Abstract
We conducted propensity-score-matched comparisons of midterm angiographic follow-up outcomes of sirolimus- versus everolimus-eluting stents (SES, EES) after elective placements for de novo coronary stenosis in small vessels (SV) in patients with diabetes mellitus (DM), because the angiographic efficacy of EES over SES for those cohorts remained unclear. The study was a non-randomized, retrospective, lesion-based, multicenter study, examining lesions followed up angiographically within 550 days, extracted from the unified database of 6 institutes. The endpoint (binary restenosis) was defined as the percentage of subjects having >50% diameter stenosis at follow-up. Propensity-score-matched analyses were conducted in 3 different vessel-size cohorts, defined by a preprocedural reference diameter (RD) <2.10, <2.35, and <2.60 mm, yielding group sizes of n = 107, 183, and 312 baseline-adjusted lesions in each of the 2 stent arms. The frequency of binary restenosis decreased significantly with increasing vessel size, at 16.8, 12.6, and 12.2%, in the SES group. However, it remained almost the same across vessel-size groups in the EES group (8.0, 6.0, and 7.5%). The p values for the significance of the differences in binary restenosis between EES and SES in each vessel size increased with the decrease in vessel size [p = 0.002, 0.040, and 0.063 (the last still nearly significant)]. Thus, in patients with DM, EES showed increasingly superior efficacy over SES for SV stenosis as the vessel size became smaller, i.e., the risk for binary restenosis became greater.
Similar content being viewed by others
References
Elezi S, Kastrati A, Neumann FJ, Hadamitzky M, Dirschinger J, Schömig A. Vessel size and long-term outcome after coronary stent placement. Circulation. 1998;98:1875–80.
Toyota T, Shiomi H, Morimoto T, Kimura T. Meta-analysis of long-term clinical outcomes of everolimus-eluting stents. Am J Cardiol. 2015;116(2):187–94. doi:10.1016/j.amjcard.2015.03.059.
Suzuki K, Ishikawa T, Mutoh M, Sakamoto H, Kubota T, Ogawa T, et al. on Behalf of a Multicenter Registry in The Jikei University. Propensity-score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- versus Everolimus- and Biolimus-eluting Stents for De novo Coronary Stenosis. Int Heart Journal (in press).
Otsuka F, Vorpahl M, Nakano M, Foerst J, Newell JB, Sakakura K, et al. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans. Circulation. 2014;129:211–23.
Kubo T, Akasaka T, Kozuma K, Kimura K, Kawamura M, Sumiyoshi T, et al. RESET Investigators. 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.
Shimamura K, Kubo T, Akasaka T, Kozuma K, Kimura K, Kawamura M, et al. Outcomes of everolimus-eluting stent incomplete stent apposition: a serial optical coherence tomography analysis. Eur Heart J Cardiovasc Imaging. 2015;16(1):23–8. doi:10.1093/ehjci/jeu174.
Kitabata H, Loh JP, Sardi GL, Badr S, Dvir D, Barbash IM, et al. Comparison of long-term outcomes between everolimus-eluting and sirolimus-eluting stents in small vessels. Am J Cardiol. 2013;111:973–8.
Kim WJ, Lee SW, Park SW, Kim YH, Yun SC, Lee JY, et al. ESSENCE-DIABETES Study Investigators. 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;124:886–92.
Maeng M, Baranauskas A, Christiansen EH, Kaltoft A, Holm NR, Krusell LR, et al. A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial). Catheter Cardiovasc Interv. 2015. doi:10.1002/ccd.25875 [Epub ahead of print].
Antonsen L, Maeng M, Thayssen P, Christiansen EH, Hansen KN, Kaltoft A, et al. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial. Catheter Cardiovasc Interv. 2014;83:864–72.
Cannon LA, Simon DI, Kereiakes D, Jones J, Mehran R, Kusano H, et al. The XIENCE nano everoli-mus eluting coronary stent system for the treatment of small coronary arteries: the SPIRIT Small Vessel trial. Catheter Cardiovasc Interv. 2012;80:546–53.
Nakano Y, Ishikawa T, Mutoh M. Long-term angiographic outcomes of sirolimus- and paclitaxel-eluting stent placement in diabetes, long lesions, and small vessels. Cardiovasc Interv Ther. 2015;30:327–37.
Pocock SJ, Lansky AJ, Mehran R, Popma JJ, Fahy MP, Na Y, et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J Am Coll Cardiol. 2008;51:23–32.
Mauri L, Orav EJ, Candia SC, Cutlip DE, Kuntz RE. Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials. Circulation. 2005;112:2833–9.
Loh JP, Pendyala LK, Kitabata H, Badr S, Torguson R, Chen F, et al. A propensity score matched analysis to determine if second-generation drug-eluting stents outperform first-generation drug-eluting stents in a complex patient population. Int J Cardiol. 2013;170:43–8.
Nakano Y, Ishikawa T, Hino S, Mutoh M. Propensity score matched lesion-based comparison of long-term clinical and angiographic outcomes after placement of sirolimus (Cypher Bx Velocity) and paclitaxel (TAXUS Express)-eluting stents for de novo native coronary stenosis. Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2014;29:93–101.
Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999;100:1872–8.
Kang SH, Park KH, Ahn HS, Park KW, Hong YJ, Koo BK, et al. Everolimus-eluting versus sirolimus-eluting coronary stents in patients with and without diabetes mellitus. EuroIntervention. 2014;10(1):74–82. doi:10.4244/EIJV10I1A13.
Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, 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. JACC Cardiovasc Interv. 2011;4:1209–15.
Aoki J, Kozuma K, Awata M, et al. XIEVCE V/PROMUS PMS investigators. Three-year clinical outcomes of everolimus-eluting stents From the Post-Marketing Surveillance Study of cobalt-chromium everolimus-eluting stent (XIENCE V/PROMUS) in Japan. Circ J. 2016;80:906–12.
Ikari Y, Kotani J, Kozuma K, Kyo E, Nakamura M, Yokoi H, J-PMS Study Group. Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS). Circ J. 2009;73(6):1038–44 Epub 2009 Apr 14.
Ishikawa T, Nakano Y, Endoh A, Kubota T, Suzuki T, Nakata K, et al. Significantly lower incidence of early definite stent thrombosis of drug-eluting stents after unrestricted use in Japan using ticlopidine compared to western countries using clopidogrel: a retrospective comparison with western mega-studies. J Cardiol. 2009;54:238–44.
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):e002817. doi:10.1161/CIRCINTERVENTIONS.115.002817.
Acknowledgements
This study was supported by a research fund from Saitama Cardiovascular Respiratory Center under Grants 13EC, 14EF, 15 EB, and 16 EB to T.I.
Author information
Authors and Affiliations
Consortia
Corresponding author
Ethics declarations
Conflict of interest
None.
Ethics
The patient provided us the signature for our informed consent for our treatments.
Rights and permissions
About this article
Cite this article
Suzuki, K., Ishikawa, T., Mutoh, M. et al. Midterm angiographic outcomes with sirolimus- and everolimus-eluting stents for small vessels in diabetic patients: propensity-score-matched comparisons in three different vessel diameters. Cardiovasc Interv and Ther 33, 205–216 (2018). https://doi.org/10.1007/s12928-017-0466-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12928-017-0466-9