Randomised trial of the comparison of drug-eluting stents in patients with diabetes: OCT DES trial

Stephen Hamshere, Alex Byrne, Tawfiq Choudhury, Sean M Gallagher, Krishnaraj S Rathod, Julia Lungley, Charles J Knight, Akhil Kapur, Daniel A Jones, Anthony Mathur, Stephen Hamshere, Alex Byrne, Tawfiq Choudhury, Sean M Gallagher, Krishnaraj S Rathod, Julia Lungley, Charles J Knight, Akhil Kapur, Daniel A Jones, Anthony Mathur

Abstract

Background: To date, there have been limited comparisons performed between everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES) in patients with diabetes mellitus (DM). The objectives of this study was to assess the use of second-generation drug-eluting stents in patients with DM, using optical coherence tomography (OCT) to compare the level of stent coverage of Boston Scientific Promus Element EES compared with Medtronic Resolute Integrity ZES.(Clinicaltrials.gov number NCT02060357).

Methods: This is a single-centre randomised blinded trials assessing two commercially available stents in 60 patients with diabetes (ZES: n=30, EES: n=30). Patients underwent intracoronary assessment at 6 months with OCT assessing stent coverage, malapposition, neointimal thickness and percentage of in-stent restenosis (ISR).

Results: Of the 60 patients randomised, 46 patients underwent OCT analysis. There was no difference in baseline characteristics between the two groups. Both Promus Element and Resolute Integrity had low rates of uncovered struts at 6 months with no significant difference between the two groups (2.44% vs 1.24%, respectively; P=0.17). Rates of malapposition struts (3.9% vs 2.5%, P=0.25) and percentage of luminal loss did not differ between stent types. In addition, there was no significant difference in major adverse cardiovascular events (P=0.24) between the stent types.

Conclusions: This study is the first randomised trial to evaluate OCT at 6 months for ZES and EES in patients with diabetes. Both stents showed comparable strut coverage at 6 months, with no difference in ISR rates at 6 months.

Keywords: bare metal stent; diabetes melatus; drug eluting stent; duel antiplatelet therapy; non ST elevation myocardial infarction; optical coherence tomography; percutaneous coronary intervention.

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Consort diagram of the OCT DES trial. DES, drug-eluting stent; EES, everolimus-eluting stent; CABG, coronary artery bypass grafting; DAPT, dual antiplatelet therapy; LV, left ventricle; OCT, optical coherence tomography; PCI, percutaneous coronary intervention; ZES, zotarolimus-eluting stent.
Figure 2
Figure 2
Comparison of prevalence of uncovered struts between ZES and EES groups. Scatter plot of uncovered stent strut (%) as assessed by OCT between EES group and ZES group. No significance seen as evaluated using Mann-Whitney U test and data shown as median±IQR. EES, everolimus-eluting stent; OCT, optical coherence tomography; ZES, zotarolimus-eluting stent.
Figure 3
Figure 3
Major adverse cardiovascular events (MACE). (A) Combined MACE; (B) MACE between EES and ZES groups. EES, everolimus-eluting stent; ZES, zotarolimus-eluting stent.
Figure 4
Figure 4
A) Relationship between analysis assessment of number of struts analysed. B) Bland-Altman plot for the interobserver variability for in-stent restenosis (ISR) percentage and interobserver correlation of strut numbers.

References

    1. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010;87:4–14. 10.1016/j.diabres.2009.10.007
    1. Elezi S, Kastrati A, Pache J, et al. . Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol 1998;32:1866–73. 10.1016/S0735-1097(98)00467-7
    1. Cutlip DE, Chhabra AG, Baim DS, et al. . Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation 2004;110:1226–30. 10.1161/01.CIR.0000140721.27004.4B
    1. Windecker S, Meier B. Late coronary stent thrombosis. Circulation 2007;116:1952–65. 10.1161/CIRCULATIONAHA.106.683995
    1. Garg P, Normand SL, Silbaugh TS, et al. . Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts Data Analysis Center Registry. Circulation 2008;118:2277–85. 10.1161/CIRCULATIONAHA.108.820159
    1. Mak K-H. Drug eluting stents for patients with diabetes. BMJ 2012;345:e5828 10.1136/bmj.e5828
    1. Armstrong EJ, Rutledge JC, Rogers JH. Coronary artery revascularization in patients with diabetes mellitus. Circulation 2013;128:1675–85. 10.1161/CIRCULATIONAHA.113.002114
    1. Miyazawa A, Ako J, Hongo Y, et al. . Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III. Am Heart J 2008;155:108–13. 10.1016/j.ahj.2007.08.008
    1. Finn AV, Joner M, Nakazawa G, et al. . Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007;115:2435–41. 10.1161/CIRCULATIONAHA.107.693739
    1. Park KW, Lee JM, Kang SH, et al. . Everolimus-eluting Xience v/Promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus. JACC Cardiovasc Interv 2014;7:471–81. 10.1016/j.jcin.2013.12.201
    1. Romaguera R, Gómez-Hospital JA, Gomez-Lara J, et al. . A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial. JACC Cardiovasc Interv 2016;9:42–50. 10.1016/j.jcin.2015.09.020
    1. Kubo T, Akasaka T, Tanimoto T, et al. . Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT. Heart Vessels 2016;31:465–73. 10.1007/s00380-015-0636-6
    1. Teirstein PS, Massullo V, Jani S, et al. . Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med 1997;336:1697–703. 10.1056/NEJM199706123362402
    1. Tanigawa J, Barlis P, Di Mario C. Intravascular optical coherence tomography: optimisation of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention 2007;3:128–36.
    1. Cutlip DE, Windecker S, Mehran R, et al. . Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. 10.1161/CIRCULATIONAHA.106.685313
    1. Kim JS, Kim JS, Kim TH, et al. . Comparison of neointimal coverage of sirolimus-eluting stents and paclitaxel-eluting stents using optical coherence tomography at 9 months after implantation. Circ J 2010;74:320–6. 10.1253/circj.CJ-09-0546
    1. Kim JS, Kim BK, Jang IK, et al. . ComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using Optical Coherence Tomography (COVER OCT). Am Heart J 2012;163:601–7. 10.1016/j.ahj.2011.10.016
    1. Izumi D, Miyahara M, Fujimoto N, et al. . Optical coherence tomography analysis of the stent strut and prediction of resolved strut malapposition at 3 months after 2nd-generation drug-eluting stent implantation. Heart Vessels 2016;31 10.1007/s00380-015-0737-2
    1. Kubo T, Akasaka T, Kozuma K, et al. . Comparison of neointimal coverage between everolimus-eluting stents and sirolimus-eluting stents: an optical coherence tomography substudy of the RESET (Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial). EuroIntervention 2015;11:564–71. 10.4244/EIJV11I5A109
    1. Shaw E, Allahwala UK, Cockburn JA, et al. . The effect of coronary artery plaque composition, morphology and burden on Absorb bioresorbable vascular scaffold expansion and eccentricity - A detailed analysis with optical coherence tomography. Int J Cardiol 2015;184:230–6. 10.1016/j.ijcard.2015.01.033
    1. Won H, Shin DH, Kim BK, et al. . Optical coherence tomography derived cut-off value of uncovered stent struts to predict adverse clinical outcomes after drug-eluting stent implantation. Int J Cardiovasc Imaging 2013;29:1255–63. 10.1007/s10554-013-0223-9
    1. Tanaka N, Terashima M, Rathore S, et al. . Different patterns of vascular response between patients with or without diabetes mellitus after drug-eluting stent implantation: optical coherence tomographic analysis. JACC Cardiovasc Interv 2010;3:1074–9. 10.1016/j.jcin.2010.08.006
    1. Toušek P, Kočka V, Malý M, et al. . Neointimal coverage and late apposition of everolimus-eluting bioresorbable scaffolds implanted in the acute phase of myocardial infarction: OCT data from the PRAGUE-19 study. Heart Vessels 2016;31:841–5. 10.1007/s00380-015-0679-8
    1. Kim JS, Shin DH, Kim BK, et al. . Randomized comparison of stent strut coverage following angiography- or optical coherence tomography-guided percutaneous coronary intervention. Rev Esp Cardiol 2015;68:190–7. 10.1016/j.rec.2014.07.025
    1. Piccolo R, Stefanini GG, Franzone A, et al. . Safety and efficacy of resolute zotarolimus-eluting stents compared with everolimus-eluting stents: a meta-analysis. Circ Cardiovasc Interv 2015;8:e002223 10.1161/CIRCINTERVENTIONS.114.002223
    1. Mabasa VH, Ensom MH. The role of therapeutic monitoring of everolimus in solid organ transplantation. Ther Drug Monit 2005;27:666–76. 10.1097/01.ftd.0000175911.70172.2e
    1. Kolandaivelu K, Swaminathan R, Gibson WJ, 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;123:1400–9. 10.1161/CIRCULATIONAHA.110.003210
    1. Patel NA, Stamper DL, Brezinski ME. Review of the ability of optical coherence tomography to characterize plaque, including a comparison with intravascular ultrasound. Cardiovasc Intervent Radiol 2005;28:1–9. 10.1007/s00270-003-0021-1
    1. Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med 1984;311:1144–7. 10.1056/NEJM198411013111802
    1. van der Heijden LC, Kok MM, Löwik MM, et al. . Three-year safety and efficacy of treating all-comers with newer-generation Resolute Integrity or PROMUS Element stents in the randomised DUTCH PEERS (TWENTE II) trial. EuroIntervention 2017;12:2128–31. 10.4244/EIJ-D-16-00571
    1. Park KW, Kang S-H, Kang H-J, et al. . A Randomized Comparison of Platinum Chromium-Based Everolimus-Eluting Stents Versus Cobalt Chromium-Based Zotarolimus-Eluting Stents in All-Comers Receiving Percutaneous Coronary Intervention. J Am Coll Cardiol 2014;63:2805–16. 10.1016/j.jacc.2014.04.013

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅