Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions

Do-Yoon Kang, Jae-Sik Jang, Mineok Chang, Cheol Hyun Lee, Pil Hyung Lee, Jung-Min Ahn, Seung-Whan Lee, Young-Hak Kim, Seong-Wook Park, Duk-Woo Park, Seung-Jung Park, LONG-DES Investigators, Do-Yoon Kang, Jae-Sik Jang, Mineok Chang, Cheol Hyun Lee, Pil Hyung Lee, Jung-Min Ahn, Seung-Whan Lee, Young-Hak Kim, Seong-Wook Park, Duk-Woo Park, Seung-Jung Park, LONG-DES Investigators

Abstract

Background: Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions.

Objectives: This study sought to compare the relative performance of different types of DES for de novo long (≥25 mm) coronary artery lesions.

Methods: Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9 months.

Results: The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41 mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12 months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES.

Conclusions: In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

Keywords: BES, biolimus-eluting stent(s); DES, drug-eluting stent(s); EES, everolimus-eluting stent(s); MACE, major adverse cardiac event(s); MI, myocardial infarction; PCI, percutaneous coronary intervention; PtCr, platinum chromium; SES, sirolimus-eluting stent(s); TLR, target-lesion revascularization; TVR, target-vessel revascularization; coronary artery disease; drug-eluting stents; percutaneous coronary intervention.

Conflict of interest statement

This work was supported by the Cardiovascular Research Foundation. The sponsors played no role in this study. There was no industry involvement in the design or conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, and approval of the manuscript; or the decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

© 2022 The Authors.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Study Flow Diagram BP-BES = Nobori biolimus-eluting stent(s); CoCr-EES = cobalt-chromium everolimus-eluting stent(s); PtCr-EES = platinum-chromium everolimus-eluting stent(s); Re-ZES = Resolute zotarolimus-eluting stent(s); SES = sirolimus-eluting stent(s).
Figure 2
Figure 2
Angiographic and Clinical Outcomes by Types of Drug-Eluting Stents In-segment late luminal loss (A) and cumulative-incidence curves of major adverse cardiac events, a composite of all-cause death, myocardial infarction, and target-vessel revascularization (B). Abbreviations as shown in Figure 1.
Figure 3
Figure 3
Adjusted HRs of Clinical Outcomes Between Different Drug-Eluting Stents Adjusted HRs are given for difference stent types compared with the SES: (A) death, (B) myocardial infarction, (C) target lesion revascularization, and (D) major adverse cardiac events (MACE). Abbreviations as in Figure 1.
Central Illustration
Central Illustration
Primary Angiographic Endpoint and Secondary Clinical Endpoint by Different Drug-Eluting Stents Abbreviations as in Figure 1.

References

    1. Kim W.J., Lee S.W., Park S.W., et al. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial. Circulation. 2011;124:886–892.
    1. Serruys P.W., Silber S., Garg S., et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136–146.
    1. Palmerini T., Benedetto U., Biondi-Zoccai G., et al. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2015;65:2496–2507.
    1. Suh J., Park D.W., Lee J.Y., et al. The relationship and threshold of stent length with regard to risk of stent thrombosis after drug-eluting stent implantation. J Am Coll Cardiol Intv. 2010;3:383–389.
    1. Kimura T., Morimoto T., Nakagawa Y., 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;125:584–591.
    1. Claessen B.E., Smits P.C., Kereiakes D.J., et al. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. J Am Coll Cardiol Intv. 2011;4:1209–1215.
    1. Jim M.H., Yiu K.H., Ho H.H., et al. Angiographic and clinical outcomes of everolimus-eluting stent in the treatment of extra long stenoses (AEETES) J Interv Cardiol. 2013;26:22–28.
    1. Li X.T., Sun H., Zhang D.P., et al. Two-year clinical outcomes of patients with overlapping second-generation drug-eluting stents for treatment of long coronary artery lesions: comparison of everolimus-eluting stents with resolute zotarolimus-eluting stents. Coron Artery Dis. 2014;25:405–411.
    1. Stefanini G.G., Holmes D.R., Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013;368:254–265.
    1. Bangalore S., Kumar S., Fusaro M., et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125:2873–2891.
    1. Palmerini T., Biondi-Zoccai G., Della Riva D., et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393–1402.
    1. Palmerini T., Biondi-Zoccai G., Della Riva D., 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;63:299–307.
    1. Jensen L.O., Thayssen P., Christiansen E.H., et al. Safety and efficacy of everolimus- versus sirolimus-eluting stents: 5-year results from SORT OUT IV. J Am Coll Cardiol. 2016;67:751–762.
    1. Sarno G., Lagerqvist B., Frobert O., et al. Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR) Eur Heart J. 2012;33:606–613.
    1. Bonaa K.H., Mannsverk J., Wiseth R., et al. Drug-eluting or bare-metal stents for coronary artery disease. N Engl J Med. 2016;375:1242–1252.
    1. Park D.W., Kim Y.H., Song H.G., et al. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. J Am Coll Cardiol Intv. 2011;4:1096–1103.
    1. Ahn J.M., Park D.W., Kim Y.H., et al. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012;5:633–640.
    1. Lee J.Y., Park D.W., Kim Y.H., et al. Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial. Circ Cardiovasc Interv. 2014;7:322–329.
    1. Lansky A.J., Dangas G., Mehran R., et al. Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation. J Am Coll Cardiol. 2002;39:274–280.
    1. McCaffrey D.F., Griffin B.A., Almirall D., Slaughter M.E., Ramchand R., Burgette L.F. A tutorial on propensity score estimation for multiple treatments using generalized boosted models. Stat Med. 2013;32:3388–3414.
    1. Rosenbaum P.R., Rubin D.B. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70:41–55.
    1. Lee C.H., Kang D.Y., Han M., et al. Differential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: An individual patient data pooled analysis of seven stent-specific registries and 17,068 patients. Int J Cardiol. 2019;282:17–23.
    1. Serruys P.W., Chevalier B., Sotomi Y., et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388:2479–2491.
    1. Asano T., Serruys P.W., Collet C., et al. Angiographic late lumen loss revisited: impact on long-term target lesion revascularization. Eur Heart J. 2018;39:3381–3389.
    1. Park S.J., Park D.W., Kim Y.H., et al. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010;362:1374–1382.
    1. Buccheri S., Franchina G., Romano S., et al. Clinical outcomes following intravascular imaging-guided versus coronary angiography-guided percutaneous coronary intervention with stent implantation: a systematic review and Bayesian network meta-analysis of 31 studies and 17,882 patients. J Am Coll Cardiol Intv. 2017;10:2488–2498.
    1. Choi K.H., Song Y.B., Lee J.M., et al. Impact of intravascular ultrasound-guided percutaneous coronary intervention on long-term clinical outcomes in patients undergoing complex procedures. J Am Coll Cardiol Intv. 2019;12(7):607–620.
    1. Park H., Ahn J.M., Kang D.Y., et al. Optimal stenting technique for complex coronary lesions: intracoronary imaging-guided pre-dilation, stent sizing, and post-dilation. J Am Coll Cardiol Intv. 2020 Jun 22;13(12):1403–1413.
    1. Hong S.J., Kim B.K., Shin D.H., et al. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JAMA. 2015;314:2155–2163.
    1. Hong S.J., Zhang J.J., Mintz G.S., et al. Improved 3-year cardiac survival after IVUS-guided long DES implantation: a patient-level analysis from 2 randomized Trials. J Am Coll Cardiol Intv. 2022;15(2):208–216.
    1. Tan C.K., Tin Z.L., Arshad M.K.M., et al. Treatment with 48-mm everolimus-eluting stents: Procedural safety and 12-month patient outcome. Herz. 2019;44(5):419–424.
    1. Lodi Rizzini M., Nagumo S., Gallo D., et al. Mismatch between morphological and functional assessment of the length of coronary artery disease. Int J Cardiol. 2021;334:1–9.
    1. Shin D., Dai N., Lee S.H., et al. Physiological distribution and local severity of coronary artery disease and outcomes after percutaneous coronary intervention. J Am Coll Cardiol Intv. 2021;14(16):1771–1785.

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