Longevity of the placebo effect in the therapeutic angiogenesis and laser myocardial revascularization trials in patients with coronary heart disease.

The long-term beneficial effects of placebo therapy were evaluated in angiogenesis and laser myocardial revascularization trials in patients who had end-stage coronary heart disease. Improvements in mean angina class, exercise treadmill time, and quality of life were mostly maintained at 30 +/- 6 months of follow-up. Persistence of effect cannot be used as evidence of efficacy, and double-blinded trials are essential in this patient population.

Pharmacological treatment of coronary artery disease with recombinant fibroblast growth factor-2: double-blind, randomized, controlled clinical trial.

Background: Single-bolus intracoronary administration of fibroblast growth factor-2 (FGF2) improved symptoms and myocardial function in a phase I, open-label trial in patients with coronary artery disease. We conducted the FGF Initiating RevaScularization Trial (FIRST) to evaluate further the efficacy and safety of recombinant FGF2 (rFGF2).

Methods And Results: FIRST is a multicenter, randomized, double-blind, placebo-controlled trial of a single intracoronary infusion of rFGF2 at 0, 0.