Skip to main content
Log in

Optical coherence tomography endpoints in stent clinical investigations: strut coverage

  • Review
  • Published:
The International Journal of Cardiovascular Imaging Aims and scope Submit manuscript

Abstract

Late stent thrombosis (LST) and very LST (VLST) are infrequent complications after drug-eluting stent (DES) implantation, but they carry a significant risk for patients. Delayed healing, which may be represented by incomplete stent coverage, has been observed in necropsy vessel specimens treated with DES. As a result, in vivo assessment of stent coverage, as well as stent apposition using optical coherence tomography (OCT), have been recently used as surrogate safety endpoints in clinical trials testing DES platforms. By adopting strut coverage assessed by OCT, one can assess the safety profile of the new generation of DES in preregistration studies. This article focuses on stent strut coverage as a central predictor of late DES thrombosis from the histopathological point of view, discusses the limitations of the current imaging modalities and presents the technical characteristics of OCT for the detection of neointimal coverage after stent implantation. We also review the preclinical and clinical investigations using this novel imaging modality.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

Abbreviations

OCT:

Optical coherence tomography

DES:

Drug-eluting stent

IVUS:

Intravascular ultrasound

SES:

Sirolimus-eluting stent

PES:

Paclitaxel-eluting stent

ZES:

Zotarolimus-eluting stent

UA:

unstable angina

SA:

Stable angina

CTO:

Chronic total occlusion

MACE:

Major cardiovascular event

MI:

Myocardial infarction

AMI:

Acute myocardial infarction

LST:

Late stent thrombosis

OLP:

Overlap

TLR:

Target lesion revascularization

AUC:

Area under the receiver operating characteristic curve

PCI:

Percutaneous coronary intervention

NIH:

Neointimal hyperplasia

TD-OCT:

Time-domain optical coherence tomography

FD-OCT:

Fourier-domain optical coherence tomography

TVR:

Target vessel revascularization

NSTACS:

Non-ST elevation acute coronary syndrome

CAD:

Coronary artery disease

CI:

Confidence interval

BMS:

Bare metal stent

PI:

Principle investigator

EES:

Everolimus-eluting stent

BAS:

Bio-active stent

DEB:

Drug-eluting balloon

BES:

Biolimus-eluting stent

References

  1. Morice MC, Serruys PW, Sousa JE et al (2002) Randomized study with the sirolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. RAVEL study group. N Engl J Med 346:1773–1780

    Article  PubMed  CAS  Google Scholar 

  2. Stone GW, Ellis SG, Cox DA et al (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. TAXUS-IV investigators. N Engl J Med 350:221–231

    Article  PubMed  CAS  Google Scholar 

  3. Sousa JE, Costa MA, Abizaid A et al (2003) Sirolimus-eluting stent for the treatment of in-stent restenosis: a quantitative angiography and three-dimensional intravascular ultrasound study. Circulation 107:24–27

    Article  PubMed  CAS  Google Scholar 

  4. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D et al (2005) Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease. A randomized controlled trial. JAMA 294:1215–1223

    Article  PubMed  CAS  Google Scholar 

  5. Thuesen L, Kelbaek H, Kløvgaard L et al (2006) Comparison of sirolimus-eluting and bare metal stents in coronary bifurcation lesions: subgroup analysis of the stenting coronary arteries in non-stress/Benestent disease trial (SCANDSTENT). Am Heart J 152:1140–1145

    Article  PubMed  CAS  Google Scholar 

  6. Pasceri V, Patti G, Speciale G et al (2007) Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. Am Heart J 153:749–754

    Article  PubMed  CAS  Google Scholar 

  7. Baumgart D, Klauss V, Baer F et al (2007) One-year results of the SCORPIUS study. A german multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. J Am Coll Cardiol 50:1627–1634

    Article  PubMed  Google Scholar 

  8. Camenzind E, Steg PG, Wijns W (2007) Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation 115:1440–1455

    Article  PubMed  Google Scholar 

  9. Daemen J, Wenawesser P, Tsuchida K, Abrecht L, Vaina S, Morger C et al (2007) Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 369:667–678

    Article  PubMed  CAS  Google Scholar 

  10. Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L, SCAAR Study Group (2007) Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356:1009–1019

    Article  PubMed  CAS  Google Scholar 

  11. Farb A, Heller PF, Shroff S et al (2001) Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 104:473–479

    Article  PubMed  CAS  Google Scholar 

  12. Guagliumi G, Farb A, Musumeci G et al (2003) Images in cardiovascular medicine: sirolimus-eluting stent implanted in human coronary artery for 16 months: pathological findings. Circulation 107:1340–1341

    Article  PubMed  Google Scholar 

  13. Sousa JE, Costa MA, Farb A et al (2004) Images in cardiovascular medicine: vascular healing 4 years after the implantation of sirolimus-eluting stent in humans: a histophatological examination. Circulation 110:e5–e6

    Article  PubMed  Google Scholar 

  14. Virmani R, Guagliumi G, Farb A et al (2004) Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 109:701–705

    Article  PubMed  Google Scholar 

  15. Joner M, Finn AV, Farb A et al (2006) Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48:193–202

    Article  PubMed  Google Scholar 

  16. Luscher TF, Steffel J, Eberli FR et al (2007) Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 115:1051–1058

    Article  PubMed  Google Scholar 

  17. Finn AV, Joner M, Nakazawa G et al (2007) Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 115:2435–2441

    Article  PubMed  Google Scholar 

  18. Nakazawa G, Finn AV, Joner M et al (2008) 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 118:1138–1145

    Article  PubMed  Google Scholar 

  19. Guagliumi G, Sirbu V (2008) Optical coherence tomography: high resolution intravascular imaging to evaluate vascular healing after coronary stenting. Catheter Cardiovasc Interv 72:237–247

    Article  PubMed  Google Scholar 

  20. Tanigawa J, Barlis P, Di Mario C et al (2007) Intravascular optical coherence tomography: optimization of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention 3:128–136

    PubMed  Google Scholar 

  21. Bezerra HG, Costa MA, Guagliumi G et al (2009) Intracoronary optical coherence tomography: a comprehensive review: clinical and research applications. JACC Cardiovasc Interv 2:1035–1046

    Article  PubMed  Google Scholar 

  22. Joner M, Nakazawa G, Finn AV et al (2008) Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 52:333–342

    Article  PubMed  CAS  Google Scholar 

  23. Klugherz BD, Llanos G, Lieuallen W et al (2002) Twenty-eight-day efficacy and pharmacokinetics of the sirolimus-eluting stent. Coron Artery Dis 13:183–188

    Article  PubMed  Google Scholar 

  24. Suzuki T, Kopia G, Hayashi S et al (2001) Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation 104:1188–1193

    Article  PubMed  CAS  Google Scholar 

  25. Carter AJ, Aggarwal M, Kopia GA et al (2004) Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in porcine coronary model. Cardiovasc Res 63:617–624

    Article  PubMed  CAS  Google Scholar 

  26. Regar E, Werner F, Siebert U et al (2000) Reproducibility of neointima quantification with motorized intravascular ultrasound pullback in stented coronary arteries. Am Heart J 139:632–637

    Article  PubMed  CAS  Google Scholar 

  27. Cook S, Wenaweser P, Togni M et al (2007) Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation 115:2426–2434

    Article  PubMed  CAS  Google Scholar 

  28. Alfonso F, Suárez A, Pérez-Vizcayno MJ et al (2007) Intravascular ultrasound findings during episodes of drug-eluting stent thrombosis. J Am Coll Cardiol 50:2095–2097

    Article  PubMed  Google Scholar 

  29. Lee CW, Kang SJ, Park DW et al (2010) Intravascular ultrasound findings in patients with very late stent thrombosis after either drug-eluting or bare-metal stent implantation. J Am Coll Cardiol 55:1936–1942

    Article  PubMed  Google Scholar 

  30. Hassan AK, Bergheanu SC, Stijnen T et al (2010) Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J 31:1172–1180

    Article  PubMed  CAS  Google Scholar 

  31. Fujii K, Carlier SG, Mintz GS et al (2005) Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after drug-eluting stent implantation. An intravascular ultrasound study. J Am Coll Cardiol 45:995–998

    Article  PubMed  CAS  Google Scholar 

  32. Okabe T, Mintz GS, Buch AN, Roy P et al (2007) Intravascular ultrasound parameters associated with stent thrombosis after drug-eluting stent deployment. Am J Cardiol 100:615–620

    Article  PubMed  CAS  Google Scholar 

  33. Lermusiaux P, Martinez R, Donadey A et al (2000) Intravascular ultrasound: limitations and prospects. J Mal Vasc 25:229–236

    PubMed  CAS  Google Scholar 

  34. Di Mario C, Gorge G, Peters R et al (1998) Clinical application and image interpretation in intracoronary ultrasound. Study group on intracoronary imaging of the working group of coronary circulation and of the subgroup on intravascular ultrasound of the working group of echocardiography of the european society of cardiology. Eur Heart J 19:207–229

    Article  PubMed  CAS  Google Scholar 

  35. Di Mario C, Barlis P (2008) Optical coherence tomography: a new tool to detect tissue coverage in drug-eluting stents. JACC Cardiovasc Interv 1:174–175

    Article  PubMed  Google Scholar 

  36. Matsumoto D, Shite J, Shinke T et al (2007) Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J 28:961–967

    Article  PubMed  CAS  Google Scholar 

  37. Sera F, Awata M, Uematsu M et al (2009) Optimal stent-sizing with intravascular ultrasound contributes to complete neointimal coverage after sirolimus-eluting stent implantation assessed by angioscopy. JACC Cardiovasc Interv 2:989–994

    Article  PubMed  Google Scholar 

  38. Kotani J, Awata M, Nanto S et al (2006) Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol 47:2108–2111

    Article  PubMed  CAS  Google Scholar 

  39. Higo T, Ueda Y, Oyabu J et al (2009) Atherosclerotic and thrombogenic neointima formed over sirolimus drug-eluting stent: an angioscopic study. JACC Cardiovasc Imaging 2:616–624

    Article  PubMed  Google Scholar 

  40. Awata M, Kotani J, Uematsu M et al (2007) Serial angioscopic evidence of incomplete neointimal coverage after sirolimus-eluting stent implantation: comparison with bare-metal stents. Circulation 116:910–916

    Article  PubMed  CAS  Google Scholar 

  41. Prati F, Zimarino M, Stabile D et al (2008) Does optical coherence tomography identify arterial healing after stenting? An in vivo comparison with histology on a rabbit carotid model. Heart 94:217–294

    Article  PubMed  CAS  Google Scholar 

  42. Murata A, Wallace-Bradley D, Tellez A et al (2010) Accuracy of optical coherence tomography in the evaluation of neointimal coverage after stent implantation. JACC Cardiovasc Imaging 3:76–84

    Article  PubMed  Google Scholar 

  43. Suzuki Y, Ikeno F, Koizumi T et al (2008) In vivo comparison between optical coherence tomography and intravascular ultrasound for detecting small degrees of in-stent neointima after stent implantation. JACC Cardiovasc Interv 1:168–173

    Article  PubMed  Google Scholar 

  44. Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA (2010) Optical coherence tomography assessment of in vivo vascular response following implantation of overlapping bare-metal and drug-eluting stents. JACC Cardivasc Interv 3:531–539

    Article  Google Scholar 

  45. Guagliumi G, Sirbu V, Costa MA, Musumeci G, Trivisonno A, Matiashvili A, Lortkipanidze N, Mihalcsik L, Valsecchi O, Bezerra HG, Suzuki N, Coletta J, Mintz G, Maehara A, Parise H, Lansky A, Cristea E, Mehran R, Stone G (2011) Long-term strut coverage of paclitaxel eluting stents compared to bare-metal stents implanted during primary PCI in acute myocardial infarction: HORIZONS-OCT. Circulation 123:274–281

    Article  PubMed  CAS  Google Scholar 

  46. Guagliumi G, Sirbu V, Bezerra HG, Zoccai GB, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa MA (2010) Strut coverage and vessel wall response to zotarolimus-eluting and bare metal stents implanted in patients with ST-elevation myocardial infarction: the OCTAMI (optical coherence tomography in acute myocardial infarction) study. JACC Cardiovasc Interv 3:680–687

    Article  PubMed  Google Scholar 

  47. Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Mathiasvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA (2010) Strut coverage and vessel wall response to a new generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: optical coherence tomography drug eluting stent investigation (OCTDESI). Circ Cardiovasc Interv 3:367–375

    Article  PubMed  CAS  Google Scholar 

  48. Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Jüni P, di Mario C (2010) An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J 31:165–176

    Article  PubMed  CAS  Google Scholar 

  49. Kim JS, Hong MK, Fan C, Kim TH, Shim JM, Park SM, Ko YG, Choi D, Jang Y (2010) Intracoronary thrombus formation after drug-eluting stents implantation: optical coherence tomographic study. Am Heart J 159:278–283

    Article  PubMed  CAS  Google Scholar 

  50. Murakami D, Takano M, Yamamoto M, Inami S, Ohba T, Seino Y, Mizuno K (2009) Advanced neointimal growth is not associated with a low risk of in-stent thrombus. Optical coherence tomographic findings after first-generation drug-eluting stent implantation. Circ J 73:1627–1634

    Article  PubMed  Google Scholar 

  51. Fan C, Kim JS, Lee JM, Kim TH, Park SM, Wi J, Paik SI, Ko YG, Choi D, Hong MK, Jang Y (2010) Different vascular healing patterns with various drug-eluting stents in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: optical coherence tomographic findings. Am J Cardiol 105:972–976

    Article  PubMed  CAS  Google Scholar 

  52. Kubo T, Imanishi T, Kitabata H, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Takarada S, Tanaka A, Nakamura N, Mizukoshi M, Tomobuchi Y, Akasaka T (2008) Comparison of vascular response after sirolimus-eluting stent implantation between patients with unstable and stable angina pectoris: a serial optical coherence tomography study. JACC Cardiovasc Imaging 1:475–484

    Article  PubMed  Google Scholar 

  53. Ozaki Y, Okumura M, Ismail TF, Naruse H, Hattori K, Kan S, Ishikawa M, Kawai T, Takagi Y, Ishii J, Prati F, Serruys PW (2010) The fate of incomplete stent apposition with drug-eluting stents: an optical coherence tomography-based natural history study. Eur Heart J 31:1470–1476

    Article  PubMed  Google Scholar 

  54. Kim JS, Jang IK, Kim JS, Kim TH, Takano M, Kume T, Hur NW, Ko YG, Choi D, Hong MK, Jang Y (2009) Optical coherence tomography evaluation of zotarolimus-eluting stents at 9-month follow-up: comparison with sirolimus-eluting stents. Heart 95:1907–1912

    Article  PubMed  CAS  Google Scholar 

  55. Chen BX, Ma FY, Luo W, Ruan JH, Xie WL, Zhao XZ, Sun SH, Guo XM, Wang F, Tian T, Chu XW (2008) Neointimal coverage of bare-metal and sirolimus-eluting stents evaluated with optical coherence tomography. Heart 94:566–570

    Article  PubMed  CAS  Google Scholar 

  56. Xie Y, Takano M, Murakami D, Yamamoto M, Okamatsu K, Inami S, Seimiya K, Ohba T, Seino Y, Mizuno K (2008) Comparison of neointimal coverage by optical coherence tomography of a sirolimus-eluting stent versus a bare-metal stent three months after implantation. Am J Cardiol 102:27–31

    Article  PubMed  CAS  Google Scholar 

  57. Katoh H, Shite J, Shinke T, Matsumoto D, Tanino Y, Ogasawara D, Sawada T, Miyoshi N, Kawamori H, Yoshino N, Hirata K (2009) Delayed neointimalization on sirolimus-eluting stents: 6-month and 12-month follow up by optical coherence tomography. Circ J 73:1033–1037

    Article  PubMed  Google Scholar 

  58. Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D (2009) A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 373:897–910

    Article  PubMed  CAS  Google Scholar 

  59. Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S (2008) A bioabsorbable everolimus-eluting coronary stent system for patients with single de novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 371:899–907

    Article  PubMed  CAS  Google Scholar 

  60. Tamburino C, La Manna A, Di Salvo ME, Sacchetta G, Capodanno D, Mehran R, Dangas G, Corcos T, Prati F (2009) First-in-man 1-year clinical outcomes of the catania coronary stent system with nanothin polyzene-F in de novo native coronary artery lesions: the ATLANTA (assessment of the latest non-thrombogenic angioplasty stent) trial. JACC Cardiovasc Interv 2:197–204

    Article  PubMed  Google Scholar 

  61. Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, Ohba T, Mizuno K (2007) Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol 99:1033–1038

    Article  PubMed  CAS  Google Scholar 

  62. Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y (2009) Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv 2:1240–1247

    Article  PubMed  Google Scholar 

  63. Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R (2007) Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol 27:1500–1510

    Article  PubMed  CAS  Google Scholar 

  64. Tian F, Chen YD, Sun ZJ, Chen L, Yuan F, Song XT, Lü SZ (2009) Evaluation of neointimal coverage of overlapping sirolimus-eluting stents by optical coherence tomography. Chin Med J 20(122):670–674

    Google Scholar 

  65. Bezerra HG, Guagliumi G, Valescchi O, Lortkipanidze N, Rosenthal N, Tahara S, Kyono H, Simon DI, Costa MA (2009) Unraveling the lack of neointimal hyperplasia detected by IVUS using OCT: lack of spatial resolution or a true biological effect? The ODESSA sub-study. J Am Coll Cardiol 53:2523

    Google Scholar 

  66. Ishigami K, Uemura S, Morikawa Y, Soeda T, Okayama S, Nishida T, Takemoto Y, Onoue K, Somekawa S, Takeda Y, Kawata H, Horii M, Saito Y (2009) Long-term follow-up of neointimal coverage of sirolimus-eluting stents—evaluation with optical coherence tomography. Circ J 73:2300–2307

    Article  PubMed  Google Scholar 

  67. Bezerra HG, Guagliumi G, Kyono H, Tahara S, Rosenthal N, Musumeci G, Sirbu V, Valescchi O, Aprile A, Simon DI, Costa MA (2009) Determining the optimal cross-sectional analysis interval for OCT assessment of coronary stenting. Circulation 120:S1000

    Google Scholar 

  68. Yao ZH, Matsubara T, Inada T, Suzuki Y, Suzuki T (2008) Neointimal coverage of sirolimus-eluting stents 6 months and 12 months after implantation: evaluation by optical coherence tomography. Chin Med J 121:503–507

    PubMed  Google Scholar 

Download references

Conflict of interest

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Marco Costa.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Tahara, S., Chamié, D., Baibars, M. et al. Optical coherence tomography endpoints in stent clinical investigations: strut coverage. Int J Cardiovasc Imaging 27, 271–287 (2011). https://doi.org/10.1007/s10554-011-9796-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10554-011-9796-3

Keywords

Navigation