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

Background: 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 (TM)). Results: 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. Conclusion: This trial demonstrated a remarkably low 6-months restenosis rate for lesions in small (<2.8 mm) coronary arteries treated with Carbostent (TM) implantation that is comparable to the rates found after drug eluting stent implantation and was significantly better in comparison to balloon angioplasty alone. (c) 2007 Wiley-Liss, Inc.