Clinical experience with a new biocompatible phosphorylcholine-coated coronary stent.

Objective: The BiodivYsio stent is a new stent coated with phosphorylcholine, a biocompatible molecule designed to reduce the formation of thrombus and potentially the risk of restenosis. The feasibility, safety, and efficacy of elective and urgent implantation of this coated coronary stent were prospectively studied.

Results: We studied 224 patients who underwent elective (67%) or bail-out implantation of 303 BiodivYsio stents in 286 lesions. Most lesions (62%) had unfavorable characteristics (type B2 or C) and half of them (50%) had thrombus and/or chronic total occlusion. Clinical follow-up was obtained in all patients at one month and in the first 132 patients at six months. Repeat angiography was undertaken in all patients with recurrent ischemia. Successful stent deployment was achieved in 284 lesions (99.3%). One emergency coronary artery bypass graft (CABG) was required. Angiographic success 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 deaths. Reference vessel diameter was 2.82 +/- 0.32 mm. Minimum luminal diameter (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 revascularization rate at 6-month follow-up was 5.4%.

Conclusions: This initial clinical experience indicates that the implantation of stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with an extremely low target vessel revascularization rate.