9‐month results of polymer‐free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all‐comer population

Kherad, Behrouz; Waliszewski, Matthias; Leschke, Matthias; Kader, M.A. Sheikh Abdul; Bang, Liew Houng; Ruíz-Poveda, Fernando Lozano; Pieske, Burkert; Krackhardt, Florian

doi:10.1111/joic.12472

Cited by 3 publications

(3 citation statements)

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“…One of these latest device generations are those with polymer-free coatings on the abluminal stent surface only. In particular, the polymer-free stent coating consisting of sirolimus and probucol as an excipient which was extensively studied in randomized controlled trials 9–11 and large all-comer populations 12,13 may hold the advantage of rapid stent coverage, thereby reducing the need for extended DAPT durations. Furthermore, delayed neointimal healing and incomplete endothelialization have gained attention as a cause for late stent thrombosis with first-generation permanent polymer-coated DES.…”

Section: Introductionmentioning

confidence: 99%

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries

Sperling

Waliszewski

Kherad

et al. 2019

Therapeutic Advances in Cardiovascular Disease

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Background:Polymer-free drug-eluting stents (DES) without permanent-polymer coating may be associated with rapid vessel healing, providing a rationale to reduce dual-antiplatelet therapy (DAPT). The aim of the current study was to compare vessel healing of a polymer-free sirolimus-eluting stent (PF-SES), its bare metal stent (BMS) analogue to a permanent polymer-based sirolimus-eluting stent (SES) with proven effectiveness in porcine coronary arteries.Material and methods:An ultrathin-strut cobalt–chromium PF-SES, its BMS analogue and an SES with a permanent polymer were used to study vessel healing and their antistenotic potential. Stents were implanted in porcine coronary arteries for histopathologic analysis at 7, 28 and 180 days.In an additional in vitro study, the thrombogenicity of PF-SES was compared with a fluoropolymer-coated everolimus-eluting stent (EES) which demonstrated low stent thrombosis rates in numerous studies.Results:In the animal study, neointimal growth and injury scores were minimal and inflammation scores were low in the neointima and adventitia in all study groups. After 28 days, neointimal area was lowest in PF-SES when compared with SES and BMS (1.48 ± 0.55 mm² versus 2.43 ± 0.69 mm² versus 1.90 ± 0.85 mm², respectively, p < 0.05) and endothelialization of luminal surfaces was nearly complete in all groups, though SES show the least coverage with occasional adherent luminal inflammatory cells (p > 0.05). At 180 days, neointimal area and thickness were most pronounced in SES (p < 0.05) and comparable with BMS implantations, which were characterized by nearly completed vessel healing. PF-SES and BMS had complete endothelialization, absence of fibrin and sustained low inflammatory reaction when compared with the permanent polymer-based SES (inflammation score: PF-SES 0.41 ± 0.74 versus SES 2.52 ± 1.72 versus BMS 0.30 ± 0.65, respectively, p < 0.05 BMS versus SES). Granuloma formation and fibrin accumulation were most pronounced in SES but did not reach statistical significance, p > 0.05). In the in vitro thrombogenicity study, the PF-SES confirmed comparable antithrombogenic properties with regard to the parameters fibrin and platelet binding, and platelet aggregation when compared with the EES.Conclusions:As compared with BMS, the ultrathin-strut cobalt–chromium PF-SES showed similar endothelialization at 28 days and comparable healing characteristics at 180 days efficacious inhibition of neointimal proliferation in porcine coronary arteries with low inflammation responses and a BMS-like endothelialization at 180 days. In addition, in an in vitro model, the PF-SES also confirmed low thrombogenicity as compared with the EES.

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Section: Introductionmentioning

confidence: 99%

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries

Sperling

Waliszewski

Kherad

et al. 2019

Therapeutic Advances in Cardiovascular Disease

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“…Nevertheless, if oral glucose tolerance testing cannot be done, the assessment of HbA1c and fasting plasma glucose is a valuable alternative. Another patient population that may have a higher risk of adverse events following PCI are patients aged 80 years or older, because they have more complex coronary artery disease and more comorbidities [39][40][41] that sometimes include cognitive disorders. 42 However, octogenarians are often underrepresented in randomized clinical trials.…”

Section: Discussionmentioning

confidence: 99%

“…38,39 Consequently, octogenarians have a higher burden of coronary artery disease that is also known to be more diffuse, calcified, and complex than in younger patients. 40,41 Furthermore, octogenarians have more comorbidities including cognitive disorders, 42 which may contribute to an overall increased risk of adverse clinical events. While life expectancy in these patients may be limited, treating octogenarians with PCI and DES may have a major impact on their quality of life by reducing chest pain and dyspnea.…”

Section: Octogenariansmentioning

confidence: 99%

New-generation drug-eluting stents in various patient populations

Ploumen¹

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Objectives:The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES). Background:The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradablepolymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimuseluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.Methods: A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.Results: Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%).Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p log-rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, p log-rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant betweenstent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES. Conclusions: Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage. * This is the number of patients treated with drug-eluting stents during the period of study enrollment, irrespective of in-or exclusion criteria. Clinical endpoints, monitoring, and event adjudicationClinical endpoints were pre-specified, according to definitions of the Academic Research Consortium. 16,17 The main composite endpoint target vessel failure (TVF) assessed device efficacy and patient safety, including cardiac death, target-vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization. Secondary endpoints were prespecified and included target lesion revascularization (TLR) and stent thrombosis, as well as individual components of several composite endpoints. The secondary composite endpoints were target lesion failure (TLF), comprising cardiac 03 Ultrathin-and very thin-strut biodegradable-polymer versus thin-strut durable-polymer drug-eluting stents fo...

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New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials

Ploumen¹,

Buiten²,

Doggen

et al. 2020

American Heart Journal

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9‐month results of polymer‐free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all‐comer population

Abstract: In octogenarians treated with PF-SES, the rates for MACE, overall mortality, and bleeding are higher as compared to the younger age groups. However, the rates for TLR and ST were not significantly different across the investigated age groups. PF-SES are safe and effective in octogenarians.

Cited by 3 publications

References 15 publications

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries

New-generation drug-eluting stents in various patient populations

New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials

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