High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer

Paolo Zocca1, Marlies M Kok1, Liefke C van der Heijden1

  • 1Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands.

Insights

Biodegradable polymer drug-eluting stents (BP-DES) demonstrated comparable safety and efficacy to durable polymer drug-eluting stents (DP-DES) in high bleeding risk patients undergoing percutaneous coronary intervention. This study found no significant differences in key clinical outcomes between the two stent types for this vulnerable patient group.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Biomaterials Science

Background:

  • Patients with high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) face elevated risks of both ischemic and bleeding events.
  • Durable polymer drug-eluting stents (DP-DES) may contribute to inflammation and delayed healing, potentially increasing risks in HBR patients.
  • Novel biodegradable polymer drug-eluting stents (BP-DES) offer a potential alternative by aiming to reduce inflammation and improve arterial healing.

Purpose of the Study:

  • To evaluate the safety and efficacy of very thin-strut biodegradable polymer drug-eluting stents (BP-DES) compared to thin-strut durable polymer drug-eluting stents (DP-DES) in patients with high bleeding risk (HBR).

Main Methods:

  • The BIO-RESORT trial randomized 3514 patients to receive either very thin-strut BP-DES or thin-strut DP-DES.
  • A subgroup analysis focused on 1009 patients identified as high bleeding risk (HBR) based on established criteria.
  • The primary endpoint was target vessel failure (cardiac death, target vessel MI, or target vessel revascularization) at 1-year follow-up.

Main Results:

  • HBR patients were older and had more comorbidities, experiencing higher rates of target vessel failure, cardiac death, and major bleeding compared to non-HBR patients.
  • In the HBR cohort (n=1009), 673 received BP-DES and 336 received DP-DES.
  • At 1-year, target vessel failure occurred in 6.5% of BP-DES patients and 7.3% of DP-DES patients (Hazard Ratio [HR] 0.88; 95% CI 0.54-1.46; P=0.63), with no significant differences in other secondary endpoints.

Conclusions:

  • Very thin-strut biodegradable polymer drug-eluting stents (BP-DES) demonstrated similar 1-year safety and efficacy outcomes compared to thin-strut durable polymer drug-eluting stents (DP-DES) in high bleeding risk patients.
  • These findings suggest that BP-DES are a viable option for HBR patients undergoing PCI, offering comparable performance to existing DP-DES.
  • Further research may explore long-term outcomes and specific patient subgroups within the HBR population.
Abstract

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