Abstract
We conducted a lesion-based retrospective sub-analyses of diabetes mellitus (DM), diffuse long lesions (stented segment ≥40 mm; LLs), and small vessels (SVs; reference diameter ≤2.6 mm) in patients who received sirolimus- (SESs) or paclitaxel-eluting stents (PESs) for nonrandom treatment of de novo native coronary stenosis in a clinical practice setting. During the period from May 2007 to February 2009, 490 of 682 PES-treated and 293 of 386 SES-treated lesions were angiographically followed up within 1500 days of PCI, and the retrospective investigation was conducted in April 2013. The frequencies of target lesion revascularization (TLR; any recurrent PCI including both marginal stent restenosis) and binary in-stent restenosis (percentage diameter of in-stent stenosis >50 %) upon follow-up angiography, evaluated by adjusting 25 baseline variables using propensity score matching analysis, after placement of SESs and PESs were the following: DM (n = 124 per arm), 14.5 vs. 15.3 % (p = 0.842), and 14.5 vs. 16.1 % (0.856); LLs (n = 81), 16.0 vs. 21.0 % (0.433), and 12.3 vs. 22.2 % (0.117); SVs (n = 107), 11.2 vs. 29.9 % (<0.001), and 11.2 vs. 30.8 % (<0.001), respectively. The p values of log-rank tests for the cumulative TLR-free ratios after SES and PES placement were 0.504 in DM, 0.625 in LLs, and <0.001 in SVs group, respectively. Thus, compared to PES, SES showed the equivalent efficacy for DM, the tendency to be superior for LLs due to approximately 24–45 % reductions in TLR and binary restenosis rates, and the promising superiority for SVs on the angiographic outcomes during a long-term observational interval.
Similar content being viewed by others
References
Kimura T, Morimoto T, Nakagawa Y, Kawai K, Miyazaki S, Muramatsu T, Shiode N, Namura M, Sone T, Oshima S, Nishikawa H, Hiasa Y, Hayashi Y, Nobuyoshi M, Mitsudo K, on behalf of the j-Cypher Registry Investigators. Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry. Circulation. 2012;125:584–91.
Natsuaki M, Morimoto T, Furukawa Y, Nakagawa Y, Kadota K, Yamaji K, Ando K, Shizuta S, Shiomi H, Tada T, Tazaki J, Kato Y, Hayano M, Abe M, Tamura T, Shirotani M, Miki S, Matsuda M, Takahashi M, Ishii K, Tanaka M, Aoyama T, Doi T, Hattori O, Kato M, Suwa S, Takizawa A, Takatsu Y, Shinoda E, Eizawa H, Takeda T, Lee JD, Inoko M, Ogawa H, Hamasaki S, Horie M, Nohara R, Kambara H, Fujiwara H, Mitsudo K, Nobuyoshi M, Kita T, Kimura T, CREDO-Kyoto PCI/CABG registry cohort-2 investigators. Late adverse events after implantation of sirolimus-eluting stent and bare-metal stent: long-term (5-7 years) follow-up of the Coronary Revascularization Demonstrating Outcome study-Kyoto registry Cohort-2. Circ Cardiovasc Interv. 2014;7(2):168–79. doi:10.1161/CIRCINTERVENTIONS.113.000987 Epub 2014 Feb 18.
Kubota T, Ishikawa T, Mutoh M. Retrospective comparison of the clinical and angiographic outcomes of the sirolimus-eluting stent and the bare-metal stent in 2031 nonrandomized consecutive de novo native coronary lesions. Intern Med. 2011;50(21):2463–70 Epub 2011 Nov 1.
Nakagawa Y, Kimura T, Morimoto T, Nomura M, Saku K, Haruta S, Muramatsu T, Nobuyoshi M, Kadota K, Fujita H, Tatami R, Shiode N, Nishikawa H, Shibata Y, Miyazaki S, Murata Y, Honda T, Kawasaki T, Doi O, Hiasa Y, Hayashi Y, Matsuzaki M, Mitsudo K, j-Cypher Registry Investigators. 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;106:329–36. doi:10.1016/j.amjcard.2010.03.031 Epub 2010 Jun 18.
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. Cardiovasc Interv Ther. 2014;29:93–101.
Ishikawa T, Nakano Y, Mutoh M. Retrospective comparison of midterm clinical and angiographic outcomes after the implantation of paclitaxel- and sirolimus-eluting stents for de novo coronary complex lesions in nonrandomized Japanese patients. Intern Med. 2012;51:2695–701.
Tsutsumi J, Ishikawa T, Nakano Y, Yoshimura M, Mutoh M (2014) Long-term clinical and angiographic outcomes after sirolimus- and paclitaxel-eluting stent placement following rotablation for severely calcified lesions: a retrospective nonrandomized study. Cardiovasc Interv Ther (Epub ahead of print).
Kim YH, Park SW, Lee CW, Hong MK, Gwon HC, Jang Y, Lee MM, Koo BK, Oh DJ, Seung KB, Tahk SJ, Yoon J, Park SJ. Comparison of sirolimus-eluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions. Catheter Cardiovasc Interv. 2006;67:181–7.
Chu WW, Kuchulakanti PK, Torguson R, Wang B, Clavijo LC, Suddath WO, Pichard AD, Satler LF, Kent KM, Waksman R. Impact of three or more sirolimus-eluting stents versus paclitaxel-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. Catheter Cardiovasc Interv. 2006;68:62–6.
Kim U, Lee SH, Hong GR, Park JS, Shin DG, Kim YJ, Jang JS, Yang TH, Kim DK, Kim DS, Kim DK, Seol SH, Kim DI, Cho YK, Kim HS, Nam CW, Hur SH, Kim KB. Two-year clinical outcomes of patients with long segments drug-eluting stents: comparison of sirolimus-eluting stent with paclitaxel-eluting stent. J Korean Med Sci. 2011;26:1299–304.
Fukumoto A, Otsuji S, Takiuchi S, Ikushima M, Asano K, Terasoma K, Hasegawa K, Yabuki M, Higashino Y. Comparison of real-world clinical outcomes between Cypher- and Taxus-eluting stents: the GARA-GARA study. Cardiovasc Interv Ther. 2011;26:202–8.
Kastrati A, Dibra A, Mehilli J, Mayer S, Pinieck S, Pache J, Dirschinger J, Schömig A. Predictive factors of restenosis after coronary implantation of sirolimus- or paclitaxel-eluting stents. Circulation. 2006;113:2293–300.
Elezi S, Dibra A, Mehilli J, Pache J, Wessely R, Schömig A, Kastrati A. Vessel size and outcome after coronary drug-eluting stent placement: results from a large cohort of patients treated with sirolimus- or paclitaxel-eluting stents. J Am Coll Cardiol. 2006;48:1304–9.
Togni M, Eber S, Widmer J, Billinger M, Wenaweser P, Cook S, Vogel R, Seiler C, Eberli FR, Maier W, Corti R, Roffi M, Lüscher TF, Garachemani A, Hess OM, Wandel S, Meier B, Jüni P, Windecker S. Impact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: a subgroup analysis of the SIRTAX trial. J Am Coll Cardiol. 2007;50:1123–31.
D’Agostino RB. Propensity Scores in Cardiovascular Research. Circulation. 2007;115:2340–3.
Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999;100:1872–8.
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, rel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344–51.
Nakamura M, Muramatsu T, Yokoi H, Okada H, Ochiai M, Suwa S, Hozawa H, Kawai K, Awata M, Mukawa H, Fujita H, Shiode N, Asano R, Tsukamoto Y, Yamada T, Yasumura Y, Ohira H, Miyamoto A, Takashima H, Ogawa T, Matsuyama Y, Nanto S (2014) On behalf of the J-DESsERT investigators. Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT). Cardiovasc Interv Ther (Epub ahead of print).
Patterson C, Mapera S, Li HH, Madamanchi N, Hilliard E, Lineberger R, Herrmann R, Charles P. Comparative effects of paclitaxel and rapamycin on smooth muscle migration and survival: role of AKT-dependent signaling. Arterioscler Thromb Vasc Biol. 2006;26:1473–80.
Suzuki T, Ishikawa T, Nakano Y, Hino S, Mutoh M. Propensity score-matched lesion-based comparison of mid-term angiographic outcomes of TAXUS Liberté with Cypher Bx Velocity stents for de novo native coronary stenosis and in patients with diabetes. Intern Med. 2014;53:1265–73 Epub 2014 Jun 15.
Dibra A, Kastrati A, Mehilli J, Pache J, Schühlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schömig A. ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005;353:663–70.
Ellis SG, Popma JJ, Lasala JM, Koglin JJ, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Stone GW. Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation. Analysis from the TAXUS-IV trial. J Am Coll Cardiol. 2005;45:1193–200.
Lee SW, Park DW, Lee CW, Hong MK, Park SW, Ko JK, Park JH, Lee JH, Choi SW, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Park SJ, Long-DES-II study investigators. Incidence and predictors of drug-eluting stent fractures in long coronary disease. Int J Cardiol. 2009;133:354–8.
Endo A, Ishikawa T, Suzuki T, Kashiwagi Y, Mutoh M. Direct microscopic observation of striations in a fractured section of a sirolimus-eluting stent (Cypher Bx Velocity®) indicates induction of stent fracture by continuous shear stress. Int Heart J. 2011;52:248–51.
Conflict of interest
None to declare.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
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 and Ther 30, 327–337 (2015). https://doi.org/10.1007/s12928-015-0321-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12928-015-0321-9