Prospective randomized study of the restenotic process in small coronary arteries using a Carbofilm™ coated stent in comparison with plain old balloon angioplasty:

Abstract

The optimal interventional approach to treat lesions in small coronary arteries is still undetermined and controversial. This randomized, multicenter trial was designed to compare the 6-months restenosis and clinical event rates in two treatment groups: balloon angioplasty as a primary strategy and provisional stenting versus primary implantation of a carbon coated stent (Carbosten). At 6 months the angiographic restenosis rate was significantly lower for the stented patients (11.6%) as compared to the balloon angioplasty patients (32.2%). However this advantage in restenosis rate did not translate into a clinical benefit in respect to target vessel revascularization rates. This trial demonstrated a remarkably low 6-months restenosis rate for lesions in small (<2.8 mm) coronary arteries treated with Carbosten implantation that is comparable to the rates found after drug eluting stent implantation and was significantly better in comparison to balloon angioplasty alone.