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 percutaneous coronary intervention procedures. The coronary stent in particular has undergone progressive structural improvements leading to the recent availability of a third generation of stents, namely, coated stents. The rapid evolution of the stent has often made its evaluation problematical, since trials are frequently confined to small groups of patients in single centers. The purpose of this registry was to verify the safety and efficacy of the BiodivYsio stent (a stent coated with phosphorylcholine polymer) in a broad population of patients who reflect the daily reality of coronary intervention in a cardiac catheterization laboratory.


RESULTS
The registry was designed to collect the principal angiographic and clinical data of a consecutive series of Oreal worldO patients. Patients were treated with a BiodivYsio stent (Biocompatibles, Galway, United Kingdom) in 12 centers (11 Italian and 1 Swiss) between January 1998 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 61.6 +/- 9.4 years (range, 36Eth 84 years). A total of 258 stents were implanted in 233 lesions (1.1 stents per lesion), of which 233 (90%) were the BiodivYsio 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%) patients with silent ischemia. Procedural success was achieved in 217/218 (99.5%) patients. Optimal results were achieved in 212 (97.7%) patients. In 34 (15.6%) cases, patients were treated with periprocedural abciximab. During the hospitalization period, one (0.4%) death occurred on day 7 due to subacute 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-generation stent. The results demonstrate a high procedural success rate and a low incidence of major adverse cardiac events at short- and medium-term follow-up. It appears that the BiodivYsio stent should be considered safe in clinical and/or anatomical situations with a high risk of complications, confirming the hypothesis that PC may have non-thrombogenic properties. To corroborate these results, an appropriately designed study would be required to measure the stentOs efficacy in the most suitable clinical context, i.e., clinical situations that are at the highest risk of ischemic relapse.
Galli
M
M
Laboratorio di Emodinamica, Ospedale S. Anna, Via Napoleona 60, Como, Italy. emodin@tiscalinet.it
Bartorelli
A
A
Bedogni
F
F
DeCesare
N
N
Klugmann
S
S
Maiello
L
L
Miccoli
F
F
Moccetti
T
T
Onofri
M
M
Paolillo
V
V
Pirisi
R
R
Presbitero
P
P
Sganzerla
P
P
Viecca
M
M
Zerboni
S
S
Lanteri
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging / Q000628:therapy*; D010767:Phosphorylcholine; D011108:Polymers; D011474:Prosthesis Design; D012449:Safety; D015607:Stents
D020099:Coated Materials, Biocompatible; D011108:Polymers; D010767:Phosphorylcholine