Six-Month Results of the NEVO RES-ELUTION I (NEVO RES-I) Trial

Abstract

on behalf of the NEVO ResElution-I InvestigatorsBackground-Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis, which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. Methods and Results-NEVO ResElution-I was a prospective randomized study in 394 patients with coronary artery disease comparing the NEVO SES with the TAXUS Liberté paclitaxel-eluting coronary stent (TAXUS Liberté PES) stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronary intervention (PCI), the primary end point favored NEVO SES (0.13Ϯ0.31 mm versus 0.36Ϯ0.48 mm, PϽ0.001 for noninferiority and superiority). The study was not powered for clinical end points and showed no significant difference for NEVO SES versus TAXUS Liberté PES: death: 0.5 versus 1.6%, Pϭ0.36; myocardial infarction: 2.0 versus 2.6%, Pϭ0.75; target lesion revascularization: 1.5 versus 3.2%, Pϭ0.33; major adverse cardiac events: 4.0 versus 7. 4%, Pϭ0.19. No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberté PES. Intravascular ultrasound showed lower percent volume obstruction for NEVO SES (5.5Ϯ11% versus 11.5Ϯ9.7%, Pϭ0.016). Key Words: angioplasty Ⅲ stents Ⅲ restenosis S ince the introduction of the CYPHER sirolimus-eluting coronary stent (CYPHER SES) in 2002, many trials have established that release of sirolimus from a nonerodible polymer significantly reduces restenosis and repeat intervention rates compared with bare-metal and other drug-eluting stents (DES) in a wide variety of clinical settings. [1][2][3][4][5] However, the clinical benefit of DES may be partially offset by a heightened incidence of late stent thrombosis. 6,7 Although the causes of late stent thrombosis are multifactorial, permanent polymer surface coatings may play a key role by inciting an inflammatory response because of permanent exposure of the polymer to the vessel wall, even long after the drug has been completely released. 8 Eliminating this risk requires DES developments that reduce both polymer exposure over time Received February 13, 2010; accepted August 23, 2010 Clinical Perspective on p 564 Conclusions-ThisThe NEVO sirolimus-eluting coronary stent (NEVO SES) (Cordis Corporation, Bridgewater, NJ) is a new cobaltchromium alloy stent platform that incorporates unique reservoir technology and a bioabsorbable polymer from which sirolimus is released. These design elements, accomplished by creating multiple laser-cut reservoirs and then filling them with a blend of sirolimus and the bioabsorbable polymer, reduce the amount of tissue exposed to the polymer. Absorption of the polymer within approximately 3 months limits the duration of vessel wall exposure to the polymer. Thereafter, only a biologically inert bare-metal pla...

Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent

“…In addition, the angiographic potency of the O-SES with an in-stent LLL of 0.10±0.32 mm at 9 months compares well with other new-generation DES. [21][22][23][24][25][26][27][28] The O-SES platform has several distinguishing characteristics. First, the strut thickness of the device is reduced to 60 μm (Figure 1).…”

“…Third, the antiproliferative drug used for drug release is the mammalian target of rapamycin inhibitor sirolimus. The drug is applied at a dose density of 1.4 μg/mm 2 , which corresponds well to the one previously used with the sirolimus-eluting Cypher and Nevo stent platforms, 27,30 and is released during a period of 3 months with 50% of drug released during the first 30 days. Fourth, the drug is released from a biodegradable poly-l lactic acid layer, which degrades into carbon dioxide and water.…”

Drug eluting stents: Current status and new developments

“…Six-month followup period demonstrated that NEVO stent is superior to TAXUS Liberté stent. Stent thrombosis was not observed in the NEVO stent group (44).…”

Intravascular Ultrasound Results From the NEVO ResElution-I Trial

“…These results matched those of the larger angiographic trial that demonstrated superiority of the NEVO SES over the TAXUS Liberté PES for the primary end point of in-stent late loss (0.13Ϯ0.31 mm versus0.36Ϯ0.48 mm, PϽ0.001 for noninferiority and superiority). 13 …”