Objectives: The usefulness and safety of percutaneous myocardial laser therapy in selected patients have been identified in previous 1-year randomized trial reports, including that from a double-blind, sham-controlled trial we independently conducted. We aimed to determine whether the 1-year effects are maintained through a long-term, longitudinal follow-up.
Methods: Patients (n=77) with chronic, stable, medically refractory angina (class III or IV) not amenable to conventional revascularization and with evidence of reversible ischemia, ejection fraction > or =25%, and myocardial wall thickness > or =8 mm were treated with percutaneous myocardial laser. After the 1-year follow-up and disclosure of all randomized assignments as prespecified in the respective study protocol, patients were followed up longitudinally for a mean of 3 years for angina class, left ventricular ejection fraction, medication usage, and adverse events.
Results: No procedural mortality, myocardial infarction, or cerebral embolism occurred. Pericardiocentesis was required in two patients (2.6%). Cardiac event-free survival was 88% at 1 year and 66% at late follow-up. Mean Canadian Cardiovascular Society angina class was significantly improved from baseline (3.2+/-0.4) at 1 year (2.2+/-1.1, P<0.001) and at a mean of 3 years (1.9+/-1.2, P<0.001). Nitrate usage was significantly reduced at late follow-up; however, ejection fraction did not change over time. In a multivariate analysis, angina improvement at 1 year was found to be a significant independent predictor of both survival and angina improvement at late follow-up.
Conclusion: We conclude that percutaneous myocardial laser therapy in selected patients with severe, medically refractory angina not treatable with conventional revascularization induces significant and sustained symptomatic benefit.