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

Journal of the American College of Cardiology

Volumn 58, Issue 15, 2011, Pages 1578-1588

  Serruys, Patrick W ^a   Onuma, Yoshinobu ^a   Dudek, Dariusz ^b   Smits, Pieter C ^c   Koolen, Jacques ^d   Chevalier, Bernard ^e   De Bruyne, Bernard ^f   Thuesen, Leif ^g   McClean, Dougal ^h   Van Geuns, Robert Jan ^b   Windecker, Stephan ⁱ   Whitbourn, Robert ^j   Meredith, Ian ^k   Dorange, Cecile ^l   Veldhof, Susan ^l   Hebert, Karine Miquel ^l   Sudhir, Krishnankutty ^l   Garcia Garcia, Hector M ^m   Ormiston, John A ⁿ  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b JAGIELLONIAN UNIVERSITY   (Poland)

^c Maasstad Hospital Rotterdam   (Netherlands)

^d CATHARINA HOSPITAL   (Netherlands)

^e Institut Jacques Cartier   (France)

^f CARDIOVASCULAR CENTER   (Belgium)

^g AARHUS UNIVERSITY HOSPITAL   (Denmark)

^h CHRISTCHURCH HOSPITAL   (New Zealand)

ⁱ UNIVERSITY OF BERN   (Switzerland)

^j ST VINCENT S HOSPITAL   (Australia)

^k MONASH UNIVERSITY   (Australia)

^l ABBOTT VASCULAR   (United States)

^m CARDIALYSIS   (Netherlands)

ⁿ AUCKLAND CITY HOSPITAL   (New Zealand)

more..

Author keywords

angiography; bioresorbable scaffold; coronary artery disease; intravascular ultrasound; optical coherence tomography

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; EVEROLIMUS; HEPARIN; METHYLERGOMETRINE;

ADULT; ANGINA PECTORIS; ANGIOCARDIOGRAPHY; ARTICLE; CONTROLLED STUDY; CORONARY ARTERY OBSTRUCTION; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HEART INFARCTION; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; OPTICAL COHERENCE TOMOGRAPHY; PRIORITY JOURNAL; RADIOFREQUENCY; RANDOMIZED CONTROLLED TRIAL; THORAX PAIN; THROMBUS; ULTRASOUND;

ABSORBABLE IMPLANTS; AGED; CORONARY STENOSIS; DRUG-ELUTING STENTS; FEASIBILITY STUDIES; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; SIROLIMUS; TIME FACTORS; TREATMENT OUTCOME;

EID: 80053325761     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2011.05.050     Document Type: Article

References (29)

1. H. Tamai, K. Igaki, and E. Kyo Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans Circulation 102 2000 399 404 (Pubitemid 30490677)
2. R. Erbel, C. Di Mario, and J. Bartunek Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial Lancet 369 2007 1869 1875 (Pubitemid 46829357)
3. G. Ghimire, J. Spiro, and R. Kharbanda Initial evidence for the return of coronary vasoreactivity following the absorption of bioabsorbable magnesium alloy coronary stents EuroIntervention 4 2009 481 484
4. R. Waksman, R. Erbel, and C. Di Mario Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries J Am Coll Cardiol Intv 2 2009 312 320
5. J.A. Ormiston, P.W. Serruys, and E. Regar A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial Lancet 371 2008 899 907 (Pubitemid 351384734)
6. P.W. Serruys, J.A. Ormiston, and Y. Onuma A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods Lancet 373 2009 897 910
7. E.S. Shin, H.M. Garcia-Garcia, and P.W. Serruys A new method to measure necrotic core and calcium content in coronary plaques using intravascular ultrasound radiofrequency-based analysis Int J Cardiovasc Imaging 26 2010 387 396
8. Y. Onuma, P.W. Serruys, and L.E. Perkins Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial Circulation 122 2010 2288 2300
9. J.A. Ormiston, M.W. Webster, and G. Armstrong First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent Catheter Cardiovasc Interv 69 2007 128 131 (Pubitemid 46052603)
10. T. Okamura, S. Garg, and J. Gutiérrez-Chico In vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: an OCT ad hoc analysis of the revision 1.0 and revision 1.1 stent design in the ABSORB clinical trial EuroIntervention 5 2010 932 938
11. S.H. Hofma, W.J. van der Giessen, and B.M. van Dalen Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation Eur Heart J 27 2006 166 170 (Pubitemid 43069032)
12. S. Tanimoto, N. Bruining, and R.T. van Domburg Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology J Am Coll Cardiol 52 2008 1616 1620
13. N. Bruining, S. de Winter, and J.R. Roelandt Monitoring in vivo absorption of a drug-eluting bioabsorbable stent with intravascular ultrasound-derived parameters a feasibility study J Am Coll Cardiol Intv 3 2010 449 456
14. A. Nair, M.P. Margolis, B.D. Kuban, and D.G. Vince Automated coronary plaque characterisation with intravascular ultrasound backscatter: ex vivo validation EuroIntervention 3 2007 113 120
15. A. Nair, B.D. Kuban, E.M. Tuzcu, P. Schoenhagen, S.E. Nissen, and D.G. Vince Coronary plaque classification with intravascular ultrasound radiofrequency data analysis Circulation 106 2002 2200 2206 (Pubitemid 35222213)
16. E.S. Shin, H.M. Garcia-Garcia, and S. Garg Assessment of the serial changes of vessel wall contents in atherosclerotic coronary lesion with bioresorbable everolimus-eluting vascular scaffolds using Shin's method: an IVUS study Int J Cardiovasc Imaging 2010 Nov 16 [E-pub ahead of print]
17. H.M. García-García, N. Gonzalo, and R. Pawar Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis A substudy of the ABSORB clinical trial EuroIntervention 4 2008 443 448
18. K. Sihan, C. Botha, and F. Post Fully automatic three-dimensional quantitative analysis of intracoronary optical coherence tomography: method and Validation Catheter Cardiovasc Interv 74 2009 1058 1065
19. N. Gonzalo, P.W. Serruys, and T. Okamura Optical coherence tomography assessment of the acute effects of stent implantation on the vessel wall: a systematic quantitative approach Heart 95 2009 1913 1919
20. N. Gonzalo, P.W. Serruys, and H.M. Garcia-Garcia Quantitative ex vivo and in vivo comparison of lumen dimensions measured by optical coherence tomography and intravascular ultrasound in human coronary arteries Rev Esp Cardiol 62 2009 615 624
21. P.W. Serruys, A.T. Ong, and J.J. Piek A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: the SPIRIT first trial EuroIntervention 1 2005 58 65
22. J. Gomez-Lara, S. Brugaletta, and R. Diletti A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds Eur Heart J 32 2011 294 304
23. P.W. Serruys, H.E. Luijten, and K.J. Beatt Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months Circulation 77 1988 361 371 (Pubitemid 18060045)
24. Y. Onuma, and P.W. Serruys Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization? Circulation 123 2011 779 797
25. M. Nobuyoshi, T. Kimura, and H. Nosaka Restenosis after successful percutaneous transluminal coronary angioplasty: serial angiographic follow-up of 229 patients J Am Coll Cardiol 12 1988 616 623
26. B.E. Claessen, M.A. Beijk, and V. Legrand Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial Circ Cardiovasc Interv 2 2009 339 347
27. S. Garg, and P.W. Serruys Coronary stents: looking forward J Am Coll Cardiol 56 2010 S43 S78
28. Y. Onuma, P.W. Serruys, and J.A. Ormiston Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial EuroIntervention 6 2010 447 453
29. K. Tsujita, A. Maehara, and G.S. Mintz Impact of myocardial bridge on clinical outcome after coronary stent placement Am J Cardiol 103 2009 1344 1348