Published data regarding stenting very small arteries are still limited. 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 implantation of the 2.0 mm coated coronary stent were prospectively studied. We studied 97 patients from three centers who underwent elective, urgent, or bailout implantation of 106 BiodivYsio mini-stents (2.0 mm) in 101 lesions. Forty percent of lesions had unfavorable characteristics (type B2 or C) and 16% had thrombus and/or chronic total occlusion. Successful stent deployment was achieved in 100/101 lesions (99%). MLD increased from 0.49 +/- 0.31 mm to 1.89 +/- 0.41 mm and diameter stenosis decreased from 89% +/- 7% to 5.6% +/- 6%. Small vessel stenting was the only procedure in 71% patients. There was one acute stent thrombosis case. During 6-month follow-up, none died, one had MI, and one was referred to CABG due to nontarget lesion progression. Angiographic restenosis that required target lesion revascularization was performed in 8/18 that had catheterization due to chest pain or significant ischemia. Most patients improved in their clinical symptoms. The rate of major adverse cardiac events was 4.1% at 30-day and 10.3% at 6-month follow-up. This initial clinical experience indicates that the implantation of 2.0 mm stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with low target vessel revascularization rate in spite of the very small vessel diameter.
Copyright 2002 Wiley-Liss, Inc.