Clinical investigation into the observation that silicon carbide coating on cobalt chromium stents leads to early differentiating functional endothelial layer, increased safety and DES-like recurrent stenosis rates: results of the PRO-Heal Registry (PRO-Kinetic enhancing rapid in-stent endothelialisation).
OBJECTIVE
Recurrent stenosis and stent thrombosis are still major concerns after drug eluting stent placement which inhibits not only the restenostic process but endothelialisation as well. In contrast, through accelerating rapid endothelialisation and development of an earlier functional endothelial layer, passive coatings have shown encouraging results. The objective of the present study was to investigate the clinical outcome and rate of recurrent stenosis of silicon carbide passive coated cobalt chromium stents (PROKinetic Coronary Stent with PROBIO coating, Biotronik AG, Switzerland) on restenosis after percutaneous coronary intervention.


RESULTS
Percutaneous coronary stent deployment was carried out in 161 lesions in 145 consecutive patients. The primary combined endpoint was the rate of target-lesion revascularisation (TLR) and late lumen loss; the secondary endpoints were the procedural success and the major adverse cardiac events at 6-months follow-up. Out of 145 patients, 141 were successfully amenable to a silicon carbide coated stent (PRO-Kinetic, Biotronik AG, Switzerland) implantation (97.2% procedural success). At follow-up, the late loss was 0.75 +/- 0.71 mm. (in-stent) respectively 0.79 +/- 0.72 mm (in-segment), TLR was 4.9% and MACE was 5.6%.


CONCLUSIONS
By augmenting rapid endothelialisation and development of an earlier functional endothelial layer, silicon carbide (PROBIO) as a passive coating on cobalt chromium stents has shown encouraging results relative to success rates, clinical outcome, TLR and late-loss in a cohort of patients with extended coronary artery disease.
Dahm
Johannes B
JB
Department of Cardiology & Angiology, Heart-& Vascular Center Neu-Bethlehem, Göttingen, Germany. dahm@herz-gefaesszentrum.org
Willems
Tine
T
Wolpers
Hans Georg
HG
Nordbeck
Hans
H
Becker
Jürgen
J
Ruppert
Jörg
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation; D017554:Carbon Compounds, Inorganic; D049109:Cell Proliferation; D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D004730:Endothelium, Vascular / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012042:Registries; D017655:Silicon Compounds; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D017554:Carbon Compounds, Inorganic; D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D017655:Silicon Compounds; C022088:silicon carbide