New coating stent design for patients with high-risk coronary lesions for thrombotic events: early and long-term results of the Camouflage registry.

BACKGROUND

Semisynthetic coating of the Camouflage bare-metal stent (BMS) (Eucatech AG, Rheinfelden, Germany) mimics luminal endothelial cell glycocalix, potentially preventing the activation of the coagulation system. Purpose. We sought to determine in a clinical registry the acute and long-term clinical and angiographic outcomes of this BMS design in patients with acute coronary syndromes (ACS) or who were unable to be on long-term clopidogrel therapy.

METHODS

From March 2007 to December 2008, 150 patients undergoing coronary stent implantation at three centers in Buenos Aires, Argentina, were included in our registry. Patients with ACS, including non-ST-elevation myocardial infarction (NSTEMI) and STelevation MI (STEMI), or those unable to be on long-term dual antiplatelet therapy were considered for inclusion. The primary endpoint was a major adverse cardiovascular event (MACE) defined as the incidence of cardiac death, MI or target lesion revascularization (TLR). The incidence of acute and late stent thrombosis (ST) was also analyzed. Angiographic late loss and the presence of late stent malapposition (LSM) was recorded at 9-month follow up. Clopidogrel was prescribed for 1 month.

RESULTS

54.7% of patients had acute MI, 36% had STEMI and 20.7% of patients were ineligible for long-term clopidogrel therapy because of previously planned non-vascular or general surgery within 30 days after percutaneous coronary intervention. During 11.5 months of clinical follow up, 2% suffered cardiac death, 4% had a MI, 8.9% underwent TLR and the overall cumulative major adverse cardiac event rate was 15.3%. No patient developed acute or late ST. There were no in-hospital complications for patients who underwent surgery. Intravascular ultrasound studies did not detect the presence of late malapposition.

CONCLUSION

In this high-risk thrombotic patient population, the Camouflage coated stent design demonstrated a very good safety profile, as reflected by the low incidence of hard adverse cardiac events including ST at follow up.