A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions

Carrié, Didier; Berland, Jacques; Verheye, Stefan; Hauptmann, Karl Eugen; Vrolix, Mathias; Violini, Roberto; Dibié, Alain; Berti, Sérgio; Maupas, Eric; Antoniucci, David; Schöfer, Joachim

doi:10.1016/j.jacc.2011.12.009

Cited by 102 publications

(83 citation statements)

References 20 publications

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“…These results should be, therefore, taken into account for future stent design, because polymer-free products are still in development. In light of our data, new drugs, whose elution from the stent platform is not much dependent on a polymer or reservoir technology, 12,13,36 could probably still represent 2 interesting fields of innovation in PF-DES development.…”

Section: Discussionmentioning

confidence: 82%

“…In this regard, a PF amphilius-eluting stent with abluminal reservoirs (Cre8 stent; CID, Saluggia, Italy) has a lower late loss compared with PB-PES with comparable clinical outcome at 1 year. 36 A reservoir system such as microporous and amphilius technology for carrying drugs can increase the amount of drug storage, control drug release, and promote endothelialization without increasing neointimal proliferation.…”

Section: Discussionmentioning

confidence: 99%

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Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent

Shiratori

Cola

Brugaletta

et al. 2014

Circ: Cardiovascular Interventions

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Background— Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks. However, a durable polymer may provoke hypersensitive reaction, delayed artery healing, and eventually stent thrombosis. The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent (PF-PES) versus a polymer-based PES (PB-PES). Methods and Results— Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES. The primary end point was late loss at 9 months. Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed. From October 2007 to April 2009, 164 patients were enrolled and randomized into 2 groups (PF-PES: n=84; PB-PES: n=80). Mean in-stent lumen loss was 0.90±0.59 mm for PF-PES and 0.49±0.52 mm for PB-PES ( P <0.001). Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES (1.42±1.09 versus 0.51±0.61 mm 2 ; P <0.001). At 2 years, a composite end point of all-cause death, any myocardial infarction, and target vessel revascularization occurred in 36.9% for PF-PES and 16.3% for PB-PES ( P =0.004), mainly driven by a higher rate of target vessel revascularization (PF-PES: 35.7%; PB-PES: 13.8%; P =0.001). One late stent thrombosis was observed in PF-PES. Conclusions— Compared with PB-PES, PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis. Polymer plays an essential role in the performance of drug-eluting stents. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01375855.

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Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent

Shiratori

Cola

Brugaletta

et al. 2014

Circ: Cardiovascular Interventions

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“…With regard to this, a PF amphilius-eluting stent, which uses abluminal reservoirs for drug elution (Cre8 TM stent; CID, Saluggia, Italy), has been found to have a lower late loss than PB-PES with similar clinical outcome at 1 year. 26 No data on EVR have so far been reported for this stent.…”

Section: Discussionmentioning

confidence: 97%

Edge Vascular Response After Polymer-Free vs. Polymer-Based Paclitaxel-Eluting Stent Implantation

Otsuki

Shiratori

Brugaletta

et al. 2014

Circ J

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Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp arterial tissue. 12 Restenosis of polymer-based paclitaxel=eluting stent (PB-PES) has been shown, for example, to be more frequent at the proximal than the distal edge, exhibiting positive vascular remodeling at the distal edge, probably due to higher downstream concentration of the drug at this level. 13-18 The AXXION TM stent is a polymer-free paclitaxel-eluting stent (PF-PES), the drug dose of which is approximately 3-fold higher than in PB-PES, and which allows faster release of paclitaxel as compared to PB-PES. The combination of paclitaxel with a polymer-free platform on EVR has not been investigated.The purpose of this study was to evaluate EVR between ompared with bare metal stents (BMS), polymer-based drug-eluting stents (DES) reduce in-stent restenosis and target vessel revascularization. 1-4 The permanent polymer coating, however, has been variously associated with impaired vascular healing and incomplete stent malapposition, which may eventually provoke stent thrombosis. 5,6 Therefore, many attempts have been done to reduce this phenomenon by introducing polymer-free or biodegradable-polymer DES. 7-11Edge vascular response (EVR) is another cautionary problem after DES implantation, because it is considered 1 of the causes of edge restenosis because of a potential toxic effect of drug on Background: It is unknown if lack of polymer can provoke a different edge response in drug-eluting stents. The aim of this study was to compare edge vascular response between polymer-free paclitaxel-eluting stent (PF-PES) and polymer-based paclitaxel-eluting stents (PB-PES).

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“…The anti-proliferative drug used is amphilimus, which was produced from sirolimus in a long-chain fatty acid mixture and is loaded into an abluminal reservoir. Compared to paclitaxel-eluting stents, Cre8 has shown a lower rate of in-stent late lumen loss but no difference in clinical end points [49]. The BioFreedom (Biosensors, Morges, Switzerland) stent has a stainless steel platform with a microstructure abluminal surface.…”

Section: Polymer-free 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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A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions

Cited by 102 publications

References 20 publications

Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent

Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent

Edge Vascular Response After Polymer-Free vs. Polymer-Based Paclitaxel-Eluting Stent Implantation

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

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