Skip to main content
SpringerLink
Log in

Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial

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

Abstract

We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R, RAVEL Study Group (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. N Engl J Med 346(23):1773–1780

    Article  CAS  PubMed  Google Scholar 

  2. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, SIRIUS Investigators (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349(14):1315–1323

    Article  CAS  PubMed  Google Scholar 

  3. Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators (2004) One-year clinical results with the slow-release, polymer-based paclitaxel eluting TAXUS stent: the TAXUS-IV trial. Circulation 109(16):1942–1947

    Article  CAS  PubMed  Google Scholar 

  4. Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350(3):221–231

    Article  CAS  PubMed  Google Scholar 

  5. Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvänne M, Suttorp MJ, Violini R, Schömig A (2007) Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J 28(22):2706–2713

    Article  PubMed  Google Scholar 

  6. Stettler C, Allemann S, Wandel S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, De Carlo M, Erglis A, Chechi T, Ortolani P, Schalij MJ, Diem P, Meier B, Windecker S, Jüni P (2008) Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis. BMJ 337:a1331

    Article  PubMed  PubMed Central  Google Scholar 

  7. Kirtane AJ, Ellis SG, Dawkins KD, Colombo A, Grube E, Popma JJ, Fahy M, Leon MB, Moses JW, Mehran R, Stone GW (2008) Paclitaxel eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials. J Am Coll Cardiol 51(7):708–715

    Article  CAS  PubMed  Google Scholar 

  8. Nakazawa G, Finn AV, Ladich E, Ribichini F, Coleman L, Kolodgie FD, Virmani R (2008) Drug-eluting stent safety: findings from preclinical studies. Expert Rev Cardiovasc Ther 6:1379–1391

    Article  PubMed  Google Scholar 

  9. Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R (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 

  10. Virmani R, Farb A, Guagliumi G, Kolodgie FD (2004) Drug-eluting stents: caution and concerns for long-term outcome. Coron Artery Dis 15:313–318

    Article  PubMed  Google Scholar 

  11. Feres F, Costa JR Jr, Abizaid A (2006) Very late thrombosis after drug-eluting stents. Catheter Cardiovasc Interv 68:83–88

    Article  PubMed  Google Scholar 

  12. Cook S, Wenaweser P, Togni M, Billinger M, Morger C, Seiler C, Vogel R, Hess O, Meier B, Windecker S (2007) Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation 115:2426–2434

    Article  CAS  PubMed  Google Scholar 

  13. Siqueira DA, Abizaid AA, Costa Jde R, Feres F, Mattos LA, Staico R, Abizaid AA, Tanajura LF, Chaves A, Centemero M, Sousa AG, Sousa JE (2007) Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes. Eur Heart J 28:1304–1309

    Article  PubMed  Google Scholar 

  14. Lemos PA, Abizaid AA, Meireles GC, Sarmento-Leite R, Prudente M, Cantarelli M, Dourado AD, Mariani J Jr, Perin MA, Costantini C, Costa RA, Costa JR, Chamie D, Campos CA, Ribeiro E (2015) Metallic limus-eluting stents abluminally coated with biodegradable polymers: angiographic and clinical comparison of a novel ultra-thin sirolimus stent versus biolimus stent in the DESTINY randomized trial. Cardiovasc Ther 33(6):367–371

    Article  CAS  PubMed  Google Scholar 

  15. Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG (2001) American College of Cardiology Clinical Expert Consensus Document on Standards for Acquisition, Measurement and Reporting of Intravascular Ultrasound Studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 37(5):1478–1492

    Article  CAS  PubMed  Google Scholar 

  16. Tearney GJ, Regar E, Akasaka T et al (2012) 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 59:1058–1072

    Article  PubMed  Google Scholar 

  17. Prati F, Guagliumi G, Mintz GS et al (2012) Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J 33:2513–2520

    Article  PubMed  PubMed Central  Google Scholar 

  18. Guagliumi G, Sirbu V, Musumeci G et al (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  CAS  PubMed  Google Scholar 

  19. Guagliumi G, Musumeci G, Sirbu V et al (2010) Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. J Am Coll Cardiol Cardiovasc Interv 3:531–539

    Article  Google Scholar 

  20. Ribeiro EE, Campos CM, Ribeiro HB, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA (2014) First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial. EuroIntervention 9(12):1380–1384

    Article  PubMed  Google Scholar 

  21. Oliveira MD, Ribeiro EE, Campos CM, Ribeiro HB, Faillace BL, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA (2015) Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial. Cardiovasc Diagn Ther 5(4):264–270

    PubMed  PubMed Central  Google Scholar 

  22. Kubo T, Akasaka T, Kozuma K, Kimura K, Fusazaki T, Okura H, Shinke T, Ino Y, Hasegawa T, Takashima H, Takamisawa I, Yamaguchi H, Igarashi K, Kadota K, Tanabe K, Nakagawa Y, Muramatsu T, Morino Y, Kimura T, NEXT Investigators (2014) Vascular response to drug-eluting stent with biodegradable vs. durable polymer. Optical coherence tomography substudy of the NEXT. Circ J 78(10):2408–2414

    Article  PubMed  Google Scholar 

  23. Adriaenssens T, Ughi GJ, Dubois C, De Cock D, Onsea K, Bennett J, Wiyono S, Sinnaeve P, Coosemans M, Ferdinande B, Belmans A, D’hooge J, Desmet W (2016) STACCATO (assessment of stents trut apposition and coverage in coronary arteries with optical coherence tomography in patients with STEMI, NSTEMI and stable/unstable angina undergoing everolimus vs. biolimus A9-eluting stent implantation): a randomised controlled trial. EuroIntervention 11(14):e1619–e1626

    Article  PubMed  Google Scholar 

  24. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R (2007) Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 115(18):2435–2441

    Article  PubMed  Google Scholar 

  25. 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 (2012) Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. J Am Coll Cardiol Cardiovasc Interv 5(1):12–20

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, 04012, Brazil

    J. Ribamar Costa Jr., Daniel Chamié, Alexandre A. C. Abizaid & Ricardo Costa

  2. Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil

    Expedito Ribeiro, Carlos A. Campos & Pedro A. Lemos

  3. Hospital do Servidor Público Estadual—IAMSPE, São Paulo, SP, Brazil

    George C. Meireles

  4. Hospital Encore, Aparecida de Goiânia, GO, Brazil

    Maurício Prudente

  5. Cardiovascular Research Center, São Paulo, SP, Brazil

    Juliana P. Castro

Authors
  1. J. Ribamar Costa Jr.
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Daniel Chamié
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Alexandre A. C. Abizaid
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Expedito Ribeiro
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. George C. Meireles
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Maurício Prudente
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Carlos A. Campos
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Juliana P. Castro
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Ricardo Costa
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Pedro A. Lemos
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to J. Ribamar Costa Jr..

Ethics declarations

This study was sponsored by Scitech. However, the company did not interfere in the data analysis and report.

Conflict of interest

All institutions involved received research grant to conduct the trial. However, none of the authors have any individual conflict of interest regarding this publication.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Additional information

Clinical trial registration: ClinicalTrials.gov identifier NCT01856088.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Costa, J.R., Chamié, D., Abizaid, A.A.C. et al. Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial. Int J Cardiovasc Imaging 33, 161–168 (2017). https://doi.org/10.1007/s10554-016-0992-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10554-016-0992-z

Keywords

Search

Navigation