TCT-565 OCT evaluation of the time course of vessel healing following implantation of new generation biodegradable polymer-coated and sirolimus-eluting cobalt-chromium coronary stent system (ALEX OCT Study).

Legutko, Jacek; Gil, Robert; Kałuża, Greg L.; Król, Marek; Wojdyla, Roman; Pawłowski, Tomasz; Brzeziński, Michał; Kondys, Marek; Skwarna, Bartosz; Jąkała, Jacek; Roleder, Tomasz; Zasada, Wojciech; Dudek, Dariusz

doi:10.1016/j.jacc.2013.08.1312

Cited by 7 publications

(10 citation statements)

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“…The clinical translation of impaired strut coverage in OCT is unclear, however up-to date the decreased proportion of protruding but covered struts has not translated into poorer outcome in the clinical setting [10]. The tissue coverage of currently evaluated BP-SES (Alex Plus) has been also assessed in the setting of a prospective clinical registry, with OCT evaluation at different time points [22]. At 3 month follow up the proportion of embedded struts was 85.8% and uncovered 10.3% whereas at 6-months the number of uncovered struts was only 1.5% at 3 months.…”

Section: Discussionmentioning

confidence: 99%

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

et al. 2016

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Background: Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), EES and BMS (0.18 ± 0.1 vs. 0.39 ± 0.1 vs. 0.34 ± 0.2 mm, respectively; p = 0.04). There was no difference in the proportion of malapposed or uncovered struts, although protruding covered struts were more common in p = 0.03). (0.24 ± 0.1 vs. 0.4 ± 0.1 vs. 0.77 ± 0.4; p < 0.01) whilst EES and BP-SES had higher fibrin scores than BMS (1.2 ± 0.4 vs. 1.3 ± 0.3 vs. 0.17 ± 0.2; p < 0.01 (Cardiol J 2016; 23, 6: 657-666) In pathology, the lowest neointimal thickness was confirmed in BP-SES (p < 0.05). The inflammation score was significantly lower in BP-SES and EES when compared to BMS

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Section: Discussionmentioning

confidence: 99%

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

et al. 2016

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“…The safety and efficacy of a studied fr-edSES (Alex, Balton) was shown in the first-in-man study [25], in which temporal vascular healing was evaluated with serial Optical Coherence Tomography (OCT) evaluation. The favourable healing profile was confirmed at three months, at which time 97% of struts were covered by neointima.…”

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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“…A previous animal study reported the value of the Alex stent in inhibiting neointimal proliferation [8]. Another study, also from Poland, used optical coherence tomography to assess the mechanistic results of the Alex stent [9]. Again, the results were highly satisfactory, with favorable profiles for arterial healing and sustained antiproliferative effects.…”

Section: Present Studymentioning

confidence: 95%

Novel sirolimus-eluting stents

Alfonso

Rivero²

2016

Coronary Artery Disease

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Drug-eluting stents (DES) have revolutionized interventional cardiology [1][2][3]. Because of their strong ability to inhibit neointimal proliferation, currently, DES represent the default strategy during coronary interventions [1][2][3]. Initially, first-generation DES proved to be very effective in reducing the restenosis rate and the need for repeated interventions [4]. These early devices included sirolimus-DES (SES) and paclitaxel-DES (PES). The RAVEL trial represented a milestone showing that, in highly selected patient and lesion subsets, a restenosis rate of 0% was indeed possible with DES [4]. This was a dream come true for interventional cardiologists. However, it soon became clear that restenosis still occurred after DES implantation, especially when these devices were used in highly complex clinical and anatomic scenarios [1][2][3]. From the very beginning, SES proved to be more effective than PES in suppressing neointimal growth. In fact, preliminary studies suggesting that the larger late loss observed with PES compared with SES had no relevant clinical implications were soon refuted by subsequent larger studies reporting the clinical benefit associated with the smaller late loss provided by SES [5].However, the risk of stent thrombosis was not reduced by first-generation DES [1][2][3][4][5]. In fact, these devices were associated with a very low, but marginally higher risk of very-late stent thrombosis compared with bare-metal stents. Delayed endothelization, inflammation, fibrin deposition, neoatherosclerosis, allergic or, actually, a real toxic effect on the vessel wall, were considered putative underlying pathologic substrates accounting for this feared complication [3]. The permanent polymers used in these early DES were a cause for concern in this respect.Second-generation DES addressed most of these limitations and eventually moved the field forward [1,2]. These devices proved to be not only more effective but also safer than first-generation DES [1,2]. Major advances in platform designs, with much thinner and more flexible struts and appealing metal alloys (shifting from stainless steel to cobalt-chromium or platinum-chromium), were made. Moreover, permanent polymers evolved to become truly biocompatible. Last but not least, a new family of highly lipophilic limus drugs was developed in an attempt to improve results. In this setting, excellent results were obtained and a renewed feeling of confidence suggested that the duration of dual antiplatelet therapy could be reduced. However, most head-to-head DES studies showing the benefits of second-generation DES selected PES as the comparator [1]. Beating the results of firstgeneration SES was eventually possible, but proved to be more challenging [2].The term 'third-generation' DES generates major controversy [3]. For many investigators most new DES should just be considered sequential iterations of former devices and do not represent clear-cut breakthroughs. However, the advent of fully biodegradable polymers clearly constitutes a qualitative t...

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TCT-565 OCT evaluation of the time course of vessel healing following implantation of new generation biodegradable polymer-coated and sirolimus-eluting cobalt-chromium coronary stent system (ALEX OCT Study).

Cited by 7 publications

References 0 publications

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

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

Novel sirolimus-eluting stents

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