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) 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 > or = 2.5 mm and < or = 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).


CONCLUSIONS
DLC coated stents did not provide better outcomes in relation to uncoated stents.
Meireles
George César Ximenes
GC
Hospital Stella Maris, São Paulo, SP, Brazil. gcxm@cardiol.br
de Abreu
Luciano Mauricio
LM
Forte
Antonio Artur da Cruz
AA
Sumita
Marcos Kiyoshi
MK
Sumita
Jorge Hideki
JH
Aliaga
Jose Del Carmen Solano
Jdel C
D000368:Aged; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary; D002244:Carbon; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013193:Stainless Steel; D015607:Stents; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D013193:Stainless Steel; D002244:Carbon