Transmyocardial laser revascularization combined with coronary artery bypass grafting: A multicenter, blinded, prospective, randomized, controlled trial

Objective: We sought to assess the safety and efficacy of transmyocardial r evascularization combined with coronary artery bypass grafting in patients not amenable to complete revascularization by coronary bypass alone. Method s: A total of 263 patients whose standard of care was coronary artery bypas s grafting and who had one or more ischemic areas not amenable to bypass gr afting 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 unrevascularize d (n = 131). Group preoperative demographics and operative characteristics were similar. Results: The operative mortality rate after coronary bypass/t ransmyocardial revascularization was 1.5% (2/132) versus 7.6% (10/131) afte r 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 coro nary bypass alone. Multivariable predictors of operative mortality were cor onary 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 fre edom from major adverse cardiac events defined as death or myocardial infar ction (92% vs 86%, P =.09) favored the combination of corollary bypass and transmyocardial revascularization. Baseline to 12-month improvement in angi na and exercise treadmill scores was similar between groups, Conclusions: I n a prospective, randomized, multicenter trial, transmyocardial revasculari zation combined with coronary artery bypass grafting in patients not amenab le to complete revascularization by coronary bypass alone was safe; however , angina relief and exercise treadmill improvement were indistinguishable b etween groups at 12 months of follow-up, Operative and I-year survival bene fits observed after adjunctive transmyocardial revascularization require co nfirmation by a larger validation study, which is ongoing.