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Original Research

Real-World Use Of Ultrathin-Strut Biodegradable Polymer–Coated Sirolimus-Eluting Stents In Patients With Coronary Artery Disease: 6-Month Clinical Outcomes

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Pages 439-447 | Published online: 18 Oct 2019

References

  • Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773–1780. doi:10.1056/NEJMoa01284312050336
  • Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350(3):221–231. doi:10.1056/NEJMoa03244114724301
  • Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370(9591):937–948. doi:10.1016/S0140-6736(07)61444-517869634
  • Räber L, Kelbæk H, Ostojic M, et al. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. JAMA. 2012;308(8):777–787. doi:10.1001/jama.2012.1006522910755
  • Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109(6):701–705. doi:10.1161/01.CIR.0000116202.41966.D414744976
  • Garg S, Bourantas C, Serruys PW. New concepts in the design of drug-eluting coronary stents. Nat Rev Cardiol. 2013;10(5):248. doi:10.1038/nrcardio.2013.1323419901
  • Kolandaivelu K, Swaminathan R, Gibson WJ, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011:123(13):1400–1409. CIRCULATIONAHA. 110.003210.21422389
  • Brancati MF, Burzotta F, Trani C, Leonzi O, Cuccia C, Crea F. Coronary stents and vascular response to implantation: literature review. Pragmat Obs Res. 2017;8:137. doi:10.2147/POR.S13243928761388
  • Burzotta F, Trani C, Todaro D, et al. Outcome of patients treated by a novel thin‐strut cobalt‐chromium stent in the drug‐eluting stent era: results of the SKICE (Skylor in real world practice) registry. Catheter Cardiovasc Interv. 2009;73(4):457–465. doi:10.1002/ccd.2188219229977
  • Hagemeister J, Baer FM, Schwinger RH, Höpp HW. Compliance of a cobalt chromium coronary stent alloy–the COVIS trial. Curr Control Trials Cardiovasc Med. 2005;6(1):17. doi:10.1186/1468-6708-6-1716255780
  • Bax JJ, Baumgartner H, Ceconi C, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60(16):1581–1598. doi:10.1016/j.jacc.2012.08.00122958960
  • Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–2351. doi:10.1161/CIRCULATIONAHA.106.68531317470709
  • Kitabata H, Kubo T, Komukai K, et al. Effect of strut thickness on neointimal atherosclerotic change over an extended follow-up period (≥ 4 years) after bare-metal stent implantation: intracoronary optical coherence tomography examination. Am Heart J. 2012;163(4):608–616. doi:10.1016/j.ahj.2012.01.00722520527
  • Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease: meta-analysis of randomized trials. Circulation. 2018;138(20):2216–2226. doi:10.1161/CIRCULATIONAHA.118.03445629945934
  • Smits PC, Hofma S, Togni M, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013;381(9867):651–660. doi:10.1016/S0140-6736(12)61852-223374650
  • 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(4):299–307. doi:10.1016/j.jacc.2013.09.06124211507
  • Lemos PA, Chandwani P, Saxena S, et al. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open. 2016;6(2):e010028. doi:10.1136/bmjopen-2015-010028
  • Raungaard B, Jensen L, Tilsted H, et al. Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial. Lancet. 2015;385(9977):1527–1535. doi:10.1016/S0140-6736(14)61794-325601789
  • Iantorno M, Lipinski MJ, Garcia-Garcia HM, et al. Meta-analysis of the impact of strut thickness on outcomes in patients with drug-eluting stents in a coronary artery. Am J Cardiol. 2018. doi:10.1016/j.amjcard.2018.07.040
  • Kim BK, Yoon JH, Shin DH, et al. Prospective and systematic analysis of unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stent implantation. Yonsei Med J. 2014;55(2):345–352. doi:10.3349/ymj.2014.55.2.34524532502
  • Kastrati A, Mehilli J, Dirschinger J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation. 2001;103(23):2816–2821. doi:10.1161/01.cir.103.23.281611401938
  • Ürgen Pache J, Kastrati A, Mehilli J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003;41(8):1283–1288. doi:10.1016/s0735-1097(03)00119-012706922
  • Morton AC, Crossman D, Gunn J. The influence of physical stent parameters upon restenosis. Pathologie Biologie. 2004;52(4):196–205. doi:10.1016/j.patbio.2004.03.01315145132
  • Koskinas KC, Chatzizisis YS, Antoniadis AP, Giannoglou GD. Role of endothelial shear stress in stent restenosis and thrombosis: pathophysiologic mechanisms and implications for clinical translation. J Am Coll Cardiol. 2012;59(15):1337–1349. doi:10.1016/j.jacc.2011.10.90322480478
  • Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48(1):193–202. doi:10.1016/j.jacc.2006.03.04216814667
  • Mehilli J, Byrne RA, Wieczorek A, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J. 2008;29(16):1975–1982. doi:10.1093/eurheartj/ehn25318550554
  • Byrne RA, Kastrati A, Kufner S, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial. Eur Heart J. 2009;30(20):2441–2449. doi:10.1093/eurheartj/ehp35219720642
  • Chevalier B, Silber S, Park SJ, et al. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial—phase 2. Circ Cardiovasc Interv. 2009;2(3):188–195. doi:10.1161/CIRCINTERVENTIONS.108.82344320031715
  • Stefanini GG, Byrne RA, Serruys PW, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012;33(10):1214–1222. doi:10.1093/eurheartj/ehs08622447805
  • Kang SH, Park KW, Kang DY, et al. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014;35(17):1147–1158. doi:10.1093/eurheartj/eht57024459196
  • Zhu L, Lv YN, Wang LY. Stent thrombosis with biodegradable polymer drug-eluting stents versus durable polymer sirolimus-eluting stents: an update meta-analysis. Cardiology. 2015;130(2):96–105. doi:10.1159/00036807325612523
  • Yang Y, Lei J, Huang W, Lei H. Efficacy and safety of biodegradable polymer sirolimus-eluting stents versus durable polymer drug-eluting stents: a meta-analysis of randomized trials. Int J Cardiol. 2016;222:486–493. doi:10.1016/j.ijcard.2016.07.27927505339
  • Navarese EP, Kubica J, Castriota F, et al. Safety and efficacy of biodegradable vs. durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials. EuroIntervention. 2011. doi:10.4244/EIJV7I8A155
  • Yin Y, Zhang Y, Zhao X. Safety and efficacy of biodegradable drug-eluting vs. bare metal stents: a meta-analysis from randomized trials. PLoS One. 2014;9(6):e99648. doi:10.1371/journal.pone.009964824945816
  • Wang G, Wang H, Xu B, et al. Efficacy and safety of a biodegradable polymer Cobalt‐Chromium sirolimus‐eluting stent (EXCEL2) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials. Catheter Cardiovasc Interv. 2017;89(S1):512–519. doi:10.1002/ccd.2688728112473
  • Onuma Y, Kukreja N, Piazza N, et al. The everolimus-eluting stent in real-world patients: 6-month follow-up of the X-SEARCH (Xience V Stent Evaluated at Rotterdam Cardiac Hospital) registry. J Am Coll Cardiol. 2009;54(3):269–276. doi:10.1016/j.jacc.2009.05.01619589442
  • Ananthakrishna R, Kristanto W, Liu L, et al. Incidence and predictors of target lesion failure in a multiethnic Asian population receiving the SYNERGY coronary stent: A prospective all‐comers registry. Catheter Cardiovasc Interv. 2018. doi:10.1002/ccd.27577
  • Barbato E, Salinger-Martinovic S, Sagic D, et al. A first-in-man clinical evaluation of Ultimaster, a new drug-eluting coronary stent system: CENTURY study. EuroIntervention. 2015;11(5):541–548. doi:10.4244/EIJY14M08_0625136883
  • Hideo-Kajita A, Garcia HG, Azizi V, et al. Comparison of clinical outcomes between magmaris (DREAMS 2G) and orsiro drug eluting stents: pooled patient level analysis from biosolve II-III and bioflow II trials. J Am Coll Cardiol. 2018;71(11 Supplement):A1109. doi:10.1016/S0735-1097(18)31650-4
  • Ge JB, Zhang F, Qian JY, Ge L, Liu XB, Zhou J. Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases. Chin Med J. 2011;124(6):831–835.21518588
  • Meredith IT, Verheye S, Dubois CL, et al. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012;59(15):1362–1370. doi:10.1016/j.jacc.2011.12.01622341736