The “Final” 5-Year Follow-Up From the ENDEAVOR IV Trial Comparing a Zotarolimus-Eluting Stent With a Paclitaxel-Eluting Stent

Kirtane, Ajay J.; Leon, Martin B.; Ball, Michael; Bajwa, Harpaul; Sketch, Michael H.; Coleman, Patrick S.; Stoler, Robert C.; Papadakos, Stylianos; Cutlip, Donald E.; Mauri, Laura; Kandzari, David E.; Investigators, Endeavor Iv

doi:10.1016/j.jcin.2012.12.123

Cited by 75 publications

(37 citation statements)

References 28 publications

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“…We report a similar probability for TLF with use of E-ZES as compared to 5-year rates of ENDEAVOR IV trial [16] (13.8% vs 14.7%) and similar probability for ARC definite/probable (1.7% vs 1.3% in ENDEAVOR IV). Patients treated with EES, demonstrated lower probability for TLF (7.5% vs 12.7%) and for TLR (3.3% vs 8.6%) at 5 years in compare to rates reported in SPIRIT III trial [17].…”

Section: Discussionsupporting

confidence: 54%

Late differences in outcomes of patients with stable angina and an isolated lesion in the proximal left anterior descending artery treated with new-generation drug-eluting stents

Toutouzas

Patsa

Matsoukis

et al. 2015

International Journal of Cardiology

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Section: Discussionsupporting

confidence: 54%

Late differences in outcomes of patients with stable angina and an isolated lesion in the proximal left anterior descending artery treated with new-generation drug-eluting stents

Toutouzas

Patsa

Matsoukis

et al. 2015

International Journal of Cardiology

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“…It seems that the type of drug, and specifically modification of the release profile, plays more pronounced role. Fast-release ZES (Endeavour, Medtronic) has shown a significant difference in clinical performance against paclitaxel-eluting stents (PES), as shown by significant risk reduction in late and very late stent thrombosis, cardiac death, and myocardial infarction [14,15]. On the other hand, at longer follow-up the excellent safety profile did not translate into efficacy, with inferior rates of angiographic surrogates of restenosis and target vessel failure when compared to SES and PES [15][16][17].…”

Section: Discussionmentioning

confidence: 99%

Dose-dependent vascular response following delivery of sirolimus via fast releasing, biodegradable polymer stent matrix: an experimental study in the porcine coronary model of restenosis

et al. 2015

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A b s t r a c tBackground: Fast releasing, rapamycin-eluting stents, although safe, showed inferior results with regard to inhibition of restenosis.Aim: Therefore, we report vascular effects of a novel, biodegradable polymer stent matrix with elevated sirolimus dose and fast release kinetics (ed-frSES, Alex, Balton) in the porcine coronary in-stent restenosis model. Methods:A total of 19 stents were implanted with 120% overstretch in the coronary arteries of seven domestic pigs: seven ed-frSES with 1.3 μg/mm 2 of sirolimus, eight frSES with 1 μg/mm 2 of sirolimus, and eight bare metal stents (BMS). For the following 28 days, coronary angiography was performed, animals were sacrificed, and the stented segments harvested for histopathological evaluation. Results:In angiography at 28 days the late lumen loss was lowest in the elevated dose sirolimus eluting stent (SES) (ed-frSES: 0.20 ± 0.2 vs. frSES: 0.80 ± 0.5 vs. BMS: 0.96 ± 0.5 mm, p < 0.01). This was confirmed in the morphometric evaluation in histopathology as represented by a significant and dose-dependent decrease in the percentage area of stenosis (ed-frSES: 22.4 ± 12.7% vs. frSES: 35 ± 10.7% vs. BMS: 47.5 ± 12.5%, p < 0.01). There was no peri-strut inflammation in any of the groups. However, the endothelialisation score was numerically not meaningfully decreased in ed-frSES (ed-frSES: 2.93 vs. frSES: 3. vs. BMS: 3, p = 0.05). Signs of fibrin were also noted in ed-frSES (ed-frSES: 0.4 vs. frSES: 0 vs. BMS: 0, p = 0.05). Conclusions:Sirolimus dose-dependent vascular response was reported. The elevated dose, fast releasing SES shows satisfactory vascular healing, similar to regular dose, fast release SES, with improved efficacy in restenosis inhibition.

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“…Moreover, a zotarolimus-eluting stent was associated with a lower rate of cardiac adverse events than a sirolimus-eluting stent in very late stent thrombosis after three years of follow-up [31]. However, Camenzind et al reported no difference in clinical outcomes at one year between Endeavor and Taxus stents, although the Endeavor stent had a significantly lower rate of stent thrombosis between one and five years [32]. The ZEST trial also showed that the Endeavor stent had better outcomes than a sirolimus-eluting stent, but similar results to a paclitaxel-eluting stent after one year of follow-up [33].…”

Section: Second Generation Dessmentioning

confidence: 99%

The Development of Coronary Artery Stents: From Bare-Metal to Bio-Resorbable Types

Chen

Wang

et al. 2016

Metals

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Abstract:Coronary artery disease is the leading cause of death worldwide. Conventional balloon angioplasty is associated with high rates of complications such as coronary dissection and vessel recoil. The deployment of bare-metal stents (BMSs) can overcome these problems and achieve a better patency rate than simple balloon angioplasty. It has been shown that the stent design including structure platform, size, length, and strut thickness has a major influence on the clinical results. Even though angioplasty with BMS implantation is widely used in coronary interventions, the restenosis rate due to neointimal hyperplasia remains high. Therefore, drug-eluting stents (DESs) coated with anti-proliferative agents and polymers have been developed to reduce the restenosis rate and improve the clinical outcomes. Although the repeat revascularization rate of DESs is lower than that of BMSs, the long-term stent thrombosis rate is higher than for BMSs. Therefore, new and emerging generations of stents, in which, for example, thinner struts and bioresorbable polymers are used, are available for clinical use. However, there are only a limited number of clinical trials, in which these newer stents have been compared with BMSs and first-and second-generation DESs. The purpose of this review was to provide up-to-date information on the evolution of coronary artery stents from BMSs to DESs to bioresorbable stents (BRSs).Keywords: coronary artery disease; stent; bioresorbable; drug; polymer; strut The Evolution of Coronary Stent DevelopmentCoronary artery disease (CAD) is a major cause of mortality and morbidity. One of the treatment options for CAD is a percutaneous coronary intervention. Balloon angioplasty alone, which involves pushing the plaque to the walls of the artery, can achieve a larger luminal diameter in the acute phase. However, arterial recoil, dissection, and late neointimal hyperplasia can result in vessel restenosis. Therefore, bare metal stents (BMSs) made from metallic materials were developed to overcome the dissection and the restenosis complications caused by recoil. Although the restenosis rate can be reduced by stenting, the in-stent restenosis (ISR) rate is still high at around 20%-30% [1,2]. ISR is mostly caused by neointimal hyperplasia.A reduction in restenosis was first achieved with the evolution of the stent platform, including thinner stent struts and new metal compounds. Furthermore, new drug delivery systems and polymer coatings have been developed to achieve better clinical outcomes. The first generation of drug-eluting stents (DESs) with a sirolimus or paclitaxel coating showed better clinical outcomes with lower rates of cardiac death, myocardial infarction, and target vessel revascularization than BMSs [3,4]. However, increased rates of stent thrombosis were reported with first-generation

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The “Final” 5-Year Follow-Up From the ENDEAVOR IV Trial Comparing a Zotarolimus-Eluting Stent With a Paclitaxel-Eluting Stent

Cited by 75 publications

References 28 publications

Late differences in outcomes of patients with stable angina and an isolated lesion in the proximal left anterior descending artery treated with new-generation drug-eluting stents

Late differences in outcomes of patients with stable angina and an isolated lesion in the proximal left anterior descending artery treated with new-generation drug-eluting stents

Dose-dependent vascular response following delivery of sirolimus via fast releasing, biodegradable polymer stent matrix: an experimental study in the porcine coronary model of restenosis

The Development of Coronary Artery Stents: From Bare-Metal to Bio-Resorbable Types

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