Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for the treatment of single de novo coronary lesions

RESUMO

Objectives We sought to investigate the performance and efficacy of the third-generation polymerfree Vestasync-eluting stent (VES). Background Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothinmicroporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 m). Methods In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and 14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. Results Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 0.32 mm and 9.98 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 0.25 mm and percent of stent obstruction was 2.8 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered. Conclusions The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results. (J Am Coll Cardiol Intv 2008;1545–51) © 2008 by the American College of Cardiology Foundation