The Hybrid Approach in CAD with Restore® DEB: Use and Clinical Outcomes in the HYPER Study

Published: 18 June 2024

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In this comprehensive video series, Dr Alfonso Ielasi (IRCCS Ospedale Galeazzi Sant'Ambrogio, IT) delves into the approach of using Restore® Drug-Eluting Balloon (DEB) in treating Coronary Artery Disease (CAD). 

This video series is supported by

Learning Objectives

  • Gain insights into the findings of the HYPER Study presented by Dr Ielasi, focusing on the hybrid approach combining a drug-eluting stent and the Restore® drug-coated balloon (DEB)
  • Understand the technological features and benefits of the Restore® DEB as explained by Dr Ielasi during the video interview
  • Comprehend the study design, including participant selection criteria and clinical outcomes of the HYPER Study
  • Recognise the significance of procedural success rates DoCE rates in evaluating the effectiveness and safety of the hybrid approach
  • Appreciate the long-term stability of favourable outcomes, including low DoCE rates, observed up to the 3-year follow-up period in the HYPER Study
  • Interpret the implications of the HYPER Study findings for clinical practice, particularly in the context of coronary artery disease management and treatment strategies involving drug-eluting stents and drug-coated balloons

Target Audience

  • Interventional Cardiologists

More from this programme

About the episode

Dr Alfonso Ielasi (IRCCS Ospedale Galeazzi Sant'Ambrogio, IT) discusses the results of the HYPER Study at the EuroPCR 2024 congress in Paris, France. 

In this video interview, Dr Ielasi explains the technology behind the Restore® drug-coated balloon (Cardionovum®) and its advantages. Furthermore, he offers a comprehensive analysis of the HYPER Study, elucidating its methodology, participant selection criteria and clinical outcomes.

Specifically, the 1-year outcomes revealed that DoCE was 3.7%. Subsequently, an extensive 2-year follow-up demonstrated a DoCE rate of 4.6%, maintaining stability up to the 3-year analysis.1

In conclusion, the HYPER Study demonstrated that the hybrid approach combining a drug eluting stent with the Restore® DEB is not only feasible but also associated with very high procedural success and a remarkably low 1-year DoCE rate. These favourable results remain consistent over the 3-year follow-up period.1


1. Ielasi A, Buono A, Pellicano M, et al. A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study. Cardiovasc Revasc Med 2021;28:14–9.

Faculty Biographies

Alfonso Ielasi

Alfonso Ielasi

Interventional Cardiologist

Dr Alfonso Ielasi is an Interventional Cardiologist at IRCCS Ospedale Galeazzi Sant'Ambrogio, Milano, IT.

Dr Ielasi's interests include interventional cardiovascular therapies of acute coronary syndromes, unprotected left main disease, complex coronary artery disease and aortic valve stenosis.

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