Clinical experience with a new biocompatible phosphorylcholine-coated coronary stent

Aims. The BiodivYsio stent is a new stent coated with phosphorylcholine, a biocompatible molecule designed to reduce the formation of thrombus and pot entially the risk of restenosis. The feasibility, safety, and efficacy of e lective and urgent implantation of this coated coronary stent were prospect ively studied. Methods and results. We studied 224 patients who underwent elective (67%) o r bail-out implantation of 303 BiodivYsio stents in 286 lesions. Most lesio ns (62%) had unfavorable characteristics (type B2 or C) and half of them (5 0%) had thrombus and/or chronic total occlusion. Clinical follow-up was obt ained in all patients at one month and in the first 132 patients at six mon ths. Repeat angiography was undertaken in all patients with recurrent ische mia, Successful stent deployment was achieved in 284 lesions (99.3%). One e mergency coronary artery bypass graft (CABG) was required. Angiographic suc cess rate was 98.3% (281/286), There was 1 (0.4%) subacute stent thrombosis associated with Q-wave myocardial infarction and two (0.9%) in-hospital de aths. Reference vessel diameter was 2.82 +/- 0.32 mm, Minimum luminal diame ter (MLD) increased from 0.38 +/- 0.25 mm to 2.97 +/- 0.35 mm and diameter stenosis decreased from 83.8 +/- 12.1% to 5.8 +/- 9.7%. Clinical restenosis rate was 6.1% (8/132 patients) at 6-month follow-up. Target vessel revascu larization rate at 6-month follow-up was 5.4%. Conclusions. This initial clinical experience indicates that the implantati on of stents coated with phosphorylcholine appears to be safe and efficacio us in the treatment of complex coronary lesions and is associated with an e xtremely low target vessel revascularization rate.