Randomized comparison of biolimus-eluting stents with biodegradable polymer versus everolimus-eluting stents with permanent polymer coatings assessed by optical coherence tomography

International Journal of Cardiovascular Imaging

Volumn 30, Issue 3, 2014, Pages 495-504

  Tada, Tomohisa ^a,b   Kastrati, Adnan ^a,b   Byrne, Robert A ^a,b   Schuster, Tibor ^c   Cuni, Rezarta ^a   King, Lamin A ^a,b   Cassese, Salvatore ^a,b   Joner, Michael ^a,b   Pache, Jürgen ^a,b   Massberg, Steffen ^b,e   Schömig, Albert ^a,b,d   Mehilli, Julinda ^b,e  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b DZHK GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH   (Germany)

^c TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^d TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^e LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

Author keywords

Biodegradable polymer; Drug eluting stent; Optical coherence tomography; Vascular healing

Indexed keywords

EVEROLIMUS; NOBORI; POLYMER; UMIROLIMUS; UNCLASSIFIED DRUG; BIOMATERIAL; IMMUNOSUPPRESSIVE AGENT; RAPAMYCIN;

ANATOMIC LANDMARK; ANGIOCARDIOGRAPHY; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HEALING; HUMAN; MALE; MULTICENTER STUDY; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OPTICAL COHERENCE TOMOGRAPHY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REVASCULARIZATION; STABLE ANGINA PECTORIS; UNSTABLE ANGINA PECTORIS; AGED; ANALOGS AND DERIVATIVES; COMPARATIVE STUDY; CORONARY BLOOD VESSEL; CORONARY RESTENOSIS; DRUG EFFECTS; IMAGE PROCESSING; MATERIALS TESTING; PROCEDURES; RISK; TREATMENT OUTCOME;

AGED; COATED MATERIALS, BIOCOMPATIBLE; CORONARY RESTENOSIS; CORONARY VESSELS; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMAGE PROCESSING, COMPUTER-ASSISTED; IMMUNOSUPPRESSIVE AGENTS; MALE; MATERIALS TESTING; ODDS RATIO; POLYMERS; PROSPECTIVE STUDIES; SIROLIMUS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME;

EID: 84899101404     PISSN: 15695794     EISSN: 15730743     Source Type: Journal    
DOI: 10.1007/s10554-014-0376-1     Document Type: Article

References (20)

1. Byrne RA, Sarafoff N, Kastrati A, Schomig A (2009) Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment. Drug Saf 32(9):749-770
2. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R (2006) Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48(1):193-202 (Pubitemid 43929240)
3. Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R (2008) Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 52(5):333-342 (Pubitemid 352001347)
4. Byrne RA, Joner M, Kastrati A (2009) Polymer coatings and delayed arterial healing following drug-eluting stent implantation. Minerva Cardioangiol 57(5):567-584
5. Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Juni P, di Mario C (2010) An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J 31(2):165-176
6. Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Juni P (2011) 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 378(9807):1940-1948
7. Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Juni P, Schomig A, Windecker S, Kastrati A (2012) 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 33(10):1214-1222
8. de Waha A, Dibra A, Byrne RA, Ndrepepa G, Mehilli J, Fusaro M, Laugwitz KL, Massberg S, Schomig A, Kastrati A (2011) Everolimus-eluting versus sirolimus-eluting stents: a meta-analysis of randomized trials. Circ Cardiovasc Interv 4(4):371-377
9. Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, Briguori C, Sabate M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW (2012) Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet 379(9824):1393-1402
10. Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW (2009) Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial-Phase 2. Circ Cardiovasc Interv 2(3):188-195
11. Tada T, Byrne RA, Schuster T, Cuni R, Kitabata H, Tiroch K, Dirninger A, Gratze F, Kaspar K, Zenker G, Joner M, Schomig A, Kastrati A (2013) Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography. Cardiovasc Revasc Med 14(2):84-89
12. Gonzalo N, Garcia-Garcia HM, Serruys PW, Commissaris KH, Bezerra H, Gobbens P, Costa M, Regar E (2009) Reproducibility of quantitative optical coherence tomography for stent analysis. EuroIntervention 5(2):224-232
13. Teramoto T, Ikeno F, Otake H, Lyons JK, van Beusekom HM, Fearon WF, Yeung AC (2010) Intriguing peri-strut low-intensity area detected by optical coherence tomography after coronary stent deployment. Circ J 74(6):1257-1259
14. Otake H, Shite J, Ikeno F, Shinke T, Teramoto T, Miyoshi N, Ako J, Honda Y, Fitzgerald PJ, Hirata KI (2010) Evaluation of the peri-strut low intensity area following sirolimus- and paclitaxel-eluting stents implantation: insights from an optical coherence tomography study in humans. Int J Cardiol. doi:S0167-5273(10)01010-7
15. Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T (2013) Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol 62(3):181-190
16. Brugaletta S, Garcia-Garcia HM, Gomez-Lara J, Radu MD, Pawar R, Khachabi J, Bruining N, Sabate M, Serruys PW (2012) Reproducibility of qualitative assessment of stent struts coverage by optical coherence tomography. Int J Cardiovasc Imaging. doi:10.1007/s10554-012-0030-8
17. Gutierrez-Chico JL, van Geuns RJ, Regar E, van der Giessen WJ, Kelbaek H, Saunamaki K, Escaned J, Gonzalo N, di Mario C, Borgia F, Nuesch E, Garcia-Garcia HM, Silber S, Windecker S, Serruys PW (2011) 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 32(19):2454-2463
18. Gutierrez-Chico JL, Juni P, Garcia-Garcia HM, Regar E, Nuesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C (2011) 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 162(5):922-931
19. Imai M, Kadota K, Goto T, Fujii S, Yamamoto H, Fuku Y, Hosogi S, Hirono A, Tanaka H, Tada T, Morimoto T, Shiomi H, Kozuma K, Inoue K, Suzuki N, Kimura T, Mitsudo K (2011) Incidence, risk factors, and clinical sequelae of angiographic peristent contrast staining after sirolimus-eluting stent implantation. Circulation 123(21):2382-2391
20. Cook S, Eshtehardi P, Kalesan B, Raber L, Wenaweser P, Togni M, Moschovitis A, Vogel R, Seiler C, Eberli FR, Luscher T, Meier B, Juni P, Windecker S (2012) Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation. Eur Heart J 33(11):1334-1343