Background <p>Regional variations in patient selection and procedural techniques for carotid artery stenting have been well documented. However, their impact on procedural outcomes, especially with the use of&#xa0;dual-layer micromesh stents, is not fully understood.</p> Methods <p>This prospective, multi-center observational study included 1965 patients with asymptomatic or symptomatic carotid artery stenosis treated with the Roadsaver dual-layer micromesh stent. The primary outcome measure was the 30-day rate of major adverse events, defined as any death or stroke occurring within 30 days post-procedure. This sub-analysis compared patient characteristics and procedural techniques across 13 participating countries and investigated differences in outcomes via logistic regression modelling.</p> Results <p>Patient demographics, comorbidities, and symptom presentation varied widely among countries. Similarly, the frequency of use of duplex ultrasound and diffusion-weighted magnetic resonance imaging at baseline and 30-day follow-up differed. Procedural approaches also varied, with differences in femoral access site selection (18.2% to 100.0%), use of embolic protection devices (0.0% to 100.0%), pre-dilatation (4.3% to 46.7%) and post-dilatation (66.7% to 100.0%). Although 30-day major adverse event rates differed across the compared countries, after adjusting for post-dilatation balloon pressure (categorized as no post-dilatation vs. ≤ 11atm vs. &gt; 11atm), and the number of enrolled patients per study site, the difference became statistically non-significant.</p> Conclusion <p>Our study reveals variability in patient selection, procedural carotid stenting practices and clinical outcomes across European countries. The differences in 30-day any death or stroke rates between countries may be attributed to differing post-dilatation practices and the number of enrolled patients per study site.</p> Level of evidence <p>Level 3, observational study.</p> Trial registration <p>Clinicaltrials.gov identifier: NCT03504228.</p> Visual Abstract <p></p>

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Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights

  • Stefan Müller-Hülsbeck,
  • Zsolt Vajda,
  • Piotr Odrowąż-Pieniążek,
  • Zoltán Ruzsa,
  • Roel Beelen,
  • Aleksandar Gjoreski,
  • Koen Deloose,
  • Sérgio Castro,
  • Benjamin Faurie,
  • Alejandro Tomasello Weitz,
  • Arne Schwindt,
  • Paweł Latacz,
  • Antonio Orgaz Pérez-Grueso,
  • Vladimir Cvetić,
  • Ralf Langhoff,
  • Sasko Kedev

摘要

Background

Regional variations in patient selection and procedural techniques for carotid artery stenting have been well documented. However, their impact on procedural outcomes, especially with the use of dual-layer micromesh stents, is not fully understood.

Methods

This prospective, multi-center observational study included 1965 patients with asymptomatic or symptomatic carotid artery stenosis treated with the Roadsaver dual-layer micromesh stent. The primary outcome measure was the 30-day rate of major adverse events, defined as any death or stroke occurring within 30 days post-procedure. This sub-analysis compared patient characteristics and procedural techniques across 13 participating countries and investigated differences in outcomes via logistic regression modelling.

Results

Patient demographics, comorbidities, and symptom presentation varied widely among countries. Similarly, the frequency of use of duplex ultrasound and diffusion-weighted magnetic resonance imaging at baseline and 30-day follow-up differed. Procedural approaches also varied, with differences in femoral access site selection (18.2% to 100.0%), use of embolic protection devices (0.0% to 100.0%), pre-dilatation (4.3% to 46.7%) and post-dilatation (66.7% to 100.0%). Although 30-day major adverse event rates differed across the compared countries, after adjusting for post-dilatation balloon pressure (categorized as no post-dilatation vs. ≤ 11atm vs. > 11atm), and the number of enrolled patients per study site, the difference became statistically non-significant.

Conclusion

Our study reveals variability in patient selection, procedural carotid stenting practices and clinical outcomes across European countries. The differences in 30-day any death or stroke rates between countries may be attributed to differing post-dilatation practices and the number of enrolled patients per study site.

Level of evidence

Level 3, observational study.

Trial registration

Clinicaltrials.gov identifier: NCT03504228.

Visual Abstract