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Implantation of Human-Sized Coronary Stents into Rat Abdominal Aorta Using a Trans-Femoral Access
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Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a

Alexandre Gautier1, Marco Roffi2, Peep Laanmets3

  • 1Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.

American Heart Journal
|March 17, 2023
PubMed

Insights

Large registries offer valuable real-world data for coronary stent evaluation, complementing randomized controlled trials (RCTs). A registry study found similar safety outcomes but higher revascularization rates in the trial group, suggesting registries enhance post-market surveillance.

Area of Science:

  • Cardiovascular Medicine
  • Clinical Trials & Epidemiology
  • Medical Device Evaluation

Background:

  • Postmarketing evaluation of coronary stents relies on large-scale registries and randomized controlled trials (RCTs).
  • The scientific relevance of registry data compared to RCTs for coronary stent performance is debated.
  • Real-world data from registries can complement RCT findings for comprehensive device assessment.

Purpose of the Study:

  • To compare the performance evidence of the Ultimaster coronary stent from a regulatory RCT and a real-world registry.
  • To assess the scientific relevance and complementary value of registry data in postmarketing surveillance.
  • To evaluate coronary stent performance across diverse patient populations and clinical settings.

Main Methods:

  • Comparison of patients from the CENTURY II (CII-UM) RCT (n=551) with the e-ULTIMASTER (e-UM) registry (n=35,389).
  • Adjudication of all major events by an independent clinical event committee in both studies.
  • Propensity weighted analysis to balance baseline and procedural differences between RCT and registry cohorts.

Main Results:

  • The e-UM registry exhibited more complex coronary artery disease compared to the CII-UM RCT.
  • One-year follow-up showed no significant differences in all-cause death, cardiac death, target lesion failure, or target vessel myocardial infarction (MI) between groups (excluding periprocedural MI).
  • The RCT group (CII-UM) had a significantly higher target vessel revascularization rate compared to the registry group (e-UM).

Conclusions:

  • Well-conducted large-scale registries provide valuable complementary evidence to RCTs for postmarket coronary stent evaluation.
  • Registries offer insights into device performance across broader patient uses and geographic areas.
  • Registry data enhances the understanding of real-world coronary stent outcomes beyond initial regulatory trials.
Abstract

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