Comparison of stainless steel stents coated with turbostratic carbon and uncoated stents for percutaneous coronary interventions.

Background: Stent coating with turbostratic carbon was supposed to minimize the local inflammatory response after stent implantation and to thereby also reduce the rates of restenosis and clinical events.

Methods And Results: From October, 1999 to February, 2002, a total of 329 patients with symptomatic coronary artery disease (CAD) eligible for single-lesion PCI were randomized for implantation of either a CarboStent (C; n = 168) or a stainless-steel stent (S; n = 161). The stainless-steel stents were Tristar stents in 60.2%, Tetra stents in 17.4% and Penta stents in 22.4%. Both groups showed no differences in baseline clinical and angiographic characteristics. Angiographic follow-up (FU) was obtained after 6 months in 287 patients (87.2%), clinical FU in 295 patients (89.7%). With the exception of a smaller post-procedure minimal luminal diameter (MLD) in the C group (2.59 0.43 mm versus 2.72 0.46 mm in the S group; p = 0.01), there were no significant differences between the C and S groups in lesion length (10.28 4.45 mm versus 10.37 4.79 mm, respectively), reference diameter (2.92 0.59 mm versus 2.89 0.53 mm, respectively), pre-procedure MLD (0.77 0.36 mm versus 0.84 0.36 mm, respectively), MLD at FU (1.67 0.64 mm versus 1.68 0.57 mm, respectively), late loss (0.93 0.63 mm versus 1.05 0.59 mm, respectively), late loss index (0.51 0.32 versus 0.57 0.32, respectively) and restenosis rate (18.1% versus 20.6%, respectively). There were also no significant differences regarding major adverse cardiac events (MACE) between the C and S groups, i.e., occurrence of death (0% versus 0.7%, respectively), myocardial infarction (0% versus 0.7%, respectively), coronary artery bypass graft (0.7% versus 1.4%, respectively) and target lesion revascularization (16.4% versus 21.5%, respectively).

Conclusion: Coronary stents coated with turbostratic carbon gave no clinically relevant reduction of in-stent restenosis and MACE rates when compared to uncoated stents.