Randomized comparative study of diamond-like carbon coated stainless steel stent versus uncoated Stent implantation in patients with coronary artery disease

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 (TM)) or uncoated stent (Penta (TM)) 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-stem 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 (TM) 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.