Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography

Cardiovascular Revascularization Medicine

Volumn 14, Issue 2, 2013, Pages 84-89

  Tada, Tomohisa ^a   Byrne, Robert A ^a   Schuster, Tibor ^b   Cuni, Rezarta ^a   Kitabata, Hironori ^c   Tiroch, Klaus ^a   Dirninger, Alfred ^d   Gratze, Franz ^d   Kaspar, Klaus ^d   Zenker, Gerald ^d   Joner, Michael ^a   Schömig, Albert ^a   Kastrati, Adnan ^a  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^c WAKAYAMA MEDICAL UNIVERSITY   (Japan)

^d Landeskrankenhaus Bruck/Mur ^*  (Austria)

Author keywords

Biodegradable polymer; Optical coherence tomography; Vascular healing

Indexed keywords

EVEROLIMUS; ITRIX; RAPAMYCIN; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BIODEGRADABLE POLYMER SIROLIMUS ELUTING STENT; CLINICAL ARTICLE; DRUG ELUTING STENT; EVEROLIMUS ELUTING STENT; FEMALE; HEALING; HUMAN; MALE; MULTICENTER STUDY; NEOINTIMA; OPTICAL COHERENCE TOMOGRAPHY; PILOT STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; VASCULAR HEALING;

ABSORBABLE IMPLANTS; AGED; CARDIOVASCULAR AGENTS; CORONARY VESSELS; DRUG-ELUTING STENTS; FEMALE; GERMANY; HUMANS; LINEAR MODELS; MALE; MIDDLE AGED; NEOINTIMA; ODDS RATIO; PERCUTANEOUS CORONARY INTERVENTION; PILOT PROJECTS; POLYMERS; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; SIROLIMUS; TIME FACTORS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; WOUND HEALING;

EID: 84875067653     PISSN: 15538389     EISSN: 18780938     Source Type: Journal    
DOI: 10.1016/j.carrev.2012.12.003     Document Type: Article

References (29)

1. Byrne R.A., Sarafoff N., Kastrati A., Schomig A. Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment. Drug Saf 2009, 32:749-770.
2. Joner M., Nakazawa G., Finn A.V., Quee S.C., Coleman L., Acampado E., et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 2008, 52:333-342.
3. Last accessed: December 2, 2012. http://www.ptca.org/news/2012/0515_XIENCE.html.
4. Kubo T., Tanaka A., Kitabata H., Ino Y., Tanimoto T., Akasaka T. Application of optical coherence tomography in percutaneous coronary intervention. Circ J 2012, 76(9):2076-2083.
5. Lowe H.C., Narula J., Fujimoto J.G., Jang I.K. Intracoronary optical diagnostics current status, limitations, and potential. JACC Cardiovasc Interv 2011, 4:1257-1270.
6. Byrne R.A., Mehilli J., Iijima R., Schulz S., Pache J., Seyfarth M., et al. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. Polymer-based drug-eluting stents. Eur Heart J 2009, 30:923-931.
7. Gonzalo N., Garcia-Garcia H.M., Serruys P.W., Commissaris K.H., Bezerra H., Gobbens P., et al. Reproducibility of quantitative optical coherence tomography for stent analysis. EuroIntervention 2009, 5:224-232.
8. Niemela K.O. Biodegradable coating for drug-eluting stents - more than a facelift?. Eur Heart J 2008, 29:1930-1931.
9. Waksman R., Maluenda G. Polymer drug-eluting stents: is the future biodegradable?. Lancet 2011, 378:1900-1902.
10. Byrne R.A., Joner M., Kastrati A. Polymer coatings and delayed arterial healing following drug-eluting stent implantation. Minerva Cardioangiol 2009, 57:567-584.
11. Byrne R.A., Kastrati A., Massberg S., Wieczorek A., Laugwitz K.L., Hadamitzky M., et al. Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol 2011, 58:1325-1331.
12. Stefanini G.G., Kalesan B., Serruys P.W., Heg D., Buszman P., Linke A., et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet 2011, 378:1940-1948.
13. Stefanini G.G., Byrne R.A., Serruys P.W., de Waha A., Meier B., Massberg S., et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: A pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and leaders randomized trials. Eur Heart J 2012, 33:1214-1222.
14. Windecker S., Serruys P.W., Wandel S., Buszman P., Trznadel S., Linke A., et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet 2008, 372:1163-1173.
15. Barlis P., Regar E., Serruys P.W., Dimopoulos K., van der Giessen W.J., van Geuns R.J., et al. An optical coherence tomography study of a biodegradable vs. Durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J 2010, 31:165-176.
16. Gutierrez-Chico J.L., Juni P., Garcia-Garcia H.M., Regar E., Nuesch E., Borgia F., et al. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J 2011, 162:922-931.
17. Guagliumi G., Sirbu V., Musumeci G., Bezerra H.G., Aprile A., Kyono H., et al. Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: optical coherence tomography drug-eluting stent investigation (OCTDESI). Circ Cardiovasc Interv 2010, 3:367-375.
18. Gutierrez-Chico J.L., van Geuns R.J., Regar E., van der Giessen W.J., Kelbaek H., Saunamaki K., et al. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. A fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All comers trial. Eur Heart J 2011, 32:2454-2463.
19. Guagliumi G., Costa M.A., Sirbu V., Musumeci G., Bezerra H.G., Suzuki N., et al. Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the harmonizing outcomes with revascularization and stents in acute myocardial infarction (HORIZONS-AMI) trial. Circulation 2011, 123:274-281.
20. Pendyala L., Jabara R., Robinson K., Chronos N. Passive and active polymer coatings for intracoronary stents: novel devices to promote arterial healing. J Interv Cardiol 2009, 22:37-48.
21. Farb A., Burke A.P., Kolodgie F.D., Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation 2003, 108:1701-1706.
22. Grewe P.H., Deneke T., Machraoui A., Barmeyer J., Muller K.M. Acute and chronic tissue response to coronary stent implantation: pathologic findings in human specimen. J Am Coll Cardiol 2000, 35:157-163.
23. Xie Y., Takano M., Murakami D., Yamamoto M., Okamatsu K., Inami S., et al. Comparison of neointimal coverage by optical coherence tomography of a sirolimus-eluting stent versus a bare-metal stent three months after implantation. Am J Cardiol 2008, 102:27-31.
24. Brugaletta S., Garcia-Garcia H.M., Gomez-Lara J., Radu M.D., Pawar R., Khachabi J., et al. Reproducibility of qualitative assessment of stent struts coverage by optical coherence tomography. Int J Cardiovasc Imaging 2012, [Epub ahead of print], Last accessed: September 7, 2012. 10.1007/s10554-012-0030-8.
25. Luscher T.F., Steffel J., Eberli F.R., Joner M., Nakazawa G., Tanner F.C., et al. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 2007, 115:1051-1058.
26. Tearney G.J., Regar E., Akasaka T., Adriaenssens T., Barlis P., Bezerra H.G., et al. Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: A report from the international working group for intravascular optical coherence tomography standardization and validation. J Am Coll Cardiol 2012, 59:1058-1072.
27. Tahara S., Chamie D., Baibars M., Alraies C., Costa M. Optical coherence tomography endpoints in stent clinical investigations: strut coverage. Int J Cardiovasc Imaging 2011, 27:271-287.
28. Guagliumi G., Sirbu V., Bezerra H., Biondi-Zoccai G., Fiocca L., Musumeci G., et al. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (optical coherence tomography in acute myocardial infarction) study. JACC Cardiovasc Interv 2010, 3:680-687.
29. Finn A.V., Joner M., Nakazawa G., Kolodgie F., Newell J., John M.C., et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007, 115:2435-2441.