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Clinical research
Of note, and in contrast to all drug eluting “active” coatings, this
favourably low late loss was achieved with a “passive” coating
accelerating a rapidly and fully functional endothelial layer without risk
of acute or late stent thrombosis (0% stent thrombosis). This includes
not only additional safety and a lower risk of stent thrombosis, but also
significant medical benefits (and lower costs) due to a substantially
shorter dual antiplatelet therapy of just four weeks.
Moreover, the remarkably low restenosis and MACE rate occurred in
a cohort of patients who represented a considerably high-risk
treatment group with lesions difficult to treat (59% of all lesions were
B2- and C-lesions).
But it is in exactly these lesions which are difficult to treat, where
due to its low profile, SiC-coating and extremely flexible design, that
the PRO-Kinetic stent could be implanted in almost all patients. The
documented rate of recurrent stenosis – with or without the
necessity for repeat revascularisation procedures – was
outstandingly low, even in comparison to published data after drug
eluting stent placement in this lesion subset. Moreover, in three of
the seven patients with invasive follow-up, TLR appeared in stents,
which have been implanted using low deployment pressures
(8 atm). This was due to the operators’ discretion and his
apprehension of possible vessel perforation in very old, respectively
severely calcified lesions.
In the present study, the silicon carbide coated cobalt chromium
PRO-Kinetic stent could be deployed in almost all lesions, although,
due to its unique flexibility and low profile, it had been used
predominantly in difficult and severe lesions. Only in 2.8% of cases
was it not possible to deploy this stent in the target lesion.
Limitations of the study
This report concerned analysis of treatment by silicon carbide
coated cobalt chromium stent deployment. While it provides
intriguing data regarding the safety and effectiveness of the silicon
carbide coated cobalt chromium stent in consecutive “real world”
patients, it is based on mono-centric data from a non-randomised,
observational, study. Despite the considerable success of the silicon
carbide coated cobalt chromium PRO-Kinetic stent in these
patients, this study offers no proof that similar or improved results
could not have been gained with a different therapeutic approach
and/or treatment modality.
Summary
Through augmenting rapid endothelialisation and development of
an earlier functional endothelial layer, silicon carbide as a passive
coating on cobalt chromium stents has shown encouraging results
regarding success rates, clinical outcome, TLR and late loss in
a cohort of 161 lesions (145 patients) with extended coronary artery
disease. Large randomised trials are needed for further investigation.
References
1. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR,
O’Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, et
al. Sirolimus-eluting stents versus standard stents in patients with stenosis
in a native coronary artery.
N Engl J Med
2003;349:1315-1323.
2. Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT,
Turco M, Caputo R, Bergin P, Greenberg J, et al. A polymer-based, pacli-
taxel-eluting stent in patients with coronary artery disease.
N Engl J Med
2004;350:221-231.
3. Serruys PW, Daemen J, Morice M-C, de Bruyne B, Colombo A,
Macaya C, Richardt G, Fajadet J, Hamm C, Dawkins K, Vranckx P,
Bressers M, van Domburg R, Schuijer M, Wittebols K, Pieters M, Stoll H-P, on
behalf of the ARTS II Investigators. Three-year follow-up of the ARTS-II -
Sirolimus-eluting stents for the treatment of patients with multivessel coro-
nary artery disease.
EuroInterv.
2008; 3:450-59.
4. Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H,
Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S,
Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D, for the Nobori
1 Clinical Investigators. Randomised comparison of Nobori(tm), biolimus
A9-eluting coronary stent with a Taxus(r), paclitaxel-eluting coronary stent
in patients with stenosis in native coronary arteries: the Nobori 1 trial.
EuroInterv.
2007;2:426-434.
5. Sangiorgi G, Biondi-Zoccai G, Agostoni P, Antoniucci D, Grube E, Di
Mario C, Reimers B, Tamburino C, Cosgrave J, Colombo A, on behalf of
the Taxus in Real-life Usage Evalutation (TRUE) Investigators. Appraising
the effectiveness and safety of paclitaxel-eluting stents in over 1,000 very
high-risk patients: overall results of the Taxus in Real-life Usage Evaluation
(TRUE) Registry.
EuroInterv.
2007; 3: 333-39.
6. Beijk M, Neumann F-J, Wiemer M, Grube E, Haase J, Thuesen L,
Hamm C, Veldhof S, Dorange C, Serruys PW, Piek J. Two-year results of a
durable polymer everolimus-eluting stent in de novo coronary artery steno-
sis (The SPIRIT FIRST Trial).
EuroInterv.
2007; 3:206-12.
7. Duckers H, Silber S, de Winter R, den Heijer P, Rensing B, Rau M,
Mudra H, Benit E, Verheye S, Wijns W, Serruys PW. Circulating endothelial
progenitor cells predict angiographic and intravascular ultrasound out-
come following percutaneous coronary interventions in the HEALING-II
trial: evaluation of an endothelial progenitor cell capturing stent.
EuroInterv.
2007;3:67-75.
8. Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC.
Use of endothelial progenitor cell capture stent (Genous Bio-Engineered
R Stent) during primary percutaneous coronary intervention in acute
myocardial infarction: intermediate- to long-term clinical follow-up.
Am
Heart J.
2008 Jan;155(1):128-32. Epub 2007 Nov 26.
9. Noordeloos AM, Soullié T, Duckers HJ, Serruys PW. JC Promoting
vascular regeneration as an alternative to conventional angioplasty-based
intervention.
Endothelium: Journal of Endothelial Cell Research
13 (6),
431-439.
10. Atalar E, Haznedaroglu I, Aytemir K, Aksöyek S, Övünç K, Oto A,
Òzmen F. Effects of stent coating on platelets and endothelial cells
after intracoronary stent implantation.
Clinical Cardiology
(2001)24 (2),
159-164.
11. Grewe PH, Deneke T, Machraoui A, et al. Acute and chronic tissue
response to coronary stent implantation: Pathologic findings in human
specimen.
J Am Coll Cardiol.
2000; 35: 157-163.
12. Van Oeveren W, Schoen P, Maijers CA. Blood compatibility of
metals and alloys used in medical devices.
Prog Biomed Res.
2000; 5:
211-214.
13. Montalescot G, Ankri A, Vicaut E, Drobinski G, Grosgogeat Y,
Thomas D. Fibrinogen after coronary angioplasty as a risk factor for
restenosis (1995)
Circulation,
92 (1), 31-38.
14. Aranson D, Bloomgarden Z, Rayfield EJ. Potential Mechanisms
Promoting Restenosis in Diabetic Patients.
J. Am. Coll. Cardiol.
27: 528-
535, 1996.