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 PROHeal Registry (PRO-Kinetic enhancing rapid in-stent endothelialisation)

EuroIntervention

Volumn 4, Issue 4, 2009, Pages 502-508

  Dahm, Johannes B ^a   Willems, Tine ^b   Wolpers, Hans Georg ^a   Nordbeck, Hans ^a   Becker, Jürgen ^a   Ruppert, Jörg ^c  

^a Department of Cardiology Angiology   (Germany)

^b Dept of Biometrics   (Belgium)

^c UNIVERSITY OF GREIFSWALD   (Germany)

Author keywords

Coronary artery disease; Endothelialisation; Passive coating; Percutaneous coronary intervention; PRO Healing; PRO Kinetic; PROBIO; Rapid; Restenosis

Indexed keywords

ANTITHROMBOCYTIC AGENT; BIOMATERIAL; CHROMIUM DERIVATIVE; INORGANIC COMPOUND; SILICON CARBIDE; SILICON DERIVATIVE;

ADULT; AGED; ANGIOCARDIOGRAPHY; ARTICLE; CELL PROLIFERATION; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; FEMALE; HUMAN; INSTRUMENTATION; MALE; MIDDLE AGED; PATHOLOGY; RADIOGRAPHY; REGISTER; RESTENOSIS; STENT; TIME; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME; VASCULAR ENDOTHELIUM;

ADULT; AGED; AGED, 80 AND OVER; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CARBON COMPOUNDS, INORGANIC; CELL PROLIFERATION; CHROMIUM ALLOYS; COATED MATERIALS, BIOCOMPATIBLE; CORONARY ANGIOGRAPHY; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; ENDOTHELIUM, VASCULAR; FEMALE; HUMANS; MALE; MIDDLE AGED; PLATELET AGGREGATION INHIBITORS; REGISTRIES; SILICON COMPOUNDS; STENTS; TIME FACTORS; TREATMENT OUTCOME;

EID: 63049095715     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV4I4A85     Document Type: Article

References (39)

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, paclitaxel- 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 coronary 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 stenosis (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 outcome 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, Övü nç K, Oto A, Ozmen 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.
15. Clowes AW, Clowes MM, Fingerle J, Reidy MA. Regulation of smooth muscle cell growth in injured artery (1989) Journal of Cardiovascular Pharmacology, 14 (Suppl. 6), pp. S12-S15.
16. Kipshidze N, Dangas G, Tsapenko M, Moses J, Leon MB, Kutryk M, Serruys P. Role of the endothelium in modulating neointimal formation: Vasculoprotective approaches to attenuate restenosis after percutaneous coronary interventions. Journal of the American College of Cardiology (2004);44(4), 733-739.
17. Windecker S, Simon R, Lins M, Klauss V, Eberli FR, Roffi M, Pedrazzini G, Moccetti T, Wenaweser P, Togni M, Tüller D, Zbinden R, Seiler C, Mehilli J, Kastrati A, Meier B, Hess OM. Randomized comparison of a titanium-nitride- oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation. 2005 May 24;111(20): 2617-22. Epub 2005 May 9.
18. Lin C-E, Janero DR, Garvey DS. Nitric oxide-based molecular strategies for restenosis therapyExpert Opinion on Therapeutic Patents (2005)15 (5), pp. 483-495.
19. Hou D, Narciso H, Kamdar K, Zhang P, Barclay B, March KL. Stent-based nitric oxide delivery reducing neointimal proliferation in a porcine carotid overstretch injury model. CardioVascular and Interventional Radiology (2005)28 (1), 60-65.
20. Harder C, Rzany A, Schaldach M. Coating of Vascular Stents with Antithrombogenic Amorphous Silicon Carbide. Prog Biomed Res. (1999); 4: 71-77.
21. Van Oeveren W. Reduced deposition of blood formed elements and fibrin onto amorphous silicon carbide coated stainless steel. Prog Biomed Res. (1999); 4: 78-83.
22. Rzany A, Schaldach M, Hahn C, Harder C. Fibrin formation on silicon carbide - A molecular level study with Scanning Force Microscopy. Prog Biomed Res. 1999; 4: 84-89.
23. Rzany A, Schaldach M. Smart Material Silicon Carbide: Reduced Activation of Cells and Proteins on a-SiC:H-coated Stainless Steel. Prog Biomed Res (2001) 4: 182-194.
24. Monnink S, Boven A, Peels HO, Tigchelaar I, de Kam PJ, Crijns HJ, van Oeveren W. Silicon-carbide coronary stents have low platelet and leukocyte adhesion during platelet activation. Journal of Investigative Medicine. 1999; 47: 304-310.
25. Heublein B, Pethig K, Elsayed AM. Silicon carbide coating - A semiconducting hybrid design of coronary stents. A feasibility study. J Invas Cardiol. 1998; 10: 255-262.
26. Koolen J, Hanekamp C, Bonnier H. A highly flexible slotted tube stent design coated with a-SiC:H. First clinical experiences. Prog Biomed Res. 1998; 3: 40-44.
27. van der Vleuten, P.A., Wijpkema, J.S., van den Heuvel, A.F., Bosma, C.A., Jessurun, G.A., Tio, R.A. Treatment synergy of silicon carbide-coated stenting and abciximab for complex coronary artery lesions: clinical results of a single-center study. Italian Heart Journal (2004) 5 (9), 663-666.
28. Hamm CW, Hugenholtz PG; TRUST Investigators. Silicon carbidecoated stents in patients with acute coronary syndrome. Catheter Cardiovasc Interv 2003 Nov;60(3): 375-81.
29. Ryan TJ, Faxon DP, Gunnar RP, ACC/AHA Task Force: Guidelines for percutanous transluminal coronary angioplasty. J Am Coll Cardiol 12: 529-545, 1988.
30. Bittl JA, Ryan TJ, Jeeny JF, Tcheng JE, Ellis SG, lsner JM, Sanborn TA. Coronary artery Perforation during excimer laser angioplasty. J Am Coll Cardiol 1993: 21: 1158-1165.
31. Huber MS, Mooney JF, Madison J, Mooney MR. Use of a morphologic classification to predict clinical outcome after dissection from coronary angioplasty. Am J Cardiol 1991; 68: 467-471.
32. The TIMI III A Investigators. Early effects oftissue-type plasminogen activator added to conventional therapy on the culprit coronary lesion in patients presenting with ischernic cardiac pain at rest. Circulation 1993;87: 38-52.
33. Haase J, Escaned J, van Swijndregt EM, Ozaki Y, Gronenschild E, Slager CJ, Serruys PW. Experimental validation of geometric and densitometric coronary measurements of the new generation Cardiovascular Angiography Analysis System (CAAS II). Catherization and Cardiovascular Diagnosis 27: 16-27, 1993.
34. Gronenschild E, Janssen J, Tijdens F. CAAS II: A Second Generation System for OFF-line and On-line Quantitative Coronary Angiography. Catherization and Cardiovascular Diagnosis 33: 61-75, 1994.
35. Welt FG, Rogers C. Inflammation and restenosis in the stent era. Arteriocler Thromb Vasc Biol 2002 Nov 1;22(11): 1769-76.
36. Kornowski R, Minz GS, Kent KM, Pichard AD, Satler LF, Bucher TA, Hong MK, Popma JJ, Leon MB. Increased restenosis in diabetes mellitus after coronary interventions is due to exaggerated intimal hyperplasia: a serial intravascular ultrasound study. Circulation 95: 1366-1369, 1997.
37. Eschwege E, Richard JL, Thibult N, Ducimetiere P, Warnet JM, Dlaude JR, Rosselin GE: The Paris Prospective Study, ten years later. Horm Metab Res 15 (Suppl.Series) 41-46, 1985.
38. Sierevogel MJ, Velema E, van der Meer FJ, Nijhuis MO, Smeets M, de Kleijn DP, Borst C, Pasterkamp G. Matrix metalloproteinase inhibition reduces adventitial thickening and collagen accumulation following balloon dilation. Cardiovasc Res. 2002 Sep;55(4): 864-9.
39. Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimuseluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8): 798-806. Epub 2006 Aug 14.