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.
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 ≥25%, and myocardial wall thickness ≥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.
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.
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.
Department of Heart Disease, Haukeland University Hospital, Bergen, Norway
Correspondence and request for reprints to Prof. Jan Erik Nordrehaug, MD, PhD, Department of Heart Disease, Haukeland University Hospital, N-5021 Bergen, Norway
Tel: +47 55 97 21 72; fax: +47 55 97 51 50; e-mail: email@example.com
Received 13 December 2005; Revised 16 February 2006; Accepted 22 February 2006