Abstract
Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan–Meier curves for the primary endpoint did not significantly differ between the two groups (p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively (p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups.
Similar content being viewed by others
References
Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R, RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346:1773–1780
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, SIRIUS Investigators (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323
Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ (2004) A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 364:583–591
Eisenberg MJ, Konnyu KJ (2006) Review of randomized clinical trials of drug-eluting stents for the prevention of in-stent restenosis. Am J Cardiol 98:375–382
Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB (2007) Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 356:998–1008
Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C, BASKET-LATE Investigators (2006) Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 48:2584–2591
Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R (2006) Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48:193–202
Kimura T, Morimoto T, Nakagawa Y, Tamura T, Kadota K, Yasumoto H, Nishikawa H, Hiasa Y, Muramatsu T, Meguro T, Inoue N, Honda H, Hayashi Y, Miyazaki S, Oshima S, Honda T, Shiode N, Namura M, Sone T, Nobuyoshi M, Kita T, Mitsudo K, j-Cypher Registry Investigators (2009) Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation 119:987–995
Mrdovic I, Savic L, Lasica R, Krijanac G, Asanin M, Brdar N, Djuricic N, Cvetinovic N, Marinkovic J, Perunicic J (2013) Usefulness of the RISK-PCI score to predict stent thrombosis in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a substudy of the RISK-PCI trial. Heart Vessels 28:424–433
Windecker S, Remondino A, Eberli FR, Jüni P, Räber L, Wenaweser P, Togni M, Billinger M, Tüller D, Seiler C, Roffi M, Corti R, Sütsch G, Maier W, Lüscher T, Hess OM, Egger M, Meier B (2005) Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 353:653–662
Kastrati A, Dibra A, Eberle S, Mehilli J, Suárez de Lezo J, Goy JJ, Ulm K, Schömig A (2005) Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA 294:819–825
Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schömig A, Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators (2006) Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 27:260–266
Schömig A, Dibra A, Windecker S, Mehilli J, Suárez de Lezo J, Kaiser C, Park SJ, Goy JJ, Lee JH, Di Lorenzo E, Wu J, Jüni P, Pfisterer ME, Meier B, Kastrati A (2007) A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 50:1373–1380
Cosgrave J, Melzi G, Corbett S, Biondi-Zoccai GG, Agostoni P, Babic R, Airoldi F, Chieffo A, Sangiorgi GM, Montorfano M, Michev I, Carlino M, Colombo A (2007) Comparable clinical outcomes with paclitaxel- and sirolimus-eluting stents in unrestricted contemporary practice. J Am Coll Cardiol 49:2320–2328
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, Academic Research Consortium (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115:2344–2351
Kashiwagi A, Kasuga M, Araki E, Oka Y, Hanafusa T, Ito H (2012) International clinical harmonization of glycated hemoglobin in Japan: from Japan Diabetes Society to National Glycohemoglobin Standadization Program Values. J Diabetes Investig 3:39–40
Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K (2009) Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis 53:982–992
Gurm HS, Boyden T, Welch KB (2008) Comparative safety and efficacy of a sirolimus-eluting versus paclitaxel-eluting stent: a meta-analysis. Am Heart J 155:630–639
Buja P, Lanzellotti D, Isabella G, Napodano M, Panfili M, Favaretto E, Iliceto S, Tarantini G (2012) Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery diseae: results from a single-center allcomers registry. Heart Vessels 27:553–558
Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME, TAXUS II Study Group (2003) Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 108:788–794
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 (2005) Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: analysis from the TAXUS-IV trial. J Am Coll Cardiol 45:1193–1200
Nakano Y, Ishikawa T, Hino S, Mutoh M (2014) 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 29(2):93–101
Acknowledgments
This study was supported by a grant-in aid for scientific research from the Ministry of Health, Labour and Welfare (23591063). The authors thank Yumi Nozawa and Ayako Onodera for secretarial assistance.
Conflict of interest
The authors declare that they have no conflict of interest.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Naito, R., Miyauchi, K., Konishi, H. et al. Comparison of long-term clinical outcomes between sirolimus- and paclitaxel-eluting stents in real-world clinical practice. Heart Vessels 30, 746–751 (2015). https://doi.org/10.1007/s00380-014-0560-1
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00380-014-0560-1