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


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.


CONCLUSIONS
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.
Braun
Peter
P
Department of Cardiology, Heart Center Duisburg, Germany. peterbraun1@t-online.de
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D001672:Biocompatible Materials; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology* / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D001672:Biocompatible Materials