Italian BiodivYsio open registry (BiodivYsio PC-coated stent): Study of clinical outcomes of the implant of a PC-coated coronary stent

Rapid technological developments have made new materials available for perc utaneous coronary intervention procedures. The coronary stent in particular has undergone progressive structural improvements leading to the recent av ailability of a third generation of stents, namely, coated stents, The rapi d evolution of the stent has often made its evaluation problematical, since trials are frequently confined to small groups of patients in single cente rs. The purpose of this registry was to verify the safety and efficacy of t he BiodivYsio stent (a stent coated with phosphorylcholine polymer) in a br oad population of patients who reflect the daily reality of coronary interv ention in a cardiac catheterization laboratory. Methods and Results. The registry was designed to collect the principal ang iographic and clinical data of a consecutive series of 'real world' patient s. Patients were treated with a BiodivYsio(TM) stent (Biocompatibles, Galwa y, United Kingdom) in 12 centers (11 Italian and 1 Swiss) between January 1 998 and January 1999. Procedural, in-hospital, 30-day and six-month follow- up data were collected. The monitoring, data entry and statistical analyses were carried out by an independent center. During the study, 218 patients were enrolled; 165 (76%) male and 53 (24%) female, with an average age of 6 1.6 +/- 9.4 years (range, 36-84 years). A total of 258 stents were implante d in 233 lesions (1.1 stents per lesion), of which 233 (90%) were the Biodi vYsio PC coated stent, the remaining 25 implants were of other stent types. The percutaneous transluminal coronary angioplasty and stenting procedure were carried out in 109 (50%) patients with unstable angina, 65 (30%) with stable angina, 29 (13%) with acute myocardial infarction, and 15 (7%) patie nts with silent ischemia, Procedural success was achieved in 217/218 (99.5% ) patients. Optimal results were achieved in 212 (97.7%) patients. In 34 (1 5.6%) cases, patients were treated with periprocedural abciximab. During th e hospitalization period, one (0.4%) death occurred on day 7 due to subacut e occlusion of the stent, and 3 (1.4%) myocardial infarctions were reported , At 30-day follow-up, 211 (97.2%) patients were asymptomatic, as were 189 (87%) patients at clinical follow-up at 6 months. Conclusions. This study evaluated the safety and efficacy of a third-genera tion stent. The results demonstrate a high procedural success rate and a lo w incidence of major adverse cardiac events at short- and medium-term follo w-np, It appears that the BiodivYsio stent should be considered safe in cli nical and/or anatomical situations with a high risk of complications, confi rming the hypothesis that PC may have non-thrombogenic properties. To corro borate these results, an appropriately designed study would be required to measure the stent's efficacy in the most suitable clinical context, i.e., c linical situations that are at the highest risk of ischemic relapse.