Advertisement

Cardiovascular Drugs and Therapy

, Volume 33, Issue 5, pp 557–566 | Cite as

Five-Year Outcomes of Biodegradable Polymer Drug-Eluting Stents Versus Second-Generation Durable Polymer Drug-Eluting Stents: a Meta-Analysis of Randomized Controlled Trials

  • Yake Lou
  • Ying Yu
  • Ziwei Xi
  • Yanan Gao
  • Wei LiuEmail author
  • Xiaomin NieEmail author
ORIGINAL ARTICLE
  • 37 Downloads

Abstract

Purpose

We investigated the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) versus second-generation durable polymer drug-eluting stents (DP-DES) in a follow-up period of 5 years.

Methods

A meta-analysis was performed using data from the PubMed, EMBASE, and Cochrane Library databases. The primary endpoint was target lesion failure (TLF), a composite endpoint of safety and efficacy, which included cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Secondary endpoints were all-cause death, MI, TLR, definite or probable stent thrombosis (ST), and definite or probable very late ST. In addition, we performed subgroup analyses based on patient and stent characteristics.

Results

Nine randomized controlled trials (RCTs) in 11,817 patients were included in the meta-analysis. Compared with second-generation DP-DES, BP-DES was not associated with increased risk of TLF (odds ratio (OR) 1.06, 95 % confidence interval [CI] 0.94–1.20; p = 0.33), all-cause death (OR 1.04, [0.92–1.18], p = 0.49), myocardial infarction (OR 0.97, [0.83–1.13], p = 0.67), target lesion revascularization (OR 1.08, [0.94–1.23], p = 0.27), definite or probable stent thrombosis (OR 0.85, [0.66–1.11], p = 0.24), or definite or probable very late stent thrombosis (OR 0.86, [0.58–1.26],p = 0.43). Furthermore, the subgroup analyses did not reveal any statistically significant differences between the stent groups.

Conclusion

At 5 years of follow-up, the safety and efficacy of BP-DES are clinically comparable to those of second-generation DP-DES.

Keywords

Drug-eluting stents Biodegradable polymer Durable polymer Meta-analysis Everolimus Zotarolimus 

Notes

Acknowledgments

We thank Clare Cox, PhD, from Liwen Bianji, Edanz Editing China (www.liwenbianji.cn/ac), for editing the English text of a draft of this manuscript.

Funding Information

This work was supported by the National Natural Science Foundation of China (NO. 81470429) and Beijing Science and Technology Development Fund of Traditional Chinese Medicine (NO. JJ2016-31).

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no conflict of interest.

Ethical Approval

This article does not contain any studies with human participants performed by any of the authors.

Supplementary material

10557_2019_6912_MOESM1_ESM.docx (642 kb)
ESM 1 (DOCX 642 kb)

References

  1. 1.
    Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370(9591):937–48.CrossRefGoogle Scholar
  2. 2.
    Ali ZA. The science of stents: angioplasty turns 40. Cardiovasc Res. 2017;113(10):e35–7.CrossRefGoogle Scholar
  3. 3.
    Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356(10):998–1008.CrossRefGoogle Scholar
  4. 4.
    Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Gruntzig Lecture ESC 2014. Eur Heart J. 2015;36(47):3320–31.CrossRefGoogle Scholar
  5. 5.
    Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48(1):193–202.CrossRefGoogle Scholar
  6. 6.
    Wang Y, Dong P, Li L, Li X, Wang H, Yang X, et al. Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents for patients with coronary artery disease: an update meta-analysis. Cardiovasc Drugs Ther. 2014;28(4):379–85.CrossRefGoogle Scholar
  7. 7.
    Kang SH, Park KW, Kang DY, Lim WH, Park KT, Han JK, et al. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014;35(17):1147–58.CrossRefGoogle Scholar
  8. 8.
    Sakurai R, Burazor I, Bonneau HN, Kaneda H. Long-term outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents: a meta-analysis of randomized controlled trials. Int J Cardiol. 2016;223:1066–71.CrossRefGoogle Scholar
  9. 9.
    Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vázquez N, Valdés M, et al. Biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: final 5-year report from the COMPARE II trial (abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent). JACC Cardiovasc Interv. 2017;10(12):1215–21.CrossRefGoogle Scholar
  10. 10.
    Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51.CrossRefGoogle Scholar
  11. 11.
    Moher D, Liberati A, Tetzlaff J, Altman DG, The PG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.CrossRefGoogle Scholar
  12. 12.
    Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ (Clinical research ed). 2003;327(7414):557–60.CrossRefGoogle Scholar
  13. 13.
    Li C, Xu B, Guan C, Gao R. Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions. Chin J Cardiol. 2017;45(11):940–7.Google Scholar
  14. 14.
    Kufner S, Byrne RA, Valeskini M, Schulz S, Ibrahim T, Hoppmann P, et al. Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial. EuroIntervention. 2016;11(12):1372–9.CrossRefGoogle Scholar
  15. 15.
    Meredith IT, Verheye S, Dubois C, Dens J, Farah B, Carrie D, et al. Final five-year clinical outcomes in the EVOLVE trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. Eurointervention. 2018;13(17):2047–50.CrossRefGoogle Scholar
  16. 16.
    Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Five-year outcome of a randomised trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer: the NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial (NEXT). EuroIntervention. 2018;14(7):815–8.CrossRefGoogle Scholar
  17. 17.
    Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, et al. Long-term clinical outcomes of a crystalline sirolimus-eluting coronary stent with a fully bioabsorbable polymer coating: five-year outcomes from the DESSOLVE I and II trials. EuroIntervention. 2018;13(18):e2147–51.CrossRefGoogle Scholar
  18. 18.
    Lefevre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, et al. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: 5-year outcomes of the randomized BIOFLOW-II trial. J Am Coll Cardiol Intv. 2018;11(10):995–1002.CrossRefGoogle Scholar
  19. 19.
    Wijns W, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez-Romo A, Barbato E, et al. Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation: final five-year results of the CENTURY II randomised clinical trial. EuroIntervention. 2018;14(3):e343–51.CrossRefGoogle Scholar
  20. 20.
    Pilgrim T, Piccolo R, Heg D, Roffi M, Tuller D, Muller O, et al. Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial. Lancet. 2018;392(10149):737–46.CrossRefGoogle Scholar
  21. 21.
    Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017;390(10105):1843–52.CrossRefGoogle Scholar
  22. 22.
    Pilgrim T, Heg D, Roffi M, Tüller D, Muller O, Vuilliomenet A, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet. 2014;384(9960):2111–22.CrossRefGoogle Scholar
  23. 23.
    Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, et al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J. 2014;35(30):2021–31.CrossRefGoogle Scholar
  24. 24.
    Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Final 3-year outcome of a randomized trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer: NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial. Circ Cardiovasc Interv. 2015;8(10).Google Scholar
  25. 25.
    de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, et al. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018;391(10119):431–40.CrossRefGoogle Scholar
  26. 26.
    El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, et al. Meta-analysis of randomized clinical trials comparing biodegradable polymer drug-eluting stent to second-generation durable polymer drug-eluting stents. JACC Cardiovasc Interv. 2017;10(5):462–73.CrossRefGoogle Scholar
  27. 27.
    Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, et al. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009;120(5):391–9.CrossRefGoogle Scholar
  28. 28.
    Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012;33(10):1214–22.CrossRefGoogle Scholar
  29. 29.
    Lu P, Lu S, Li Y, Deng M, Wang Z, Mao X. A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: a systematic review and meta-analysis. Sci Rep. 2017;7(1):14997.CrossRefGoogle Scholar
  30. 30.
    Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Smits PC, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014;63(4):299–307.CrossRefGoogle Scholar
  31. 31.
    Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013;6(8):777–89.CrossRefGoogle Scholar
  32. 32.
    Mridha N, Subhaharan D, Niranjan S, Rashid MK, Psaltis P, Singh K. A meta-analysis of randomized controlled trials to compare long-term clinical outcomes of bioabsorbable polymer and durable polymer drug-eluting stents. Eur Heart J Qual Care Clin Outcomes. 2019;5(2):105–13.CrossRefGoogle Scholar
  33. 33.
    Onuma Y, Miquel-Hebert K, Serruys PW. Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial. EuroIntervention. 2013;8(9):1047–51.CrossRefGoogle Scholar
  34. 34.
    Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, et al. Safety and efficacy of everolimus- versus sirolimus-eluting stents: 5-year results from SORT OUT IV. J Am Coll Cardiol. 2016;67(7):751–62.CrossRefGoogle Scholar
  35. 35.
    Koppara T, Cheng Q, Yahagi K, Mori H, Sanchez OD, Feygin J, et al. Thrombogenicity and early vascular healing response in metallic biodegradable polymer-based and fully bioabsorbable drug-eluting stents. Circ Cardiovasc Interv. 2015;8(6):e002427.CrossRefGoogle Scholar
  36. 36.
    Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011;123(13):1400–9.CrossRefGoogle Scholar
  37. 37.
    Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease. Circulation. 2018;138(20):2216–26.CrossRefGoogle Scholar
  38. 38.
    Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van der Heijden LC, Kok MM, et al. Outcomes in patients treated with thin-strut, very thin-strut, or ultrathin-strut drug-eluting stents in small coronary vessels: a prespecified analysis of the randomized BIO-RESORT trial. JAMA Cardiol. 2019;4(7):659–69.CrossRefGoogle Scholar
  39. 39.
    Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, et al. Differential clinical responses to everolimus-eluting and paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011;124(8):893–900.CrossRefGoogle Scholar
  40. 40.
    Franzone A, Pilgrim T, Heg D, Roffi M, Tuller D, Vuilliomenet A, et al. Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial. Circ Cardiovasc Interv. 2015;8(6).Google Scholar
  41. 41.
    Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015;11(3):272–9.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Cardiology, Beijing Anzhen Hospital, Beijing Institute of Heart Lung and Blood Vessel DiseaseCapital Medical UniversityBeijingChina
  2. 2.Department of Neurology, Beijing Tiantan HospitalCapital Medical UniversityBeijingChina

Personalised recommendations