OBJECTIVE: To compare restenosis and major cardiac event rates at one and six months after DLC-coated stent implantation with those of uncoated stents. METHODS: Randomized, prospective, comparative study of 180 patients with coronary insufficiency undergoing DLC coated stent (Phytis™) or uncoated stent (Penta™) implantation, from January, 2003 to July, 2004. Inclusion criteria were: de novo lesion with >50% diameter stenosis in a coronary artery with reference diameter > 2,5 mm and < 4 mm, and length < 20 mm. Exclusion criteria were: left main coronary artery and bifurcation lesions, chronic total occlusion, and in-stent restenosis. RESULTS: Clinical and angiographic baseline characteristics of the groups were similar. Procedural success was achieved in 98.9% of the patients in both groups. One cardiac death occurred in each group during hospitalization. Reference diameter and acute gain were greater in the Penta™ group (3.21±0.37 mm vs. 3.34±0.8 mm, p=0.02 and 2.3±0.5 vs. 2.49±0.5, p=0.009, respectively). Angiographic follow-up at six months showed similar rates of restenosis (24.3% vs. 21.8%, p=0.84) and of major cardiac events (16.8% vs. 17.5%, p=1). CONCLUSION: DLC coated stents did not provide better outcomes in relation to uncoated stents.
Coronary disease; coronary restenosis; angioplasty transluminal percutaneous coronary
