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

Volumn 12, Issue 4, 2016, Pages 482-489

  Räber, Lorenz ^a   Onuma, Yoshinobu ^b,c   Brugaletta, Salvatore ^d   Garcia Garcia, Hector M ^b   Backx, Bianca ^b   Iñiguez, Andres ^e   Jensen, Lisette Okkels ^f   Cequier Fillat, Àngel ^g   Pilgrim, Thomas ^a   Christiansen, Evald Høi ^h   Hofma, Sjoerd H ⁱ   Suttorp, Maarten ^j   Serruys, Patrick W ^k   Sabaté, Manel ^d   Windecker, Stephan ^a  

^a UNIVERSITY OF BERN   (Switzerland)

^b CARDIALYSIS   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d UNIVERSITY OF BARCELONA   (Spain)

^e Meixoeiro Hospital   (Spain)

^f ODENSE UNIVERSITY HOSPITAL   (Denmark)

^g HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^h AARHUS UNIVERSITY HOSPITAL   (Denmark)

ⁱ MEDICAL CENTER LEEUWARDEN   (Netherlands)

^j ST ANTONIUS HOSPITAL   (Netherlands)

^k IMPERIAL COLLEGE LONDON   (United Kingdom)

more..

Author keywords

Absorb BVS; Bioresorbable vascular scaffold; Drug eluting stent; Optical frequency domain imaging; ST elevation myocardial infarction

Indexed keywords

ACETYLSALICYLIC ACID; FIBRINOGEN RECEPTOR ANTAGONIST; GLYCERYL TRINITRATE; HEPARIN; HIRULOG; PRASUGREL; TICAGRELOR; CARDIOVASCULAR AGENT; EVEROLIMUS; IMMUNOSUPPRESSIVE AGENT; POLYMER; RAPAMYCIN;

ADULT; ANGIOGRAPHY; ANTICOAGULANT THERAPY; ARTICLE; BARE METAL STENT; BIOLIMUS ELUTING CORONARY STENT; BIORESORBABLE SCAFFOLD; CARDIOVASCULAR PARAMETERS; CAROTID ARTERY STENTING; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; CORONARY ANGIOGRAPHY; DEVICE FAILURE; EQUIPMENT DESIGN; EVEROLIMUS ELUTING BIORESORBABLE VASCULAR SCAFFOLD; EVEROLIMUS ELUTING CORONARY STENT; EVEROLIMUS ELUTING METALLIC STENT; FOLLOW UP; HEART DEATH; HEART INFARCTION; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; METAL STENT; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STENT THROMBOSIS; TREATMENT OUTCOME; TREATMENT RESPONSE; ADOLESCENT; ADVERSE EFFECTS; BIODEGRADABLE IMPLANT; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; FEMALE; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PROCEDURES; YOUNG ADULT;

ABSORBABLE IMPLANTS; ADOLESCENT; ADULT; CARDIOVASCULAR AGENTS; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; EVEROLIMUS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; POLYMERS; SIROLIMUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84983089077     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY15M08_03     Document Type: Article

References (19)

1. Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009;5 Suppl F:F15-22.
2. Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373:897-910.
3. Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2011; 122:2301-12.
4. 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. 2014;385:43-54.
5. Zhang YJ, Bourantas CV, Muramatsu T, Iqbal J, Farooq V, Diletti R, Campos CA, Onuma Y, Garcia-Garcia HM, Serruys PW. Comparison of acute gain and late lumen loss after PCI with bioresorbable vascular scaffolds versus everolimus-eluting stents: an exploratory observational study prior to a randomised trial. EuroIntervention. 2014;10:672-80.
6. 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.
7. Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008;118:1138-45.
8. Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009;2:445-52.
9. Raber L, Zanchin T, Baumgartner S, Taniwaki M, Kalesan B, Moschovitis A, Garcia-Garcia HM, Justiz J, Pilgrim T, Wenaweser P, Meier B, Jüni P, Windecker S. Differential healing response attributed to culprit lesions of patients with acute coronary syndromes and stable coronary artery after implantation of drug-eluting stents: an optical coherence tomography study. Int J Cardiol. 2014;173:259-67.
10. Brugaletta S, Heo JH, Garcia-Garcia HM, Farooq V, van Geuns RJ, de Bruyne B, Dudek D, Smits PC, Koolen J, McClean D, Dorange C, Veldhof S, Rapoza R, Onuma Y, Bruining N, Ormiston JA, Serruys PW. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? Eur Heart J. 2012;33:1325-33.
11. Raber L, Kelbaek H, Taniwaki M, Ostojic M, Heg D, Baumbach A, von Birgelen C, Roffi M, Tuller D, Engstrom T, Moschovitis A, Pedrazzini G, Wenaweser P, Kornowski R, Weber K, Luscher TF, Matter CM, Meier B, Jüni P, Windecker S; COMFORTABLE AMI Trial Investigators. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial. Circ Cardiovasc Interv. 2014;7:355-64.
12. Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Hernadez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Backx B, Serruys PW. The EXAMINATION trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-year results from a multicenter randomized controlled trial. JACC Cardiovasc Interv. 2014;7:64-71.
13. Diletti R, Karanasos A, Muramatsu T, Nakatani S, Van Mieghem NM, Onuma Y, Nauta ST, Ishibashi Y, Lenzen MJ, Ligthart J, Schultz C, Regar E, de Jaegere PP, Serruys PW, Zijlstra F, van Geuns RJ. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. Eur Heart J. 2014;35:777-86.
14. Kocka V, Lisa L, Tousek P, Budesinsky T, Widimsky P. ST elevation myocardial infarction treated with bioresorbable vascular scaffold: rationale and first cases. Eur Heart J. 2013;34:2073.
15. Gori T, Schulz E, Hink U, Wenzel P, Post F, Jabs A, Munzel T. Early outcome after implantation of Absorb bioresorbable drugeluting scaffolds in patients with acute coronary syndromes. EuroIntervention. 2014;9:1036-41.
16. Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Scalone G, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Munzel T, Lee CH, Cequier A, Valdes M, Widimsky P, Serruys PW, Sabaté M. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015;8:189-97.
17. Garcia-Garcia HM, Muramatsu T, Nakatani S, Lee IS, Holm NR, Thuesen L, van Geuns RJ, van der Ent M, Borovicanin V, Paunovic D, Onuma Y, Serruys PW. Serial optical frequency domain imaging in STEMI patients: the follow-up report of TROFI study. Eur Heart J Cardiovasc Imaging. 2014;15:987-95.
18. Onuma Y, Thuesen L, van Geuns RJ, van der Ent M, Desch S, Fajadet J, Christiansen E, Smits P, Holm NR, Regar E, van Mieghem N, Borovicanin V, Paunovic D, Senshu K, van Es GA, Muramatsu T, Lee IS, Schuler G, Zijlstra F, Garcia-Garcia HM, Serruys PW; TROFI Investigators. Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study-TROFI trial. Eur Heart J. 2013;34: 1050-60.
19. Guagliumi G, Sirbu V, Musumeci G, Gerber R, Biondi-Zoccai G, Ikejima H, Ladich E, Lortkipanidze N, Matiashvili A, Valsecchi O, Virmani R, Stone GW. Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. JACC Cardiovasc Interv. 2012;5:12-20.