Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: A 3-year serial optical coherence tomography study

JACC: Cardiovascular Interventions

Volumn 7, Issue 12, 2014, Pages 1361-1369

  Zhang, Yao Jun ^a,b   Iqbal, Javaid ^a,c   Nakatani, Shimpei ^a   Bourantas, Christos V ^a   Campos, Carlos M ^a   Ishibashi, Yuki ^a   Cho, Yun Kyeong ^a   Veldhof, Susan ^d   Wang, Jin ^d   Onuma, Yoshinobu ^a   Garcia Garcia, Hector M ^a   Dudek, Dariusz ^e   Van Geuns, Robert Jan ^a   Serruys, Patrick W ^a,f  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b NANJING MEDICAL UNIVERSITY   (China)

^c UNIVERSITY OF SHEFFIELD   (United Kingdom)

^d ABBOTT VASCULAR   (United States)

^e JAGIELLONIAN UNIVERSITY   (Poland)

^f IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

Absorb BVS; Bioresorbable scaffold; Edge vascular response; In scaffold vascular response; Optical coherence tomography

Indexed keywords

ADULT; ARTICLE; BIORESORBABLE SCAFFOLD; BLOOD VESSEL REACTIVITY; CLINICAL ARTICLE; COHORT ANALYSIS; DRUG ELUTING STENT; EVEROLIMUS ELUTING BIORESORBABLE SCAFFOLD; FEMALE; FOLLOW UP; HEART INFARCTION; HUMAN; LEFT ANTERIOR DESCENDING CORONARY ARTERY; MALE; OPTICAL COHERENCE TOMOGRAPHY; PRIORITY JOURNAL; RESTENOSIS; STENT THROMBOSIS; ADVERSE EFFECTS; AGED; ANALOGS AND DERIVATIVES; BIODEGRADABLE IMPLANT; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CORONARY BLOOD VESSEL; CORONARY RESTENOSIS; CORONARY THROMBOSIS; DEVICES; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PREDICTIVE VALUE; PROSTHESIS DESIGN; TIME FACTOR; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

BIOCOMPATIBLE COATED MATERIAL; CARDIOVASCULAR AGENT; EVEROLIMUS; RAPAMYCIN;

ABSORBABLE IMPLANTS; AGED; ANGIOPLASTY, BALLOON, CORONARY; CARDIOVASCULAR AGENTS; COATED MATERIALS, BIOCOMPATIBLE; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; CORONARY THROMBOSIS; CORONARY VESSELS; EVEROLIMUS; FEMALE; HUMANS; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; PROSTHESIS DESIGN; SIROLIMUS; TIME FACTORS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME;

EID: 84922571413     PISSN: 19368798     EISSN: 18767605     Source Type: Journal    
DOI: 10.1016/j.jcin.2014.06.025     Document Type: Article

References (34)

1. Albiero R, Nishida T, Adamian M, et al. Edge restenosis after implantation of high activity (32)P radioactive beta-emitting stents. Circulation 2000;101:2454-7.
2. van Der Giessen WJ, Regar E, Harteveld MS, et al. "Edge Effect" of (32)p radioactive stents is caused by the combination of chronic stent injury and radioactive dose falloff. Circulation 2001;104: 2236-41.
3. Serruys PW, Kay IP. I like the candy, I hate the wrapper: the (32)P radioactive stent. Circulation 2000;101:3-7.
4. Serruys PW, Ormiston JA, Sianos G, et al. Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial. J Am Coll Cardiol 2004;44:1363-7.
5. Gogas BD, Garcia-Garcia HM, Onuma Y, et al. Edge vascular response after percutaneous coronary intervention: an intracoronary ultrasound and optical coherence tomography appraisal: from radioactive platforms to first- and secondgeneration drug-eluting stents and bioresorbable scaffolds. J Am Coll Cardiol Intv 2013;6:211-21.
6. Serruys PW, Silber S, Garg S, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010;363:136-46.
7. Windecker S, Serruys PW, Wandel S, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet 2008; 372:1163-73.
8. Gogas BD, Bourantas CV, Garcia-Garcia HM, et al. The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: insights from the first-in-man ABSORB Cohort B and SPIRIT II trials. EuroIntervention 2013;9:709-20.
9. Ormiston JA, Serruys PW, Onuma Y, et al. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv 2012;5: 620-32.
10. Gogas BD, Onuma Y, van Geuns RJ, Serruys PW. The edge vascular response following implantation of a fully bioresorbable device: 'a miss always counts'. Int J Cardiol 2012;158: 455-7.
11. Gogas BD, Muramatsu T, Garcia-Garcia HM, et al. In vivo three dimensional optical coherence tomography. A novel imaging modality to visualize the edge vascular response. Int J Cardiol 2013; 164:e35-7.
12. Serruys PW, Onuma Y, Dudek D, et al. 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.
13. Nakatani S, Onuma Y, Ishibashi Y, et al. Early (before 6 months), late (6-12 months) and very late (after 12 months) angiographic scaffold restenosis in the ABSORB Cohort B trial. Euro- Intervention 2014 Feb 27 [E-pub ahead of print].
14. Iqbal J, Gunn J, Serruys PW. Coronary stents: historical development, current status and future directions. Br Med Bull 2013;106:193-211.
15. Weissman NJ, Wilensky RL, Tanguay JF, et al. Extent and distribution of in-stent intimal hyperplasia and edge effect in a non-radiation stent population. Am J Cardiol 2001;88:248-52.
16. Tearney GJ, Regar E, Akasaka T, et al. 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.
17. Muramatsu T, Garcia-Garcia HM, Onuma Y, et al. Intimal flaps detected by optical frequency domain imaging in the proximal segments of native coronary arteries. Circ J 2013;77:2327-33.
18. Popma JJ, Leon MB, Moses JW, et al. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation 2004;110:3773-80.
19. King SB 3rd, Williams DO, Chougule P, et al. Endovascular beta-radiation to reduce restenosis after coronary balloon angioplasty: results of the beta energy restenosis trial (BERT). Circulation 1998;97:2025-30.
20. Condado JA, Waksman R, Gurdiel O, et al. Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans. Circulation 1997;96:727-32.
21. Wakabayashi K, Waksman R, Weissman NJ. Edge effect from drug-eluting stents as assessed with serial intravascular ultrasound: a systematic review. Circ Cardiovasc Interv 2012;5:305-11.
22. Serruys PW, Degertekin M, Tanabe K, et al. Vascular responses at proximal and distal edges of paclitaxel-eluting stents: serial intravascular ultrasound analysis from the TAXUS II trial. Circulation 2004;109:627-33.
23. Weissman NJ, Ellis SG, Grube E, et al. Effect of the polymer-based, paclitaxel-eluting TAXUS Express stent on vascular tissue responses: a volumetric intravascular ultrasound integrated analysis from the TAXUS IV, V, and VI trials. Eur Heart J 2007;28:1574-82.
24. Sakurai R, Hongo Y, Yamasaki M, et al. Detailed intravascular ultrasound analysis of Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy stent in de novo coronary lesions (results from the ENDEAVOR II trial). Am J Cardiol 2007;100:818-23.
25. Waseda K, Miyazawa A, Ako J, et al. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol Intv 2009;2:779-84.
26. Jimenez-Quevedo P, Sabate M, Angiolillo DJ, et al. Vascular effects of sirolimus-eluting versus bare-metal stents in diabetic patients: threedimensional ultrasound results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial. J Am Coll Cardiol 2006;47:2172-9.
27. Jensen LO, Maeng M, Mintz GS, et al. Serial intravascular ultrasound analysis of peri-stent remodeling and proximal and distal edge effects after sirolimus-eluting or paclitaxel-eluting stent implantation in patients with diabetes mellitus. Am J Cardiol 2009;103:1083-8.
28. Shimohama T, Ako J, Yamasaki M, et al. SPIRIT III JAPAN versus SPIRIT III USA: a comparative intravascular ultrasound analysis of the everolimuseluting stent. Am J Cardiol 2010;106:13-7.
29. Arbab-Zadeh A, DeMaria AN, Penny WF, Russo RJ, Kimura BJ, Bhargava V. Axial movement of the intravascular ultrasound probe during the cardiac cycle: implications for three-dimensional reconstruction and measurements of coronary dimensions. Am Heart J 1999;138:865-72.
30. von BC, de Vrey EA, Mintz GS, et al. ECGgated three-dimensional intravascular ultrasound: feasibility and reproducibility of the automated analysis of coronary lumen and atherosclerotic plaque dimensions in humans. Circulation 1997; 96:2944-52.
31. Bruining N, von BC, de Feyter PJ, et al. ECGgated versus nongated three-dimensional intracoronary ultrasound analysis: implications for volumetric measurements. Cathet Cardiovasc Diagn 1998;43:254-60.
32. Gogas BD, Serruys PW, Diletti R, et al. Vascular response of the segments adjacent to the proximal and distal edges of the ABSORB everolimuseluting bioresorbable vascular scaffold: 6-month and 1-year follow-up assessment: a virtual histology intravascular ultrasound study from the first-in-man ABSORB cohort B trial. J Am Coll Cardiol Intv 2012;5:656-65.
33. Serruys PW, Onuma Y, Garcia-Garcia HM, et al. 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.
34. Strandberg E, Zeltinger J, Schulz DG, Kaluza GL. Late positive remodeling and late lumen gain contribute to vascular restoration by a non-drug eluting bioresorbable scaffold: a fouryear intravascular ultrasound study in normal porcine coronary arteries. Circ Cardiovasc Interv 2012;5:39-46.