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Clinical research

EuroInterv.2008;4:

502-508

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)

Johannes B. Dahm

1

*, MD; Tine Willems

2

, PhD; Hans Georg Wolpers

1

, MD; Hans Nordbeck

1

, MD;

Jürgen Becker

1

, MD; Jörg Ruppert

3

, MD

1. Department of Cardiology & Angiology, Heart-& Vascular Center Neu-Bethlehem, Göttingen, Germany; 2. Core Laboratories & Dept. of

Biometrics, Genae Ass., Antwerp, Belgium; 3. Department of Cardiology, Ernst-Moritz-Arndt University, Greifswald, Germany

None of the authors have conflict of interest to declare.

Abstract

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

®

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

®

) 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.

KEYWORDS

PRO-Healing, passive

coating, coronary

artery disease,

percutaneous coronary

intervention,

restenosis, rapid,

PROBIO, PRO-Kinetic,

endothelialisation

* Corresponding author: Dept. of Cardiology, Heart-& Vascular Center Neu-Bethlehem, Humboldtallee 6, D - 37073 Göttingen, Germany

E-mail: dahm@herz-gefaesszentrum.org