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Cardiovascular Diabetology
Published in: Cardiovascular Diabetology 1/2018

Open Access 01-12-2018 | Original investigation

Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents in patients with and without diabetes mellitus: a single-center study

Authors: Xiao-Fang Tang, Yuan-Liang Ma, Ying Song, Jing-Jing Xu, Yi Yao, Chen He, Huan-Huan Wang, Ping Jiang, Lin Jiang, Ru Liu, Zhan Gao, Xue-yan Zhao, Shu-Bin Qiao, Yue-Jin Yang, Run-Lin Gao, Bo Xu, Jin-Qing Yuan

Published in: Cardiovascular Diabetology | Issue 1/2018

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Abstract

Background

To improve outcomes in patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remain an unmet clinical need. The study aimed to evaluate the efficacy and safety of G2-DESs and BP-DESs in patients with and without DM in a single center in China.

Methods

A total of 7666 consecutive patients who exclusively had G2-DES or BP-DES implantation throughout 2013 in our center were studied. The primary efficacy endpoint was any target lesion revascularization (TLR), whereas the primary safety endpoint was a composite of death or myocardial infarction (MI) at 2-year follow-up.

Results

G2-DESs had a similar occurrence of death, non-fatal MI, TLR, stroke, and stent thrombosis compared with BP-DESs in patients with DM (all P > 0.05). The incidence of TVR and TLR was lower for G2-DESs than for BP-DESs in patients without DM (3.2% vs. 5.1%, P = 0.002; 2.2% vs. 4.5%, P < 0.001, respectively). Kaplan–Meier analysis also showed better TVR- and TLR-free survival rates for G2-DESs than for BP-DESs in patients without DM. Multivariate analysis showed that a BP-DES was an independent risk factor for TLR (hazard ratio 1.963, 95% confidence interval 1.390–2.772, P < 0.001) in patients without DM, which was not predictive of other components of major adverse cardiac events (P > 0.05).

Conclusions

G2-DESs have better efficacy, represented by a reduced risk of TLR, and similar safety compared with BP-DESs in patients without DM. G2-DESs have similar efficacy and safety compared with BP-DESs in patients with DM at 2-year follow-up.
Appendix
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Literature
1.
Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013;368(3):254–65.CrossRefPubMed
2.
Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007;28(22):2706–13.CrossRefPubMed
3.
Kimura T, Morimoto T, Nakagawa Y, Kawai K, Miyazaki S, Muramatsu T, Shiode N, Namura M, Sone T, Oshima S, et al. Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry. Circulation. 2012;125(4):584–91.CrossRefPubMed
4.
Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D’Ascenzo F, Kimura T, Briguori C, Sabate M, Kim HS, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379(9824):1393–402.CrossRefPubMed
5.
Nakagawa Y, Kimura T, Morimoto T, Nomura M, Saku K, Haruta S, Muramatsu T, Nobuyoshi M, Kadota K, Fujita H, et al. Incidence and risk factors of late target lesion revascularization after sirolimus-eluting stent implantation (3-year follow-up of the j-Cypher Registry). Am J Cardiol. 2010;106(3):329–36.CrossRefPubMed
6.
Poder TG, Erraji J, Coulibaly LP, Koffi K. Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: systematic review and cost-benefit analysis. PLoS ONE. 2017;12(5):e0177476.CrossRefPubMedPubMedCentral
7.
Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabate M, Valgimigli M, Frati G, Kedhi E, Smits PC, Kaiser C, et al. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2013;62(6):496–504.CrossRefPubMed
8.
Garg S, Bourantas C, Serruys PW. New concepts in the design of drug-eluting coronary stents. Nat Rev Cardiol. 2013;10(5):248–60.CrossRefPubMed
9.
Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109(6):701–5.CrossRefPubMed
10.
Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Hanaoka KI, Tanabe K, Morino Y, et al. Five-year outcome of a randomized 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. https://​doi.​org/​10.​4244/​EIJ-D-17-01050.PubMedCrossRef
11.
Meredith IT, Verheye S, Dubois C, Dens J, Farah B, Carrie D, Walsh S, Oldroyd K, Varenne O, El-Jack S, 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.CrossRefPubMed
12.
Lefevre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, 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. JACC Cardiovasc Interv. 2018;11(10):995–1002.CrossRefPubMed
13.
Kufner S, Byrne RA, Valeskini M, Schulz S, Ibrahim T, Hoppmann P, Schneider S, Laugwitz KL, Schunkert H, Kastrati A, 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.CrossRefPubMed
14.
Schofer J, Schluter M, Rau T, Hammer F, Haag N, Mathey DG. Influence of treatment modality on angiographic outcome after coronary stenting in diabetic patients: a controlled study. J Am Coll Cardiol. 2000;35(6):1554–9.CrossRefPubMed
15.
West NE, Ruygrok PN, Disco CM, Webster MW, Lindeboom WK, O’Neill WW, Mercado NF, Serruys PW. Clinical and angiographic predictors of restenosis after stent deployment in diabetic patients. Circulation. 2004;109(7):867–73.CrossRefPubMed
16.
Qin SY, Zhou Y, Jiang HX, Hu BL, Tao L, Xie MZ. The association of diabetes mellitus with clinical outcomes after coronary stenting: a meta-analysis. PLoS ONE. 2013;8(9):e72710.CrossRefPubMedPubMedCentral
17.
Bangalore S, Toklu B, Feit F. Outcomes with coronary artery bypass graft surgery versus percutaneous coronary intervention for patients with diabetes mellitus: can newer generation drug-eluting stents bridge the gap? Circ Cardiovasc Interv. 2014;7(4):518–25.CrossRefPubMed
18.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Writing Group on the Joint ESCAAHAWHFTFftUDoMI, Thygesen K, Alpert JS, White HD, et al. Third universal definition of myocardial infarction. Eur Heart J. 2012;33(20):2551–67.CrossRefPubMed
19.
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51.CrossRefPubMed
20.
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736–47.CrossRefPubMed
21.
Nishida K, Nakatsuma K, Shiomi H, Natsuaki M, Kawai K, Morimoto T, Kozuma K, Igarashi K, Kadota K, Tanabe K, et al. Second-generation vs. first-generation drug-eluting stents in patients with calcified coronary lesions- pooled analysis from the RESET and NEXT trials. Circ J. 2018;82(2):376–87.CrossRefPubMed
22.
Foin N, Lee RD, Torii R, Guitierrez-Chico JL, Mattesini A, Nijjer S, Sen S, Petraco R, Davies JE, Di Mario C, et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol. 2014;177(3):800–8.CrossRefPubMed
23.
Kawai K, Ichikawa M, Masuyama T, Kijima Y. Angioscopic comparison of arterial repair after second-generation drug-eluting stent implantation into vulnerable and stable coronary plaques. Int J Cardiol. 2016;221:855–8.CrossRefPubMed
24.
Rodriguez-Granillo A, Rubilar B, Rodriguez-Granillo G, Rodriguez AE. Advantages and disadvantages of biodegradable platforms in drug eluting stents. World J Cardiol. 2011;3(3):84–92.CrossRefPubMedPubMedCentral
25.
Godino C, Beneduce A, Ferrante G, Ielasi A, Pivato AC, Chiarito M, Cappelletti A, Perfetti G, Magni V, Prati E, et al. One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry). Int J Cardiol. 2018;260:36–41.CrossRefPubMed
26.
Maupas E, Lipiecki J, Levy R, Faurie B, Karsenty B, Moulichon ME, Brunelle F, Maillard L, de Poli F, Lefevre T. Safety and efficacy outcomes of 3rd generation DES in an all-comer population of patients undergoing PCI: 12-month and 24-month results of the e-Biomatrix French registry. Catheter Cardiovasc Interv. 2017;90(6):890–7.CrossRefPubMedPubMedCentral
27.
Kornowski R, Roguin A, Danenberg H, Assa HV, Abergel E, Rozenbaum E, Guetta V, Landes U, Jabara R, Merdler A, et al. BIOFLOW-III satellite-One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance. Cardiovasc Revasc Med. 2017;18(5):338–43.CrossRefPubMed
28.
Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Erglis A, Dewilde W, Winkens M, Hegeler-Molkewehrum C, et al. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016;11(10):1106–10.CrossRefPubMed
29.
Meliga E, Lupi A, Latib A, Gagnor A, Boccuzzi G, Alcantara M, Lombardi P, Sticchi A, Aranzulla TC, Scrocca I, et al. Biolimus-Eluting StenT For de-novo coRonary artery dIsease in patiENts with Diabetes mellituS: the BESTFRIENDS multicentre registry. J Cardiovasc Med. 2016;17(10):729–35.CrossRef
30.
Cassese S, Byrne RA, Juni P, Wykrzykowska JJ, Puricel S, Ndrepepa G, Schunkert H, Fusaro M, Cook S, Kimura T, et al. Midterm clinical outcomes with everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents for percutaneous coronary interventions: a meta-analysis of randomised trials. EuroIntervention. 2018;13(13):1565–73.CrossRefPubMed
31.
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.CrossRefPubMed
32.
Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Slagboom T, Goy JJ, den Heijer P, 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.CrossRefPubMed
33.
Raungaard B, Christiansen EH, Botker HE, Hansen HS, Ravkilde J, Thuesen L, Aaroe J, Villadsen AB, Terkelsen CJ, Krusell LR, et al. Comparison of durable-polymer zotarolimus-eluting and biodegradable-polymer biolimus-eluting coronary stents in patients with coronary artery disease: 3-year clinical outcomes in the randomized SORT OUT VI trial. JACC Cardiovasc Interv. 2017;10(3):255–64.CrossRefPubMed
34.
El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, Mavromatis K, Tamis-Holland J, Samady H. 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.CrossRefPubMed
35.
Wiemer M, Stoikovic S, Samol A, Dimitriadis Z, Ruiz-Nodar JM, Birkemeyer R, Monsegu J, Finet G, Hildick-Smith D, Tresukosol D, et al. Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up. Cardiovasc Diabetol. 2017;16(1):23.CrossRefPubMedPubMedCentral
36.
Li Y, Han Y, Zhang L, Jing Q, Wang X, Yan G, Ma Y, Wang G, Wang S, Chen X, et al. Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study. Catheter Cardiovasc Interv. 2013;81(7):1127–33.CrossRefPubMed
37.
Nakatsuma K, Shiomi H, Natsuaki M, Morimoto T, Igarashi K, Kadota K, Muramatsu T, Tanabe K, Morino Y, Akasaka T, et al. Second-generation versus first-generation drug-eluting stents in patients with and without diabetes mellitus: pooled analysis from the RESET and NEXT trials. Cardiovasc Interv Ther. 2018;33(2):125–34.CrossRefPubMed
38.
Kedhi E, Gomes ME, Lagerqvist B, Smith JG, Omerovic E, James S, Harnek J, Olivecrona GK. Clinical impact of second-generation everolimus-eluting stent compared with first-generation drug-eluting stents in diabetes mellitus patients: insights from a nationwide coronary intervention register. JACC Cardiovasc Interv. 2012;5(11):1141–9.CrossRefPubMed
39.
Harada Y, Colleran R, Kufner S, Giacoppo D, Rheude T, Michel J, Cassese S, Ibrahim T, Laugwitz KL, Kastrati A, et al. Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial. Cardiovasc Diabetol. 2016;15(1):124.CrossRefPubMedPubMedCentral
40.
Sprimont P, Pierard S, Vanoverschelde JL, Debbas N. Efficacy and safety of biodegradable polymer biolimus A9-eluting stent versus durable polymer everolimus-eluting stent in diabetic patients: a prospective non-randomized single-centre long-term comparison. Acta Cardiol. 2014;69(5):523–31.CrossRefPubMed
41.
Franzone A, Pilgrim T, Heg D, Roffi M, Tuller D, Vuilliomenet A, Muller O, Cook S, Weilenmann D, Kaiser C, 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):e002319.CrossRefPubMed
42.
Kuroda M, Shinke T, Otake H, Sugiyama D, Takaya T, Takahashi H, Terashita D, Uzu K, Tahara N, Kashiwagi D, et al. Effects of daily glucose fluctuations on the healing response to everolimus-eluting stent implantation as assessed using continuous glucose monitoring and optical coherence tomography. Cardiovasc Diabetol. 2016;15:79.CrossRefPubMedPubMedCentral
43.
Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, et al. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014;10(7):806–14.PubMed
Metadata
Title
Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents in patients with and without diabetes mellitus: a single-center study
Authors
Xiao-Fang Tang
Yuan-Liang Ma
Ying Song
Jing-Jing Xu
Yi Yao
Chen He
Huan-Huan Wang
Ping Jiang
Lin Jiang
Ru Liu
Zhan Gao
Xue-yan Zhao
Shu-Bin Qiao
Yue-Jin Yang
Run-Lin Gao
Bo Xu
Jin-Qing Yuan
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Cardiovascular Diabetology / Issue 1/2018
Electronic ISSN: 1475-2840
DOI
https://doi.org/10.1186/s12933-018-0758-0

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