Abstract
The long-term outcome and compliance of dual-antiplatelet therapy after implantation of drug-eluting stent in the “real world” setting in Japan has not been well investigated. The purpose of this study was to provide information on the introduction and outcomes including status and compliance of dual-antiplatelet therapy of sirolimus-eluting stent (SES). Five-year follow-up was achieved in 1937 of 2050 patients (94.5%). Off-label use was 87.3% in this study. The incidence of MACE was 23.2%, including death (13.4%), MI (3.4%), and target lesion revascularization (TLR, 9.6%). Multivariate analysis for TLR predicted dialysis [hazard ratio (HR) 3.5, 95% confidence interval (CI) 2.13–5.93], lesion length >30 mm (HR 1.89, 95% CI 1.24–2.84), vessel diameter <2.5 mm (HR 1.55, 95% CI 1.10–2.18), ostial lesion (HR 1.59, 95% CI 1.10–2.31), and previous PCI (HR 1.42, 95% CI 1.00–2.00). There were 25 events of definite/probable thrombosis. Very late thrombosis was identified in 17 cases, and the slope of the linear portion of the cumulative incidence curve of stent thrombosis was 0.28% per year. Seven of the 17 events (41.2%) occurred under dual anti-platelet therapy. Five-year outcomes after SES implantation in the “real world” in Japanese showed that dialysis, previous PCI, small vessel <2.5 mm, long lesion >30 mm, and ostial lesions were the predictors of TLR at 5-years. Stent thrombosis rate was lower than previous reports.
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References
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315–23.
Ikari Y, Kotani J, Kozuma K, Kyo E, Nakamura M, Yokoi H, et al. 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;73:1038–44.
Kozuma K, Ota Y, Nagai Y, Katsuta Y, Nozaki E, Onodera T, et al. Clinical and angiographic outcomes with sirolimus-eluting stent for coronary bifurcation lesions. The J-PMS study. Circ J. 2010;5:306–14.
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344–51.
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004;364:1519–21.
Kimura T, Morimoto T, Nakagawa Y, Tamura T, Kadota K, Yasumoto H, et al. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation. 2009;119:987–95.
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369:667–78.
Kimura T, Morimoto T, Kozuma K, Honda Y, Kume T, Aizawa T, et al. Comparisons of baseline demographics, clinical presentation, and long-term outcome among patients with early, late, and very late stent thrombosis of sirolimus-eluting stents: observations from the Registry of Stent Thrombosis for Review and Reevaluation (RESTART). Circulation. 2010;122:52–61.
van Werkum JW, Heestermans AA, Zomer AC, Kelder JC, Suttorp MJ, Rensing BJ, et al. Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry. J Am Coll Cardiol. 2009;53:1399–409.
ten Berg JM, Kelder JC, Suttorp MJ, Verheugt FW, Thijs Plokker HW. Influence of planned six-month follow-up angiography on late outcome after percutaneous coronary intervention: a randomized study. J Am Coll Cardiol. 2001;38:1061–9.
Weisz G, Leon MB, Holmes DR Jr, Kereiakes DJ, Popma JJ, Teirstein PS, et al. Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (sirolimus-eluting stent in de novo native coronary lesions) Trial. J Am Coll Cardiol. 2009;53:1488–97.
Daemen J, Kukreja N, van Twisk PH, Onuma Y, de Jaegere PP, van Domburg R, et al. Four-year clinical follow-up of the rapamycin-eluting stent evaluated at Rotterdam Cardiology Hospital registry. Am J Cardiol. 2008;101:1105–11.
Otsuka Y, Ishiwata S, Inada T, Kanno H, Kyo E, Hayashi Y, et al. Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: insights from the Japan multi-centre post-marketing surveillance registry. Eur Heart J. 2011;32:829–837.
Nakamura M, Yokoi H, Hamazaki Y, Watarai M, Kijima M, Mitsudo K. Impact of insulin-treated diabetes and hemodialysis on long-term clinical outcomes following sirolimus-eluting stent deployment. Insights from a sub-study of the Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) Registry. Circ J. 2010;74:2592–7.
Shirai S, Kimura T, Nobuyoshi M, Morimoto T, Ando K, Soga Y, et al. Impact of multiple and long sirolimus-eluting stent implantation on 3-year clinical outcomes in the j-Cypher Registry. JACC Cardiovasc Interv. 2009;3:180–8.
Stone GW, Ellis SG, Colombo A, Grube E, Popma JJ, Uchida T, et al. Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis from the TAXUS clinical trial program. JACC Cardiovasc Interv. 2011;4:530–42.
Airoldi F, Colombo A, Morici N, Latib A, Cosgrave J, Buellesfeld L, et al. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation. 2007;116:745–54.
Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, et al. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010;362:1374–82.
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This study was supported by the Jonson and Jonson Cordis Corporation (Warren, NJ, USA) as an approval condition of Cypher™ stent under the control of Japanese government.
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Kotani, Ji., Ikari, Y., Kyo, E. et al. Five-year outcomes of Cypher™ coronary stent: report from J-PMS Study. Cardiovasc Interv and Ther 27, 63–71 (2012). https://doi.org/10.1007/s12928-011-0092-x
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DOI: https://doi.org/10.1007/s12928-011-0092-x