Fluvastatin for the prevention of restenosis after coronary balloon angioplasty: angiographic and methodological background of the fluvastatin angioplasty restenosis trial.

Luminal renarrowing (restenosis) is the major limitation of percutaneous transluminal coronary angioplasty (PTCA), and the search for a 'magic bullet' to prevent this apparent biological healing response to vessel injury has thus far been unsuccessful. Large clinical trials using serial quantitative coronary angiography have, however, provided some valuable insight into this area. In particular, the restenosis process may be measured as the loss in minimal luminal diameter from post-PTCA to follow-up angiography, and is essentially ubiquitous and normally distributed. The angiographic outcome of clinical trials can thus be appropriately evaluated using a continuous rather than a categorical approach, which also considerably reduces the number of patients required. Fluvastatin, a synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, has been shown experimentally to reduce the neointimal proliferative response after PTCA, independent of its lipid-lowering action. The FLuvastatin Angioplasty REstenosis trial was designed to evaluate whether fluvastatin 40 mg twice daily, commencing at least 2 weeks before planned PTCA, can reduce luminal loss by 30% from successful PTCA to follow-up angiography at 26 +/- 2 weeks in 730 evaluable patients.