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)

Aims: 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 (PRO-Kinetic Coronary Stent with PROBIO (R) coating, Biotronik AG, Switzerland) on restenosis after percutaneous coronary intervention. Methods and 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 (R)) 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.