BioDiamond
Clinical Data
A Study
This study was conducted from P. Barragand CHP Beauregrad, Marseille, France
Between May 1998 and November 1998 163 patients underwent 248 implantations with BioDiamond DLC coated stents on 233 coronary lesions. 9 mm (33%), 16 mm (55%) and 25 mm long (12%) premounted BioDiamond stents were deployed in native coronary (98%) or saphenous by-pass lesions (2%). Indications for stenting were: 75.5% for de novo lesions, 2.5% for total chronic occlusions, 3.5% for restenosis, 4.5 % for in-stent restenosis and 12% for acute myocardial infarction. The clinical data were: mean age 62+/- 10 years, male 77%, prior myocardial infarction (MI) 24%, prior coronary artery bypass grafting (CABG) 12%, prior percutaneous transluminal coronary angioplasty (PTCA) 22%, unstable angina 34%, acute MI 17%. The mean left ventricular ejection fraction (LVEF) was 63 +/- 13 and 67% of patients had multivessel disease. Coronary lesions were frequently complex (25% B2 and 28% C), occurring in relatively small arteries (mean reference diameter 2.85 +/- 0.6mm). Six month follow-up was available in 98.6% of patients for the occurrence of major adverse clinical events (MACE).
Results:
BioDiamond stent implantation was effective in 98% of coronary lesions. The minimal lumen diameter (MLD) increased from 0.76+/-0.4mm before to 2.57+/-0.5 mm after the procedure, diameter stenosis decreased from 73+/-18% to 12+/-7%. At one month MACE were: death 0.6%, q-wave MI 0%, target lesions revascularization (TVR) 1.3% (o.6% non-urgent CABG and 0.9% urgent PTCA). The 7.9+/-1.7 months follow-up showed an overall mortality of 0.7%, qMI of 0.7% and a TVR of 8.8% with a de novo artery lesion
TVR of 3.7%.
Conclusion:
Despite non-selected routine lesions, the BioDiamond expandable stent can be safely and successfully implanted in most lesions (98%). Because of the 3.7 TVR rate for de novo artery lesions, a prospecitive randomized trial appears warranted.