascularization combined with coronary artery bypass grafting in patients not amenable to complete revascularization by coronary bypass alone.
  
  
  METHODS
  A total of 263 patients whose standard of care was coronary artery bypass grafting and who had one or more ischemic areas not amenable to bypass grafting were prospectively randomized to receive coronary bypass of suitable vessels plus transmyocardial revascularization to areas not graftable (n = 132) or coronary bypass alone with nongraftable areas left unrevascularized (n = 131). Group preoperative demographics and operative characteristics were similar.
  
  
  RESULTS
  The operative mortality rate after coronary bypass/transmyocardial revascularization was 1.5% (2/132) versus 7.6% (10/131) after coronary bypass alone (P =.02). Patients undergoing both coronary bypass and transmyocardial revascularization required less postoperative inotropic support (30% vs 55%, P =.0001) and had a trend toward fewer insertions of intra-aortic balloon pumps (4% vs 8%, P =.13) than did patients having coronary bypass alone. Multivariable predictors of operative mortality were coronary artery bypass alone (odds ratio, 5.3; 95% confidence interval, 1.1-25.7; P =.04) and increased age (odds ratio, 1.1; 95% confidence interval, 1. 0-1.2; P =.03). One-year Kaplan-Meier survival (95% vs 89%, P =.05) and freedom from major adverse cardiac events defined as death or myocardial infarction (92% vs 86%, P =.09) favored the combination of coronary bypass and transmyocardial revascularization. Baseline to 12-month improvement in angina and exercise treadmill scores was similar between groups.
  
  
  CONCLUSIONS
  In a prospective, randomized, multicenter trial, transmyocardial revascularization combined with coronary artery bypass grafting in patients not amenable to complete revascularization by coronary bypass alone was safe; however, angina relief and exercise treadmill improvement were indistinguishable between groups at 12 months of follow-up. Operative and 1-year survival benefits observed after adjunctive transmyocardial revascularization require confirmation by a larger validation study, which is ongoing.
authors.affiliation: Departments of Cardiothoracic Surgery, St Vincent Hospital, Indiana Heart Institute, Indianapolis, IN, USA. cvsurgeon@iquest.com
authors.forename: K B
authors.initials: KB
authors.lastname: Allen
authors.forename: R D
authors.initials: RD
authors.lastname: Dowling
authors.forename: A J
authors.initials: AJ
authors.lastname: DelRossi
authors.forename: F
authors.initials: F
authors.lastname: Realyvasques
authors.forename: E A
authors.initials: EA
authors.lastname: Lefrak
authors.forename: T A
authors.initials: TA
authors.lastname: Pfeffer
authors.forename: T L
authors.initials: TL
authors.lastname: Fudge
authors.forename: M
authors.initials: M
authors.lastname: Mostovych
authors.forename: D
authors.initials: D
authors.lastname: Schuch
authors.forename: S
authors.initials: S
authors.lastname: Szentpetery
authors.forename: C J
authors.initials: CJ
authors.lastname: Shaar
mesh_terms: D001026:Coronary Artery Bypass; D005080:Exercise Test; D005260:Female; D006801:Humans; D053685:Laser Therapy; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D016037:Single-Blind Method