Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus

Godino, Cosmo; Pivato, Carlo Andrea; Chiarito, Mauro; Donahue, Michael; Testa, Luca; Colantonio, Riccardo; Cappelletti, Alberto; Milazzo, Diego; Parisi, Rosario; Nicolino, Annamaria; Moshiri, Shahram; Aprigliano, Gianfranco; Palloshi, Altin; Parenti, Dennis Zavalloni; Rutigliano, David; Locuratolo, Nicola; Melillo, Francesco; Scotti, Andrea; Arrigoni, Luca; Montorfano, Matteo; Fattori, Rossella; Presbitero, Patrizia; Sardella, Gennaro; Bedogni, Francesco; Margonato, Alberto; Briguori, Carlo; Colombo, Antonio; REgistry, Italian Nobori Stent ProspectIve; investigators, AmphilimuS iTalian mUlticenTre rEgistry

doi:10.1016/j.ijcard.2017.06.028

Cited by 16 publications

(13 citation statements)

References 41 publications

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“…Consistent with our findings, the hazard ratio (HR [PF‐AES/EES] 0.75, 95%CI 0.37–1.53, P = 0.43) was similar in magnitude to our results. Also consistent with our data, another propensity‐score matched analysis reported a similar 1‐year TLF rate of PF‐AES (4.9%) as we found, and compared them to biodegradable polymer biolimus‐eluting stents (8.2%, P < 0.001) in patients with and without diabetes mellitus. Importantly, the rate of definite stent thrombosis at 1‐year follow‐up was low for PF‐AES and biolimus‐eluting stents.…”

Section: Discussionsupporting

confidence: 90%

“…The secondary outcome of TLF occurred in with no significant between-group differences for the primary outcome. Also consistent with our data, another propensity-score matched analysis 21 Subgroup analyses for the primary outcome at 1-year follow-up. CKF, chronic kidney failure; MI, myocardial infarction; PF-AES, polymer-free amphilimus-eluting stent; PP-ZES, permanent polymer zotarolimus-eluting stent previous report 28 investigating patients needing short DAPT (i.e.…”

Section: Clinical Outcomessupporting

confidence: 90%

“…A growing body of evidence demonstrates that PF‐AES performs well in diabetic and non‐diabetic patients. These findings may be explained by the distinct features of PF‐AES (Figure ): thinner struts (80 μm vs. 91 μm), coating with a pure i‐carbofilm supposed to induce faster stent strut endothelialisation, and a formulation for controlled and sustained drug‐release directly into the vessel wall.…”

Section: Discussionmentioning

confidence: 99%

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One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis

Rozemeijer

Muiden

Koudstaal

et al. 2019

Cathet Cardio Intervent

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Background Polymer‐free amphilimus‐eluting stents (PF‐AES) represent a novel elution‐technology in coronary stenting. We aimed to assess 1‐year clinical outcomes of PF‐AES as compared to latest‐generation permanent polymer zotarolimus‐eluting stents (PP‐ZES) in a real‐world all‐comers setting. Methods A prospective registry of patients treated with either PF‐AES or PP‐ZES between 2014 and 2016 was conducted. The primary outcome was defined as major adverse cardiac and cerebrovascular events (MACCE), and the secondary outcome was defined as target‐lesion failure (TLF) at 1 year. To account for measured confounders, a propensity‐score adjusted Cox proportional‐hazard model was built to evaluate clinical outcomes. Results A total of 734 consecutive patients with 1,269 DES implantations were enrolled. The population was characterized by 28% diabetes, 24% ST‐segment elevation myocardial infarction, and a high number of complex lesions (69%). The rate of MACCE was 11.5% for PF‐AES and 13.6% for PP‐ZES, p log‐rank = 0.11. TLF was numerically lower in PF‐AES as compared to PP‐ZES (5.4 vs. 6.1%, p log‐rank = 0.68). After propensity‐score adjustment, PF‐AES showed a trend toward a lower rate of MACCE and a favorable rate of TLF as compared to PP‐ZES (HR 0.70; 95%CI 0.45 to 1.10, P = 0.12; and HR 0.88; 95%CI 0.47 to 1.65, P = 0.68, respectively). Rates of definite ST were low (0.8 vs. 0.3%, p log‐rank = 0.62). Conclusions Our study suggests that implantation of PF‐AES was safe and effective in real‐world patients, with low‐rates of MACCE and TLF at 1 year. Our data needs to be confirmed by a large trial to evaluate the clinical outcomes of this novel polymer‐free, eluting‐technology used in PF‐AES.

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Section: Discussionsupporting

confidence: 90%

Section: Clinical Outcomessupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis

Rozemeijer

Muiden

Koudstaal

et al. 2019

Cathet Cardio Intervent

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“…Our reported rates of TLF at 1 year are lower than those reported for first-generation DESs 6,19 and closely resemble those recently reported for contemporary DESs. 17,[20][21][22][23] The mechanism by which DESs fail in some patients, and in some segments within the same patient, is unclear and likely multifactorial. Multiple biological, mechanical, and technical causes have been suggested in this regard, such as drug resistance or hypersensitivity to stents components, stent underexpansion or fracture, stent gap, and residual uncovered plaques.…”

Section: Discussionmentioning

confidence: 99%

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation—Individual patient data pooled analysis from 6 randomized controlled trials

Konigstein

Madhavan

Ben‐Yehuda

et al. 2019

American Heart Journal

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Background-Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. Methods-Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. Results-Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.

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“…Stent type was found to be an independent predictor of TLF, with an odds ratio of 2.76 (95 % CI 1.36-5.56) 38. Future Randomised StudiesWhile the growing body of randomised and observational data supports the efficacy of the Cre8™ DES, studies to date have not been powered to demonstrate superiority over comparator DES.…”

mentioning

confidence: 99%

Challenges in Patients with Diabetes: Improving Clinical Outcomes After Percutaneous Coronary Intervention Through EVOlving Stent Technology

Byrne

Banai²,

Colleran

et al. 2017

Interventional Cardiology Review

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Patients with diabetes have poorer outcomes after percutaneous coronary intervention than patients without diabetes. The Cre8™ EVO drug-eluting stent (DES) has design features that aim to improve clinical outcomes in patients with diabetes. These include Abluminal Reservoir Technology - a proprietary polymer-free drug-release system consisting of reservoirs on the abluminal surface of the stent that control drug release and direct the drug exclusively towards the vessel wall - and the Amphilimus™ drug formulation, which enables enhanced drug-tissue permeation utilising fatty acid transport pathways. The latter is particularly advantageous in patients with diabetes, whose cell metabolism favours increased cellular uptake of fatty acid. Furthermore, evidence suggests that mTOR inhibitors (-limus drugs) utilised in conventional DES are less effective in diabetic cells. The new stent architecture provides high device deliverability and conformability, facilitating clinical use in complex disease patterns and high-risk lesion morphologies. Clinical evidence for the efficacy and safety of the Cre8™ DES in patients with diabetes has been demonstrated in a number of clinical trials and observational registries. These data are reviewed herein, along with an overview of on-going randomised trials.

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Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus

Cited by 16 publications

References 41 publications

One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis

One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation—Individual patient data pooled analysis from 6 randomized controlled trials

Challenges in Patients with Diabetes: Improving Clinical Outcomes After Percutaneous Coronary Intervention Through EVOlving Stent Technology

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