Bioresorbable vascular scaffold treatment induces the formation of neointimal cap that seals the underlying plaque without compromising the luminal dimensions: A concept based on serial optical coherence tomography data

EuroIntervention

Volumn 11, Issue 7, 2015, Pages 746-756

  Bourantas, Christos V ^a   Serruys, Patrick W ^a   Nakatani, Shimpei ^a   Zhang, Yao Jun ^a   Farooq, Vasim ^a   Diletti, Roberto ^a   Ligthart, Jurgen ^a   Sheehy, Alexander ^b   Van Geuns, Robert Jan M ^a   McClean, Dougal ^c   Chevalier, Bernard ^d   Windecker, Stephan ^e   Koolen, Jacques ^f   Ormiston, John ^g   Whitbourn, Robert ^h   Rapoza, Richard ^b   Veldhof, Susan ^b   Onuma, Yoshinobu ^a   Garcia Garcia, Hector M ^a   Guagliumi, Giulio ⁱ  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ABBOTT VASCULAR   (United States)

^c CHRISTCHURCH HOSPITAL   (New Zealand)

^d INSTITUT CARDIOVASCULAIRE PARIS SUD   (France)

^e UNIVERSITY OF BERN   (Switzerland)

^f CATHARINA HOSPITAL   (Netherlands)

^g AUCKLAND CITY HOSPITAL   (New Zealand)

^h ST VINCENT S HOSPITAL   (Australia)

ⁱ PAPA GIOVANNI XXIII HOSPITAL   (Italy)

Author keywords

Bioresorbable vascular scaffold; High risk plaque; Neointimal formation; Optical coherence tomography

Indexed keywords

ADULT; ARTICLE; ATHEROMA; BARE METAL STENT; BIORESORBABLE SCAFFOLD; BIORESORBABLE VASCULAR SCAFFOLD; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEVICE SAFETY; FEMALE; FOLLOW UP; HEART DISEASE; HEART INFARCTION; HUMAN; MALE; MULTICENTER STUDY; NEOINTIMA; OBSERVATIONAL STUDY; OPTICAL COHERENCE TOMOGRAPHY; OPTICAL COHERENCE TOMOGRAPHY DEVICE; PHENOTYPE; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; TARGET LESION REVASCULARIZATION; THIN CAPPED FIBROATHEROMA; ADVERSE EFFECTS; AGED; ATHEROSCLEROTIC PLAQUE; BIODEGRADABLE IMPLANT; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; CORONARY ANGIOGRAPHY; CORONARY BLOOD VESSEL; DEVICES; FIBROSIS; MIDDLE AGED; PATHOLOGY; PERCUTANEOUS CORONARY INTERVENTION; PREDICTIVE VALUE; PROSTHESIS DESIGN; RADIOGRAPHY; STENT; TIME FACTOR; TREATMENT OUTCOME;

METAL;

ABSORBABLE IMPLANTS; AGED; CLINICAL TRIALS AS TOPIC; CORONARY ANGIOGRAPHY; CORONARY ARTERY DISEASE; CORONARY VESSELS; FEMALE; FIBROSIS; FOLLOW-UP STUDIES; HUMANS; MALE; METALS; MIDDLE AGED; NEOINTIMA; PERCUTANEOUS CORONARY INTERVENTION; PHENOTYPE; PLAQUE, ATHEROSCLEROTIC; PREDICTIVE VALUE OF TESTS; PROSTHESIS DESIGN; STENTS; TIME FACTORS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME;

EID: 84947921384     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY14M10_06     Document Type: Article

References (37)

1. 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.
2. 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.
3. 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 bioab-sorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009; 373: 897-910.
4. Bourantas CV, Papafaklis MI, Kotsia A, Farooq V, Muramatsu T, Gomez-Lara J, Zhang YJ, Iqbal J, Kalatzis FG, Naka KK, Fotiadis DI, Dorange C, Wang J, Rapoza R, Garcia-Garcia HM, Onuma Y, Mchalis LK, Serruys PW. Effect of the endothelial shear stress patterns on neointimal proliferation following drug-eluting bioresorbable vascular scaffold implantation: an optical coherence tomography study. JACC Cardiovasc Interv. 2014; 7: 315-24.
5. Onuma Y, Serruys PW, Perkins LE, Okamura T, Gonzalo N, Garcia-Garcia HM, Regar E, Kamberi M, Powers JC, Rapoza R, van Beusekom H, van der Giessen W, Virmani R. 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. 2010; 122: 2288-300.
6. Brugaletta S, Radu MD, Garcia-Garcia HM, Heo JH, Farooq V, Girasis C, van Geuns RJ, Thuesen L, McClean D, Chevalier B, Windecker S, Koolen J, Rapoza R, Miquel-Hebert K, Ormiston J, Serruys PW. Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: can the scaffold cap the plaque? Atherosclerosis. 2012; 221: 106-12.
7. Wykrzykowska JJ, Diletti R, Gutierrez-Chico JL, van Geuns RJ, van der Giessen WJ, Ramcharitar S, Duckers HE, Schultz C, de Feyter P, van der Ent M, Regar E, de Jaegere P, Garcia-Garcia HM, Pawar R, Gonzalo N, Ligthart J, de Schepper J, van den Berg N, Milewski K, Granada JF, Serruys PW. Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT). EuroIntervention. 2012; 8: 945-54.
8. 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. 2010; 122: 2301-12.
9. Diletti R, Garcia-Garcia HM, Bourantas CV, van Geuns RJ, Van Mieghem NM, Agostoni P, Muramatsu T, Farooq V, Spencer R, De Schepper J, Pomeranz M, Stella P, Serruys PW. Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: the Svelte Coronary Stent Integrated Delivery System first-in-man trial. EuroIntervention. 2013; 9: 125-34.
10. Guagliumi G, Costa MA, Sirbu V, Musumeci G, Bezerra HG, Suzuki N, Matiashvili A, Lortkipanidze N, Mihalcsik L, Trivisonno A, Valsecchi O, Mintz GS, Dressler O, Parise H, Maehara A, Cristea E, Lansky AJ, Mehran R, Stone GW. Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial. Circulation. 2011; 123: 274-81.
11. Bruining N, de Winter S, Roelandt JR, Regar E, Heller I, van Domburg RT, Hamers R, Onuma Y, Dudek D, Webster MW, Thuesen L, Ormiston JA, Cheong WF, Mquel-Hebert K, Veldhof S, Serruys PW. Monitoring in vivo absorption of a drug-eluting bioab-sorbable stent with intravascular ultrasound-derived parameters a feasibility study. JACC Cardiovasc Interv. 2010; 3: 449-56.
12. Brugaletta S, Gomez-Lara J, Garcia-Garcia HM, Heo JH, Farooq V, van Geuns RJ, Chevalier B, Windecker S, McClean D, Thuesen L, Whitbourn R, Meredith I, Dorange C, Veldhof S, Rapoza R, Ormiston JA, Serruys PW. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold. Int J Cardiovasc Imaging. 2012; 28: 1307-14.
13. Tearney GJ, Waxman S, Shishkov M, Vakoc BJ, Suter MJ, Freilich MI, Desjardins AE, Oh WY, Bartlett LA, Rosenberg M, Bouma BE. Three-dimensional coronary artery microscopy by intracoronary optical frequency domain imaging. JACC Cardiovasc Imaging. 2008; 1: 752-61.
14. Waxman S, Freilich MI, Suter MJ, Shishkov M, Bilazarian S, Virmani R, Bouma BE, Tearney GJ. A case of lipid core plaque progression and rupture at the edge of a coronary stent: elucidating the mechanisms of drug-eluting stent failure. Circ Cardiovasc Interv. 2010; 3: 193-6.
15. Ormiston JA, Serruys PW, Onuma Y, 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, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the 2nd generation of Absorb everolimus eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012; 5: 620-32.
16. Nishio S, Kosuga K, Igaki K, Okada M, Kyo E, Tsuji T, Takeuchi E, Inuzuka Y, Takeda S, Hata T, Takeuchi Y, Kawada Y, Harita T, Seki J, Akamatsu S, Hasegawa S, Bruining N, Brugaletta S, de Winter S, Muramatsu T, Onuma Y, Serruys PW, Ikeguchi S. Long-term (>10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation. 2012; 125: 2343-53.
17. Bourantas CV, Garcia-Garcia HM, Diletti R, Muramatsu T, Serruys PW. Early detection and invasive passivation of future culprit lesions: a future potential or an unrealistic pursuit of chimeras? Am Heart J. 2013; 165: 869-81.e4.
18. Kornowski R, Hong MK, Tio FO, Bramwell O, Wu H, Leon MB. In-stent restenosis: contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol. 1998; 31: 224-30.
19. Kibos A, Campeanu A, Tintoiu I. Pathophysiology of coronary artery in-stent restenosis. Acute Card Care. 2007; 9: 111-9.
20. Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002; 105: 2974-80.
21. Farooq V, Gogas BD, Serruys PW. Restenosis: delineating the numerous causes of drug-eluting stent restenosis. Circ Cardiovasc Interv. 2011; 4: 195-205.
22. Shimada Y, Kataoka T, Courtney BK, Morino Y, Bonneau HN, Yock PG, Grube E, Honda Y, Fitzgerald PJ. Influence of plaque calcium on neointimal hyperplasia following bare metal and drug-eluting stent implantation. Catheter Cardiovasc Interv. 2006; 67: 866-9.
23. Kubo T, Maehara A, Mintz GS, Garcia-Garcia HM, Serruys PW, Suzuki T, Klauss V, Sumitsuji S, Lerman A, Marso SP, Margolis MP, Margolis JR, Foster MC, De Bruyne B, Leon MB, Stone GW. Analysis of the long-term effects of drug-eluting stents on coronary arterial wall morphology as assessed by virtual histology intravascular ultrasound. Am Heart J. 2010; 159: 271-7.
24. Manfrini O, Mont E, Leone O, Arbustini E, Eusebi V, Virmani R, Bugiardini R. Sources of error and interpretation of plaque morphology by optical coherence tomography. Am J Cardiol. 2006; 98: 156-9.
25. Kimura T, Tamura T, Yokoi H, Nobuyoshi M. Long-term clinical and angiographic follow-up after placement of Palmaz-Schatz coronary stent: a single center experience. J Interv Cardiol. 1994; 7: 129-39.
26. Shiratori Y, Brugaletta S, Alvarez-Contreras L, Azpeitia Y, Ospino N, Gaido S, Delahanty A, Santos A, Martin-Yuste V, Masotti M, Serruys PW, Windecker S, Sabate M. One-year head to head comparison of the neointimal response between sirolimus eluting stent with reservoir technology and everolimus eluting stent: an optical coherence tomography study. Catheter Cardiovasc Interv. 2013; 82:E428-36.
27. Kim JS, Hong MK, Shin DH, Kim BK, Ko YG, Choi D, Jang Y Quantitative and qualitative changes in DES-related neointimal tissue based on serial OCT. JACC Cardiovasc Imaging. 2012; 5: 1147-55.
28. Radu MD, Raber L, Heo J, Gogas BD, Jorgensen E, Kelbaek H, Muramatsu T, Farooq V, Helqvist S, Garcia-Garcia HM, Windecker S, Saunamaki K, Serruys PW. Natural history of optical coherence tomography-detected non-flow-limiting edge dissections following drug-eluting stent implantation. EuroIntervention. 2014; 9: 1085-94.
29. Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia H, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonada S, Suter M, Takarada S, Tanaka A, Terashima M, Troels T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012; 59: 1058-72.
30. Raber L, Radu MD, Garcia-Garcia HM, Akasaka T, Banz Y, Kume T, Windecker S, Serruys PW. Atherosclerosis. In: Radu MD, Raber L, Garcia-Garcia H, Serruys PW, editors. The clinical atlas of optical coherence tomography. Toulouse, France: Europa Edition; 2012.
31. Sheehy A, Gutierrez-Chico JL, Diletti R, Oberhauser JP Glauser T, Harrington J, Kossuth MB, Rapoza RJ, Onuma Y, Serruys PW. In vivo characterisation of bioresorbable vascular scaffold strut interfaces using optical coherence tomography with Gaussian line spread function analysis. EuroIntervention. 2012; 7: 1227-35.
32. Gutierrez-Chico JL, Radu MD, Diletti R, Sheehy A, Kossuth MB, Oberhauser JP, Glauser T, Harrington J, Rapoza RJ, Onuma Y, Serruys PW. Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly(L-lactide) backbone of a bioresorbable vascular scaffold. Circ J. 2012; 76: 342-50.
33. 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. Tissue coverage of a hydrophilic polymercoated 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. 2011; 32: 2454-63.
34. Gnanadesigan M, van Soest G, White S, Scoltock S, Ughi GJ, Baumbach A, van der Steen AF, Regar E, Johnson TW. Effect of temperature and fixation on the optical properties of atherosclerotic tissue: a validation study of an ex-vivo whole heart cadaveric model. Biomed Opt Express. 2014; 5: 1038-49.
35. Virmani R, Burke AP, Farb A, Kolodgie FD. Pathology of the vulnerable plaque. J Am Coll Cardiol. 2006; 47:C13-8.
36. Burke AP, Farb A, Malcom GT, Liang YH, Smialek J, Virmani R. Coronary risk factors and plaque morphology in men with coronary disease who died suddenly. N Engl J Med. 1997; 336: 1276-82.
37. Cohen J. A coefficient of agreement for nominal scales. Educ 'Psychol Meas. 1960; 20: 37-46.