Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Sarno, Giovanna; Lagerqvist, Bo; Olivecrona, Göran; Varenhorst, Christoph; Danielewicz, Mikael; Hambræus, Kristina; Lindholm, Daniel; Råmunddal, Truls; Witt, Nils; James, Stefan

doi:10.1002/ccd.27030

Cited by 36 publications

(21 citation statements)

References 27 publications

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“…Whilst the efficacy of the Synergy stent system has been widely tested [[6], [7], [8], [9], [10], [11], [12], [13]], there is still no randomized data studying the performance of the Xlimus, but only a limited size registry [14].…”

Section: Introductionmentioning

confidence: 99%

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

Testa

Pero

Bollati

et al. 2019

IJC Heart & Vasculature

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Background Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. Aim To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). Methods XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. Conclusions A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. Trial registration ClinicalTrials.gov Identifier: NCT03745053 . Registered on November 19, 2018.

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Section: Introductionmentioning

confidence: 99%

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

Testa

Pero

Bollati

et al. 2019

IJC Heart & Vasculature

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“…In the current issue of Catheterization and Cardiovascular Interventions , Sarno et al report an analysis from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) database comparing the safety and efficacy of the Synergy bioreabsorbable polymer stent and other newer generation DES (including other bioabsorbable polymer stents) in more than 42,000 patients undergoing 72,000 stent implantations . In this study, more than 60% of patients in both groups presented with acute coronary syndromes and primary percutaneous coronary intervention (PCI) was performed in over 99% of patients presenting with ST‐elevation myocardial infarction (STEMI).…”

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confidence: 99%

Real life experience with bioresorbable‐polymer everolimus‐eluting stents. Is this an answer in search of a question?

Rahban

Kimmelstiel

2017

Cathet Cardio Intervent

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Stent thrombosis and clinically driven restenosis are rare in the era of newer generation DES. The Synergy bioresorbable polymer DES appears to be comparable to other durable polymer and other bioabsorbable polymer DES in terms of safety and efficacy at 1-year post implantation. Further long-term study is needed to determine the specific role of the Synergy stent and other DES with bioabsorbable polymers.

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“…were developed with an ultrathin abluminal biodegradable polymer (BP) coating that is completely absorbed within 4 months, and have shown favorable clinical outcomes in large clinical trials. 8,9 Evaluating the differences in intrastent conditions among each era of stents using intravascular imaging is important for the optimal medical management of patients with coronary artery disease (CAD). Of the available imaging techniques, coronary angioscopy is the only modality that can directly visualize local conditions, and provide insights on the pathophysiology and treatment of CAD.…”

mentioning

confidence: 99%

Impact of Neointimal Condition and Platelet Reactivity on Intrastent Thrombus at Long-Term Follow-up After 2nd- and 3rd-Generation Drug-Eluting Stent Implantation　― Insights From a Coronary Angioscopy and Pharmacodynamic Study ―

Matsuura

Ueno

Watanabe

et al. 2020

Circ J

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Background: Although the incidence of very late stent failure (VLSF) is reduced with newer generation drug-eluting stent (DES), the mechanism of VLSF has not been fully explored. Methods and Results: This study evaluated both local vascular healing using coronary angioscopy and systemic factors determined by platelet reactivity at long-term follow-up after 2nd-and 3rd-generation DES implantation in patients with acute coronary syndrome. Coronary angioscopy was performed to assess neointimal coverage (NIC), yellow color (YC) grade and presence of thrombus. The obtained findings were compared with 2nd-and 3rd-DES. Platelet aggregation was assessed by light transmittance aggregometry. 100 consecutive patients were prospectively enrolled: 2nd-(n=50) and 3rd-DES (n=50). 3rd-DES patients had significantly higher NIC grade and lower YC grade compared with 2nd-DES. The presence of thrombus was tended to be lower with 3rd-DES than with 2nd-DES (8% vs. 18%, P=0.11). Patients with thrombus had significantly higher maximum platelet aggregation and higher prevalence of high on-treatment platelet reactivity (HPR) than those without thrombus. Multivariable analysis showed stent strut exposure and HPR as independent predictors of thrombus. Conclusions: Newer generation DES contribute to better vascular healing depending on the degree of neointimal coverage. In addition to local factors at the stented lesion, systemic factors such as degree of platelet reactivity might also contribute to VLSF.

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Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Abstract: In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc.

Cited by 36 publications

References 27 publications

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

Real life experience with bioresorbable‐polymer everolimus‐eluting stents. Is this an answer in search of a question?

Impact of Neointimal Condition and Platelet Reactivity on Intrastent Thrombus at Long-Term Follow-up After 2nd- and 3rd-Generation Drug-Eluting Stent Implantation　― Insights From a Coronary Angioscopy and Pharmacodynamic Study ―

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Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Abstract: In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc.

Cited by 36 publications

References 27 publications

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

Real life experience with bioresorbable‐polymer everolimus‐eluting stents. Is this an answer in search of a question?

Impact of Neointimal Condition and Platelet Reactivity on Intrastent Thrombus at Long-Term Follow-up After 2nd- and 3rd-Generation Drug-Eluting Stent Implantation ― Insights From a Coronary Angioscopy and Pharmacodynamic Study ―

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Impact of Neointimal Condition and Platelet Reactivity on Intrastent Thrombus at Long-Term Follow-up After 2nd- and 3rd-Generation Drug-Eluting Stent Implantation　― Insights From a Coronary Angioscopy and Pharmacodynamic Study ―