Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial

Wijns, William; Vrolix, Mathias; Verheye, Stefan; Schoors, Danny; Slagboom, Ton; Gosselink, Marcel; Benit, Edouard; Donohoe, Dennis; Knape, Charlene; Attizzani, Guilherme F.; Lansky, Alexandra J.; Ormiston, John; Investigators, Dessolve Ii

doi:10.4244/eijy14m05_03

Cited by 35 publications

(27 citation statements)

References 28 publications

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“…It was concluded that, in real world, the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible. Another trial (64), that compared the MiStent bioabsorbable polymer sirolimuseluting stent with zotarolimus-drug eluting stent, showed superiority in the primary efficacy endpoint of 9-month mean late lumen loss for absorbable polymer sirolimuseluting stent compared to zotarolimus-eluting stent. However, in this trial, the 9-month stent thrombosis rate as defined by the Academic Research Consortium was 0.9% in 117 patients with absorbable polymer sirolimus-eluting stent and 1.7% in 60 patients with zotarolimus-eluting stent.…”

Section: Bioresorbable and Bioabsorbable Stent Advantages Disadvantamentioning

confidence: 99%

Thrombotic responses to coronary stents, bioresorbable scaffolds and the Kounis hypersensitivity-associated acute thrombotic syndrome

et al. 2017

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Percutaneous transluminal coronary angioplasty with coronary stent implantation is a lifesaving medical procedure that has become, nowadays, the most frequent performed therapeutic procedure in medicine. Plain balloon angioplasty, bare metal stents, first and second generation drug-eluting stents, bioresorbable and bioabsorbable scaffolds have offered diachronically a great advance against coronary artery disease and have enriched our medical armamentarium. Stented areas constitute vulnerable sites for endothelial damage, endothelial dysfunction, flow turbulence, hemorheologic changes, platelet dysfunction, coagulation changes and fibrinolytic disturbances. Implant surface attracts several proteins such as albumin, fibronectin, fibrinogen, and complement that lead to complement system activation. Macrophages recognize the implant as foreign substance due to protein adsorption and its continuous presence results in macrophage differentiation and fusion into foreign body giant cells. Polymer coating, stent metallic platforms and the released drugs can act as strong antigenic complex that apply continuous, repetitive, persistent and chronic hypersensitivity irritation to the coronary intima. The concomitant administration of oral antiplatelet drugs and environmental exposures can induce hypersensitivity inflammation. A class of platelets, activated via high-affinity and low-affinity IgE hypersensitivity receptors FCγRI, FCγRII, FCεRI and FCεRII, can induce Kounis hypersensitivity-associated thrombotic syndrome inside the stented coronaries. Type III variant of this syndrome is diagnosed when coronary artery stent thrombosis is associated with thrombus infiltrated by eosinophils or mast cells and/or when coronary intima, media and adventitia adjacent to stent, is infiltrated by eosinophils or mast cells. Careful history of hypersensitivity reactions to all implanted materials and concomitant drugs with monitoring of inflammatory mediators as well as lymphocyte transformation studies to detect hypersensitivity must be undertaken in order to avoid disastrous consequences. Food and Drug Administration recommendations for coronary stent implantation should be applied also to bioresorbable scaffolds. Further studies with inert and non-allergenic implants are necessary.

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Section: Bioresorbable and Bioabsorbable Stent Advantages Disadvantamentioning

confidence: 99%

Thrombotic responses to coronary stents, bioresorbable scaffolds and the Kounis hypersensitivity-associated acute thrombotic syndrome

et al. 2017

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“…Table 1 summarizes the results of the main randomized clinical trials on these novel SES that are either polymer free or use a biodegradable polymer [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]. As discussed, microporous metal platforms currently allow one to retain on the stent surface the desired concentrations of the drug whereas other platforms provide sophisticated designs with microreservoirs to hold the pharmaceutical product [3].…”

Section: Trials With Novel Sirolimus-eluting Stentsmentioning

confidence: 99%

“…The theoretical attractiveness of polymer-free and fully bioresorbable polymer DES over permanent polymer DES is clear. Nevertheless, additional studies and, in particular, a very long-term follow-up of existing trials [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] are required to convincingly demonstrate the clinical benefit of these innovative devices.…”

Section: Trials With Novel Sirolimus-eluting Stentsmentioning

confidence: 99%

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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“…The subsequent, larger DESSOLVE II trial (NCT01294748) compared the efficacy and safety of the MiStent with a first generation Zotarolimus-eluting stent, Endeavor™ (E-ZES; Medtronic, Santa Rosa, USA) [75]. A total of 184 patients were randomized in a 2:1 fashion with MiStent (n=123) versus E-ZES (n=61).…”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents

Akinapelli¹,

Chen

Roy

et al. 2017

CCR

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Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.

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Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial

Cited by 35 publications

References 28 publications

Thrombotic responses to coronary stents, bioresorbable scaffolds and the Kounis hypersensitivity-associated acute thrombotic syndrome

Thrombotic responses to coronary stents, bioresorbable scaffolds and the Kounis hypersensitivity-associated acute thrombotic syndrome

Novel sirolimus-eluting stents

Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents

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