Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting bioresorbable scaffold and an everolimus-eluting metallic stent: Insights from the randomised ABSORB Japan trial

EuroIntervention

Volumn 12, Issue 9, 2016, Pages 1090-1101

  Onuma, Yoshinobu ^a   Sotomi, Yohei ^b   Shiomi, Hiroki ^c   Ozaki, Yukio ^d   Namiki, Atsuro ^e   Yasuda, Satoshi ^f   Ueno, Takafumi ^g   Ando, Kenji ^h   Furuya, Jungo ⁱ   Igarashi, Keiichi ⁱ   Kozuma, Ken ^j   Tanabe, Kengo ^k   Kusano, Hajime ^l   Rapoza, Richard ^l   Popma, Jeffrey J ^m   Stone, Gregg W ⁿ   Simonton, Charles ^l   Serruys, Patrick W ^o   Kimura, Takeshi ^c  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c KYOTO UNIVERSITY HOSPITAL   (Japan)

^d FUJITA HEALTH UNIVERSITY HOSPITAL   (Japan)

^e KANTO ROSAI HOSPITAL   (Japan)

^f NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^g KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^h KOKURA MEMORIAL HOSPITAL   (Japan)

ⁱ Japan Community Healthcare Organization Hokkaido Hospital   (Japan)

^j TEIKYO UNIVERSITY HOSPITAL   (Japan)

^k MITSUI MEMORIAL HOSPITAL   (Japan)

^l ABBOTT VASCULAR   (United States)

^m BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

ⁿ NewYork Presbyterian Hospital   (United States)

^o IMPERIAL COLLEGE LONDON   (United Kingdom)

more..

Author keywords

Everolimus eluting bioresorbable scaffold; Everolimus eluting metallic stent; Optical coherence tomography; Randomised trial

Indexed keywords

ACETYLSALICYLIC ACID; ANTIDIABETIC AGENT; CILOSTAZOL; CLOPIDOGREL; ANTINEOPLASTIC AGENT; EVEROLIMUS;

ADULT; AGED; ANGIOGRAPHY; ANTICOAGULANT THERAPY; ARTICLE; BIORESORBABLE SCAFFOLD; BLOOD VESSEL DIAMETER; CARDIOVASCULAR PARAMETERS; CARDIOVASCULAR RISK; COBALT CHROMIUM EVEROLIMUS ELUTING METALLIC STENT; CONTROLLED STUDY; CORONARY ANGIOGRAPHY; DIABETES MELLITUS; DYSLIPIDEMIA; EQUIPMENT DESIGN; EVEROLIMUS ELUTING BIORESORBABLE SCAFFOLD; EVEROLIMUS ELUTING CORONARY STENT; FEMALE; FLOW RATE; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; METAL STENT; MULTICENTER STUDY; OPTICAL COHERENCE TOMOGRAPHY; POPULATION RESEARCH; POSTOPERATIVE PERIOD; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SINGLE BLIND PROCEDURE; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; THROMBOSIS; TREATMENT OUTCOME; VERY LATE SCAFFOLD THROMBOSIS; BIODEGRADABLE IMPLANT; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COMPARATIVE STUDY; CORONARY ARTERY DISEASE; DIAGNOSTIC IMAGING; DRUG ELUTING STENT; FOLLOW UP; GRAFT OCCLUSION, VASCULAR; HEART MUSCLE REVASCULARIZATION; JAPAN; MIDDLE AGED; MORTALITY; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; POSTOPERATIVE COMPLICATIONS; TISSUE SCAFFOLD; UTILIZATION;

ABSORBABLE IMPLANTS; AGED; ANTINEOPLASTIC AGENTS; CARDIOVASCULAR DISEASES; CORONARY ANGIOGRAPHY; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; EVEROLIMUS; FEMALE; FOLLOW-UP STUDIES; GRAFT OCCLUSION, VASCULAR; HUMANS; JAPAN; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; MYOCARDIAL REVASCULARIZATION; PERCUTANEOUS CORONARY INTERVENTION; POSTOPERATIVE COMPLICATIONS; SINGLE-BLIND METHOD; THROMBOSIS; TISSUE SCAFFOLDS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME;

EID: 84994667680     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY16M09_01     Document Type: Article

References (29)

1. Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J. 2012;33:16-25b.
2. Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43-54.
3. Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015;373:1905-15.
4. Gao R, Yang Y, Han Y, Huo Y, Chen J, Yu B, Su X, Li L, Kuo HC, Ying SW, Cheong WF, Zhang Y, Su X, Xu B, Popma JJ, Stone GW; ABSORB China Investigators. Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial. J Am Coll Cardiol. 2015;66: 2298-309.
5. Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015;36:3332-42.
6. Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016;387:1277-89.
7. Chevalier B, Onuma Y, van Boven AJ, Piek JJ, Sabate M, Helqvist S, Baumbach A, Smits PC, Kumar R, Wasungu L, Serruys PW. Randomised comparison of a bioresorbable everolimus-eluting scaffold with a metallic everolimus-eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions: the 2-year clinical outcomes of the ABSORB II trial. EuroIntervention. 2016 Aug 27. [Epub ahead of print]
8. Karanasos A, Van Mieghem N, van Ditzhuijzen N, Felix C, Daemen J, Autar A, Onuma Y, Kurata M, Diletti R, Valgimigli M, Kauer F, van Beusekom H, de Jaegere P, Zijlstra F, van Geuns RJ, Regar E. Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience. Circ Cardiovasc Interv. 2015;8(5).
9. Raber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabate M, Windecker S. Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. J Am Coll Cardiol. 2015;66:1901-14.
10. Räber L, Onuma Y, Brugaletta S, Garcia-Garcia HM, Backx B, Iñiguez A, Okkels Jensen L, Cequier-Fillat À, Pilgrim T, Christiansen EH, Hofma SH, Suttorp M, Serruys PW, Sabaté M, Windecker S. Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction: rationale and design of the randomised TROFI II study. EuroIntervention. 2016;12:482-9.
11. Nakatani S, Sotomi Y, Ishibashi Y, Grundeken MJ, Tateishi H, Tenekecioglu E, Zeng Y, Suwannasom P, Regar E, Radu MD, Raber L, Bezerra H, Costa MA, Fitzgerald P, Prati F, Costa RA, Dijkstra J, Kimura T, Kozuma K, Tanabe K, Akasaka T, Di Mario C, Serruys PW, Onuma Y Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomo-graphy at baseline and follow-up. EuroIntervention. 2015 Oct 9. [Epub ahead of print].
12. Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Piot C, Richardt G, Merkely B, Schneider H, Bilger J, Erne P, Waksman R, Zaugg S, Juni P, Lefevre T. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv. 2015;8:e001441.
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 Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136-46.
14. Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016;67:921-31.
15. de la Torre Hernandez JM, Alfonso F, Gimeno F, Diarte JA, Lopez-Palop R, Perez de Prado A, Rivero F, Sanchis J, Larman M, Diaz JF, Elizaga J, Moreiras JM, Gomez Jaume A, Hernandez JM, Mauri J, Recalde AS, Bullones JA, Rumoroso JR, Del Blanco BG, Baz JA, Bosa F, Botas J, Hernandez F; ESTROFA-2 Study Group. Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Espanol Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2). JACC Cardiovasc Interv. 2010;3:911-9.
16. Räber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Juni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012;125:1110-21.
17. Onuma Y, Serruys PW, Muramatsu T, Nakatani S, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Garcia-Garcia HM, Veldhof S, Rapoza R, Ormiston JA. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2014;7: 1400-11.
18. Mangiameli A, Ohno Y, Attizzani GF, Capodanno D, Tamburino C. Neoatherosclerosis as the cause of late failure of a bioresorbable vascular scaffold. JACC Cardiovasc Interv. 2015;8:633-4.
19. Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014;9:1271-84.
20. Maier W, Windecker S, Kung A, Lutolf R, Eberli FR, Meier B, Hess OM. Exercise-induced coronary artery vasodilation is not impaired by stent placement. Circulation. 2002;105:2373-7.
21. Iannaccone M, D'Ascenzo F, Templin C, Omede P, Montefusco A, Guagliumi G, Serruys PW, Di Mario C, Kochman J, Quadri G, Biondi-Zoccai G, Luscher TF, Moretti C, D'Amico M, Gaita F, Stone GW. Optical coherence tomography evaluation of intermediate-term healing of different stent types: systemic review and meta-analysis. Eur Heart J Cardiovasc Imaging. 2016 Apr 20. [Epub ahead of print].
22. Onuma Y, Kimura T, Räber L, Magro M, Girasis C, van Domburg R, Windecker S, Mtsudo K, Serruys PW; Bern-Rotterdam and j-Cypher registries. Differences in coronary risk factors, procedural characteristics, mortality and stent thrombosis between two allcomers percutaneous coronary intervention registries from Europe and Japan: a patient-level data analysis of the Bern-Rotterdam and j-Cypher registries. EuroIntervention. 2015;11:533-40.
23. Gutiérrez-Chico JL, Wykrzykowska J, Nüesch E, van 'Geuns RJ, Koch KT, Koolen JJ, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Regar E, Serruys PW. Vascular tissue reaction to acute malapposition in human coronary arteries: sequential assessment with optical coherence tomography. Circ Cardiovasc Interv. 2012;5:20-9, s1-8.
24. Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011;58:1578-88.
25. de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es GA. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J. 1998;19:1214-23.
26. Brugaletta S, Gogas BD, Garcia-Garcia HM, Farooq V, Girasis C, Heo JH, van Geuns RJ, de Bruyne B, Dudek D, Koolen J, Smits P, Veldhof S, Rapoza R, Onuma Y, Ormiston J, Serruys PW. Vascular compliance changes of the coronary vessel wall after bioresorbable vascular scaffold implantation in the treated and adjacent segments. Circ J. 2012;76:1616-23.
27. Gomez-Lara J, Brugaletta S, Farooq V, Onuma Y, Diletti R, Windecker S, Thuesen L, McClean D, Koolen J, Whitbourn R, Dudek D, Smits PC, Chevalier B, Regar E, Veldhof S, Rapoza R, Ormiston JA, Garcia-Garcia HM, Serruys PW. Head-to-head comparison of the neointimal response between metallic and bioresorb-able everolimus-eluting scaffolds using optical coherence tomography. JACC Cardiovasc Interv. 2011;4:1271-80.
28. Sabate M, Windecker S, Iniguez A, Okkels-Jensen L, Cequier A, Brugaletta S, Hofma SH, Raber L, Christiansen EH, Suttorp M, Pilgrim T, Anne van Es G, Sotomi Y, Garcia-Garcia HM, Onuma Y, Serruys PW. Everolimus-eluting biore-sorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the ran domized ABSORB ST-segment elevation myo-cardial infarction-TROFI II trial. Eur Heart J. 2016;37:229-40.
29. Sotomi Y, Tateishi H, Suwannasom P, Dijkstra J, Eggermont J, Liu S, Tenekecioglu E, Zheng Y, Abdelghani M, Cavalcante R, de Winter RJ, Wykrzykowska JJ, Onuma Y, Serruys PW, Kimura T. Quantitative assessment of the stent/scaffold strut embedment anal-ysis by optical coherence tomography. Int J Cardiovasc Imaging. 2016;32:871-83.