Abstract
The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES.
Highlights
Drug-eluting stents (DES) marked a breakthrough technology in the field of percutaneous coronary intervention (PCI) due to a profound reduction in neointimal hyperplasia and the need for repeat revascularization compared with bare-metal stents (BMS) [1,2,3]
Several concerns related to a higher risk of late thrombotic events and catch-up in efficacy during long-term follow-up hampered their widespread adoption in clinical practice [4,5,6,7,8,9,10,11,12,13,14]
At 12 months, there was no significant difference between the Ultimaster BP-SES and EES groups with respect to target lesion failure (TLF) (6.9% vs. 7.7%, p = 0.72), cardiac death (1.1% vs. 1.2%, p = 0.90), target-vessel myocardial infarction (MI) (1.8% vs. 3.2%, p = 0.30), target-lesion revascularization (TLR) (4.0% vs. 5.7%, p = 0.37), and definite or probable stent thrombosis (ST) (0.7% vs. 1.2%, p = 0.57)
Summary
Drug-eluting stents (DES) marked a breakthrough technology in the field of percutaneous coronary intervention (PCI) due to a profound reduction in neointimal hyperplasia and the need for repeat revascularization compared with bare-metal stents (BMS) [1,2,3]. Histopathological studies revealed a frequent occurrence of chronic inflammatory response to the early-generation of DES, to the components of permanent polymers, which were found to delay vessel healing and stent endothelialization. New-generation DES were developed with the specific aim to hone the safety profile of earlier devices. Newer generation DES were made with more biocompatible durable polymers or biodegradable-polymers (BP), which eliminated in turn the persistent inflammatory stimulus from the stent surface. Available evidence indicates that new-generation DES, including BP-DES, are safer and more effective than both BMS and early-generation DES, resulting in a paradigm shift in clinical practice [15,16,17,18,19,20]. New-gInet.nJ.eMraolt.iSocni. 2D01E6,S17a, 1r4e90currently indicated in almost all lesion and patient subsets [21]. 2 of 10 Notably, refinements in DES technology involved not solely the polymer, and the stent platfoarnmd earnlyd-gtehneeracthioonicDeEoS,fretshueltianngtiinpraopliafreardaitgimveshaigfteintc.liniTcahlepraavctaicilea[b1i5l–it2y0].oAf scaorbeasultl-tc, hnreowm- ium and pgleanteinrautmion-cDhEroSmarieucmurrpelnattlfyoirnmdiscarteemd ainrkaalmbloystdaellclreesaiosnedansdtrpuattitehnitcksunbessest,s w[21it]h. out affecting radial force andNsotteanbtlyv, irseifbinileimtye. ntSsininceDEstSrutetchthnioclkognyesisnvioslvinedtenrtowt isnoeledlywthitehponleyominert,imbuatl ahlsyopethreplsatesniat and thromppbllaaottgfinoeurnmmic-iactnhydr[o2mt2h,ie2u3mc]h,porielcadetfuoocrfimntshgersetamennattirpktrhaobilcliykfendreaetscisvreeiassakegedeynstta.rtuTitmhtehpiacrokvnvaieilnsasgb,iwtlihtiyetheooffufitccoaabfcfayelctat-icnnhdgrosrmaadfieuiatmyl fpoarrnocdefile of any caonrdonastreyntdevvisicibei.liFtyin. aSlliny,cesirsotlriumt utshiacnkdneosstheisr ainntaelrotwguineesdofwthiteh “nliemoiunstimfaaml ilhyy”pherapvlaesbiaecaonmde the antiptrhorloifmerbaotgiveenidcirtuyg[2s2o,2f3c]h, roeidcueciinngnestwen-gt ethnieckranteisosnisDkEeyS,aotwiminpgrotvoinggrethaeteerffeifcfiaccyacayndthsaanfeptyapclriotfaixleel
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