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 Z25%, and
myocardial wall thickness Z8mm 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. Coron Artery Dis 17:385–390
c 2006