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Published on: January 21, 2020
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.
Purpose:
Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.
Methods:
Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.
Results:
Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54-1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61-1.39], p = 0.69) and other secondary endpoints.
Conclusions:
At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.
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