Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents

EuroIntervention

Volumn 9, Issue 3, 2013, Pages 389-397

  Denardo, Scott J ^a,b   Carpinone, Paul L ^c   Vock, David M ^b   Tcheng, James E ^a,b   Phillips, Harry R ^a,b   Willenberg, Bradley J ^d   Batich, Christopher D ^d   Pepine, Carl J ^e  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF FLORIDA   (United States)

^d University of Florida   (United States)

^e UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

Author keywords

Coronary artery disease; Drug eluting stents; Endothelial dysfunction; Microvascular dysfunction; Polymer

Indexed keywords

CYPHER; EVEROLIMUS; PACLITAXEL; POLY(N BUTYL METHACRYLIC ACID); POLY(VINYLIDENE FLUORIDE CO HEXAFLUOROPROPYLENE); POLYMER; POLYVINYL ACETATE; RAPAMYCIN; UNCLASSIFIED DRUG;

ARTICLE; BALLOON; BARE METAL STENT; BIOMEDICAL TECHNOLOGY ASSESSMENT; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG ELUTING STENT; EQUIPMENT DESIGN; IMPLANT DELIVERY DEVICE; IN VITRO STUDY; IN VIVO STUDY; MATERIAL COATING; MEMBRANE MICROPARTICLE; PARTICLE SIZE; QUANTITATIVE STUDY; RAMAN SPECTROMETRY; SCANNING ELECTRON MICROSCOPY; SURFACE PROPERTY;

EID: 84880858337     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV9I3A62     Document Type: Article

References (46)

1. OECD (2010), "Mortality from Heart Disease and Stroke", in OECD/European Union, Health at a Glance: Europe 2010, OECD Publishing. doi: 10.1787/9789264090316-9-en
2. Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2010 update: A report from the American Heart Association. Circulation. 2010;121:e46-e215.
3. Dixon SR, Grines CL, O'Neill WW. The year in interventional cardiology. J Am Coll Cardiol. 2010;55:2272-86.
4. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-23.
5. Violini R, Musto C, De Felice F, Nazzaro MS, Cifarelli A, Petitti T, Fiorilli R. Maintenance of long-term clinical benefit with sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction 3-year results of the SESAMI (sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction) trial. J Am Coll Cardiol. 2010;55:810-4.
6. Jiménez-Quevedo P, Sabaté M, Angiolillo DJ, Alfonso F, Hernández-Antolín R, SanMartín M, Gómez-Hospital JA, Bañuelos C, Escaned J, Moreno R, Fernández C, Fernández- Avilés F, Macaya C; DIABETES Investigators. Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: Long-term results of the DIABETES trial. Eur Heart J. 2007;28:1946-52.
7. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME; TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: A randomized controlled trial. JAMA. 2005;294:1215-23.
8. Alfonso F, Pérez-Vizcayno MJ, Hernández R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Iñiguez A, Morís C, Cequier A, Sabaté M, Escaned J, Jiménez-Quevedo P, Bañuelos C, Suárez A, Macaya C; RIBS-II Investigators. Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis: Results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am Coll Cardiol. 2008;52: 1621-7.
9. Ardissino D, Cavallini C, Bramucci E, Indolfi C, Marzocchi A, Manari A, Angeloni G, Carosio G, Bonizzoni E, Colusso S, Repetto M, Merlini PA; SES-SMART Investigators. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: A randomized trial. JAMA. 2004;292:2727-34.
10. DeMaria AN, Bax JJ, Ben-Yehuda O, Feld GK, Greenberg BH, Hall J, Hlatky M, Lew WY, Lima JA, Maisel AS, Narayan SM, Nissen S, Sahn DJ, Tsimikas S. Highlights of the year in JACC 2010. J Am Coll Cardiol. 2011; 57:480-514.
11. Garg S, Serruys PW. Coronary stents: Current status. J Am Coll Cardiol. 2010;56:S1-S42.
12. Togni M, Windecker S, Cocchia R, Wenaweser P, Cook S, Billinger M, Meier B, Hess OM. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol. 2005;46:231-6.
13. Hofma SH, van der Giessen WJ, van Dalen BM, Lemos PA, McFadden EP, Sianos G, Ligthart JM, van Essen D, de Feyter PJ, Serruys PW. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J. 2006;27:166-70.
14. Togni M, Räber L, Cocchia R, Wenaweser P, Cook S, Windecker S, Meier B, Hess OM. Local vascular dysfunction after coronary paclitaxel-eluting stent implantation. Int J Cardiol. 2007;120:212-20.
15. Hamilos M, Sarma J, Ostojic M, Cuisset T, Sarno G, Melikian N, Ntalianis A, Muller O, Barbato E, Beleslin B, Sagic D, De Bruyne B, Bartunek J, Wijns W. Interference of drug-eluting stents with endothelium-dependent coronary vasomotion: Evidence for device-specific responses. Circ Cardiovasc Interv. 2008;115:1051-8.
16. Kim JW, Seo HS, Park JH, Na JO, Choi CU, Lim HE, Kim EJ, Rha SW, Park CG, Oh DJ. A prospective, randomized, 6-month comparison of the coronary vasomotor response associated with a zotarolimus-versus a sirolimus-eluting stent. Differential recovery of coronary endothelial dysfunction. J Am Coll Cardiol. 2009;53:1653-9.
17. Groeneveld PW, Polsky D, Yang F, Yang L, Epstein AJ. The impact of new cardiovascular device technology on health care costs. Arch Intern Med. 2011;171:1289-91.
18. Otsuka Y, Chronos NA, Apkarian RP, Robinson KA. Scanning electron microscopic analysis of defects in polymer coatings of three commercially available stents: Comparison of BiodivYsio, Taxus and Cypher stents. J Invasive Cardiol. 2007;19:71-6.
19. Basalus MW, Ankone MJ, van Houwelingen GK, de Man FH, von Birgelen C. Coating irregularities of durable polymer-based drug-eluting stents as assessed by scanning electron microscopy. EuroIntervention. 2009;5:157-65.
20. Basalus MW, von Birgelen C. Benchside testing of drug-eluting stent surface and geometry. Interv Cardiol. 2010;2:159-75.
21. Basalus MW, Tandjung K, van Apeldoorn AA, Ankone MJ, von Birgelen C. Effect of oversized partial postdilatation on coatings of contemporary durable polymer-based drug-eluting stents: A scanning electron microscopy study. J Interv Cardiol. 2011;24:149-61.
22. Mehta RI, Mehta RI, Solis OE, Jahan R, Salamon N, Tobis JM, Yong WH, Vinters HV, Fishbein MC. Hydrophilic polymer emboli: An under-recognized iatrogenic cause of ischemia and infarct. Mod Pathol. 2010;7:921-30.
23. Denardo SJ, Carpinone PL, Vock DM, Batich CD, Pepine CJ. Changes to polymer surface of drug-eluting stents during balloon expansion. JAMA. 2012;307:2148-50.
24. Crank J. Diffusion in a plane sheet. In: The Mathematics of Diffusion. 2nd ed. London: Oxford University Press; 1975: P. 44-68.
25. Ritger PL, Peppas NA. A simple equation for description of solute release, In: Fickian and non-Fickian release from non-swellable devices in the form of slabs, spheres, cylinders or discs. J Control Rel. 1987;5:23-36.
26. Lambert TL, Dev V, Rechavia E, Forrester JS, Litvack F, Eigler NL. Localized arterial wall drug delivery from a polymer-coated removable metallic stent. Kinetics, distribution, and bioactivity of forskolin. Circulation. 1994;90:1003-11.
27. Summary of Safety and Effectiveness Data-PROMUS(r) ElementTM Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM and Over-The-Wire). U.S. Department of Health and Human Services; Food and Drug Administration; Center for Devices and Radiological Health (CDRH). November 2011. Available at: Http://www.accessdata.fda.gov/cdrh-docs/pdf11/P110010b.pdf .
28. Summary of Safety and Effectiveness Data-Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity). U.S. Department of Health and Human Services; Food and Drug Administration; Center for Devices and Radiological Health (CDRH). March 2012. Available at: Http://www.accessdata.fda.gov/cdrh-docs/pdf11/P110013b.pdf
29. Weldon DG. Failure analysis of paints and coatings (revised edition). West Sussex, England: John Wiley & Sons, 2001.
30. Brooks CR, Choudhury A. Failure analysis of engineering materials. New York, United States of America: McGraw-Hill Professional, 2002.
31. Hopkins CG, McHugh PE, McGarry JP. Computational investigation of the delamination of polymer coatings during stent deployment. Ann Biomed Eng. 2010;38:2263-73.
32. Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Devices and Radiological Health (CDRH); Center for Drug Evaluation and Research (CDER). March 2008. Available at: Http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM072193.pdf.
33. Hwang CW, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stent-based delivery. Circulation. 2001;104:600-5.
34. Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010;56:1897-907.
35. Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: Importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007;27:1500-10.
36. Byrne RA, Joner M, Kastrati A. Polymer coatings and delayed arterial healing following drug-eluting stent implantation. Minerva Cardioangiol. 2009;57:567-84.
37. Gonzalo N, Serruys PW, Okamura T, Shen ZJ, Onuma Y, Garcia-Garcia HM, Sarno G, Schultz C, van Geuns RJ, Ligthart J, Regar E. Optical coherence tomography patterns of stent restenosis. Am Heart J. 2009;158:284-93.
38. Zingg W, Neumann AW, Strong AB, Hum OS, Absolom DR. Platelet adhesion to smooth and rough hydrophobic and hydrophilic surfaces under conditions of static exposure and laminar flow. Biomaterials. 1981;2:156-8.
39. Lyman DJ, Klein KG, Brash JL, Fritzinger BK. The interactions of platelets with polymer surfaces. I. Uncharged hydrophobic polymer surfaces. Thromb Diath Haemorrh. 1970;23:120-1.
40. Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, Briguori C, Sabatè M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW. Stent thrombosis with drug-eluting and bare-metal stents: Evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393-402.
41. Cassese S, Piccolo R, Galasso G, De Rosa R, Piscione F. Twelve-month clinical outcomes of everolimus-eluting stent as compared to paclitaxel-and sirolimus-eluting stent in patients undergoing percutaneous coronary interventions. A meta-analysis of randomized clinical trials. Int J Cardiol. 2011;150:84-9.
42. Jaffe R, Charron T, Puley G, Dick A, Strauss BH. Microvascular obstruction and the no-reflow phenomenon after percutaneous coronary intervention. Circulation. 2008;117:3152-6.
43. Thanyasiri P, Kathir K, Celermajer DS, Adams MR. Endothelial dysfunction and restenosis following percutaneous coronary intervention. Int J Cardiol. 2007;119:362-7.
44. Wakabayashi K, Delhaye C, Mahmoudi M, Belle L, Ben-Dor I, Gaglia MA Jr, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Impact of drug-eluting stent type on periprocedural myocardial necrosis. EuroIntervention. 2011;7:136-42.
45. Wiemer M, Butz T, Schmidt W, Schmitz KP, Horstkotte D, Langer C. Scanning electron microscopic analysis of different drug eluting stents after failed implantation: From nearly undamaged to major damaged polymers. Catheter Cardiovasc Interv. 2010;75:905-11.
46. European Medicines Agency. (2008). Guideline on The Clinical and Non Clinical Evaluation During the Consultation Procedure on Medicinal Substances Contained in Drug eluting (Medicinal Substance-Eluting) Coronary Stents. (Doc. Ref. EMEA/CHMP/EWP/110540/2007). London: U.K. Available at: Http://www.ema. europa.eu/ema/index.jsp? curl=pages/includes/document/document-detail.jsp? webContentId=WC500003275&mid=WC0b01ac058009a3dc.