Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: The NOBORI 2 study

EuroIntervention

Volumn 8, Issue 1, 2012, Pages 109-116

  Danzi, Gian Battista ^a   Chevalier, Bernard ^b   Urban, Philip ^c   Fath Ordoubadi, Farzin ^d   Carrie, Didier ^e   Wiemer, Marcus ^f   Serra, Antonio ^g,h   Wijns, William ⁱ   Kala, Petr ^j   Stabile, Amerigo ^k   Ruigomez, Javier Goicolea ^l   Sagic, Dragan ^m   Laanmets, Peep ⁿ   Strupp, Gerhard ^o   West, Nick ^p   Paunovic, Dragica ^q  

^a FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^b INSTITUT CARDIOVASCULAIRE PARIS SUD   (France)

^c LA TOUR HOSPITAL   (Switzerland)

^d MANCHESTER ROYAL INFIRMARY   (United Kingdom)

^e CHU RANGUEIL   (France)

^f RUHR UNIVERSITY BOCHUM   (Germany)

^g HOSPITAL DEL MAR   (Spain)

^h Hospital St Pau   (Spain)

ⁱ CARDIOVASCULAR CENTER   (Belgium)

^j UNIVERSITY HOSPITAL BRNO   (Czech Republic)

^k Dipartimento di Neuroscienze   (Italy)

^l HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^m Institute for Cardiovascular Disease Dedinje   (Serbia)

ⁿ North Estonia Regional Hospital   (Estonia)

^o Klinikum Fulda AG   (Germany)

^p PAPWORTH HOSPITAL   (United Kingdom)

^q Terumo Europe NV   (Belgium)

more..

Author keywords

Biodegradable polymer; Drug eluting stent; Off label indication

Indexed keywords

DRUG CARRIER; POLYLACTIC ACID; UMIROLIMUS;

ACUTE CORONARY SYNDROME; ADULT; ANGINA PECTORIS; ARTICLE; BARE METAL STENT; BIODEGRADABLE IMPLANT; CLINICAL EFFECTIVENESS; COMORBIDITY; CONTROLLED STUDY; CORONARY ARTERY CALCIFICATION; CORONARY ARTERY DISEASE; CORONARY ARTERY RECANALIZATION; CORONARY STENT; DRUG ELUTING STENT; DRUG TREATMENT FAILURE; FEMALE; FOLLOW UP; HEART DEATH; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OFF LABEL DRUG USE; OUTCOME ASSESSMENT; PATIENT SAFETY; POSTOPERATIVE HEMORRHAGE; PROSPECTIVE STUDY; STENT THROMBOSIS; TREATMENT INDICATION;

ABSORBABLE IMPLANTS; AGED; ANALYSIS OF VARIANCE; ANGIOPLASTY, BALLOON, CORONARY; ASIA; CARDIOVASCULAR AGENTS; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; EUROPE; FEMALE; GUIDELINE ADHERENCE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; POLYMERS; PRACTICE GUIDELINES AS TOPIC; PRODUCT LABELING; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; REGISTRIES; SIROLIMUS; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84864202983     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV8I1A17     Document Type: Article

References (31)

1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773-1780.
2. 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. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-1323.
3. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221-231.
4. Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006;114:798-806.
5. Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrié D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006:2:286-94
6. 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. 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. 2009;2:188-195.
7. Applegate RJ, Sacrinty MT, Kutcher MA, Santos RM, Gandhi SK, Baki TT, Little WC. "Off-label" stent therapy 2-year comparison of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2008;51:607-614.
8. Beohar N, Davidson CJ, Kip KE, Goodreau L, Vlachos HA, Meyers SN, Benzuly KH, Flaherty JD, Ricciardi MJ, Bennett CL, Williams DO. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA. 2007;297:1992-2000.
9. Bezerra H, Perin E, Berger P, Block P, Ramee S, Katz S, Kellet M, Dippel E, Schaer G, Britto S, Cohen S, Costa M. Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry. J Invasive Cardiol. 2010;22:48-55.
10. Brodie BR, Stuckey T, Downey W, Humphrey A, Bradshaw B, Metzger C, Hermiller J, Krainin F, Juk S, Cheek B, Duffy P, Smith H, Edmunds J, Varanasi J, Simonton CA. Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group. JACC Cardiovasc Interv. 2008;1:405-414.
11. Latib A, Ferri L, Ielasi A, Godino C, Chieffo A, Magni V, Bassanelli G, Sharp AS, Gerber R, Michev I, Carlino M, Airoldi F, Sangiorgi GM, Montorfano M, Colombo A. Clinical outcomes after unrestricted implantation of everolimus-eluting stents. JACC Cardiovasc Interv. 2009;2:1219-1226.
12. Marroquin OC, Selzer F, Mulukutla SR, Williams DO, Vlachos HA, Wilensky RL, Tanguay JF, Holper EM, Abbott JD, Lee JS, Smith C, Anderson WD, Kelsey SF, Kip KE. A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med. 2008;358:342-352.
13. Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van LF, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136-146.
14. Win HK, Caldera AE, Maresh K, Lopez J, Rihal CS, Parikh MA, Granada JF, Marulkar S, Nassif D, Cohen DJ, Kleiman NS. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA. 2007;297:2001-2009.
15. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di MC, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. 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.
16. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369:667-678.
17. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005;293:2126-2130.
18. Kuchulakanti PK, Chu WW, Torguson R, Ohlmann P, Rha SW, Clavijo LC, Kim SW, Bui A, Gevorkian N, Xue Z, Smith K, Fournadjieva J, Suddath WO, Satler LF, Pichard AD, Kent KM, Waksman R. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation. 2006;113:1108-1113.
19. Kadota K, Muramatsu T, Iwabuchi M, Saito S, Hayashi Y, Ikari Y, et al. Randomized comparison of the Nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries. Catheter Cardiovasc Interv. 2011 Jul 29. doi: 10.1002/ccd.23280. [Epub ahead of print]
20. Danzi GB, Chevalier B, Ostojic M, Hamilos M, Wijns W. Nobori drug eluting stent system: clinical evidence update. Minerva Cardioangiol. 2010;58:599-610.
21. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-2351.
22. Charlson ME, Pompei P, Ales KL, McKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chron Dis. 1987;40:373-83.
23. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48:193-202.
24. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701-705.
25. Hamilos MI, Ostojic M, Beleslin B, Sagic D, Mangovski L, Stojkovic S, Nedeljkovic M, Orlic D, Milosavljevic B, Topic D, Karanovic N, Wijns W. Differential effects of drug-eluting stents on local endothelium-dependent coronary vasomotion. J Am Coll Cardiol. 2008;51:2123-2129.
26. Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008;299:409-416.
27. Smits PC, Kedhi E, Royaards KJ, Joesoef KS, Wassing J, Rademaker-Havinga TA, McFadden E.2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial). J Am Coll Cardiol. 2011;58:11-8.
28. Krucoff MW, Rutledge DR, Gruberg L, Jonnavithula L, Katopodis JN, Lombardi W, Mao VW, Sharma SK, Simonton CA, Tamboli HP, Wang J, Wilburn O, Zhao W, Sudhir K, Hermiller JB. A New Era of Prospective Real-World Safety Evaluation Primary Report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market Study). JACC Cardiovasc Interv. 2011;4:1298-309.
29. Novack V, Cutlip D, Kleiman N, Pencina M, Mauri L, Yen CH, Berger P, Goldberg S, Kellett M, Waksman R, Hong M, Raizner AE, Cohen DJ. In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009;2:767-775.
30. Ong AT, van Domburg RT, Aoki J, Sonnenschein K, Lemos PA, Serruys PW. Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol 2006;47:1356-1360.
31. 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, Jüni P. 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 3;378:1940-8.